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Clinical Trial Results:
A MULTI-CENTER, RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, DOSE RANGING STUDY FOLLOWED BY AN OBSERVATIONAL PERIOD TO EVALUATE THE EFFICACY AND SAFETY OF DAPIROLIZUMAB PEGOL IN SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS

Summary
EudraCT number	2015-004457-40
Trial protocol	DE RO HU BG ES PL
Global end of trial date	15 Nov 2018

Results information
Results version number	v2(current)
This version publication date	26 Jul 2021
First version publication date	02 Dec 2019
Other versions	v1
Version creation reason

Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information

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Trial information

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Sponsor protocol code

SL0023

ISRCTN number

US NCT number

NCT02804763

WHO universal trial number (UTN)

Sponsor organisation name

UCB Biopharma SPRL

Sponsor organisation address

Allée de la Recherche 60, Brussels, Belgium, 1070

Public contact

Clin Trial Reg & Results Disclosure, UCB BIOSCIENCES GmbH, clinicaltrials@ucb.com

Scientific contact

Clin Trial Reg & Results Disclosure, UCB BIOSCIENCES GmbH, clinicaltrials@ucb.com

Is trial part of an agreed paediatric investigation plan (PIP)

Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?

Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?

Analysis stage

Final

Date of interim/final analysis

31 Jan 2019

Is this the analysis of the primary completion data?

Global end of trial reached?

Yes

Global end of trial date

15 Nov 2018

Was the trial ended prematurely?

Main objective of the trial

To assess the dose-response for the efficacy of intravenous (iv) dapirolizumab pegol (DZP; 3 dose groups) at week 24 in adult subjects with moderately to severely active systemic lupus erythematosus (SLE) receiving stable standard-of-care treatment.

Protection of trial subjects

During the conduct of the study all participants were closely monitored.

Background therapy

Mandatory background medication with either antimalarials, immunosuppressants or corticosteroids as stand-alone treatment or in combination. Other Background therapy as permitted in the protocol.

Evidence for comparator

Not Applicable

Actual start date of recruitment

02 Jun 2016

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Yes

Number of subjects enrolled per country

Country: Number of subjects enrolled

Bulgaria: 2

Country: Number of subjects enrolled

Colombia: 18

Country: Number of subjects enrolled

Germany: 10

Country: Number of subjects enrolled

Mexico: 13

Country: Number of subjects enrolled

Peru: 26

Country: Number of subjects enrolled

Poland: 16

Country: Number of subjects enrolled

Romania: 12

Country: Number of subjects enrolled

Russian Federation: 15

Country: Number of subjects enrolled

Spain: 2

Country: Number of subjects enrolled

Ukraine: 15

Country: Number of subjects enrolled

United States: 53

Worldwide total number of subjects

182

EEA total number of subjects

Number of subjects enrolled per age group

In utero

Preterm newborn - gestational age < 37 wk

Newborns (0-27 days)

Infants and toddlers (28 days-23 months)

Children (2-11 years)

Adolescents (12-17 years)

Adults (18-64 years)

178

From 65 to 84 years

85 years and over

Subject disposition

Top of page

Recruitment details

The study started to enroll patients in June 2016 and concluded in November 2018.

Screening details

The study included a 4-week Screening Period, a 24-week Double-Blind Treatment Period and a 24-week Observational Period. Participant Flow refers to the Randomized Set.

Period 1 title

Double-Blind Period (Week 1 to Week 24)

Is this the baseline period?

Yes

Allocation method

Randomised - controlled

Blinding used

Double blind

Roles blinded

Assessor, Carer, Investigator, Subject

Are arms mutually exclusive

Yes

SOC + Placebo iv Q4W

Arm description

This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period.

Arm type

Placebo

Investigational medicinal product name

Placebo

Investigational medicinal product code

PBO

Other name

Pharmaceutical forms

Solvent for solution for infusion

Routes of administration

Intravenous use

Dosage and administration details

During the 24-week Double-Blind Treatment Period participants received an intravenous (iv) infusion of PBO every 4 weeks (Q4W) for a total of 6 doses.

SOC + DZP 6mg/kg iv Q4W

Arm description

This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6 milligrams (mg)/kilogram (kg) intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period.

Arm type

Experimental

Investigational medicinal product name

Dapirolizumab pegol

Investigational medicinal product code

DZP

Other name

Pharmaceutical forms

Powder for concentrate for solution for infusion

Routes of administration

Intravenous use

Dosage and administration details

During the 24-week Double-Blind Treatment Period participants received an intravenous (iv) infusion of DZP 6mg/kg, 24mg/kg or 45mg/kg, every 4 weeks (Q4W) for a total of 6 doses.

SOC + DZP 24mg/kg iv Q4W

Arm description

This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period.

Arm type

Experimental

Investigational medicinal product name

Dapirolizumab pegol

Investigational medicinal product code

DZP

Other name

Pharmaceutical forms

Powder for concentrate for solution for infusion

Routes of administration

Intravenous use

Dosage and administration details

During the 24-week Double-Blind Treatment Period participants received an intravenous (iv) infusion of DZP 6mg/kg, 24mg/kg or 45mg/kg, every 4 weeks (Q4W) for a total of 6 doses.

SOC + DZP 45mg/kg iv Q4W

Arm description

This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 45mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period.

Arm type

Experimental

Investigational medicinal product name

Dapirolizumab pegol

Investigational medicinal product code

DZP

Other name

Pharmaceutical forms

Powder for concentrate for solution for infusion

Routes of administration

Intravenous use

Dosage and administration details

During the 24-week Double-Blind Treatment Period participants received an intravenous (iv) infusion of DZP 6mg/kg, 24mg/kg or 45mg/kg, every 4 weeks (Q4W) for a total of 6 doses.

Number of subjects in period 1	SOC + Placebo iv Q4W	SOC + DZP 6mg/kg iv Q4W	SOC + DZP 24mg/kg iv Q4W	SOC + DZP 45mg/kg iv Q4W
Started	45	45	45	47
Completed Week 24	44	45	44	45
Finished Wk24 began Observational Period	44	44	44	45
Completed	44	44	44	45
Not completed	1	1	1	2
Consent withdrawn by subject	-	-	1	2
Consent withdrawal after Week 24	-	1	-	-
Adverse event, non-fatal	1	-	-	-

Period 2 title

Observational Period (Wk 24 to Wk 48)

Is this the baseline period?

Allocation method

Randomised - controlled

Blinding used

Double blind

Roles blinded

Assessor, Carer, Investigator, Subject

Blinding implementation details

Participants who completed the 24-week Double-Blind Treatment Period continued into a 24-week Observational Period, during which participants didn't receive study drug but received standard-of-care (SOC) treatment. Sponsor was unblinded during the Observational Period.

Are arms mutually exclusive

Yes

SOC + Placebo iv Q4W

Arm description

Arm type

Placebo

Investigational medicinal product name

Placebo

Investigational medicinal product code

PBO

Other name

Pharmaceutical forms

Solvent for solution for infusion

Routes of administration

Intravenous use

Dosage and administration details

During the 24-week Double-Blind Treatment Period participants received an intravenous (iv) infusion of PBO every 4 weeks (Q4W) for a total of 6 doses.

SOC + DZP 6mg/kg iv Q4W

Arm description

Arm type

Experimental

Investigational medicinal product name

Dapirolizumab pegol

Investigational medicinal product code

DZP

Other name

Pharmaceutical forms

Powder for concentrate for solution for infusion

Routes of administration

Intravenous use

Dosage and administration details

During the 24-week Double-Blind Treatment Period participants received an intravenous (iv) infusion of DZP 6mg/kg, 24mg/kg or 45mg/kg, every 4 weeks (Q4W) for a total of 6 doses.

SOC + DZP 24mg/kg iv Q4W

Arm description

Arm type

Experimental

Investigational medicinal product name

Dapirolizumab pegol

Investigational medicinal product code

DZP

Other name

Pharmaceutical forms

Powder for concentrate for solution for infusion

Routes of administration

Intravenous use

Dosage and administration details

During the 24-week Double-Blind Treatment Period participants received an intravenous (iv) infusion of DZP 6mg/kg, 24mg/kg or 45mg/kg, every 4 weeks (Q4W) for a total of 6 doses.

SOC + DZP 45mg/kg iv Q4W

Arm description

Arm type

Experimental

Investigational medicinal product name

Dapirolizumab pegol

Investigational medicinal product code

DZP

Other name

Pharmaceutical forms

Powder for concentrate for solution for infusion

Routes of administration

Intravenous use

Dosage and administration details

During the 24-week Double-Blind Treatment Period participants received an intravenous (iv) infusion of DZP 6mg/kg, 24mg/kg or 45mg/kg, every 4 weeks (Q4W) for a total of 6 doses.

Number of subjects in period 2	SOC + Placebo iv Q4W	SOC + DZP 6mg/kg iv Q4W	SOC + DZP 24mg/kg iv Q4W	SOC + DZP 45mg/kg iv Q4W
Started	44	44	44	45
Completed	38	43	41	42
Not completed	6	1	3	3
Consent withdrawn by subject	4	-	2	2
Patient moved out of state	-	1	-	-
Lost to follow-up	2	-	1	1

Baseline characteristics

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Reporting group title

SOC + Placebo iv Q4W

Reporting group description

Reporting group title

SOC + DZP 6mg/kg iv Q4W

Reporting group description

Reporting group title

SOC + DZP 24mg/kg iv Q4W

Reporting group description

Reporting group title

SOC + DZP 45mg/kg iv Q4W

Reporting group description

Reporting group values	SOC + Placebo iv Q4W	SOC + DZP 6mg/kg iv Q4W	SOC + DZP 24mg/kg iv Q4W	SOC + DZP 45mg/kg iv Q4W	Total
Number of subjects	45	45	45	47	182
Age categorical
Units: Subjects
<=18 years	0	0	0	0	0
Between 18 and 65 years	44	44	44	46	178
>=65 years	1	1	1	1	4
Age continuous
Units: years
arithmetic mean (standard deviation)	43.50 ( 12.79 )	40.81 ( 11.55 )	42.77 ( 10.42 )	38.94 ( 12.92 )	-
Gender categorical
Units: Subjects
Male	4	3	5	4	16
Female	41	42	40	43	166

End points

Top of page

Reporting group title

SOC + Placebo iv Q4W

Reporting group description

Reporting group title

SOC + DZP 6mg/kg iv Q4W

Reporting group description

Reporting group title

SOC + DZP 24mg/kg iv Q4W

Reporting group description

Reporting group title

SOC + DZP 45mg/kg iv Q4W

Reporting group description

Reporting group title

SOC + Placebo iv Q4W

Reporting group description

Reporting group title

SOC + DZP 6mg/kg iv Q4W

Reporting group description

Reporting group title

SOC + DZP 24mg/kg iv Q4W

Reporting group description

Reporting group title

SOC + DZP 45mg/kg iv Q4W

Reporting group description

Subject analysis set title

SOC + Placebo iv Q4W (FAS)

Subject analysis set type

Full analysis

Subject analysis set description

Subject analysis set title

SOC + DZP 6mg/kg iv Q4W (FAS)

Subject analysis set type

Full analysis

Subject analysis set description

This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the FAS.

Subject analysis set title

SOC + DZP 24mg/kg iv Q4W (FAS)

Subject analysis set type

Full analysis

Subject analysis set description

Subject analysis set title

SOC + DZP 45mg/kg iv Q4W (FAS)

Subject analysis set type

Full analysis

Subject analysis set description

Subject analysis set title

SOC + Placebo iv Q4W (SS)

Subject analysis set type

Safety analysis

Subject analysis set description

Subject analysis set title

SOC + DZP 6mg/kg iv Q4W (SS)

Subject analysis set type

Safety analysis

Subject analysis set description

Subject analysis set title

SOC + DZP 24mg/kg iv Q4W (SS)

Subject analysis set type

Safety analysis

Subject analysis set description

Subject analysis set title

SOC + DZP 45mg/kg iv Q4W (SS)

Subject analysis set type

Safety analysis

Subject analysis set description

Primary: Percentage of participants with British Isles Lupus Assessment Group Disease Activity Index 2004 (BILAG 2004)-based Composite Lupus Assessment (BICLA) (mNRI) response across 3 doses of dapirolizumab pegol (DZP) and placebo (PBO) at Week 24

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End point title

Percentage of participants with British Isles Lupus Assessment Group Disease Activity Index 2004 (BILAG 2004)-based Composite Lupus Assessment (BICLA) (mNRI) response across 3 doses of dapirolizumab pegol (DZP) and placebo (PBO) at Week 24

End point description

Primary efficacy variable was assessed by establishing if there was a dose response relationship between BICLA response at Week 24 and dose, using MCP-Mod. 4 candidate dose-response models were evaluated: linear model, logistic model, 2 Emax models, and MCP-Mod methodology controlled for multiplicity. BICLA response was defined as meeting all of the following criteria: BILAG 2004 improvement: A scores at Baseline improved to B, C or D; B scores improved to C or D; no new A scores and ≤ 1 new B; No worsening in SLEDAI-2K, defined as no increase in SLEDAI-2K total score; No worsening in PGA, defined as <10 mm increase on a 100 mm VAS; and No disallowed changes in concomitant medications, including increases in corticosteroids, immunosuppressants and antimalarials. FAS- all participants in Randomized Set with exception of 1 study participant who received less than 1 full dose during study and 5 study participants who were randomized at Site 321. Missing values were imputed using mNRI.

End point type

Primary

End point timeframe

Week 24

End point values	SOC + Placebo iv Q4W (FAS)	SOC + DZP 6mg/kg iv Q4W (FAS)	SOC + DZP 24mg/kg iv Q4W (FAS)	SOC + DZP 45mg/kg iv Q4W (FAS)
Number of subjects analysed	43	43	44	46
Units: percentage of participants
number (not applicable)	0	0	0	0

Statistical analysis 1

Statistical analysis description

Multiple contrast testing (Multiple Comparison Procedure - Modelling (MCP-mod) methodology) was used to test for a statistically significant dose-response relationship between the primary endpoint (BICLA at Week 24) and dose, which would indicate a drug effect of DZP over Placebo. The best fitting statistically significant model could be used to estimate the dose needed to achieve desired treatment effect.

Comparison groups

SOC + Placebo iv Q4W (FAS) v SOC + DZP 6mg/kg iv Q4W (FAS) v SOC + DZP 24mg/kg iv Q4W (FAS) v SOC + DZP 45mg/kg iv Q4W (FAS)

Number of subjects included in analysis

176

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0727 ^[1]

Method

MCP-Mod

Confidence interval

Notes
[1] - The lowest p-value (z-statistic with the highest value) was used to establish proof of dose response.

Secondary: The percentage of participants with BICLA (mNRI) response in the individual dose groups at Week 24

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End point title

The percentage of participants with BICLA (mNRI) response in the individual dose groups at Week 24

End point description

BICLA response was defined as meeting all of the following criteria: (1)BILAG 2004 improvement: A scores at Baseline improved to B, C or D; B scores improved to C or D; no new A scores and ≤ 1 new B. (2)No worsening in Systemic Lupus Erythematosus Activity Index 2000 (SLEDAI-2K), defined as no increase in SLEDAI-2K total score. (3)No worsening in Physician’s Global Assessment of Disease Activity (PGA), defined as < 10 millimeter (mm) increase on a 100 mm visual analog scale (VAS). (4)No disallowed changes in concomitant medications, mainly including increases in corticosteroids, immunosuppressants, and antimalarials. The Full Analysis Set (FAS) consisted of all participants in the Randomized Set with the exception of 1 study participant who received less than 1 full dose during the study and 5 study participants who were randomized at Site 321. Missing values were imputed using a modified non-responder imputation (mNRI).

End point type

Secondary

End point timeframe

Week 24

End point values	SOC + Placebo iv Q4W (FAS)	SOC + DZP 6mg/kg iv Q4W (FAS)	SOC + DZP 24mg/kg iv Q4W (FAS)	SOC + DZP 45mg/kg iv Q4W (FAS)
Number of subjects analysed	43	43	44	46
Units: percentage of participants
number (not applicable)	37.2	48.8	54.5	52.2

Statistical analysis 1

Statistical analysis description

Missing values were imputed using modified non-responder imputation (mNRI) dataset: at most 1 missing BICLA (mNRI) component (scale) may have been carried forward from the immediately preceding visit, and missing data in the individual items within scales may have been carried forward from the immediately preceding visit. If there was still missing data after this limited imputation, the study participant was counted as a non-responder on the BICLA (mNRI) for that visit.

Comparison groups

SOC + Placebo iv Q4W (FAS) v SOC + DZP 6mg/kg iv Q4W (FAS)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.2699 ^[2]

Method

Chi-squared

Parameter type

Odds ratio (OR)

Point estimate

1.6

Confidence interval

level

95%

sides

2-sided

lower limit

0.7

upper limit

3.8

Notes
[2] - Generalized linear models with factors for treatment and corticosteroid strata were fit using a logit link function for the odds ratios and p-values.

Statistical analysis 2

Statistical analysis description

Comparison groups

SOC + Placebo iv Q4W (FAS) v SOC + DZP 24mg/kg iv Q4W (FAS)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.1036 ^[3]

Method

Chi-squared

Parameter type

Odds ratio (OR)

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

0.9

upper limit

4.8

Notes
[3] - Generalized linear models with factors for treatment and corticosteroid strata were fit using a logit link function for the odds ratios and p-values.

Statistical analysis 3

Statistical analysis description

Comparison groups

SOC + Placebo iv Q4W (FAS) v SOC + DZP 45mg/kg iv Q4W (FAS)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.1518 ^[4]

Method

Chi-squared

Parameter type

Odds ratio (OR)

Point estimate

1.9

Confidence interval

level

95%

sides

2-sided

lower limit

0.8

upper limit

4.3

Notes
[4] - Generalized linear models with factors for treatment and corticosteroid strata were fit using a logit link function for the odds ratios and p-values.

Statistical analysis 4

Statistical analysis description

Comparison groups

SOC + Placebo iv Q4W (FAS) v SOC + DZP 6mg/kg iv Q4W (FAS)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

Method

Chi-squared

Parameter type

Difference vs PBO

Point estimate

11.6

Confidence interval

level

95%

sides

2-sided

lower limit

-9.2

upper limit

32.4

Statistical analysis 5

Statistical analysis description

Comparison groups

SOC + Placebo iv Q4W (FAS) v SOC + DZP 24mg/kg iv Q4W (FAS)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

Method

Chi-squared

Parameter type

Difference vs PBO

Point estimate

17.3

Confidence interval

level

95%

sides

2-sided

lower limit

-3.3

upper limit

Statistical analysis 6

Statistical analysis description

Comparison groups

SOC + Placebo iv Q4W (FAS) v SOC + DZP 45mg/kg iv Q4W (FAS)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

Method

Chi-squared

Parameter type

Difference vs PBO

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

-5.5

upper limit

35.4

Statistical analysis 7

Statistical analysis description

Comparison groups

SOC + Placebo iv Q4W (FAS) v SOC + DZP 6mg/kg iv Q4W (FAS)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

Method

Chi-squared

Parameter type

LS Mean Difference vs PBO

Point estimate

11.9

Confidence interval

level

95%

sides

2-sided

lower limit

-8.7

upper limit

32.5

Statistical analysis 8

Statistical analysis description

Comparison groups

SOC + Placebo iv Q4W (FAS) v SOC + DZP 24mg/kg iv Q4W (FAS)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

Method

Chi-squared

Parameter type

LS Mean Difference vs PBO

Point estimate

17.6

Confidence interval

level

95%

sides

2-sided

lower limit

-3.2

upper limit

38.3

Statistical analysis 9

Statistical analysis description

Comparison groups

SOC + Placebo iv Q4W (FAS) v SOC + DZP 45mg/kg iv Q4W (FAS)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

Method

Chi-squared

Parameter type

LS Mean Difference vs PBO

Point estimate

15.2

Confidence interval

level

95%

sides

2-sided

lower limit

-5.2

upper limit

35.6

Secondary: Percentage of participants with at least one Adverse Events (AEs)

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End point title

Percentage of participants with at least one Adverse Events (AEs)

End point description

An AE was any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product that did not necessarily have a causal relationship with this treatment. An adverse event (AE) was therefore any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. All AEs that occurred during the study were considered related unless clearly unrelated. The Safety Set (SS) consisted of all study participants who were randomized and received at least 1 dose (any amount) of study drug.

End point type

Secondary

End point timeframe

From Baseline (Week 1) until end of the study (Week 48)

End point values	SOC + Placebo iv Q4W (SS)	SOC + DZP 6mg/kg iv Q4W (SS)	SOC + DZP 24mg/kg iv Q4W (SS)	SOC + DZP 45mg/kg iv Q4W (SS)
Number of subjects analysed	45	45	45	47
Units: percentage of participants
number (not applicable)	66.7	66.7	82.2	74.5

No statistical analyses for this end point

Secondary: Percentage of participants with a Serious Adverse Event (SAE)

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End point title

Percentage of participants with a Serious Adverse Event (SAE)

End point description

A Serious Adverse Event (SAE) must have met 1 or more of the following criteria: •Death •Life threatening •Significant or persistent disability/incapacity •Congenital anomaly/birth defect (including that occurring in a fetus) •Important medical event that, based upon appropriate medical judgment, may have jeopardized the study participant, and may have required medical or surgical intervention to prevent 1 of the other outcomes listed in the definition of serious •Initial inpatient hospitalization or prolongation of hospitalization. The Safety Set (SS) consisted of all study participants who were randomized and received at least 1 dose (any amount) of study drug.

End point type

Secondary

End point timeframe

From Baseline (Week 1) until end of the study (Week 48)

End point values	SOC + Placebo iv Q4W (SS)	SOC + DZP 6mg/kg iv Q4W (SS)	SOC + DZP 24mg/kg iv Q4W (SS)	SOC + DZP 45mg/kg iv Q4W (SS)
Number of subjects analysed	45	45	45	47
Units: percentage of participants
number (not applicable)	13.3	11.1	13.3	10.6

No statistical analyses for this end point

Secondary: Percentage of participants with at least one Adverse Events (AEs) of interest

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End point title

Percentage of participants with at least one Adverse Events (AEs) of interest

End point description

Adverse events of interest (AEOI) were identified by the Investigator based on definitions per protocol, documented on the electronic Case Report Form (eCRF), adequately monitored, and source controlled. AEOI (regardless of seriousness): •Moderate to severe infections, including opportunistic infections and tuberculosis (TB) •Infusion reactions (including hypersensitivity and anaphylaxis) •Thromboembolic events (including but not limited to cardiovascular events, stroke, myocardial infarction, pulmonary embolism, and deep vein thrombosis) •Prespecified neurological events: severe and/or serious headache, positional headache, cranial nerve dysfunction, or signs and symptoms of meningitis (photophobia, neck stiffness) •Malignancies. The Safety Set (SS) consisted of all study participants who were randomized and received at least 1 dose (any amount) of study drug.

End point type

Secondary

End point timeframe

From Baseline (Week 1) until end of the study (Week 48)

End point values	SOC + Placebo iv Q4W (SS)	SOC + DZP 6mg/kg iv Q4W (SS)	SOC + DZP 24mg/kg iv Q4W (SS)	SOC + DZP 45mg/kg iv Q4W (SS)
Number of subjects analysed	45	45	45	47
Units: percentage of participants
number (not applicable)	24.4	26.7	28.9	25.5

No statistical analyses for this end point

Secondary: Percentage of participants who permanently withdrew of study drug due to an Adverse Event (AE)

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End point title

Percentage of participants who permanently withdrew of study drug due to an Adverse Event (AE)

End point description

End point type

Secondary

End point timeframe

From Baseline (Week 1) until end of the study (Week 48)

End point values	SOC + Placebo iv Q4W (SS)	SOC + DZP 6mg/kg iv Q4W (SS)	SOC + DZP 24mg/kg iv Q4W (SS)	SOC + DZP 45mg/kg iv Q4W (SS)
Number of subjects analysed	45	45	45	47
Units: percentage of participants
number (not applicable)	8.9	0	4.4	4.3

No statistical analyses for this end point

Secondary: Mean change from baseline in Systolic Blood Pressure

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End point title

Mean change from baseline in Systolic Blood Pressure

End point description

Blood pressure was measured in millimetre of mercury (mmHg). The Safety Set (SS) consisted of all study participants who were randomized and received at least 1 dose (any amount) of study drug. Here, 'n' (Number analyzed) signifies participants who were evaluable at specified time points.

End point type

Secondary

End point timeframe

From Baseline (Week 1) to Week 48

End point values	SOC + Placebo iv Q4W (SS)	SOC + DZP 6mg/kg iv Q4W (SS)	SOC + DZP 24mg/kg iv Q4W (SS)	SOC + DZP 45mg/kg iv Q4W (SS)
Number of subjects analysed	45	45	45	47
Units: mmHg
arithmetic mean (standard deviation)
Week 2 (45, 45, 45, 44)	3.3 ( 12.9 )	5.1 ( 10.5 )	0.7 ( 10.7 )	3.2 ( 9.9 )
Week 4 (43, 44, 43, 46)	0.6 ( 10.8 )	1.0 ( 7.9 )	-2.0 ( 8.9 )	0.6 ( 12.4 )
Week 6 (43, 45, 44, 45)	0.3 ( 11.5 )	4.0 ( 9.9 )	2.3 ( 11.0 )	2.4 ( 10.6 )
Week 8 (44, 44, 44, 43)	0.5 ( 12.4 )	3.3 ( 12.6 )	-2.4 ( 9.9 )	-0.7 ( 11.9 )
Week 12 (44, 45, 45, 44)	-0.7 ( 10.1 )	3.2 ( 10.5 )	-3.0 ( 11.8 )	0.8 ( 9.2 )
Week 16 (43, 44, 43, 44)	2.1 ( 12.3 )	2.1 ( 11.6 )	-2.8 ( 10.6 )	0.9 ( 11.1 )
Week 20 (42, 45, 42, 44)	1.6 ( 9.9 )	2.6 ( 9.8 )	-1.7 ( 12.3 )	1.5 ( 11.3 )
Week 24 (43, 44, 44, 44)	-0.7 ( 14.3 )	1.1 ( 13.1 )	0.3 ( 11.0 )	3.6 ( 9.3 )
Week 28 (44, 43, 42, 44)	1.8 ( 12.3 )	3.7 ( 13.1 )	0.9 ( 10.5 )	2.5 ( 11.8 )
Week 32 (44, 44, 43, 45)	2.2 ( 11.1 )	3.0 ( 13.2 )	0.4 ( 11.3 )	4.3 ( 13.7 )
Week 36 (42, 42, 41, 41)	2.1 ( 11.0 )	3.1 ( 12.6 )	0.2 ( 10.5 )	2.4 ( 12.9 )
Week 40 (42, 43, 41, 44)	-1.0 ( 14.1 )	6.2 ( 12.9 )	-2.0 ( 11.7 )	2.5 ( 11.3 )
Week 44 (39, 41, 41, 42)	0.1 ( 12.6 )	3.3 ( 14.1 )	1.3 ( 10.4 )	4.2 ( 11.8 )
Week 48 (38, 42, 40, 42)	-1.5 ( 11.5 )	4.9 ( 14.3 )	0.1 ( 10.2 )	4.4 ( 12.0 )

No statistical analyses for this end point

Secondary: Mean change from baseline in Diastolic Blood Pressure

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End point title

Mean change from baseline in Diastolic Blood Pressure

End point description

End point type

Secondary

End point timeframe

From Baseline (Week 1) to Week 48

End point values	SOC + Placebo iv Q4W (SS)	SOC + DZP 6mg/kg iv Q4W (SS)	SOC + DZP 24mg/kg iv Q4W (SS)	SOC + DZP 45mg/kg iv Q4W (SS)
Number of subjects analysed	45	45	45	47
Units: mmHg
arithmetic mean (standard deviation)
Week 2 (45, 45, 45, 44)	2.1 ( 10.5 )	1.4 ( 8.6 )	1.5 ( 9.3 )	2.4 ( 8.2 )
Week 4 (43, 44, 43, 46)	-0.7 ( 7.8 )	-1.5 ( 6.3 )	-1.7 ( 8.2 )	-0.1 ( 8.3 )
Week 6 (43, 45, 44, 45)	1.0 ( 10.0 )	1.5 ( 8.6 )	1.8 ( 10.0 )	1.9 ( 7.9 )
Week 8 (44, 44, 44, 43)	1.1 ( 9.2 )	0.4 ( 9.1 )	0.1 ( 8.6 )	1.0 ( 8.0 )
Week 12 (44, 45, 45, 44)	-0.9 ( 8.4 )	-0.3 ( 6.9 )	-2.2 ( 9.6 )	-0.3 ( 6.9 )
Week 16 (43, 44, 43, 44)	-0.3 ( 8.9 )	-1.3 ( 7.6 )	-0.7 ( 9.5 )	-0.1 ( 7.0 )
Week 20 (42, 45, 42, 44)	1.5 ( 8.1 )	-1.1 ( 8.7 )	-0.7 ( 9.6 )	0.9 ( 8.8 )
Week 24 (43, 44, 44, 44)	1.9 ( 11.2 )	1.6 ( 8.7 )	2.3 ( 10.7 )	0.6 ( 8.7 )
Week 28 (44, 43, 42, 44)	1.5 ( 9.1 )	-0.2 ( 8.8 )	1.4 ( 8.4 )	2.5 ( 8.4 )
Week 32 (44, 44, 43, 45)	2.3 ( 10.1 )	2.8 ( 9.3 )	0.7 ( 10.2 )	2.3 ( 8.1 )
Week 36 (42, 42, 41, 41)	3.4 ( 9.8 )	1.4 ( 10.2 )	1.4 ( 8.4 )	2.2 ( 8.0 )
Week 40 (42, 43, 41, 44)	1.0 ( 9.2 )	2.6 ( 7.6 )	0.5 ( 9.9 )	3.6 ( 8.8 )
Week 44 (39, 41, 41, 42)	0.8 ( 10.2 )	1.5 ( 8.1 )	0.4 ( 9.4 )	2.2 ( 10.3 )
Week 48 (38, 42, 40, 42)	1.4 ( 9.0 )	2.3 ( 8.8 )	1.1 ( 9.4 )	2.4 ( 8.6 )

No statistical analyses for this end point

Secondary: Mean change from baseline in Pulse Rate

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End point title

Mean change from baseline in Pulse Rate

End point description

Pulse Rate was measured in beats per minute (beats/min). The Safety Set (SS) consisted of all study participants who were randomized and received at least 1 dose (any amount) of study drug. Here, 'n' (Number analyzed) signifies participants who were evaluable at specified time points.

End point type

Secondary

End point timeframe

From Baseline (Week 1) to Week 48

End point values	SOC + Placebo iv Q4W (SS)	SOC + DZP 6mg/kg iv Q4W (SS)	SOC + DZP 24mg/kg iv Q4W (SS)	SOC + DZP 45mg/kg iv Q4W (SS)
Number of subjects analysed	45	45	45	47
Units: beats/min
arithmetic mean (standard deviation)
Week 2 (45, 45, 45, 44)	-0.2 ( 8.3 )	0.2 ( 10.4 )	2.3 ( 9.7 )	-0.9 ( 10.4 )
Week 4 (43, 44, 43, 46)	1.7 ( 9.6 )	1.5 ( 8.0 )	0.4 ( 8.4 )	-3.3 ( 9.7 )
Week 6 (43, 45, 44, 45)	-0.7 ( 10.2 )	0.1 ( 8.5 )	0.8 ( 8.9 )	-0.6 ( 8.8 )
Week 8 (44, 44, 44, 43)	1.3 ( 9.0 )	0.3 ( 9.2 )	1.4 ( 10.2 )	-2.6 ( 10.2 )
Week 12 (44, 45, 45, 44)	0.6 ( 10.3 )	1.1 ( 9.8 )	-0.3 ( 10.4 )	-1.5 ( 9.7 )
Week 16 (43, 44, 43, 44)	-0.8 ( 9.2 )	0.3 ( 8.9 )	0.9 ( 10.7 )	-1.6 ( 10.6 )
Week 20 (42, 45, 42, 44)	0.3 ( 10.6 )	1.1 ( 9.9 )	0.8 ( 9.5 )	0.4 ( 6.6 )
Week 24 (43, 44, 44, 44)	-1.5 ( 10.7 )	0.8 ( 10.9 )	-0.3 ( 10.2 )	-1.0 ( 8.7 )
Week 28 (44, 43, 42, 44)	0.6 ( 11.8 )	1.3 ( 10.9 )	0.0 ( 9.2 )	0.6 ( 8.8 )
Week 32 (44, 44, 43, 45)	0.4 ( 9.8 )	1.3 ( 10.9 )	0.8 ( 11.4 )	-2.1 ( 11.0 )
Week 36 (42, 42, 41, 41)	-0.7 ( 10.9 )	0.2 ( 8.3 )	0.7 ( 10.4 )	-0.2 ( 9.8 )
Week 40 (42, 43, 41, 44)	-0.1 ( 10.9 )	-0.1 ( 9.8 )	0.6 ( 10.2 )	-1.3 ( 9.6 )
Week 44 (39, 41, 41, 42)	-0.2 ( 10.2 )	-0.1 ( 9.8 )	0.3 ( 11.7 )	-0.6 ( 8.9 )
Week 48 (38, 42, 40, 42)	-0.2 ( 11.1 )	-0.7 ( 10.6 )	-0.9 ( 11.9 )	-2.0 ( 7.7 )

No statistical analyses for this end point

Secondary: Mean change from baseline in Temperature

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End point title

Mean change from baseline in Temperature

End point description

Temperature was measured in Grad Celsius (°C). The Safety Set (SS) consisted of all study participants who were randomized and received at least 1 dose (any amount) of study drug. Here, 'n' (Number analyzed) signifies participants who were evaluable at specified time points.

End point type

Secondary

End point timeframe

From Baseline (Week 1) to Week 48

End point values	SOC + Placebo iv Q4W (SS)	SOC + DZP 6mg/kg iv Q4W (SS)	SOC + DZP 24mg/kg iv Q4W (SS)	SOC + DZP 45mg/kg iv Q4W (SS)
Number of subjects analysed	45	45	45	47
Units: Temperature (C)
arithmetic mean (standard deviation)
Week 2 (45, 45, 45, 44)	-0.1 ( 0.4 )	0.0 ( 0.3 )	0.1 ( 0.5 )	0.0 ( 0.4 )
Week 4 (43, 44, 43, 46)	-0.1 ( 0.4 )	0.0 ( 0.4 )	0.0 ( 0.4 )	0.0 ( 0.3 )
Week 6 (43, 45, 44, 45)	-0.2 ( 0.5 )	0.0 ( 0.4 )	0.1 ( 0.5 )	0.0 ( 0.5 )
Week 8 (44, 44, 44, 43)	-0.1 ( 0.4 )	-0.1 ( 0.3 )	0.0 ( 0.4 )	0.0 ( 0.4 )
Week 12 (44, 45, 45, 44)	-0.1 ( 0.4 )	-0.1 ( 0.4 )	0.0 ( 0.3 )	0.0 ( 0.4 )
Week 16 (43, 44, 43, 44)	-0.1 ( 0.4 )	0.0 ( 0.4 )	0.0 ( 0.4 )	0.0 ( 0.3 )
Week 20 (42, 45, 42, 44)	-0.1 ( 0.4 )	0.0 ( 0.4 )	0.0 ( 0.4 )	0.0 ( 0.5 )
Week 24 (43, 44, 44, 44)	-0.1 ( 0.5 )	0.0 ( 0.4 )	0.1 ( 0.5 )	0.0 ( 0.4 )
Week 28 (44, 43,42 , 44)	0.0 ( 0.4 )	0.0 ( 0.4 )	0.1 ( 0.5 )	0.1 ( 0.5 )
Week 32 (44, 44, 43, 45)	0.0 ( 0.4 )	0.0 ( 0.4 )	0.1 ( 0.5 )	0.0 ( 0.4 )
Week 36 (42, 42, 41, 41)	-0.1 ( 0.3 )	0.0 ( 0.6 )	0.0 ( 0.4 )	0.1 ( 0.4 )
Week 40 (42, 43, 41, 44)	0.0 ( 0.4 )	0.0 ( 0.4 )	0.0 ( 0.5 )	0.1 ( 0.3 )
Week 44 (39, 41, 41, 42)	0.0 ( 0.6 )	0.0 ( 0.5 )	0.1 ( 0.4 )	0.0 ( 0.4 )
Week 48 (38, 42, 40, 42)	-0.1 ( 0.4 )	0.0 ( 0.4 )	0.0 ( 0.5 )	0.0 ( 0.4 )

No statistical analyses for this end point

Secondary: Mean change from baseline in Weight

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End point title

Mean change from baseline in Weight

End point description

Weight was measured in kilograms (kg). The Safety Set (SS) consisted of all study participants who were randomized and received at least 1 dose (any amount) of study drug. Here, 'n' (Number analyzed) signifies participants who were evaluable at specified time points.

End point type

Secondary

End point timeframe

Baseline (Week 1), Week 4, Week 8, Week 12, Week 16, and Week 20

End point values	SOC + Placebo iv Q4W (SS)	SOC + DZP 6mg/kg iv Q4W (SS)	SOC + DZP 24mg/kg iv Q4W (SS)	SOC + DZP 45mg/kg iv Q4W (SS)
Number of subjects analysed	45	45	45	47
Units: kg
arithmetic mean (standard deviation)
Week 4 (43, 44, 43, 46)	0.0 ( 1.0 )	0.2 ( 1.0 )	0.4 ( 0.9 )	0.3 ( 1.2 )
Week 8 (44, 44, 43, 43)	0.3 ( 1.9 )	0.6 ( 1.4 )	0.6 ( 1.8 )	0.4 ( 1.8 )
Week 12 (43, 45, 44, 44)	0.4 ( 2.3 )	0.5 ( 1.6 )	0.5 ( 2.0 )	0.6 ( 2.3 )
Week 16 (43, 44, 43, 44)	0.3 ( 2.3 )	0.7 ( 2.3 )	0.8 ( 2.3 )	0.5 ( 2.4 )
Week 20 (42, 45, 42, 44)	0.3 ( 2.4 )	0.7 ( 2.6 )	1.0 ( 2.6 )	0.5 ( 2.8 )

No statistical analyses for this end point

Secondary: Mean change from baseline in Height

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End point title

Mean change from baseline in Height

End point description

Height was measured in centimeters (cm). The Safety Set (SS) consisted of all study participants who were randomized and received at least 1 dose (any amount) of study drug. Here, '999' was used as a placeholder and signifies that height was only measured at Screening as per planned analysis. Therefore, data was not collected for this outcome measure.

End point type

Secondary

End point timeframe

From Baseline (Week 1) to Week 48

End point values	SOC + Placebo iv Q4W (SS)	SOC + DZP 6mg/kg iv Q4W (SS)	SOC + DZP 24mg/kg iv Q4W (SS)	SOC + DZP 45mg/kg iv Q4W (SS)
Number of subjects analysed	45	45	45	47
Units: cm
arithmetic mean (standard deviation)	999 ( 999 )	999 ( 999 )	999 ( 999 )	999 ( 999 )

No statistical analyses for this end point

Secondary: Number of participants with 12-Lead electrocardiogram (ECG) abnormal findings

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End point title

Number of participants with 12-Lead electrocardiogram (ECG) abnormal findings

End point description

Twelve-lead ECG assessments should have been performed prior to dosing (if applicable) and prior to obtaining pharmacokinetic (PK) or other laboratory samples. Electrocardiograms were recorded digitally and read by the Investigator for recording in the electronic Case Report Form (eCRF). The Safety Set (SS) consisted of all study participants who were randomized and received at least 1 dose (any amount) of study drug.

End point type

Secondary

End point timeframe

Screening, Week 4, Week 24, Week 28, and Week 48

End point values	SOC + Placebo iv Q4W (SS)	SOC + DZP 6mg/kg iv Q4W (SS)	SOC + DZP 24mg/kg iv Q4W (SS)	SOC + DZP 45mg/kg iv Q4W (SS)
Number of subjects analysed	45	45	45	47
Units: participants
Screening	8	11	6	6
Week 4	11	12	7	10
Week 24	9	7	6	10
Week 28	1	0	0	0
Week 48	8	7	11	9

No statistical analyses for this end point

Secondary: Mean change from baseline in Hemoglobin

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End point title

Mean change from baseline in Hemoglobin

End point description

Hemoglobin was measured in grams per liter (g/L). The Safety Set (SS) consisted of all study participants who were randomized and received at least 1 dose (any amount) of study drug. Here, 'n' (Number analyzed) signifies participants who were evaluable at specified time points.

End point type

Secondary

End point timeframe

From Baseline (Week 1) to Week 48

End point values	SOC + Placebo iv Q4W (SS)	SOC + DZP 6mg/kg iv Q4W (SS)	SOC + DZP 24mg/kg iv Q4W (SS)	SOC + DZP 45mg/kg iv Q4W (SS)
Number of subjects analysed	45	45	45	47
Units: g/L
arithmetic mean (standard deviation)
Week 2 (44, 42, 45, 42)	0.4 ( 6.4 )	-1.8 ( 5.8 )	-0.7 ( 6.9 )	-0.7 ( 6.8 )
Week 4 (44, 44, 43, 46)	-1.0 ( 7.2 )	-0.7 ( 7.7 )	-1.4 ( 8.6 )	-0.8 ( 5.8 )
Week 8 (43, 44, 44, 44)	-0.3 ( 7.3 )	-1.9 ( 7.9 )	-1.9 ( 8.6 )	-1.3 ( 7.4 )
Week 12 (44, 44, 44, 44)	-0.5 ( 9.5 )	-0.5 ( 8.5 )	-0.5 ( 10.1 )	0.2 ( 8.3 )
Week 16 (44, 43, 43, 45)	0.3 ( 10.4 )	-0.3 ( 10.0 )	-0.8 ( 10.6 )	-2.7 ( 8.3 )
Week 20 (43, 43, 41, 43)	-0.7 ( 11.5 )	0.3 ( 9.9 )	-0.5 ( 10.1 )	-2.4 ( 7.2 )
Week 24 (42, 43, 44, 44)	-0.4 ( 9.7 )	-0.7 ( 11.2 )	-0.7 ( 10.5 )	-2.9 ( 8.1 )
Week 28 (44, 41, 41, 44)	0.7 ( 10.6 )	-3.4 ( 11.0 )	0.0 ( 14.1 )	-3.1 ( 9.5 )
Week 32 (43, 43, 43, 42)	1.6 ( 12.5 )	-1.3 ( 9.8 )	1.0 ( 12.5 )	-1.3 ( 9.6 )
Week 40 (42, 43, 41, 44)	0.7 ( 13.5 )	-0.3 ( 13.5 )	1.9 ( 14.9 )	1.1 ( 11.0 )
Week 48 (38, 42, 39, 42)	-0.5 ( 14.3 )	-1.5 ( 11.6 )	0.9 ( 12.5 )	-0.7 ( 10.0 )

No statistical analyses for this end point

Secondary: Mean change from baseline in Hematocrit

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End point title

Mean change from baseline in Hematocrit

End point description

Hematocrit was measured in volume percentage (%) of red blood cells in blood. The Safety Set (SS) consisted of all study participants who were randomized and received at least 1 dose (any amount) of study drug. Here, 'n' (Number analyzed) signifies participants who were evaluable at specified time points.

End point type

Secondary

End point timeframe

From Baseline (Week 1) to Week 48

End point values	SOC + Placebo iv Q4W (SS)	SOC + DZP 6mg/kg iv Q4W (SS)	SOC + DZP 24mg/kg iv Q4W (SS)	SOC + DZP 45mg/kg iv Q4W (SS)
Number of subjects analysed	45	45	45	47
Units: volume % of red blood cells
arithmetic mean (standard deviation)
Week 2 (44, 42, 45, 42)	0.42 ( 2.52 )	-0.25 ( 2.26 )	-0.32 ( 2.37 )	0.00 ( 2.71 )
Week 4 (44, 44, 43, 46)	-0.46 ( 2.29 )	-0.17 ( 2.75 )	-0.79 ( 2.92 )	-0.11 ( 2.31 )
Week 8 (43, 44, 44, 44)	-0.27 ( 2.23 )	-0.12 ( 2.94 )	-0.86 ( 2.72 )	-0.42 ( 2.31 )
Week 12 (44, 44, 44, 44)	-0.23 ( 2.67 )	-0.13 ( 2.72 )	-0.32 ( 3.39 )	-0.02 ( 2.54 )
Week 16 (44, 43, 43, 45)	-0.12 ( 2.86 )	0.05 ( 3.25 )	-0.57 ( 3.32 )	-0.84 ( 2.95 )
Week 20 (43, 43, 41, 43)	-0.41 ( 3.20 )	0.13 ( 2.99 )	-0.42 ( 3.32 )	-0.80 ( 2.83 )
Week 24 (42, 43, 44, 44)	-0.09 ( 2.61 )	-0.40 ( 3.19 )	-0.29 ( 3.14 )	-0.76 ( 2.33 )
Week 28 (44, 41, 41, 44)	0.03 ( 2.98 )	-1.02 ( 3.23 )	-0.22 ( 3.99 )	-0.89 ( 2.47 )
Week 32 (43, 43, 43, 42)	0.29 ( 2.89 )	-0.62 ( 2.86 )	0.17 ( 3.43 )	-0.21 ( 2.82 )
Week 40 (42, 43, 41, 44)	-0.20 ( 3.32 )	-0.24 ( 4.37 )	0.58 ( 4.11 )	0.37 ( 2.72 )
Week 48 (38, 42, 39, 42)	-0.59 ( 3.51 )	-0.37 ( 3.58 )	-0.08 ( 3.21 )	-0.11 ( 2.54 )

No statistical analyses for this end point

Secondary: Mean change from baseline in Erythrocytes

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End point title

Mean change from baseline in Erythrocytes

End point description

Erythrocytes was measured in number of erythrocytes per liter (10^12/L). The Safety Set (SS) consisted of all study participants who were randomized and received at least 1 dose (any amount) of study drug. Here, 'n' (Number analyzed) signifies participants who were evaluable at specified time points.

End point type

Secondary

End point timeframe

From Baseline (Week 1) to Week 48

End point values	SOC + Placebo iv Q4W (SS)	SOC + DZP 6mg/kg iv Q4W (SS)	SOC + DZP 24mg/kg iv Q4W (SS)	SOC + DZP 45mg/kg iv Q4W (SS)
Number of subjects analysed	45	45	45	47
Units: 10^12 erythrocytes per liter
arithmetic mean (standard deviation)
Week 2 (44, 42, 45, 42)	-0.004 ( 0.246 )	-0.035 ( 0.237 )	-0.032 ( 0.223 )	-0.028 ( 0.237 )
Week 4 (44, 44, 43, 46)	-0.080 ( 0.243 )	-0.018 ( 0.293 )	-0.052 ( 0.273 )	-0.033 ( 0.210 )
Week 8 (43, 44, 44, 44)	-0.039 ( 0.224 )	-0.039 ( 0.280 )	-0.069 ( 0.262 )	-0.044 ( 0.242 )
Week 12 (44, 44, 44, 44)	-0.024 ( 0.271 )	0.014 ( 0.292 )	-0.010 ( 0.267 )	0.019 ( 0.226 )
Week 16 (44, 43, 43, 45)	-0.002 ( 0.312 )	0.041 ( 0.360 )	0.000 ( 0.302 )	-0.051 ( 0.265 )
Week 20 (43, 43, 41, 43)	-0.029 ( 0.333 )	0.062 ( 0.309 )	-0.001 ( 0.325 )	-0.047 ( 0.302 )
Week 24 (42, 43, 44, 44)	0.005 ( 0.308 )	0.036 ( 0.312 )	0.013 ( 0.319 )	-0.038 ( 0.240 )
Week 28 (44, 41, 41, 44)	0.018 ( 0.340 )	-0.040 ( 0.304 )	0.019 ( 0.346 )	-0.050 ( 0.270 )
Week 32 (43, 43, 43, 42)	0.048 ( 0.320 )	0.001 ( 0.284 )	0.032 ( 0.289 )	0.027 ( 0.277 )
Week 40 (42, 43, 41, 44)	-0.005 ( 0.343 )	0.042 ( 0.382 )	0.054 ( 0.368 )	0.060 ( 0.256 )
Week 48 (38, 42, 39, 42)	-0.024 ( 0.332 )	-0.018 ( 0.295 )	0.017 ( 0.299 )	-0.028 ( 0.245 )

No statistical analyses for this end point

Secondary: Mean change from baseline in Erythrocytes Mean Corpuscular Volume

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End point title

Mean change from baseline in Erythrocytes Mean Corpuscular Volume

End point description

Erythrocytes Mean Corpuscular Volume was measured in femtolitres (fL). The Safety Set (SS) consisted of all study participants who were randomized and received at least 1 dose (any amount) of study drug. Here, 'n' (Number analyzed) signifies participants who were evaluable at specified time points.

End point type

Secondary

End point timeframe

From Baseline (Week 1) to Week 48

End point values	SOC + Placebo iv Q4W (SS)	SOC + DZP 6mg/kg iv Q4W (SS)	SOC + DZP 24mg/kg iv Q4W (SS)	SOC + DZP 45mg/kg iv Q4W (SS)
Number of subjects analysed	45	45	45	47
Units: Femtolitres (fL)
arithmetic mean (standard deviation)
Week 2 (44, 42, 45, 42)	1.01 ( 2.28 )	0.24 ( 2.40 )	-0.09 ( 2.66 )	0.45 ( 2.96 )
Week 4 (44, 44, 43, 46)	0.60 ( 2.35 )	0.08 ( 2.66 )	-0.68 ( 2.10 )	0.40 ( 3.02 )
Week 8 (43, 44, 44, 44)	0.23 ( 3.48 )	-0.30 ( 5.36 )	-0.54 ( 2.85 )	-0.16 ( 2.79 )
Week 12 (44, 44, 44, 44)	0.06 ( 3.57 )	-0.52 ( 3.44 )	-0.55 ( 4.67 )	-0.57 ( 3.09 )
Week 16 (44, 43, 43, 45)	-0.25 ( 3.41 )	-0.65 ( 4.38 )	-1.38 ( 4.87 )	-0.97 ( 3.62 )
Week 20 (43, 43, 41, 43)	-0.37 ( 3.73 )	-0.92 ( 4.58 )	-1.00 ( 5.01 )	-0.97 ( 3.54 )
Week 24 (42, 43, 44, 44)	-0.23 ( 3.83 )	-1.63 ( 4.07 )	-0.92 ( 6.51 )	-1.05 ( 4.00 )
Week 28 (44, 41, 41,44 )	-0.33 ( 3.61 )	-1.40 ( 4.61 )	-0.96 ( 6.46 )	-1.21 ( 4.91 )
Week 32 (43, 43, 43, 42)	-0.27 ( 4.45 )	-1.33 ( 4.32 )	-0.45 ( 6.81 )	-1.06 ( 4.69 )
Week 40 (42, 43, 41, 44)	-0.36 ( 5.34 )	-1.46 ( 4.72 )	0.07 ( 6.27 )	-0.24 ( 4.85 )
Week 48 (38, 42, 39, 42)	-0.98 ( 5.34 )	-0.50 ( 4.97 )	-0.63 ( 6.92 )	0.34 ( 4.31 )

No statistical analyses for this end point

Secondary: Mean change from baseline in Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration

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End point title

Mean change from baseline in Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration

End point description

Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration was measured in grams per liter (g/L). The Safety Set (SS) consisted of all study participants who were randomized and received at least 1 dose (any amount) of study drug. Here, 'n' (Number analyzed) signifies participants who were evaluable at specified time points.

End point type

Secondary

End point timeframe

From Baseline (Week 1) to Week 48

End point values	SOC + Placebo iv Q4W (SS)	SOC + DZP 6mg/kg iv Q4W (SS)	SOC + DZP 24mg/kg iv Q4W (SS)	SOC + DZP 45mg/kg iv Q4W (SS)
Number of subjects analysed	45	45	45	47
Units: g/L
arithmetic mean (standard deviation)
Week 2 (44, 42, 45, 42)	-2.3 ( 9.8 )	-2.6 ( 10.9 )	0.7 ( 9.8 )	-1.9 ( 10.1 )
Week 4 (44, 44, 43, 46)	1.4 ( 8.7 )	-0.9 ( 10.1 )	2.7 ( 8.6 )	-1.2 ( 12.5 )
Week 8 (43, 44, 44, 44)	1.7 ( 11.5 )	-3.8 ( 13.4 )	2.1 ( 8.2 )	-0.1 ( 11.5 )
Week 12 (44, 44, 44, 44)	0.5 ( 11.1 )	-0.6 ( 10.7 )	0.6 ( 12.3 )	0.5 ( 12.7 )
Week 16 (44, 43, 43, 45)	1.6 ( 13.8 )	-1.5 ( 10.1 )	2.3 ( 11.3 )	-0.2 ( 14.1 )
Week 20 (43, 43, 41, 43)	1.6 ( 12.9 )	-0.9 ( 11.3 )	2.4 ( 11.2 )	0.4 ( 12.6 )
Week 24 (42, 43, 44, 44)	0.0 ( 13.7 )	1.0 ( 13.2 )	0.4 ( 12.8 )	-1.2 ( 13.1 )
Week 28 (44, 41, 41, 44)	1.6 ( 13.4 )	-1.3 ( 14.4 )	1.7 ( 13.8 )	-0.6 ( 16.5 )
Week 32 (43, 43, 43, 42)	1.7 ( 18.9 )	1.1 ( 13.8 )	1.2 ( 15.0 )	-1.4 ( 16.0 )
Week 40 (42, 43, 41, 44)	3.4 ( 17.6 )	0.8 ( 16.5 )	0.1 ( 15.8 )	0.1 ( 15.4 )
Week 48 (38, 42, 39, 42)	3.6 ( 17.1 )	-0.6 ( 16.2 )	2.9 ( 14.5 )	0.0 ( 13.5 )

No statistical analyses for this end point

Secondary: Mean change from baseline in Erythrocytes Mean Corpuscular Hemoglobin

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End point title

Mean change from baseline in Erythrocytes Mean Corpuscular Hemoglobin

End point description

Erythrocytes Mean Corpuscular Hemoglobin was measured in picograms (pg). The Safety Set (SS) consisted of all study participants who were randomized and received at least 1 dose (any amount) of study drug. Here, 'n' (Number analyzed) signifies participants who were evaluable at specified time points.

End point type

Secondary

End point timeframe

From Baseline (Week 1) to Week 48

End point values	SOC + Placebo iv Q4W (SS)	SOC + DZP 6mg/kg iv Q4W (SS)	SOC + DZP 24mg/kg iv Q4W (SS)	SOC + DZP 45mg/kg iv Q4W (SS)
Number of subjects analysed	45	45	45	47
Units: Picograms (pg)
arithmetic mean (standard deviation)
Week 2 (44, 42, 45, 42)	0.12 ( 0.71 )	-0.18 ( 0.65 )	0.04 ( 0.43 )	0.00 ( 0.47 )
Week 4 (44, 44, 43, 46)	0.31 ( 0.63 )	-0.06 ( 0.79 )	0.04 ( 0.64 )	0.02 ( 0.65 )
Week 8 (43, 44, 44, 44)	0.20 ( 0.87 )	-0.25 ( 0.87 )	0.04 ( 0.81 )	-0.04 ( 0.74 )
Week 12 (44, 44, 44, 44)	0.04 ( 1.08 )	-0.25 ( 1.03 )	-0.09 ( 1.25 )	-0.12 ( 0.90 )
Week 16 (44, 43, 43, 45)	0.03 ( 1.43 )	-0.36 ( 1.31 )	-0.20 ( 1.52 )	-0.31 ( 1.19 )
Week 20 (43, 43, 41, 43)	0.00 ( 1.49 )	-0.39 ( 1.40 )	-0.10 ( 1.63 )	-0.26 ( 1.24 )
Week 24 (42, 43, 44, 44)	-0.13 ( 1.57 )	-0.43 ( 1.39 )	-0.25 ( 1.96 )	-0.44 ( 1.42 )
Week 28 (44, 41, 41, 44)	0.01 ( 1.68 )	-0.55 ( 1.45 )	-0.15 ( 2.09 )	-0.44 ( 1.68 )
Week 32 (43, 43, 43, 42)	0.01 ( 2.12 )	-0.33 ( 1.28 )	-0.06 ( 2.39 )	-0.48 ( 1.63 )
Week 40 (42, 43, 41, 44)	0.17 ( 2.50 )	-0.40 ( 1.30 )	0.03 ( 2.32 )	-0.09 ( 2.00 )
Week 48 (38, 42, 39, 42)	0.02 ( 2.58 )	-0.21 ( 1.48 )	0.06 ( 2.55 )	0.10 ( 1.90 )

No statistical analyses for this end point

Secondary: Mean change from baseline in Leukocytes

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End point title

Mean change from baseline in Leukocytes

End point description

Leukocytes was measured in number of leukocytes per liter (10^9/L). The Safety Set (SS) consisted of all study participants who were randomized and received at least 1 dose (any amount) of study drug. Here, 'n' (Number analyzed) signifies participants who were evaluable at specified time points.

End point type

Secondary

End point timeframe

From Baseline (Week 1) to Week 48

End point values	SOC + Placebo iv Q4W (SS)	SOC + DZP 6mg/kg iv Q4W (SS)	SOC + DZP 24mg/kg iv Q4W (SS)	SOC + DZP 45mg/kg iv Q4W (SS)
Number of subjects analysed	45	45	45	47
Units: 10^9 leukocytes per liter
arithmetic mean (standard deviation)
Week 2 (44, 42, 45, 42)	0.34 ( 2.45 )	0.27 ( 1.23 )	0.49 ( 1.46 )	0.20 ( 1.62 )
Week 4 (44, 44, 43, 46)	0.10 ( 1.88 )	0.27 ( 1.63 )	0.25 ( 1.47 )	0.52 ( 2.11 )
Week 8 (43, 44, 44, 44)	-0.25 ( 2.12 )	0.46 ( 1.41 )	-0.05 ( 1.50 )	-0.10 ( 1.65 )
Week 12 (44, 44, 44, 43)	-0.27 ( 1.80 )	0.18 ( 1.73 )	0.17 ( 2.00 )	0.23 ( 2.01 )
Week 16 (44, 43, 43, 45)	-0.31 ( 2.18 )	0.13 ( 1.55 )	0.21 ( 1.69 )	-0.20 ( 2.12 )
Week 20 (43, 43, 41, 43)	-0.24 ( 2.27 )	-0.06 ( 1.59 )	-0.22 ( 1.74 )	0.30 ( 2.61 )
Week 24 (42, 43, 44, 44)	-0.22 ( 2.41 )	-0.12 ( 1.83 )	-0.14 ( 1.75 )	-0.34 ( 1.97 )
Week 28 (44, 41, 41, 44)	0.05 ( 2.04 )	0.06 ( 1.93 )	0.26 ( 2.04 )	-0.58 ( 1.70 )
Week 32 (43, 43, 43, 42)	-0.14 ( 2.20 )	0.08 ( 1.64 )	0.19 ( 1.67 )	-0.44 ( 1.68 )
Week 40 (42, 43, 41, 44)	0.17 ( 2.54 )	0.04 ( 1.60 )	-0.35 ( 1.49 )	-0.49 ( 1.96 )
Week 48 (38, 42, 39, 42)	-0.49 ( 1.83 )	0.30 ( 1.53 )	-0.14 ( 2.06 )	-0.62 ( 1.87 )

No statistical analyses for this end point

Secondary: Mean change from baseline in Basophils

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End point title

Mean change from baseline in Basophils

End point description

Basophils was measured in number of basophils per liter (10^9/L). The Safety Set (SS) consisted of all study participants who were randomized and received at least 1 dose (any amount) of study drug. Here, 'n' (Number analyzed) signifies participants who were evaluable at specified time points.

End point type

Secondary

End point timeframe

From Baseline (Week 1) to Week 48

End point values	SOC + Placebo iv Q4W (SS)	SOC + DZP 6mg/kg iv Q4W (SS)	SOC + DZP 24mg/kg iv Q4W (SS)	SOC + DZP 45mg/kg iv Q4W (SS)
Number of subjects analysed	45	45	45	47
Units: 10^9 basophils per liter
arithmetic mean (standard deviation)
Week 2 (42, 39, 44, 41)	0.01 ( 0.03 )	0.02 ( 0.04 )	0.00 ( 0.03 )	0.00 ( 0.02 )
Week 4 (43, 43, 41, 46)	0.01 ( 0.03 )	0.00 ( 0.03 )	0.01 ( 0.04 )	0.00 ( 0.02 )
Week 8 (42, 41, 43, 43)	0.01 ( 0.04 )	0.01 ( 0.04 )	0.01 ( 0.03 )	0.00 ( 0.02 )
Week 12 (44, 40, 44, 42)	0.01 ( 0.03 )	0.01 ( 0.04 )	0.00 ( 0.03 )	0.00 ( 0.03 )
Week 16 (43, 42, 43, 44)	0.01 ( 0.04 )	0.00 ( 0.03 )	0.01 ( 0.03 )	0.00 ( 0.03 )
Week 20 (42, 40, 40, 42)	0.00 ( 0.03 )	0.01 ( 0.03 )	0.00 ( 0.03 )	0.00 ( 0.03 )
Week 24 (41, 40, 44, 44)	0.00 ( 0.03 )	0.02 ( 0.04 )	0.00 ( 0.03 )	0.00 ( 0.03 )
Week 28 (44, 39, 40, 44)	0.02 ( 0.05 )	0.01 ( 0.04 )	0.00 ( 0.02 )	0.00 ( 0.03 )
Week 32 (41, 40, 43, 42)	0.00 ( 0.03 )	0.00 ( 0.02 )	0.01 ( 0.03 )	0.00 ( 0.03 )
Week 40 (41, 42, 40, 43)	0.00 ( 0.02 )	0.00 ( 0.02 )	0.01 ( 0.03 )	0.00 ( 0.03 )
Week 48 (37, 41, 39, 41)	0.00 ( 0.03 )	0.00 ( 0.02 )	0.00 ( 0.03 )	0.01 ( 0.03 )

No statistical analyses for this end point

Secondary: Mean change from baseline in Basophils/Leukocytes

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End point title

Mean change from baseline in Basophils/Leukocytes

End point description

Basophils/Leukocytes was measured in percentages (%). The Safety Set (SS) consisted of all study participants who were randomized and received at least 1 dose (any amount) of study drug. Here, 'n' (Number analyzed) signifies participants who were evaluable at specified time points.

End point type

Secondary

End point timeframe

From Baseline (Week 1) to Week 48

End point values	SOC + Placebo iv Q4W (SS)	SOC + DZP 6mg/kg iv Q4W (SS)	SOC + DZP 24mg/kg iv Q4W (SS)	SOC + DZP 45mg/kg iv Q4W (SS)
Number of subjects analysed	45	45	45	47
Units: % of Basophils per Leukocytes
arithmetic mean (standard deviation)
Week 2 (42, 39, 44, 41)	-0.05 ( 0.23 )	0.02 ( 0.20 )	-0.05 ( 0.31 )	-0.03 ( 0.27 )
Week 4 (43, 43, 41, 46)	0.03 ( 0.27 )	-0.06 ( 0.26 )	-0.01 ( 0.43 )	-0.07 ( 0.26 )
Week 8 (42, 41, 43, 43)	0.08 ( 0.42 )	0.03 ( 0.32 )	0.00 ( 0.33 )	-0.06 ( 0.23 )
Week 12 (44, 40, 44, 42)	0.04 ( 0.30 )	0.09 ( 0.48 )	0.00 ( 0.25 )	-0.07 ( 0.28 )
Week 16 (43, 42, 43, 44)	0.01 ( 0.25 )	0.00 ( 0.28 )	-0.02 ( 0.31 )	-0.05 ( 0.30 )
Week 20 (42, 40, 40, 42)	-0.02 ( 0.26 )	0.00 ( 0.27 )	-0.07 ( 0.29 )	-0.04 ( 0.32 )
Week 24 (41, 40, 44, 44)	-0.04 ( 0.31 )	0.15 ( 0.44 )	-0.03 ( 0.24 )	-0.03 ( 0.21 )
Week 28 (44, 39, 40, 44)	0.08 ( 0.54 )	0.03 ( 0.29 )	0.00 ( 0.24 )	0.07 ( 0.32 )
Week 32 (41, 40, 43, 42)	-0.03 ( 0.29 )	0.00 ( 0.23 )	0.01 ( 0.25 )	0.01 ( 0.25 )
Week 40 (41, 42, 40, 43)	-0.08 ( 0.24 )	-0.03 ( 0.25 )	0.07 ( 0.29 )	0.01 ( 0.29 )
Week 48 (37, 41, 39, 41)	-0.01 ( 0.29 )	-0.08 ( 0.21 )	0.02 ( 0.25 )	0.06 ( 0.28 )

No statistical analyses for this end point

Secondary: Mean change from baseline in Eosinophils

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End point title

Mean change from baseline in Eosinophils

End point description

Eosinophils was measured in number of eosinophils per liter (10^9/L). The Safety Set (SS) consisted of all study participants who were randomized and received at least 1 dose (any amount) of study drug. Here, 'n' (Number analyzed) signifies participants who were evaluable at specified time points.

End point type

Secondary

End point timeframe

From Baseline (Week 1) to Week 48

End point values	SOC + Placebo iv Q4W (SS)	SOC + DZP 6mg/kg iv Q4W (SS)	SOC + DZP 24mg/kg iv Q4W (SS)	SOC + DZP 45mg/kg iv Q4W (SS)
Number of subjects analysed	45	45	45	47
Units: 10^9 eosinophils per liter
arithmetic mean (standard deviation)
Week 2 (42, 39, 44, 41)	-0.01 ( 0.04 )	0.01 ( 0.06 )	0.00 ( 0.09 )	-0.01 ( 0.05 )
Week 4 (43, 43, 41, 46)	-0.01 ( 0.04 )	-0.01 ( 0.06 )	0.00 ( 0.04 )	-0.01 ( 0.04 )
Week 8 (42, 41, 43, 43)	-0.01 ( 0.04 )	0.03 ( 0.16 )	0.00 ( 0.04 )	0.01 ( 0.07 )
Week 12 (44, 40, 44, 42)	0.00 ( 0.04 )	0.04 ( 0.20 )	0.02 ( 0.10 )	0.02 ( 0.17 )
Week 16 (43, 42, 43, 44)	0.00 ( 0.05 )	0.02 ( 0.11 )	0.01 ( 0.05 )	0.00 ( 0.06 )
Week 20 (42, 40, 40, 42)	0.00 ( 0.05 )	0.04 ( 0.24 )	0.01 ( 0.05 )	-0.01 ( 0.05 )
Week 24 (41, 40, 44, 44)	-0.01 ( 0.05 )	0.04 ( 0.15 )	0.02 ( 0.07 )	-0.02 ( 0.06 )
Week 28 (44, 39, 40, 44)	-0.01 ( 0.04 )	0.01 ( 0.07 )	0.01 ( 0.05 )	0.00 ( 0.06 )
Week 32 (41, 40, 43, 42)	-0.01 ( 0.06 )	0.01 ( 0.10 )	0.01 ( 0.05 )	-0.02 ( 0.04 )
Week 40 (41, 42, 40, 43)	0.00 ( 0.05 )	0.01 ( 0.06 )	0.02 ( 0.06 )	0.00 ( 0.07 )
Week 48 (37, 41, 39, 41)	0.00 ( 0.04 )	-0.01 ( 0.05 )	0.00 ( 0.06 )	0.00 ( 0.06 )

No statistical analyses for this end point

Secondary: Mean change from baseline in Eosinophils/Leukocytes

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End point title

Mean change from baseline in Eosinophils/Leukocytes

End point description

Eosinophils/Leukocytes was measured in percentages (%). The Safety Set (SS) consisted of all study participants who were randomized and received at least 1 dose (any amount) of study drug. Here, 'n' (Number analyzed) signifies participants who were evaluable at specified time points.

End point type

Secondary

End point timeframe

From Baseline (Week 1) to Week 48

End point values	SOC + Placebo iv Q4W (SS)	SOC + DZP 6mg/kg iv Q4W (SS)	SOC + DZP 24mg/kg iv Q4W (SS)	SOC + DZP 45mg/kg iv Q4W (SS)
Number of subjects analysed	45	45	45	47
Units: % of Eosinophils per Leukocytes
arithmetic mean (standard deviation)
Week 2 (42, 39, 44, 41)	-0.19 ( 1.07 )	0.07 ( 0.86 )	-0.18 ( 1.13 )	-0.29 ( 1.22 )
Week 4 (43, 43, 41, 46)	-0.32 ( 0.96 )	-0.05 ( 1.26 )	-0.12 ( 1.01 )	-0.26 ( 0.94 )
Week 8 (42, 41, 43, 43)	-0.05 ( 1.09 )	0.54 ( 2.13 )	0.10 ( 1.11 )	0.22 ( 1.89 )
Week 12 (44, 40, 44, 42)	0.18 ( 1.03 )	0.70 ( 3.12 )	0.33 ( 1.68 )	0.05 ( 1.83 )
Week 16 (43, 42, 43, 44)	0.06 ( 1.05 )	0.36 ( 1.24 )	0.20 ( 1.40 )	-0.11 ( 1.33 )
Week 20 (42, 40, 40, 42)	0.04 ( 1.11 )	0.83 ( 3.58 )	0.11 ( 1.24 )	-0.39 ( 1.29 )
Week 24 (41, 40, 44, 44)	0.11 ( 1.16 )	0.82 ( 2.89 )	-0.01 ( 1.22 )	0.06 ( 1.63 )
Week 28 (44, 39, 40, 44)	0.06 ( 1.00 )	0.21 ( 1.33 )	0.18 ( 1.02 )	-0.03 ( 1.35 )
Week 32 (41, 40, 43, 42)	0.02 ( 1.09 )	0.28 ( 1.60 )	0.16 ( 1.13 )	-0.20 ( 1.03 )
Week 40 (41, 42, 40, 43)	-0.10 ( 0.85 )	0.05 ( 1.09 )	0.40 ( 1.23 )	-0.09 ( 1.47 )
Week 48 (37, 41, 39, 41)	0.09 ( 1.02 )	-0.17 ( 1.08 )	0.06 ( 0.90 )	0.24 ( 1.03 )

No statistical analyses for this end point

Secondary: Mean change from baseline in Lymphocytes

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End point title

Mean change from baseline in Lymphocytes

End point description

Lymphocytes was measured in number of lymphocytes per liter (10^9/L). The Safety Set (SS) consisted of all study participants who were randomized and received at least 1 dose (any amount) of study drug. Here, 'n' (Number analyzed) signifies participants who were evaluable at specified time points.

End point type

Secondary

End point timeframe

From Baseline (Week 1) to Week 48

End point values	SOC + Placebo iv Q4W (SS)	SOC + DZP 6mg/kg iv Q4W (SS)	SOC + DZP 24mg/kg iv Q4W (SS)	SOC + DZP 45mg/kg iv Q4W (SS)
Number of subjects analysed	45	45	45	47
Units: 10^9 lymphocytes per liter
arithmetic mean (standard deviation)
Week 2 (42, 39, 44, 41)	-0.03 ( 0.39 )	0.05 ( 0.36 )	0.16 ( 0.29 )	0.24 ( 0.37 )
Week 4 (43, 43, 41, 46)	-0.04 ( 0.36 )	-0.01 ( 0.47 )	-0.01 ( 0.41 )	0.23 ( 0.42 )
Week 8 (42, 41, 43, 43)	-0.15 ( 0.48 )	-0.03 ( 0.39 )	0.06 ( 0.46 )	0.14 ( 0.50 )
Week 12 (44, 40, 44, 42)	-0.06 ( 0.43 )	0.02 ( 0.59 )	0.01 ( 0.42 )	0.21 ( 0.51 )
Week 16 (43, 42, 43, 44)	-0.09 ( 0.52 )	-0.11 ( 0.51 )	-0.02 ( 0.47 )	0.04 ( 0.40 )
Week 20 (42, 40, 40, 42)	-0.14 ( 0.56 )	-0.13 ( 0.54 )	0.02 ( 0.39 )	0.13 ( 0.55 )
Week 24 (41, 40, 44, 44)	-0.11 ( 0.51 )	-0.08 ( 0.60 )	-0.03 ( 0.45 )	0.05 ( 0.52 )
Week 28 (44, 39, 40, 44)	-0.04 ( 0.57 )	-0.02 ( 0.59 )	0.01 ( 0.53 )	0.03 ( 0.56 )
Week 32 (41, 40, 43, 42)	-0.11 ( 0.57 )	-0.16 ( 0.59 )	0.05 ( 0.45 )	-0.02 ( 0.44 )
Week 40 (41, 42, 40, 43)	-0.11 ( 0.54 )	-0.11 ( 0.52 )	-0.11 ( 0.43 )	-0.03 ( 0.48 )
Week 48 (37, 41, 39, 41)	-0.19 ( 0.68 )	-0.19 ( 0.60 )	-0.10 ( 0.44 )	-0.02 ( 0.49 )

No statistical analyses for this end point

Secondary: Mean change from baseline in Lymphocytes/Leukocytes

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End point title

Mean change from baseline in Lymphocytes/Leukocytes

End point description

Lymphocytes/Leukocytes was measured in percentages (%). The Safety Set (SS) consisted of all study participants who were randomized and received at least 1 dose (any amount) of study drug. Here, 'n' (Number analyzed) signifies participants who were evaluable at specified time points.

End point type

Secondary

End point timeframe

From Baseline (Week 1) to Week 48

End point values	SOC + Placebo iv Q4W (SS)	SOC + DZP 6mg/kg iv Q4W (SS)	SOC + DZP 24mg/kg iv Q4W (SS)	SOC + DZP 45mg/kg iv Q4W (SS)
Number of subjects analysed	45	45	45	47
Units: % of Lymphocytes per Leukocytes
arithmetic mean (standard deviation)
Week 2 (42, 39, 44, 41)	-1.88 ( 9.01 )	0.19 ( 6.55 )	1.18 ( 6.09 )	2.61 ( 6.11 )
Week 4 (43, 43, 41, 46)	-0.88 ( 7.09 )	-1.02 ( 6.34 )	-1.18 ( 9.93 )	0.97 ( 8.00 )
Week 8 (42, 41, 43, 43)	-1.98 ( 10.59 )	-1.40 ( 7.13 )	0.56 ( 10.20 )	1.97 ( 8.51 )
Week 12 (44, 40, 44, 42)	0.21 ( 7.87 )	0.56 ( 10.58 )	-0.44 ( 9.90 )	2.46 ( 10.18 )
Week 16 (43, 42, 43, 44)	-0.91 ( 8.33 )	-1.49 ( 7.50 )	-1.18 ( 9.65 )	0.12 ( 9.34 )
Week 20 (42, 40, 40, 42)	-1.97 ( 10.37 )	-0.66 ( 6.58 )	0.88 ( 10.69 )	0.71 ( 10.32 )
Week 24 (41, 40, 44, 44)	-0.75 ( 8.69 )	-0.56 ( 7.35 )	-0.52 ( 10.55 )	1.85 ( 9.67 )
Week 28 (44, 39, 40, 44)	-1.18 ( 8.27 )	-0.05 ( 8.51 )	-0.05 ( 9.97 )	1.61 ( 10.55 )
Week 32 (41, 40, 43, 42)	-1.59 ( 7.69 )	-2.56 ( 6.51 )	-0.16 ( 7.70 )	0.70 ( 8.74 )
Week 40 (41, 42, 40, 43)	-2.60 ( 9.18 )	-2.02 ( 5.99 )	-1.36 ( 10.12 )	0.33 ( 8.41 )
Week 48 (37, 41, 39, 41)	-1.46 ( 11.29 )	-3.71 ( 7.41 )	-0.84 ( 9.42 )	1.69 ( 10.05 )

No statistical analyses for this end point

Secondary: Mean change from baseline in Monocytes

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End point title

Mean change from baseline in Monocytes

End point description

Monocytes was measured in number of monocytes per liter (10^9/L). The Safety Set (SS) consisted of all study participants who were randomized and received at least 1 dose (any amount) of study drug. Here, 'n' (Number analyzed) signifies participants who were evaluable at specified time points.

End point type

Secondary

End point timeframe

From Baseline (Week 1) to Week 48

End point values	SOC + Placebo iv Q4W (SS)	SOC + DZP 6mg/kg iv Q4W (SS)	SOC + DZP 24mg/kg iv Q4W (SS)	SOC + DZP 45mg/kg iv Q4W (SS)
Number of subjects analysed	45	45	45	47
Units: 10^9 monocytes per liter
arithmetic mean (standard deviation)
Week 2 (42, 39, 44, 41)	-0.01 ( 0.17 )	0.01 ( 0.18 )	0.05 ( 0.14 )	0.01 ( 0.13 )
Week 4 (43, 43, 41, 46)	0.01 ( 0.18 )	0.04 ( 0.18 )	0.01 ( 0.14 )	0.06 ( 0.19 )
Week 8 (42, 41, 43, 43)	-0.03 ( 0.18 )	0.04 ( 0.18 )	0.03 ( 0.16 )	0.02 ( 0.17 )
Week 12 (44, 40, 44, 42)	-0.01 ( 0.19 )	0.00 ( 0.14 )	0.04 ( 0.18 )	0.06 ( 0.15 )
Week 16 (43, 42, 43, 44)	-0.01 ( 0.17 )	0.01 ( 0.17 )	0.05 ( 0.18 )	0.03 ( 0.14 )
Week 20 (42, 40, 40, 42)	-0.03 ( 0.19 )	0.00 ( 0.16 )	0.00 ( 0.13 )	0.05 ( 0.19 )
Week 24 (41, 40, 44, 44)	0.00 ( 0.19 )	0.04 ( 0.19 )	0.03 ( 0.17 )	0.00 ( 0.17 )
Week 28 (44, 39, 40, 44)	0.00 ( 0.20 )	0.04 ( 0.21 )	0.08 ( 0.19 )	0.02 ( 0.17 )
Week 32 (41, 40, 43, 42)	-0.01 ( 0.18 )	0.02 ( 0.19 )	0.05 ( 0.23 )	-0.01 ( 0.19 )
Week 40 (41, 42, 40, 43)	0.03 ( 0.17 )	0.05 ( 0.16 )	0.04 ( 0.16 )	-0.01 ( 0.18 )
Week 48 (37, 41, 39, 41)	-0.02 ( 0.20 )	-0.01 ( 0.13 )	0.03 ( 0.15 )	-0.02 ( 0.18 )

No statistical analyses for this end point

Secondary: Mean change from baseline in Monocytes/Leukocytes

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End point title

Mean change from baseline in Monocytes/Leukocytes

End point description

Monocytes/Leukocytes was measured in percentages (%). The Safety Set (SS) consisted of all study participants who were randomized and received at least 1 dose (any amount) of study drug. Here, 'n' (Number analyzed) signifies participants who were evaluable at specified time points.

End point type

Secondary

End point timeframe

From Baseline (Week 1) to Week 48

End point values	SOC + Placebo iv Q4W (SS)	SOC + DZP 6mg/kg iv Q4W (SS)	SOC + DZP 24mg/kg iv Q4W (SS)	SOC + DZP 45mg/kg iv Q4W (SS)
Number of subjects analysed	45	45	45	47
Units: % of Monocytes per Leukocytes
arithmetic mean (standard deviation)
Week 2 (42, 39, 44, 41)	-0.87 ( 2.50 )	-0.07 ( 2.46 )	0.23 ( 3.03 )	-0.37 ( 2.25 )
Week 4 (43, 43, 41, 46)	0.26 ( 3.30 )	0.27 ( 2.41 )	-0.16 ( 3.11 )	-0.24 ( 2.82 )
Week 8 (42, 41, 43, 43)	-0.21 ( 3.47 )	0.07 ( 3.61 )	0.51 ( 3.83 )	0.08 ( 3.12 )
Week 12 (44, 40, 44, 42)	0.07 ( 2.79 )	-0.11 ( 2.38 )	0.22 ( 3.37 )	0.45 ( 2.74 )
Week 16 (43, 42, 43, 44)	0.06 ( 3.30 )	0.59 ( 2.85 )	0.43 ( 3.31 )	0.28 ( 3.13 )
Week 20 (42, 40, 40, 42)	-0.27 ( 3.84 )	0.56 ( 3.08 )	0.33 ( 3.81 )	0.43 ( 3.39 )
Week 24 (41, 40, 44, 44)	0.06 ( 3.45 )	0.84 ( 2.97 )	0.46 ( 3.00 )	0.41 ( 3.24 )
Week 28 (44, 39, 40, 44)	-0.24 ( 3.54 )	0.69 ( 3.24 )	0.64 ( 3.67 )	0.94 ( 3.78 )
Week 32 (41, 40, 43, 42)	-0.08 ( 3.11 )	0.13 ( 2.62 )	0.46 ( 3.91 )	-0.03 ( 3.76 )
Week 40 (41, 42, 40, 43)	0.49 ( 3.55 )	0.64 ( 2.92 )	0.83 ( 3.69 )	0.59 ( 3.07 )
Week 48 (37, 41, 39, 41)	-0.04 ( 3.79 )	-0.13 ( 2.41 )	0.47 ( 3.82 )	0.29 ( 3.30 )

No statistical analyses for this end point

Secondary: Mean change from baseline in Neutrophils

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End point title

Mean change from baseline in Neutrophils

End point description

Neutrophils was measured in number of neutrophils per liter (10^9/L). The Safety Set (SS) consisted of all study participants who were randomized and received at least 1 dose (any amount) of study drug. Here, 'n' (Number analyzed) signifies participants who were evaluable at specified time points.

End point type

Secondary

End point timeframe

From Baseline (Week 1) to Week 48

End point values	SOC + Placebo iv Q4W (SS)	SOC + DZP 6mg/kg iv Q4W (SS)	SOC + DZP 24mg/kg iv Q4W (SS)	SOC + DZP 45mg/kg iv Q4W (SS)
Number of subjects analysed	45	45	45	47
Units: 10^9 neutrophils per liter
arithmetic mean (standard deviation)
Week 2 (43, 39, 44, 41)	0.28 ( 2.43 )	0.26 ( 1.17 )	0.17 ( 1.33 )	-0.01 ( 1.46 )
Week 4 (43, 43, 41, 46)	0.07 ( 1.82 )	0.27 ( 1.40 )	0.21 ( 1.64 )	0.23 ( 1.96 )
Week 8 (42, 41, 43, 43)	-0.13 ( 2.20 )	0.41 ( 1.32 )	-0.07 ( 1.53 )	-0.20 ( 1.49 )
Week 12 (44, 41, 44, 42)	-0.24 ( 1.56 )	0.20 ( 1.65 )	0.10 ( 1.94 )	-0.01 ( 2.03 )
Week 16 (43, 42, 43, 44)	-0.22 ( 2.13 )	0.20 ( 1.41 )	0.15 ( 1.61 )	-0.20 ( 2.14 )
Week 20 (42, 41, 40, 42)	-0.07 ( 2.21 )	0.01 ( 1.22 )	-0.39 ( 1.69 )	0.09 ( 2.51 )
Week 24 (41, 40, 44, 44)	-0.12 ( 2.24 )	-0.06 ( 1.54 )	-0.16 ( 1.77 )	-0.38 ( 1.92 )
Week 28 (44, 39, 40, 44)	0.04 ( 1.81 )	0.13 ( 1.64 )	0.10 ( 1.91 )	-0.62 ( 1.78 )
Week 32 (41, 40, 43, 42)	-0.07 ( 1.87 )	0.33 ( 1.27 )	0.07 ( 1.54 )	-0.40 ( 1.67 )
Week 40 (41, 42, 40, 43)	0.16 ( 2.37 )	0.16 ( 1.31 )	-0.32 ( 1.57 )	-0.41 ( 1.88 )
Week 48 (37, 41, 39, 41)	-0.29 ( 1.58 )	0.55 ( 1.15 )	-0.09 ( 2.02 )	-0.54 ( 1.78 )

No statistical analyses for this end point

Secondary: Mean change from baseline in Neutrophils/Leukocytes

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End point title

Mean change from baseline in Neutrophils/Leukocytes

End point description

Neutrophils/Leukocytes was measured in percentages (%). The Safety Set (SS) consisted of all study participants who were randomized and received at least 1 dose (any amount) of study drug. Here, 'n' (Number analyzed) signifies participants who were evaluable at specified time points.

End point type

Secondary

End point timeframe

From Baseline (Week 1) to Week 48

End point values	SOC + Placebo iv Q4W (SS)	SOC + DZP 6mg/kg iv Q4W (SS)	SOC + DZP 24mg/kg iv Q4W (SS)	SOC + DZP 45mg/kg iv Q4W (SS)
Number of subjects analysed	45	45	45	47
Units: % of Neutrophils per Leukocytes
arithmetic mean (standard deviation)
Week 2 (42, 39, 44, 41)	2.99 ( 10.73 )	-0.21 ( 7.94 )	-1.20 ( 8.40 )	-1.93 ( 8.18 )
Week 4 (43, 43, 41, 46)	0.91 ( 9.37 )	0.89 ( 7.82 )	1.47 ( 12.70 )	-0.37 ( 10.27 )
Week 8 (42, 41, 43, 43)	2.15 ( 12.95 )	0.79 ( 8.80 )	-1.17 ( 13.28 )	-2.23 ( 10.92 )
Week 12 (44, 40, 44, 42)	-0.52 ( 9.44 )	-1.25 ( 11.78 )	-0.12 ( 13.18 )	-2.90 ( 12.85 )
Week 16 (43, 42, 43, 44)	0.77 ( 11.02 )	0.54 ( 8.50 )	0.56 ( 12.48 )	-0.24 ( 12.23 )
Week 20 (42, 40, 40, 42)	2.22 ( 13.21 )	-0.73 ( 8.42 )	-1.25 ( 14.29 )	-0.71 ( 13.91 )
Week 24 (41, 40, 44, 44)	0.65 ( 11.48 )	-1.25 ( 8.74 )	0.10 ( 13.20 )	-2.30 ( 12.41 )
Week 28 (44, 39, 40, 44)	1.28 ( 10.38 )	-0.88 ( 10.56 )	-0.77 ( 13.27 )	-2.60 ( 13.79 )
Week 32 (41, 40, 43, 42)	1.67 ( 9.93 )	2.15 ( 7.42 )	-0.47 ( 9.80 )	-0.48 ( 12.08 )
Week 40 (41, 42, 40, 43)	2.29 ( 11.66 )	1.36 ( 6.95 )	0.07 ( 13.23 )	-0.93 ( 11.50 )
Week 48 (37, 41, 39, 41)	1.41 ( 13.58 )	4.09 ( 8.40 )	0.30 ( 12.47 )	-2.28 ( 12.38 )

No statistical analyses for this end point

Secondary: Mean change from baseline in Platelets

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End point title

Mean change from baseline in Platelets

End point description

Platelets was measured in number of platelets per liter (10^9/L). The Safety Set (SS) consisted of all study participants who were randomized and received at least 1 dose (any amount) of study drug. Here, 'n' (Number analyzed) signifies participants who were evaluable at specified time points.

End point type

Secondary

End point timeframe

From Baseline (Week 1) to Week 48

End point values	SOC + Placebo iv Q4W (SS)	SOC + DZP 6mg/kg iv Q4W (SS)	SOC + DZP 24mg/kg iv Q4W (SS)	SOC + DZP 45mg/kg iv Q4W (SS)
Number of subjects analysed	45	45	45	47
Units: 10^9 platelets per liter
arithmetic mean (standard deviation)
Week 2 (41, 42, 45, 42)	5.9 ( 33.2 )	10.0 ( 40.0 )	1.4 ( 47.5 )	-1.0 ( 52.0 )
Week 4 (43, 44, 43, 46)	-5.2 ( 51.3 )	0.0 ( 32.4 )	4.9 ( 43.8 )	8.1 ( 42.6 )
Week 8 (42, 44, 44, 44)	0.2 ( 45.3 )	-0.3 ( 40.3 )	3.9 ( 52.0 )	-6.4 ( 40.5 )
Week 12 (43, 43, 43, 44)	-4.3 ( 50.6 )	-1.7 ( 38.8 )	-2.7 ( 49.0 )	1.8 ( 49.4 )
Week 16 (44, 43, 43, 45)	0.7 ( 57.7 )	-0.7 ( 40.5 )	-1.5 ( 66.7 )	-2.3 ( 68.1 )
Week 20 (42, 43, 41, 42)	9.2 ( 57.1 )	-3.3 ( 43.0 )	0.5 ( 44.6 )	0.8 ( 64.4 )
Week 24 (42, 41, 44, 43)	0.2 ( 60.2 )	-5.2 ( 43.8 )	2.4 ( 68.6 )	1.7 ( 67.0 )
Week 28 (42, 41, 41, 44)	3.6 ( 64.6 )	1.8 ( 52.6 )	-5.8 ( 71.9 )	1.5 ( 64.4 )
Week 32 (42, 42, 42, 40)	4.0 ( 71.8 )	-1.9 ( 55.4 )	-4.6 ( 57.5 )	9.9 ( 93.8 )
Week 40 (42, 43, 41, 43)	10.3 ( 74.9 )	14.2 ( 52.7 )	-8.8 ( 63.2 )	-1.5 ( 67.4 )
Week 48 (37, 42, 39, 42)	7.1 ( 67.4 )	3.5 ( 58.2 )	-9.5 ( 70.9 )	-8.8 ( 66.5 )

No statistical analyses for this end point

Secondary: Mean change from baseline in cluster of differentiation 3 (CD3)

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End point title

Mean change from baseline in cluster of differentiation 3 (CD3)

End point description

Cluster of differentiation 3 (CD3) was measured in cells per microliter (cells/µL). The Safety Set (SS) consisted of all study participants who were randomized and received at least 1 dose (any amount) of study drug. Here, 'n' (Number analyzed) signifies participants who were evaluable at specified time points.

End point type

Secondary

End point timeframe

From Baseline (Week 1) to Week 48

End point values	SOC + Placebo iv Q4W (SS)	SOC + DZP 6mg/kg iv Q4W (SS)	SOC + DZP 24mg/kg iv Q4W (SS)	SOC + DZP 45mg/kg iv Q4W (SS)
Number of subjects analysed	45	45	45	47
Units: cells/µL
arithmetic mean (standard deviation)
Week 2 (38, 40, 42, 40)	33.0 ( 313.6 )	77.7 ( 383.6 )	106.6 ( 283.1 )	126.9 ( 338.9 )
Week 4 (39, 40, 40, 39)	-30.6 ( 293.5 )	-47.7 ( 504.3 )	24.0 ( 394.9 )	227.2 ( 412.1 )
Week 8 (38, 40, 39, 40)	-64.7 ( 405.7 )	-58.6 ( 422.8 )	-20.5 ( 403.2 )	78.3 ( 560.0 )
Week 12 (41, 41, 40, 40)	-44.2 ( 283.2 )	-48.8 ( 452.1 )	-57.8 ( 385.1 )	43.7 ( 599.3 )
Week 16 (38, 42, 38, 42)	-81.9 ( 479.4 )	-141.2 ( 516.1 )	-4.5 ( 383.2 )	-45.4 ( 520.8 )
Week 20 (40, 40, 39, 42)	-92.7 ( 391.1 )	-173.4 ( 490.9 )	5.9 ( 352.9 )	-89.9 ( 577.7 )
Week 24 (39, 39, 42, 43)	-85.8 ( 472.5 )	-128.9 ( 569.4 )	-88.5 ( 462.1 )	-78.3 ( 570.7 )
Week 28 (41, 40, 39, 38)	-27.6 ( 507.3 )	-81.2 ( 652.7 )	46.1 ( 482.2 )	7.4 ( 561.2 )
Week 32 (41, 41, 41, 41)	-70.9 ( 428.4 )	-173.6 ( 565.8 )	18.0 ( 415.0 )	-90.5 ( 504.0 )
Week 40 (40, 41, 39, 43)	-110.5 ( 526.4 )	-166.9 ( 542.2 )	-1.8 ( 410.7 )	31.7 ( 528.8 )
Week 48 (35, 40, 35, 41)	-115.6 ( 581.1 )	-253.1 ( 637.0 )	36.1 ( 492.3 )	22.3 ( 558.0 )

No statistical analyses for this end point

Secondary: Mean change from baseline in CD3/Lymphocytes

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End point title

Mean change from baseline in CD3/Lymphocytes

End point description

CD3/Lymphocytes was measured in percentages (%). The Safety Set (SS) consisted of all study participants who were randomized and received at least 1 dose (any amount) of study drug. Here, 'n' (Number analyzed) signifies participants who were evaluable at specified time points.

End point type

Secondary

End point timeframe

From Baseline (Week 1) to Week 48

End point values	SOC + Placebo iv Q4W (SS)	SOC + DZP 6mg/kg iv Q4W (SS)	SOC + DZP 24mg/kg iv Q4W (SS)	SOC + DZP 45mg/kg iv Q4W (SS)
Number of subjects analysed	45	45	45	47
Units: % of CD3 per Leukocytes
arithmetic mean (standard deviation)
Week 2 (38, 40, 42, 40)	-0.7 ( 6.1 )	-0.9 ( 4.6 )	-2.0 ( 5.7 )	-0.2 ( 7.8 )
Week 4 (39, 40, 40, 39)	-2.1 ( 7.3 )	-0.5 ( 6.0 )	-1.9 ( 5.0 )	-0.5 ( 6.8 )
Week 8 (38, 40, 39, 40)	-0.9 ( 6.1 )	-1.2 ( 4.8 )	-2.6 ( 5.9 )	0.6 ( 9.5 )
Week 12 (41, 41, 40, 40)	-0.4 ( 5.6 )	-1.1 ( 8.2 )	-2.4 ( 6.0 )	-0.1 ( 9.2 )
Week 16 (38, 42, 38, 42)	-1.9 ( 5.8 )	-1.6 ( 7.8 )	-1.9 ( 7.6 )	-1.4 ( 7.9 )
Week 20 (40, 40, 39, 42)	-0.8 ( 5.0 )	0.0 ( 8.6 )	-2.3 ( 6.9 )	0.6 ( 9.2 )
Week 24 (39, 39, 42, 43)	0.0 ( 6.5 )	-0.1 ( 8.8 )	-1.8 ( 6.6 )	18.7 ( 114.3 )
Week 28 (41, 40, 39, 38)	-0.2 ( 6.9 )	0.2 ( 8.3 )	-2.9 ( 7.2 )	0.9 ( 10.2 )
Week 32 (41, 41, 41, 41)	-1.3 ( 7.0 )	0.2 ( 7.9 )	-1.8 ( 6.8 )	1.4 ( 8.5 )
Week 40 (40, 41, 39, 43)	0.2 ( 6.7 )	1.4 ( 6.9 )	0.5 ( 6.5 )	3.3 ( 7.9 )
Week 48 (35, 40, 35, 41)	1.3 ( 8.0 )	0.3 ( 7.6 )	0.1 ( 6.2 )	4.5 ( 7.3 )

No statistical analyses for this end point

Secondary: Mean change from baseline in cluster of differentiation 19 (CD19)

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End point title

Mean change from baseline in cluster of differentiation 19 (CD19)

End point description

Cluster of differentiation 19 (CD19) was measured in cells per microliter (cells/µL). The Safety Set (SS) consisted of all study participants who were randomized and received at least 1 dose (any amount) of study drug. Here, 'n' (Number analyzed) signifies participants who were evaluable at specified time points.

End point type

Secondary

End point timeframe

From Baseline (Week 1) to Week 48

End point values	SOC + Placebo iv Q4W (SS)	SOC + DZP 6mg/kg iv Q4W (SS)	SOC + DZP 24mg/kg iv Q4W (SS)	SOC + DZP 45mg/kg iv Q4W (SS)
Number of subjects analysed	45	45	45	47
Units: cells/µL
arithmetic mean (standard deviation)
Week 2 (38, 40, 42, 40)	9.6 ( 56.7 )	12.3 ( 76.2 )	24.8 ( 71.0 )	63.4 ( 133.5 )
Week 4 (39, 40, 40, 39)	-2.8 ( 46.3 )	-31.2 ( 177.0 )	9.2 ( 60.5 )	82.8 ( 154.5 )
Week 8 (38, 40, 39, 40)	-13.3 ( 72.9 )	-29.4 ( 183.5 )	8.7 ( 70.8 )	19.4 ( 146.4 )
Week 12 (41, 41, 40, 40)	-2.6 ( 83.4 )	-48.1 ( 207.1 )	-17.9 ( 77.8 )	53.2 ( 203.6 )
Week 16 (38, 42, 38, 42)	-12.5 ( 84.3 )	-50.1 ( 201.5 )	-10.0 ( 92.4 )	13.2 ( 147.8 )
Week 20 (40, 40, 39, 42)	-15.1 ( 86.0 )	-75.4 ( 216.6 )	-2.5 ( 57.1 )	2.7 ( 132.6 )
Week 24 (39, 39, 42, 43)	-15.0 ( 89.3 )	-77.2 ( 231.9 )	-20.3 ( 72.0 )	-1.1 ( 135.0 )
Week 28 (41, 40, 39, 38)	-20.6 ( 106.7 )	-69.6 ( 206.7 )	-13.1 ( 84.5 )	-13.0 ( 123.2 )
Week 32 (41, 41, 41, 41)	-14.3 ( 106.3 )	-75.8 ( 225.7 )	-10.4 ( 93.0 )	-20.9 ( 168.1 )
Week 40 (40, 41, 39, 43)	-24.8 ( 103.3 )	-68.6 ( 211.0 )	-26.9 ( 83.0 )	-46.9 ( 138.0 )
Week 48 (35, 40, 35, 41)	-37.0 ( 132.7 )	-82.4 ( 243.7 )	-15.5 ( 83.2 )	-41.2 ( 120.0 )

No statistical analyses for this end point

Secondary: Mean change from baseline in CD19/Lymphocytes

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End point title

Mean change from baseline in CD19/Lymphocytes

End point description

CD19/Lymphocytes was measured in percentages (%). The Safety Set (SS) consisted of all study participants who were randomized and received at least 1 dose (any amount) of study drug. Here, 'n' (Number analyzed) signifies participants who were evaluable at specified time points.

End point type

Secondary

End point timeframe

From Baseline (Week 1) to Week 48

End point values	SOC + Placebo iv Q4W (SS)	SOC + DZP 6mg/kg iv Q4W (SS)	SOC + DZP 24mg/kg iv Q4W (SS)	SOC + DZP 45mg/kg iv Q4W (SS)
Number of subjects analysed	45	45	45	47
Units: % of CD19 per Leukocytes
arithmetic mean (standard deviation)
Week 2 (38, 40, 42, 40)	-0.3 ( 2.1 )	-0.1 ( 3.0 )	1.0 ( 3.5 )	1.5 ( 5.9 )
Week 4 (39, 40, 40, 39)	0.0 ( 2.9 )	-0.5 ( 3.7 )	0.7 ( 3.3 )	2.8 ( 5.7 )
Week 8 (38, 40, 39, 40)	0.1 ( 2.8 )	-0.5 ( 4.2 )	0.7 ( 2.5 )	0.4 ( 6.4 )
Week 12 (41, 41, 40, 40)	-0.2 ( 3.2 )	-1.0 ( 3.9 )	-0.4 ( 3.1 )	1.7 ( 7.9 )
Week 16 (38, 42, 38, 42)	0.0 ( 4.7 )	-1.2 ( 5.0 )	-0.4 ( 3.3 )	0.7 ( 5.9 )
Week 20 (40, 40, 39, 42)	-0.4 ( 3.8 )	-2.1 ( 6.2 )	-0.3 ( 3.0 )	-0.2 ( 6.9 )
Week 24 (39, 39, 42, 43)	-0.9 ( 4.5 )	-2.0 ( 6.5 )	-0.6 ( 3.3 )	-0.3 ( 7.3 )
Week 28 (41, 40, 39, 38)	-1.2 ( 5.4 )	-2.5 ( 5.9 )	-1.1 ( 3.3 )	-1.0 ( 6.6 )
Week 32 (41, 41, 41, 41)	-0.4 ( 4.7 )	-2.4 ( 5.5 )	-0.6 ( 4.4 )	-1.6 ( 6.3 )
Week 40 (40, 41, 39, 43)	-1.2 ( 4.7 )	-2.6 ( 5.4 )	-1.9 ( 4.2 )	-3.4 ( 6.7 )
Week 48 (35, 40, 35, 41)	-1.2 ( 6.8 )	-2.6 ( 7.2 )	-1.6 ( 4.9 )	-3.3 ( 6.2 )

No statistical analyses for this end point

Secondary: Mean change from baseline in Aspartate Aminotransferase

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End point title

Mean change from baseline in Aspartate Aminotransferase

End point description

Aspartate Aminotransferase was measured in units per liter (U/L). The Safety Set (SS) consisted of all study participants who were randomized and received at least 1 dose (any amount) of study drug. Here, 'n' (Number analyzed) signifies participants who were evaluable at specified time points.

End point type

Secondary

End point timeframe

From Baseline (Week 1) to Week 48

End point values	SOC + Placebo iv Q4W (SS)	SOC + DZP 6mg/kg iv Q4W (SS)	SOC + DZP 24mg/kg iv Q4W (SS)	SOC + DZP 45mg/kg iv Q4W (SS)
Number of subjects analysed	45	45	45	47
Units: U/L
arithmetic mean (standard deviation)
Week 2 (42, 45, 45, 43)	-0.5 ( 8.8 )	0.2 ( 8.0 )	4.3 ( 43.1 )	0.0 ( 7.2 )
Week 4 (44, 44, 43, 46)	-0.1 ( 11.2 )	0.2 ( 7.4 )	-1.1 ( 7.6 )	-1.9 ( 8.0 )
Week 8 (44, 43, 44, 44)	-0.1 ( 8.7 )	-1.5 ( 6.2 )	0.5 ( 13.0 )	-1.1 ( 8.1 )
Week 12 (44, 44, 45, 44)	5.1 ( 27.0 )	0.9 ( 6.2 )	-1.8 ( 10.0 )	-2.9 ( 7.1 )
Week 16 (44, 44, 43, 45)	0.4 ( 7.7 )	0.0 ( 6.3 )	-2.3 ( 11.6 )	-2.8 ( 8.4 )
Week 20 (43, 43, 41, 44)	4.1 ( 24.1 )	1.0 ( 11.5 )	-0.7 ( 13.8 )	-3.8 ( 8.1 )
Week 24 (42, 43, 44, 44)	0.6 ( 11.8 )	1.6 ( 10.4 )	-1.8 ( 11.5 )	-3.8 ( 8.4 )
Week 28 (43, 42, 40, 42)	0.0 ( 12.3 )	0.0 ( 10.2 )	-1.5 ( 11.1 )	-3.4 ( 9.1 )
Week 32 (44, 44, 43, 44)	-0.3 ( 11.0 )	0.3 ( 6.8 )	-0.7 ( 12.9 )	-3.4 ( 9.2 )
Week 40 (42, 42, 41, 44)	-0.6 ( 10.2 )	0.1 ( 9.1 )	-0.3 ( 11.5 )	-1.5 ( 9.8 )
Week 48 (38, 42, 40, 43)	1.1 ( 10.8 )	0.1 ( 13.1 )	1.4 ( 13.4 )	-2.1 ( 8.6 )

No statistical analyses for this end point

Secondary: Mean change from baseline in Alanine Aminotransferase

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End point title

Mean change from baseline in Alanine Aminotransferase

End point description

Alanine Aminotransferase was measured in units per liter (U/L). The Safety Set (SS) consisted of all study participants who were randomized and received at least 1 dose (any amount) of study drug. Here, 'n' (Number analyzed) signifies participants who were evaluable at specified time points.

End point type

Secondary

End point timeframe

From Baseline (Week 1) to Week 48

End point values	SOC + Placebo iv Q4W (SS)	SOC + DZP 6mg/kg iv Q4W (SS)	SOC + DZP 24mg/kg iv Q4W (SS)	SOC + DZP 45mg/kg iv Q4W (SS)
Number of subjects analysed	45	45	45	47
Units: U/L
arithmetic mean (standard deviation)
Week 2 (42, 45, 45, 43)	2.4 ( 14.1 )	2.6 ( 10.6 )	0.5 ( 11.1 )	-0.1 ( 8.6 )
Week 4 (44, 44, 43, 46)	0.8 ( 9.9 )	-0.5 ( 8.5 )	0.9 ( 7.4 )	0.3 ( 8.2 )
Week 8 (44, 43, 44, 44)	0.2 ( 10.2 )	-0.8 ( 8.3 )	5.3 ( 28.8 )	-0.6 ( 9.6 )
Week 12 (44, 44, 45, 44)	7.0 ( 21.3 )	0.8 ( 14.3 )	-0.8 ( 8.1 )	-0.1 ( 7.6 )
Week 16 (44, 44, 43, 45)	1.5 ( 13.3 )	-0.4 ( 9.3 )	0.0 ( 10.3 )	-1.1 ( 7.8 )
Week 20 (43, 43, 42, 44)	5.3 ( 23.6 )	-0.2 ( 10.2 )	1.4 ( 10.8 )	-3.7 ( 6.3 )
Week 24 (42, 43, 44, 44)	3.1 ( 20.9 )	0.5 ( 14.1 )	2.0 ( 12.0 )	-2.8 ( 7.7 )
Week 28 (43, 42, 40, 42)	1.0 ( 13.9 )	0.7 ( 10.5 )	-0.4 ( 9.3 )	-2.7 ( 7.2 )
Week 32 (44, 44, 43, 44)	1.2 ( 13.4 )	-0.5 ( 10.3 )	1.3 ( 10.8 )	-3.2 ( 6.1 )
Week 40 (42, 42, 41, 44)	-0.5 ( 13.4 )	2.6 ( 12.8 )	3.0 ( 12.9 )	-0.7 ( 8.3 )
Week 48 (38, 42, 40, 43)	0.4 ( 11.5 )	-1.2 ( 10.4 )	3.5 ( 17.0 )	-1.1 ( 7.8 )

No statistical analyses for this end point

Secondary: Mean change from baseline in Alkaline Phosphatase

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End point title

Mean change from baseline in Alkaline Phosphatase

End point description

Alkaline Phosphatase was measured in units per liter (U/L). The Safety Set (SS) consisted of all study participants who were randomized and received at least 1 dose (any amount) of study drug. Here, 'n' (Number analyzed) signifies participants who were evaluable at specified time points.

End point type

Secondary

End point timeframe

From Baseline (Week 1) to Week 48

End point values	SOC + Placebo iv Q4W (SS)	SOC + DZP 6mg/kg iv Q4W (SS)	SOC + DZP 24mg/kg iv Q4W (SS)	SOC + DZP 45mg/kg iv Q4W (SS)
Number of subjects analysed	45	45	45	47
Units: U/L
arithmetic mean (standard deviation)
Week 2 (42, 45, 45, 44)	1.8 ( 10.7 )	2.4 ( 10.6 )	1.5 ( 8.0 )	-3.6 ( 10.1 )
Week 4 (44, 44, 43, 46)	-1.7 ( 9.7 )	0.7 ( 9.2 )	-0.7 ( 8.4 )	-4.7 ( 9.4 )
Week 8 (44, 43, 44, 44)	1.7 ( 12.9 )	2.4 ( 12.7 )	1.8 ( 15.6 )	-6.1 ( 11.0 )
Week 12 (44, 44, 45, 44)	2.2 ( 11.6 )	4.2 ( 16.4 )	1.9 ( 12.9 )	-4.4 ( 11.8 )
Week 16 (44, 45, 43, 45)	3.1 ( 10.7 )	2.7 ( 13.0 )	0.0 ( 10.4 )	-6.7 ( 12.8 )
Week 20 (43, 45, 42, 44)	3.9 ( 14.0 )	1.4 ( 11.8 )	1.4 ( 11.8 )	-7.4 ( 11.2 )
Week 24 (42, 43, 44, 44)	4.7 ( 15.0 )	3.7 ( 14.0 )	2.8 ( 11.6 )	-2.7 ( 14.0 )
Week 28 (43, 43, 40, 43)	2.8 ( 14.0 )	3.1 ( 14.2 )	1.9 ( 9.5 )	-2.1 ( 13.5 )
Week 32 (44, 44, 43, 45)	3.8 ( 14.6 )	2.7 ( 16.0 )	3.2 ( 12.1 )	1.0 ( 15.9 )
Week 40 (42, 42, 41, 44)	2.4 ( 17.1 )	1.3 ( 13.1 )	2.7 ( 13.0 )	-3.0 ( 18.0 )
Week 48 (38, 42, 40, 43)	2.6 ( 13.3 )	4.0 ( 16.8 )	5.5 ( 12.8 )	-4.5 ( 18.8 )

No statistical analyses for this end point

Secondary: Mean change from baseline in Gamma Glutamyl Transferase

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End point title

Mean change from baseline in Gamma Glutamyl Transferase

End point description

Gamma Glutamyl Transferase was measured in units per liter (U/L). The Safety Set (SS) consisted of all study participants who were randomized and received at least 1 dose (any amount) of study drug. Here, 'n' (Number analyzed) signifies participants who were evaluable at specified time points.

End point type

Secondary

End point timeframe

From Baseline (Week 1) to Week 48

End point values	SOC + Placebo iv Q4W (SS)	SOC + DZP 6mg/kg iv Q4W (SS)	SOC + DZP 24mg/kg iv Q4W (SS)	SOC + DZP 45mg/kg iv Q4W (SS)
Number of subjects analysed	45	45	45	47
Units: U/L
arithmetic mean (standard deviation)
Week 2 (42, 45, 45, 43)	0.3 ( 7.6 )	2.0 ( 11.5 )	8.8 ( 68.9 )	-3.4 ( 24.3 )
Week 4 (44, 44, 43, 46)	2.1 ( 8.7 )	-1.3 ( 8.8 )	2.7 ( 28.5 )	-6.5 ( 35.5 )
Week 8 (44, 43, 44, 44)	3.5 ( 23.0 )	0.3 ( 10.5 )	-2.8 ( 49.3 )	-9.2 ( 43.3 )
Week 12 (44, 44, 45, 44)	4.1 ( 21.0 )	0.5 ( 13.4 )	-5.1 ( 29.3 )	-8.3 ( 46.1 )
Week 16 (44, 45, 43, 45)	6.5 ( 20.2 )	2.1 ( 12.5 )	-6.1 ( 45.0 )	-10.6 ( 47.7 )
Week 20 (43, 44, 42, 44)	3.5 ( 14.1 )	0.2 ( 13.4 )	-3.7 ( 50.3 )	-8.5 ( 50.5 )
Week 24 (42, 43, 44, 44)	7.1 ( 22.0 )	4.0 ( 18.7 )	-0.4 ( 53.1 )	-9.5 ( 47.2 )
Week 28 (43, 43, 40, 43)	4.6 ( 25.7 )	2.2 ( 18.3 )	-7.0 ( 46.8 )	0.0 ( 23.1 )
Week 32 (44, 44, 43, 45)	4.4 ( 28.6 )	1.5 ( 16.7 )	-5.9 ( 44.5 )	-8.2 ( 37.4 )
Week 40 (42, 42, 41, 44)	3.4 ( 41.3 )	5.7 ( 32.4 )	0.4 ( 10.1 )	-9.1 ( 45.3 )
Week 48 (38, 42, 40,43 )	1.8 ( 11.4 )	5.3 ( 23.9 )	4.7 ( 21.6 )	-9.8 ( 44.5 )

No statistical analyses for this end point

Secondary: Mean change from baseline in Bilirubin

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End point title

Mean change from baseline in Bilirubin

End point description

Bilirubin was measured in micromols per liter (µmol/L). The Safety Set (SS) consisted of all study participants who were randomized and received at least 1 dose (any amount) of study drug. Here, 'n' (Number analyzed) signifies participants who were evaluable at specified time points.

End point type

Secondary

End point timeframe

From Baseline (Week 1) to Week 48

End point values	SOC + Placebo iv Q4W (SS)	SOC + DZP 6mg/kg iv Q4W (SS)	SOC + DZP 24mg/kg iv Q4W (SS)	SOC + DZP 45mg/kg iv Q4W (SS)
Number of subjects analysed	45	45	45	47
Units: μmol/L
arithmetic mean (standard deviation)
Week 2 (42, 45, 45, 43)	0.35 ( 2.72 )	-0.48 ( 2.71 )	0.28 ( 2.38 )	-0.78 ( 3.13 )
Week 4 (44, 44, 43, 46)	0.07 ( 2.50 )	-0.18 ( 2.09 )	-0.05 ( 2.14 )	-0.79 ( 2.80 )
Week 8 (44, 43, 44, 44)	-0.09 ( 2.66 )	-0.69 ( 2.22 )	-0.19 ( 2.13 )	-0.23 ( 2.80 )
Week 12 (44, 44, 45, 44)	-0.04 ( 2.60 )	-0.70 ( 2.74 )	0.37 ( 2.17 )	-0.33 ( 3.28 )
Week 16 (44, 45, 43, 45)	0.06 ( 2.41 )	-0.45 ( 2.43 )	-0.20 ( 2.71 )	-0.51 ( 3.64 )
Week 20 (43, 43, 42, 44)	-0.54 ( 2.89 )	-0.38 ( 2.51 )	0.51 ( 2.81 )	-0.30 ( 3.03 )
Week 24 (42, 43, 44, 44)	0.08 ( 2.75 )	-0.14 ( 2.86 )	0.54 ( 2.18 )	-0.38 ( 3.57 )
Week 28 (43, 42, 40, 42)	-0.10 ( 2.98 )	-0.26 ( 3.23 )	0.79 ( 2.71 )	-0.82 ( 2.61 )
Week 32 (44, 44, 43, 44)	0.09 ( 2.75 )	-0.38 ( 2.61 )	0.93 ( 3.18 )	-0.38 ( 3.61 )
Week 40 (42, 42, 41, 44)	-0.26 ( 3.70 )	0.07 ( 3.18 )	1.03 ( 2.35 )	-0.15 ( 2.64 )
Week 48 (38, 42, 40, 43)	0.69 ( 3.57 )	-0.50 ( 3.12 )	0.79 ( 3.04 )	-0.20 ( 2.52 )

No statistical analyses for this end point

Secondary: Mean change from baseline in Direct Bilirubin

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End point title

Mean change from baseline in Direct Bilirubin

End point description

Direct Bilirubin was measured in micromols per liter (µmol/L). The Safety Set (SS) consisted of all study participants who were randomized and received at least 1 dose (any amount) of study drug. Here, 'n' (Number analyzed) signifies participants who were evaluable at specified time points.

End point type

Secondary

End point timeframe

From Baseline (Week 1) to Week 48

End point values	SOC + Placebo iv Q4W (SS)	SOC + DZP 6mg/kg iv Q4W (SS)	SOC + DZP 24mg/kg iv Q4W (SS)	SOC + DZP 45mg/kg iv Q4W (SS)
Number of subjects analysed	45	45	45	47
Units: μmol/L
arithmetic mean (standard deviation)
Week 2 (42, 45, 45, 43)	0.03 ( 0.92 )	-0.06 ( 0.92 )	0.09 ( 1.12 )	-0.24 ( 1.10 )
Week 4 (44, 44, 43, 46)	0.10 ( 1.03 )	0.03 ( 0.75 )	-0.04 ( 0.82 )	-0.10 ( 0.93 )
Week 8 (44, 43, 44, 44)	0.03 ( 0.91 )	-0.18 ( 0.55 )	-0.17 ( 0.86 )	0.03 ( 1.10 )
Week 12 (44, 44, 45, 44)	0.15 ( 0.99 )	-0.07 ( 0.95 )	-0.01 ( 1.06 )	-0.05 ( 1.30 )
Week 16 (44, 45, 43, 45)	0.18 ( 0.81 )	-0.01 ( 0.66 )	-0.07 ( 1.04 )	-0.01 ( 1.40 )
Week 20 (43, 43, 42, 44)	-0.04 ( 0.95 )	0.07 ( 0.91 )	0.02 ( 0.94 )	0.00 ( 1.19 )
Week 24 (42, 43, 44, 44)	0.05 ( 1.10 )	0.14 ( 0.95 )	0.08 ( 1.02 )	-0.08 ( 1.25 )
Week 28 (43, 42, 40, 42)	0.06 ( 1.06 )	-0.06 ( 1.00 )	0.11 ( 0.80 )	-0.06 ( 1.15 )
Week 32 (44, 44, 43, 44)	0.12 ( 1.16 )	0.05 ( 0.90 )	0.21 ( 1.21 )	-0.04 ( 1.36 )
Week 40 (42, 42, 41, 44)	0.07 ( 1.31 )	0.03 ( 0.76 )	0.23 ( 1.00 )	0.07 ( 1.05 )
Week 48 (38, 42, 40, 43)	0.31 ( 1.34 )	-0.05 ( 1.01 )	0.20 ( 1.25 )	0.08 ( 0.98 )

No statistical analyses for this end point

Secondary: Mean change from baseline in Lactate Dehydrogenase

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End point title

Mean change from baseline in Lactate Dehydrogenase

End point description

Lactate Dehydrogenase was measured in units per liter (U/L). The Safety Set (SS) consisted of all study participants who were randomized and received at least 1 dose (any amount) of study drug. Here, 'n' (Number analyzed) signifies participants who were evaluable at specified time points.

End point type

Secondary

End point timeframe

From Baseline (Week 1) to Week 48

End point values	SOC + Placebo iv Q4W (SS)	SOC + DZP 6mg/kg iv Q4W (SS)	SOC + DZP 24mg/kg iv Q4W (SS)	SOC + DZP 45mg/kg iv Q4W (SS)
Number of subjects analysed	45	45	45	47
Units: U/L
arithmetic mean (standard deviation)
Week 2 (42, 45, 45, 44)	-3.3 ( 27.8 )	-7.8 ( 21.2 )	-5.9 ( 35.2 )	-12.8 ( 24.8 )
Week 4 (44, 44, 43, 46)	-3.0 ( 23.4 )	-3.7 ( 37.0 )	-5.6 ( 35.6 )	-18.5 ( 34.1 )
Week 8 (44, 43, 44, 44)	-5.7 ( 27.4 )	-11.8 ( 31.5 )	-9.2 ( 39.0 )	-20.4 ( 37.4 )
Week 12 (44, 44, 45, 44)	3.0 ( 28.7 )	-7.4 ( 34.6 )	-11.1 ( 45.1 )	-24.4 ( 39.0 )
Week 16 (44, 44, 43, 45)	-2.2 ( 25.5 )	-11.1 ( 29.9 )	-10.6 ( 48.6 )	-22.4 ( 43.3 )
Week 20 (43, 45, 41, 44)	-0.7 ( 33.9 )	-10.8 ( 37.0 )	-9.9 ( 47.8 )	-28.5 ( 32.1 )
Week 24 (42, 43, 44, 44)	-4.5 ( 31.3 )	-14.3 ( 31.5 )	-14.6 ( 34.4 )	-29.3 ( 32.2 )
Week 28 (43, 43, 40, 43)	0.0 ( 40.8 )	-16.0 ( 40.9 )	-13.2 ( 35.0 )	-34.8 ( 36.9 )
Week 32 (44, 44, 43, 45)	5.0 ( 55.0 )	-9.9 ( 43.4 )	-8.1 ( 33.5 )	-22.9 ( 40.6 )
Week 40 (42, 42, 41, 44)	-1.6 ( 38.1 )	-2.9 ( 41.1 )	-8.0 ( 28.4 )	-20.5 ( 40.1 )
Week 48 (38, 42, 40, 43)	-8.8 ( 35.2 )	-4.2 ( 54.3 )	-1.5 ( 32.7 )	-16.0 ( 36.3 )

No statistical analyses for this end point

Secondary: Mean change from baseline in Creatinine

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End point title

Mean change from baseline in Creatinine

End point description

Creatinine was measured in micromols per liter (µmol/L). The Safety Set (SS) consisted of all study participants who were randomized and received at least 1 dose (any amount) of study drug. Here, 'n' (Number analyzed) signifies participants who were evaluable at specified time points.

End point type

Secondary

End point timeframe

From Baseline (Week 1) to Week 48

End point values	SOC + Placebo iv Q4W (SS)	SOC + DZP 6mg/kg iv Q4W (SS)	SOC + DZP 24mg/kg iv Q4W (SS)	SOC + DZP 45mg/kg iv Q4W (SS)
Number of subjects analysed	45	45	45	47
Units: μmol/L
arithmetic mean (standard deviation)
Week 2 (42, 45, 45, 44)	0.9 ( 9.1 )	-0.1 ( 8.0 )	1.5 ( 5.8 )	0.6 ( 7.2 )
Week 4 (44, 44, 43, 46)	-0.8 ( 8.9 )	-0.2 ( 9.3 )	-0.6 ( 7.3 )	-1.4 ( 8.2 )
Week 8 (44, 43, 44, 44)	0.5 ( 7.0 )	0.3 ( 7.6 )	-0.5 ( 6.9 )	0.1 ( 8.4 )
Week 12 (44, 44, 45, 44)	-0.3 ( 7.0 )	1.4 ( 7.5 )	-0.4 ( 6.4 )	-0.7 ( 8.2 )
Week 16 (44, 45, 43, 45)	-0.1 ( 9.8 )	1.0 ( 8.2 )	0.7 ( 6.8 )	-1.1 ( 9.4 )
Week 20 (43, 45, 42, 44)	0.7 ( 8.6 )	1.4 ( 10.2 )	0.8 ( 6.9 )	-0.3 ( 7.7 )
Week 24 (42, 43, 44, 44)	0.0 ( 8.8 )	0.8 ( 8.8 )	0.3 ( 6.6 )	0.9 ( 9.7 )
Week 28 (43, 43, 40, 43)	2.5 ( 10.0 )	2.7 ( 10.0 )	1.0 ( 7.8 )	-0.9 ( 7.8 )
Week 32 (44, 44, 43, 45)	5.5 ( 35.7 )	0.5 ( 8.1 )	3.6 ( 7.8 )	1.6 ( 11.2 )
Week 40 (42, 42, 41, 44)	2.3 ( 9.5 )	2.2 ( 8.5 )	3.9 ( 6.0 )	3.0 ( 8.4 )
Week 48 (38, 42, 40, 43)	1.9 ( 10.6 )	0.7 ( 7.6 )	2.5 ( 5.2 )	2.9 ( 9.8 )

No statistical analyses for this end point

Secondary: Mean change from baseline in Urea Nitrogen

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End point title

Mean change from baseline in Urea Nitrogen

End point description

Urea Nitrogen was measured in millimoles per liter (mmol/L). The Safety Set (SS) consisted of all study participants who were randomized and received at least 1 dose (any amount) of study drug. Here, 'n' (Number analyzed) signifies participants who were evaluable at specified time points.

End point type

Secondary

End point timeframe

From Baseline (Week 1) to Week 48

End point values	SOC + Placebo iv Q4W (SS)	SOC + DZP 6mg/kg iv Q4W (SS)	SOC + DZP 24mg/kg iv Q4W (SS)	SOC + DZP 45mg/kg iv Q4W (SS)
Number of subjects analysed	45	45	45	47
Units: mmol/L
arithmetic mean (standard deviation)
Week 2 (42, 45, 45, 43)	0.28 ( 1.55 )	-0.09 ( 1.23 )	-0.05 ( 1.32 )	-0.02 ( 1.31 )
Week 4 (44, 44, 43, 46)	-0.07 ( 1.21 )	-0.33 ( 1.52 )	-0.14 ( 1.20 )	0.04 ( 1.19 )
Week 8 (44, 43, 44, 44)	0.06 ( 1.25 )	-0.26 ( 1.22 )	-0.19 ( 1.07 )	0.17 ( 1.59 )
Week 12 (44, 44, 45, 44)	0.03 ( 1.13 )	-0.39 ( 1.31 )	-0.29 ( 1.17 )	-0.22 ( 1.15 )
Week 16 (44, 45, 43, 45)	0.19 ( 1.35 )	-0.18 ( 1.40 )	0.19 ( 1.49 )	-0.03 ( 1.41 )
Week 20 (43, 44, 42, 44)	-0.18 ( 1.29 )	-0.20 ( 1.33 )	-0.25 ( 1.22 )	-0.16 ( 1.08 )
Week 24 (42, 43, 44, 44)	0.08 ( 1.69 )	-0.44 ( 1.38 )	-0.13 ( 1.18 )	-0.09 ( 1.50 )
Week 28 (43, 43, 40, 43)	0.13 ( 1.38 )	0.03 ( 1.61 )	-0.23 ( 1.26 )	-0.22 ( 1.14 )
Week 32 (44, 44, 43, 45)	0.40 ( 2.37 )	-0.30 ( 1.65 )	0.21 ( 1.17 )	0.10 ( 1.43 )
Week 40 (42, 42, 41, 44)	0.29 ( 1.54 )	0.10 ( 1.73 )	0.21 ( 1.20 )	0.14 ( 1.43 )
Week 48 (38, 42, 40, 43)	0.05 ( 1.22 )	-0.31 ( 1.54 )	0.23 ( 1.38 )	-0.02 ( 1.56 )

No statistical analyses for this end point

Secondary: Mean change from baseline in Sodium

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End point title

Mean change from baseline in Sodium

End point description

Sodium was measured in millimoles per liter (mmol/L). The Safety Set (SS) consisted of all study participants who were randomized and received at least 1 dose (any amount) of study drug. Here, 'n' (Number analyzed) signifies participants who were evaluable at specified time points.

End point type

Secondary

End point timeframe

From Baseline (Week 1) to Week 48

End point values	SOC + Placebo iv Q4W (SS)	SOC + DZP 6mg/kg iv Q4W (SS)	SOC + DZP 24mg/kg iv Q4W (SS)	SOC + DZP 45mg/kg iv Q4W (SS)
Number of subjects analysed	45	45	45	47
Units: mmol/L
arithmetic mean (standard deviation)
Week 2 (42, 45, 45, 44)	-0.1 ( 1.9 )	-0.4 ( 2.4 )	0.1 ( 1.6 )	0.0 ( 2.2 )
Week 4 (44, 44, 43, 46)	-0.3 ( 2.0 )	-0.6 ( 2.1 )	0.3 ( 2.1 )	-0.1 ( 2.4 )
Week 8 (44, 43, 44, 44)	0.1 ( 2.2 )	-0.4 ( 2.4 )	0.3 ( 2.2 )	0.1 ( 2.3 )
Week 12 (44, 44, 45, 44)	-0.3 ( 2.0 )	-0.5 ( 2.0 )	0.2 ( 2.0 )	0.1 ( 2.3 )
Week 16 (44, 45, 43, 45)	-0.4 ( 2.3 )	-0.2 ( 1.9 )	0.0 ( 2.0 )	-0.2 ( 2.3 )
Week 20 (43, 45, 42, 44)	0.3 ( 2.2 )	-0.8 ( 2.2 )	-0.1 ( 2.0 )	-0.5 ( 2.4 )
Week 24 (42, 43, 44, 44)	-0.1 ( 2.5 )	-0.4 ( 2.2 )	0.0 ( 2.2 )	-0.3 ( 2.1 )
Week 28 (43, 43, 40, 43)	0.0 ( 1.9 )	-0.4 ( 2.4 )	0.2 ( 1.9 )	0.1 ( 2.3 )
Week 32 (44, 44, 43, 45)	0.0 ( 2.3 )	-0.8 ( 3.2 )	0.1 ( 2.1 )	0.2 ( 2.2 )
Week 40 (42, 42, 41, 44)	-0.1 ( 2.2 )	-1.2 ( 2.2 )	-0.1 ( 1.6 )	-0.3 ( 2.4 )
Week 48 (38, 42, 40, 43)	-0.4 ( 2.0 )	-1.1 ( 2.6 )	-0.5 ( 1.7 )	0.2 ( 2.3 )

No statistical analyses for this end point

Secondary: Mean change from baseline in Potassium

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End point title

Mean change from baseline in Potassium

End point description

Potassium was measured in millimoles per liter (mmol/L). The Safety Set (SS) consisted of all study participants who were randomized and received at least 1 dose (any amount) of study drug. Here, 'n' (Number analyzed) signifies participants who were evaluable at specified time points.

End point type

Secondary

End point timeframe

From Baseline (Week 1) to Week 48

End point values	SOC + Placebo iv Q4W (SS)	SOC + DZP 6mg/kg iv Q4W (SS)	SOC + DZP 24mg/kg iv Q4W (SS)	SOC + DZP 45mg/kg iv Q4W (SS)
Number of subjects analysed	45	45	45	47
Units: mmol/L
arithmetic mean (standard deviation)
Week 2 (42, 45, 44, 44)	0.04 ( 0.45 )	0.15 ( 0.40 )	0.00 ( 0.36 )	-0.03 ( 0.37 )
Week 4 (44, 44, 43, 46)	0.06 ( 0.44 )	0.08 ( 0.35 )	-0.07 ( 0.41 )	-0.12 ( 0.40 )
Week 8 (44, 43, 44, 44)	-0.04 ( 0.40 )	0.11 ( 0.38 )	0.00 ( 0.35 )	-0.07 ( 0.40 )
Week 12 (44, 44, 44, 44)	-0.01 ( 0.33 )	0.02 ( 0.31 )	-0.07 ( 0.41 )	-0.12 ( 0.34 )
Week 16 (44, 44, 43, 45)	-0.01 ( 0.34 )	0.16 ( 0.33 )	-0.09 ( 0.42 )	-0.05 ( 0.33 )
Week 20 (43, 45, 40, 43)	0.04 ( 0.38 )	0.14 ( 0.33 )	-0.04 ( 0.46 )	-0.08 ( 0.37 )
Week 24 (42, 43, 43, 43)	0.06 ( 0.43 )	0.07 ( 0.39 )	0.03 ( 0.33 )	-0.11 ( 0.37 )
Week 28 (41, 43, 40, 43)	0.09 ( 0.43 )	0.12 ( 0.47 )	0.06 ( 0.42 )	0.03 ( 0.45 )
Week 32 (44, 44, 43, 45)	0.03 ( 0.44 )	0.07 ( 0.44 )	0.10 ( 0.46 )	-0.05 ( 0.38 )
Week 40 (42, 41, 41, 44)	0.06 ( 0.33 )	0.16 ( 0.51 )	0.16 ( 0.39 )	-0.06 ( 0.37 )
Week 48 (38, 42, 40, 43)	-0.01 ( 0.30 )	0.00 ( 0.30 )	-0.02 ( 0.39 )	-0.07 ( 0.40 )

No statistical analyses for this end point

Secondary: Mean change from baseline in Calcium

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End point title

Mean change from baseline in Calcium

End point description

Calcium was measured in millimoles per liter (mmol/L). The Safety Set (SS) consisted of all study participants who were randomized and received at least 1 dose (any amount) of study drug. Here, 'n' (Number analyzed) signifies participants who were evaluable at specified time points.

End point type

Secondary

End point timeframe

From Baseline (Week 1) to Week 48

End point values	SOC + Placebo iv Q4W (SS)	SOC + DZP 6mg/kg iv Q4W (SS)	SOC + DZP 24mg/kg iv Q4W (SS)	SOC + DZP 45mg/kg iv Q4W (SS)
Number of subjects analysed	45	45	45	47
Units: mmol/L
arithmetic mean (standard deviation)
Week 2 (42, 45, 45, 44)	0.008 ( 0.104 )	-0.001 ( 0.103 )	0.004 ( 0.088 )	-0.008 ( 0.092 )
Week 4 (44, 44, 43, 46)	0.007 ( 0.108 )	-0.018 ( 0.099 )	-0.018 ( 0.090 )	-0.001 ( 0.086 )
Week 8 (44, 43, 44, 44)	-0.006 ( 0.093 )	-0.033 ( 0.117 )	-0.014 ( 0.106 )	-0.003 ( 0.089 )
Week 12 (44, 44, 45, 44)	0.006 ( 0.108 )	-0.011 ( 0.121 )	-0.013 ( 0.097 )	-0.004 ( 0.111 )
Week 16 (44, 45, 43, 45)	-0.025 ( 0.106 )	-0.004 ( 0.088 )	-0.013 ( 0.095 )	-0.024 ( 0.119 )
Week 20 (43, 45, 42, 44)	-0.036 ( 0.116 )	-0.020 ( 0.084 )	-0.015 ( 0.108 )	0.005 ( 0.080 )
Week 24 (42, 43, 44, 44)	-0.027 ( 0.106 )	-0.026 ( 0.094 )	-0.012 ( 0.095 )	0.007 ( 0.100 )
Week 28 (43, 43, 40, 43)	-0.031 ( 0.121 )	-0.039 ( 0.091 )	-0.016 ( 0.113 )	-0.014 ( 0.092 )
Week 32 (44, 44, 43, 45)	0.003 ( 0.098 )	-0.043 ( 0.099 )	0.019 ( 0.107 )	-0.001 ( 0.105 )
Week 40 (42, 42, 41, 44)	-0.027 ( 0.114 )	-0.022 ( 0.115 )	0.006 ( 0.115 )	-0.012 ( 0.105 )
Week 48 (38, 42, 40, 43)	-0.013 ( 0.096 )	-0.037 ( 0.119 )	-0.004 ( 0.104 )	-0.017 ( 0.110 )

No statistical analyses for this end point

Secondary: Mean change from baseline in Phosphate

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End point title

Mean change from baseline in Phosphate

End point description

Phosphate was measured in millimoles per liter (mmol/L). The Safety Set (SS) consisted of all study participants who were randomized and received at least 1 dose (any amount) of study drug. Here, 'n' (Number analyzed) signifies participants who were evaluable at specified time points.

End point type

Secondary

End point timeframe

From Baseline (Week 1) to Week 48

End point values	SOC + Placebo iv Q4W (SS)	SOC + DZP 6mg/kg iv Q4W (SS)	SOC + DZP 24mg/kg iv Q4W (SS)	SOC + DZP 45mg/kg iv Q4W (SS)
Number of subjects analysed	45	45	45	47
Units: mmol/L
arithmetic mean (standard deviation)
Week 2 (42, 45, 44, 43)	0.044 ( 0.163 )	0.032 ( 0.192 )	-0.047 ( 0.230 )	0.033 ( 0.168 )
Week 4 (44, 44, 43, 46)	-0.004 ( 0.162 )	-0.029 ( 0.185 )	-0.070 ( 0.187 )	0.020 ( 0.163 )
Week 8 (44, 43, 44, 44)	0.006 ( 0.178 )	-0.063 ( 0.225 )	-0.028 ( 0.207 )	0.051 ( 0.187 )
Week 12 (44, 44, 44, 44)	0.029 ( 0.159 )	-0.004 ( 0.149 )	-0.015 ( 0.236 )	0.045 ( 0.183 )
Week 16 (44, 44, 43, 45)	-0.010 ( 0.186 )	0.012 ( 0.182 )	-0.025 ( 0.195 )	0.005 ( 0.178 )
Week 20 (43, 43, 41, 43)	-0.030 ( 0.208 )	-0.037 ( 0.244 )	-0.031 ( 0.177 )	0.013 ( 0.187 )
Week 24 (42, 43, 43, 43)	-0.013 ( 0.181 )	-0.042 ( 0.160 )	-0.040 ( 0.229 )	0.035 ( 0.200 )
Week 28 (41, 42, 40, 42)	-0.024 ( 0.189 )	0.008 ( 0.238 )	-0.031 ( 0.232 )	0.037 ( 0.184 )
Week 32 (44, 44, 43, 44)	-0.002 ( 0.217 )	-0.056 ( 0.223 )	0.015 ( 0.220 )	0.030 ( 0.190 )
Week 40 (42, 41, 41, 44)	0.018 ( 0.207 )	0.009 ( 0.196 )	-0.022 ( 0.208 )	0.034 ( 0.224 )
Week 48 (38, 41, 40, 43)	0.032 ( 0.183 )	-0.012 ( 0.167 )	-0.044 ( 0.214 )	0.035 ( 0.190 )

No statistical analyses for this end point

Secondary: Mean change from baseline in Cholesterol

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End point title

Mean change from baseline in Cholesterol

End point description

Cholesterol was measured in millimoles per liter (mmol/L). The Safety Set (SS) consisted of all study participants who were randomized and received at least 1 dose (any amount) of study drug. Here, 'n' (Number analyzed) signifies participants who were evaluable at specified time points.

End point type

Secondary

End point timeframe

From Baseline (Week 1) to Week 48

End point values	SOC + Placebo iv Q4W (SS)	SOC + DZP 6mg/kg iv Q4W (SS)	SOC + DZP 24mg/kg iv Q4W (SS)	SOC + DZP 45mg/kg iv Q4W (SS)
Number of subjects analysed	45	45	45	47
Units: mmol/L
arithmetic mean (standard deviation)
Week 2 (42, 45, 45, 43)	0.00 ( 0.49 )	-0.07 ( 0.46 )	-0.06 ( 0.51 )	-0.19 ( 0.47 )
Week 4 (44, 44, 43, 46)	-0.08 ( 0.49 )	-0.03 ( 0.46 )	-0.07 ( 0.68 )	-0.07 ( 0.57 )
Week 8 (44, 43, 44, 44)	-0.09 ( 0.57 )	-0.07 ( 0.46 )	-0.15 ( 0.81 )	-0.17 ( 0.59 )
Week 12 (44, 44, 45, 44)	-0.14 ( 0.72 )	-0.16 ( 0.61 )	-0.23 ( 0.68 )	-0.10 ( 0.75 )
Week 16 (44, 45, 43, 45)	-0.16 ( 0.80 )	-0.16 ( 0.66 )	-0.35 ( 0.80 )	-0.27 ( 0.72 )
Week 20 (43, 44, 42, 44)	-0.27 ( 0.77 )	-0.22 ( 0.60 )	-0.42 ( 0.81 )	-0.23 ( 0.85 )
Week 24 (42, 43, 44, 44)	-0.12 ( 0.87 )	-0.17 ( 0.66 )	-0.28 ( 0.96 )	-0.16 ( 0.78 )
Week 28 (43, 43, 40, 43)	-0.17 ( 0.89 )	-0.37 ( 0.63 )	-0.35 ( 0.97 )	-0.29 ( 0.80 )
Week 32 (44, 44, 43, 45)	-0.13 ( 0.86 )	-0.22 ( 0.63 )	-0.16 ( 0.83 )	-0.15 ( 0.81 )
Week 40 (42, 42, 41, 44)	-0.34 ( 0.87 )	-0.25 ( 0.80 )	-0.19 ( 0.77 )	-0.13 ( 1.15 )
Week 48 (38, 42, 40, 43)	-0.40 ( 0.80 )	-0.36 ( 0.74 )	-0.23 ( 0.97 )	-0.18 ( 1.09 )

No statistical analyses for this end point

Secondary: Mean change from baseline in Triglycerides

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End point title

Mean change from baseline in Triglycerides

End point description

Triglycerides was measured in millimoles per liter (mmol/L). The Safety Set (SS) consisted of all study participants who were randomized and received at least 1 dose (any amount) of study drug. Here, 'n' (Number analyzed) signifies participants who were evaluable at specified time points.

End point type

Secondary

End point timeframe

From Baseline (Week 1) to Week 48

End point values	SOC + Placebo iv Q4W (SS)	SOC + DZP 6mg/kg iv Q4W (SS)	SOC + DZP 24mg/kg iv Q4W (SS)	SOC + DZP 45mg/kg iv Q4W (SS)
Number of subjects analysed	45	45	45	47
Units: mmol/L
arithmetic mean (standard deviation)
Week 2 (42, 45, 45, 44)	-0.176 ( 1.593 )	0.046 ( 0.683 )	0.110 ( 0.855 )	0.183 ( 0.751 )
Week 4 (44, 44, 43, 46)	-0.189 ( 1.212 )	-0.004 ( 0.510 )	-0.030 ( 0.471 )	0.084 ( 0.529 )
Week 8 (44, 43, 44, 44)	-0.182 ( 1.554 )	0.076 ( 0.582 )	-0.084 ( 0.498 )	0.046 ( 0.585 )
Week 12 (44, 44, 45, 44)	-0.265 ( 1.445 )	0.088 ( 0.713 )	0.063 ( 0.578 )	0.009 ( 0.514 )
Week 16 (44, 45, 43, 45)	-0.164 ( 1.345 )	0.099 ( 1.488 )	0.142 ( 0.580 )	0.112 ( 1.035 )
Week 20 (43, 45, 42, 44)	-0.233 ( 1.391 )	-0.104 ( 0.837 )	0.008 ( 0.622 )	-0.060 ( 0.707 )
Week 24 (42, 43, 44, 44)	-0.263 ( 1.515 )	-0.045 ( 0.774 )	-0.013 ( 0.608 )	-0.030 ( 0.707 )
Week 28 (43, 43, 40, 43)	-0.013 ( 1.559 )	-0.125 ( 0.782 )	-0.043 ( 0.423 )	-0.036 ( 0.663 )
Week 32 (44, 44, 43, 45)	-0.260 ( 1.418 )	0.045 ( 0.717 )	0.057 ( 0.532 )	0.112 ( 0.718 )
Week 40 (42, 42, 41, 44)	-0.134 ( 1.175 )	-0.159 ( 0.765 )	0.177 ( 0.821 )	0.022 ( 0.644 )
Week 48 (38, 42, 40, 43)	-0.242 ( 1.516 )	-0.149 ( 0.758 )	0.114 ( 0.507 )	0.054 ( 0.752 )

No statistical analyses for this end point

Secondary: Mean change from baseline in Protein

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End point title

Mean change from baseline in Protein

End point description

Protein was measured in grams per liter (g/L). The Safety Set (SS) consisted of all study participants who were randomized and received at least 1 dose (any amount) of study drug. Here, 'n' (Number analyzed) signifies participants who were evaluable at specified time points.

End point type

Secondary

End point timeframe

From Baseline (Week 1) to Week 48

End point values	SOC + Placebo iv Q4W (SS)	SOC + DZP 6mg/kg iv Q4W (SS)	SOC + DZP 24mg/kg iv Q4W (SS)	SOC + DZP 45mg/kg iv Q4W (SS)
Number of subjects analysed	45	45	45	47
Units: g/L
arithmetic mean (standard deviation)
Week 2 (42, 45, 45, 44)	-0.2 ( 3.7 )	-1.2 ( 4.0 )	-1.0 ( 4.2 )	-1.1 ( 3.8 )
Week 4 (44, 44, 43, 46)	-1.5 ( 4.4 )	-1.6 ( 4.2 )	-1.5 ( 4.7 )	-1.7 ( 4.4 )
Week 8 (44, 43, 44, 44)	-1.1 ( 4.4 )	-2.1 ( 4.1 )	-1.8 ( 5.7 )	-2.0 ( 3.9 )
Week 12 (44, 44, 45, 44)	-0.8 ( 3.8 )	-1.3 ( 4.7 )	-1.4 ( 5.2 )	-1.2 ( 5.8 )
Week 16 (44, 45, 43, 45)	-1.2 ( 5.2 )	-0.3 ( 4.1 )	-2.3 ( 5.6 )	-3.8 ( 5.0 )
Week 20 (43, 45, 42, 44)	-2.7 ( 6.0 )	-1.6 ( 4.6 )	-2.6 ( 4.7 )	-3.1 ( 5.4 )
Week 24 (42, 43, 44, 44)	-2.2 ( 7.5 )	-1.8 ( 4.6 )	-1.8 ( 5.5 )	-2.0 ( 4.7 )
Week 28 (43, 43, 40, 43)	-3.1 ( 7.4 )	-2.4 ( 4.6 )	-2.5 ( 5.7 )	-3.6 ( 6.4 )
Week 32 (44, 44, 43, 45)	-1.4 ( 6.9 )	-1.5 ( 5.7 )	-0.8 ( 5.0 )	-1.9 ( 6.4 )
Week 40 (42, 42, 41, 44)	-2.2 ( 6.5 )	-0.9 ( 5.0 )	-1.8 ( 5.3 )	-2.6 ( 6.1 )
Week 48 (38, 42, 40, 43)	-2.3 ( 6.2 )	-2.4 ( 5.9 )	-0.9 ( 5.1 )	-3.4 ( 6.4 )

No statistical analyses for this end point

Secondary: Mean change from baseline in Albumin

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End point title

Mean change from baseline in Albumin

End point description

Albumin was measured in grams per liter (g/L). The Safety Set (SS) consisted of all study participants who were randomized and received at least 1 dose (any amount) of study drug. Here, 'n' (Number analyzed) signifies participants who were evaluable at specified time points.

End point type

Secondary

End point timeframe

From Baseline (Week 1) to Week 48

End point values	SOC + Placebo iv Q4W (SS)	SOC + DZP 6mg/kg iv Q4W (SS)	SOC + DZP 24mg/kg iv Q4W (SS)	SOC + DZP 45mg/kg iv Q4W (SS)
Number of subjects analysed	45	45	45	47
Units: g/L
arithmetic mean (standard deviation)
Week 2 (42, 45, 45, 44)	0.1 ( 2.1 )	-0.4 ( 2.4 )	-0.5 ( 2.4 )	-0.5 ( 1.9 )
Week 4 (44, 44, 43, 46)	-0.5 ( 2.4 )	-0.4 ( 2.3 )	-0.2 ( 2.4 )	-0.3 ( 1.9 )
Week 8 (44, 43, 44, 44)	-0.3 ( 2.3 )	-0.3 ( 2.5 )	-0.3 ( 3.0 )	0.1 ( 2.2 )
Week 12 (44, 44, 45, 44)	-0.1 ( 2.2 )	0.2 ( 2.7 )	0.2 ( 2.7 )	0.7 ( 3.0 )
Week 16 (44, 45, 43, 45)	0.0 ( 2.5 )	1.0 ( 2.5 )	0.1 ( 2.9 )	-0.2 ( 2.9 )
Week 20 (43, 45, 42, 44)	-0.7 ( 2.7 )	0.1 ( 2.7 )	0.4 ( 2.4 )	0.4 ( 2.2 )
Week 24 (42, 43, 44, 44)	-0.1 ( 2.9 )	0.0 ( 2.1 )	0.4 ( 2.4 )	1.2 ( 2.7 )
Week 28 (43, 43, 40, 43)	-0.7 ( 3.0 )	-0.4 ( 2.3 )	0.1 ( 2.9 )	0.1 ( 2.6 )
Week 32 (44, 44, 43, 45)	0.6 ( 2.8 )	-0.1 ( 3.0 )	0.9 ( 3.2 )	0.7 ( 2.8 )
Week 40 (42, 42, 41, 44)	0.1 ( 2.8 )	-0.1 ( 2.9 )	0.2 ( 2.6 )	0.3 ( 3.0 )
Week 48 (38, 42, 40, 43)	0.1 ( 2.8 )	-0.7 ( 3.0 )	0.2 ( 3.0 )	-0.8 ( 3.5 )

No statistical analyses for this end point

Secondary: Mean change from baseline in Glucose

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End point title

Mean change from baseline in Glucose

End point description

Glucose was measured in millimoles per liter (mmol/L). The Safety Set (SS) consisted of all study participants who were randomized and received at least 1 dose (any amount) of study drug. Here, 'n' (Number analyzed) signifies participants who were evaluable at specified time points.

End point type

Secondary

End point timeframe

From Baseline (Week 1) to Week 48

End point values	SOC + Placebo iv Q4W (SS)	SOC + DZP 6mg/kg iv Q4W (SS)	SOC + DZP 24mg/kg iv Q4W (SS)	SOC + DZP 45mg/kg iv Q4W (SS)
Number of subjects analysed	45	45	45	47
Units: mmol/L
arithmetic mean (standard deviation)
Week 2 (42, 45, 44, 43)	0.18 ( 0.75 )	0.26 ( 0.70 )	0.09 ( 0.78 )	0.13 ( 1.28 )
Week 4 (44, 44, 43, 46)	0.04 ( 0.71 )	0.03 ( 0.70 )	-0.04 ( 0.90 )	0.11 ( 1.10 )
Week 8 (44, 43, 44, 44)	0.17 ( 0.66 )	0.12 ( 0.90 )	0.23 ( 0.95 )	0.12 ( 1.16 )
Week 12 (44, 44, 43, 44)	-0.08 ( 0.69 )	0.08 ( 0.66 )	-0.13 ( 0.79 )	-0.15 ( 0.99 )
Week 16 (44, 45, 43, 45)	0.11 ( 0.77 )	0.06 ( 0.63 )	0.16 ( 0.92 )	-0.18 ( 1.47 )
Week 20 (43, 44, 42, 43)	0.16 ( 0.85 )	0.20 ( 0.84 )	0.13 ( 0.83 )	-0.08 ( 1.01 )
Week 24 (42, 43, 43, 43)	-0.07 ( 0.85 )	0.05 ( 0.49 )	-0.09 ( 0.73 )	-0.22 ( 1.06 )
Week 28 (39, 43, 40, 43)	0.22 ( 1.01 )	0.09 ( 0.76 )	-0.01 ( 0.74 )	0.07 ( 1.22 )
Week 32 (44, 44, 42, 45)	-0.04 ( 0.72 )	-0.07 ( 0.63 )	-0.08 ( 0.65 )	0.06 ( 1.10 )
Week 40 (41, 41, 41, 44)	-0.05 ( 0.62 )	0.08 ( 0.71 )	-0.09 ( 0.68 )	-0.08 ( 1.07 )
Week 48 (38, 42, 40, 43)	-0.14 ( 0.78 )	-0.11 ( 0.61 )	-0.06 ( 0.64 )	-0.14 ( 1.25 )

No statistical analyses for this end point

Secondary: Mean change from baseline in Lipase, Pancreatic

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End point title

Mean change from baseline in Lipase, Pancreatic

End point description

Lipase, Pancreatic was measured in units per liter (U/L). The Safety Set (SS) consisted of all study participants who were randomized and received at least 1 dose (any amount) of study drug. Here, 'n' (Number analyzed) signifies participants who were evaluable at specified time points.

End point type

Secondary

End point timeframe

From Baseline (Week 1) to Week 48

End point values	SOC + Placebo iv Q4W (SS)	SOC + DZP 6mg/kg iv Q4W (SS)	SOC + DZP 24mg/kg iv Q4W (SS)	SOC + DZP 45mg/kg iv Q4W (SS)
Number of subjects analysed	45	45	45	47
Units: U/L
arithmetic mean (standard deviation)
Week 2 (42, 45, 45, 44)	-1.1 ( 10.5 )	2.2 ( 11.9 )	0.1 ( 9.2 )	-0.2 ( 7.5 )
Week 4 (44, 44, 43, 46)	-2.1 ( 9.8 )	0.9 ( 9.1 )	0.1 ( 10.6 )	-1.2 ( 10.0 )
Week 8 (44, 43, 44, 44)	-3.1 ( 9.2 )	3.7 ( 11.8 )	2.0 ( 20.0 )	-1.8 ( 10.3 )
Week 12 (44, 44, 45, 44)	-0.5 ( 8.7 )	1.0 ( 11.1 )	-0.7 ( 13.4 )	-0.6 ( 9.6 )
Week 16 (44, 45, 43, 45)	0.4 ( 7.4 )	2.7 ( 8.4 )	0.5 ( 11.3 )	-0.2 ( 11.8 )
Week 20 (43, 45, 42, 44)	-0.6 ( 10.4 )	2.1 ( 8.0 )	-0.9 ( 9.0 )	-1.7 ( 9.3 )
Week 24 (42, 43, 44, 44)	-0.5 ( 11.0 )	-0.1 ( 9.1 )	-0.1 ( 8.1 )	1.2 ( 11.8 )
Week 28 (43, 43, 40, 43)	1.6 ( 13.1 )	1.7 ( 10.5 )	0.5 ( 11.9 )	1.7 ( 14.1 )
Week 32 (44, 44, 43, 45)	1.1 ( 15.1 )	1.0 ( 11.0 )	1.2 ( 10.6 )	3.8 ( 21.6 )
Week 40 (42, 42, 41, 44)	1.2 ( 11.0 )	1.3 ( 7.0 )	-0.3 ( 8.9 )	2.5 ( 8.9 )
Week 48 (38, 42, 40, 43)	1.4 ( 10.1 )	2.2 ( 10.0 )	0.3 ( 10.7 )	3.7 ( 10.2 )

No statistical analyses for this end point

Secondary: Mean change from baseline in Creatine Kinase

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End point title

Mean change from baseline in Creatine Kinase

End point description

Creatine Kinase was measured in units per liter (U/L). The Safety Set (SS) consisted of all study participants who were randomized and received at least 1 dose (any amount) of study drug. Here, 'n' (Number analyzed) signifies participants who were evaluable at specified time points.

End point type

Secondary

End point timeframe

From Baseline (Week 1) to Week 48

End point values	SOC + Placebo iv Q4W (SS)	SOC + DZP 6mg/kg iv Q4W (SS)	SOC + DZP 24mg/kg iv Q4W (SS)	SOC + DZP 45mg/kg iv Q4W (SS)
Number of subjects analysed	45	45	45	47
Units: U/L
arithmetic mean (standard deviation)
Week 2 (42, 45, 45, 43)	-3.0 ( 67.1 )	-2.2 ( 55.6 )	-2.2 ( 18.2 )	0.1 ( 46.5 )
Week 4 (44, 44, 43, 46)	29.6 ( 218.4 )	-6.2 ( 54.8 )	3.2 ( 22.0 )	-16.9 ( 56.5 )
Week 8 (44, 43, 44, 44)	-4.9 ( 56.9 )	-8.5 ( 52.7 )	-1.5 ( 23.6 )	-4.6 ( 122.1 )
Week 12 (44, 44, 45, 44)	-6.3 ( 57.5 )	-8.4 ( 85.8 )	-3.0 ( 22.4 )	-29.4 ( 80.7 )
Week 16 (44, 45, 43, 45)	0.9 ( 59.4 )	-11.5 ( 105.1 )	-7.5 ( 22.2 )	-23.2 ( 106.3 )
Week 20 (43, 43, 42, 44)	-8.2 ( 60.0 )	5.9 ( 149.1 )	-3.5 ( 22.2 )	-33.4 ( 95.3 )
Week 24 (42, 43, 44, 44)	-6.4 ( 48.6 )	-5.4 ( 123.7 )	-2.6 ( 27.4 )	-27.7 ( 98.9 )
Week 28 (43, 42, 40, 43)	-1.5 ( 67.3 )	-19.1 ( 131.5 )	-0.7 ( 25.4 )	-36.7 ( 103.8 )
Week 32 (44, 44, 43, 45)	2.0 ( 67.0 )	-10.0 ( 167.0 )	34.0 ( 222.1 )	-24.2 ( 91.2 )
Week 40 (42, 42, 41, 44)	9.9 ( 109.1 )	-20.4 ( 131.4 )	-2.7 ( 25.4 )	-16.3 ( 106.4 )
Week 48 (38, 42, 40, 43)	7.8 ( 67.3 )	-20.4 ( 138.3 )	-3.6 ( 25.5 )	-33.4 ( 106.5 )

No statistical analyses for this end point

Secondary: Mean change from baseline in pH

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End point title

Mean change from baseline in pH

End point description

The Safety Set (SS) consisted of all study participants who were randomized and received at least 1 dose (any amount) of study drug. Here, 'n' (Number analyzed) signifies participants who were evaluable at specified time points.

End point type

Secondary

End point timeframe

From Baseline (Week 1) to Week 48

End point values	SOC + Placebo iv Q4W (SS)	SOC + DZP 6mg/kg iv Q4W (SS)	SOC + DZP 24mg/kg iv Q4W (SS)	SOC + DZP 45mg/kg iv Q4W (SS)
Number of subjects analysed	45	45	45	47
Units: pH
arithmetic mean (standard deviation)
Week 2 (43, 43, 44, 43)	-0.01 ( 0.66 )	0.03 ( 0.62 )	-0.07 ( 0.67 )	0.15 ( 0.78 )
Week 4 (43, 43, 43, 43)	0.10 ( 0.77 )	0.15 ( 0.52 )	0.06 ( 0.72 )	0.16 ( 0.74 )
Week 8 (42, 44, 44, 42)	-0.12 ( 0.79 )	0.00 ( 0.62 )	-0.08 ( 0.56 )	-0.04 ( 0.65 )
Week 12 (44, 43, 43, 42)	0.00 ( 0.81 )	0.15 ( 0.69 )	0.03 ( 0.79 )	0.20 ( 0.83 )
Week 16 (44, 45, 39, 45)	-0.02 ( 0.61 )	0.00 ( 0.51 )	-0.09 ( 0.81 )	0.11 ( 0.69 )
Week 20 (42, 43, 41, 43)	-0.11 ( 0.75 )	-0.01 ( 0.59 )	0.06 ( 0.58 )	0.07 ( 0.88 )
Week 24 (43, 42, 44, 42)	0.03 ( 0.85 )	-0.01 ( 0.46 )	-0.11 ( 0.81 )	0.02 ( 0.81 )
Week 28 (44, 42, 42, 41)	-0.13 ( 0.84 )	-0.06 ( 0.57 )	-0.05 ( 0.73 )	-0.01 ( 0.69 )
Week 32 (44, 44, 42, 43)	-0.02 ( 0.75 )	-0.03 ( 0.55 )	-0.18 ( 0.66 )	0.09 ( 0.86 )
Week 40 (42, 43, 41, 44)	-0.14 ( 0.81 )	0.19 ( 0.66 )	-0.21 ( 0.81 )	-0.07 ( 0.62 )
Week 48 (38, 42, 40, 43)	-0.11 ( 0.66 )	0.06 ( 0.73 )	-0.11 ( 0.74 )	-0.08 ( 0.72 )

No statistical analyses for this end point

Secondary: Mean change from baseline in Erythrocytes (/HPF)

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End point title

Mean change from baseline in Erythrocytes (/HPF)

End point description

End point type

Secondary

End point timeframe

From Baseline (Week 1) to Week 48

End point values	SOC + Placebo iv Q4W (SS)	SOC + DZP 6mg/kg iv Q4W (SS)	SOC + DZP 24mg/kg iv Q4W (SS)	SOC + DZP 45mg/kg iv Q4W (SS)
Number of subjects analysed	45	45	45	47
Units: % of Erythrocytes per HPF
arithmetic mean (standard deviation)
Week 2 (43, 43, 44, 43)	-6.8 ( 53.7 )	0.1 ( 8.4 )	0.2 ( 2.4 )	0.9 ( 7.9 )
Week 4 (43, 43, 43, 43)	-8.7 ( 52.6 )	-0.8 ( 4.1 )	1.4 ( 10.5 )	-0.6 ( 3.2 )
Week 8 (42, 44, 44, 42)	-8.7 ( 53.5 )	-0.3 ( 6.9 )	0.4 ( 6.1 )	0.0 ( 6.8 )
Week 12 (44, 43, 43, 42)	-8.6 ( 52.6 )	1.3 ( 17.4 )	-0.4 ( 2.4 )	17.4 ( 118.5 )
Week 16 (43, 45, 39, 45)	-5.7 ( 48.0 )	-1.3 ( 4.1 )	-0.6 ( 2.6 )	-0.5 ( 5.5 )
Week 20 (42, 43, 41, 43)	-7.7 ( 53.7 )	-1.0 ( 3.5 )	-0.1 ( 3.9 )	-0.6 ( 4.4 )
Week 24 (43, 42, 44, 42)	-7.2 ( 53.5 )	-1.2 ( 3.9 )	-0.3 ( 2.3 )	-0.9 ( 4.6 )
Week 28 (44, 42, 42, 41)	-7.6 ( 51.3 )	-1.3 ( 4.2 )	-0.7 ( 2.9 )	3.0 ( 16.9 )
Week 32 (44, 44, 42, 43)	-8.5 ( 52.5 )	4.9 ( 41.8 )	0.0 ( 3.9 )	0.1 ( 4.5 )
Week 40 (42, 43, 41, 44)	-9.1 ( 53.2 )	3.5 ( 18.8 )	-0.5 ( 3.5 )	0.4 ( 5.4 )
Week 48 (38, 42, 40, 43)	-9.7 ( 56.3 )	-0.4 ( 5.4 )	1.9 ( 15.5 )	0.1 ( 4.0 )

No statistical analyses for this end point

Secondary: Mean change from baseline in Leukocytes (/HPF)

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End point title

Mean change from baseline in Leukocytes (/HPF)

End point description

End point type

Secondary

End point timeframe

From Baseline (Week 1) to Week 48

End point values	SOC + Placebo iv Q4W (SS)	SOC + DZP 6mg/kg iv Q4W (SS)	SOC + DZP 24mg/kg iv Q4W (SS)	SOC + DZP 45mg/kg iv Q4W (SS)
Number of subjects analysed	45	45	45	47
Units: % of Leukocytes per HPF
arithmetic mean (standard deviation)
Week 2 (43, 43, 44, 43)	-0.1 ( 11.4 )	-1.4 ( 8.1 )	-0.8 ( 2.9 )	2.9 ( 13.7 )
Week 4 (43, 43, 43, 43)	-0.2 ( 9.0 )	-0.6 ( 8.5 )	-0.7 ( 4.5 )	3.0 ( 12.6 )
Week 8 (42, 44, 44, 42)	-1.2 ( 10.4 )	4.8 ( 29.3 )	-0.3 ( 6.8 )	3.0 ( 14.4 )
Week 12 (44, 43, 43, 42)	-1.1 ( 11.3 )	4.4 ( 42.2 )	-1.3 ( 4.2 )	2.7 ( 13.9 )
Week 16 (43, 45, 39, 45)	0.1 ( 9.6 )	-1.6 ( 12.5 )	-0.2 ( 9.6 )	1.8 ( 12.9 )
Week 20 (42, 43, 41, 43)	-0.1 ( 10.1 )	3.7 ( 13.3 )	0.4 ( 9.8 )	1.7 ( 4.0 )
Week 24 (43, 42, 44, 42)	-1.0 ( 10.9 )	10.7 ( 52.1 )	-0.7 ( 4.5 )	0.4 ( 4.5 )
Week 28 (44, 42, 42, 41)	-0.2 ( 9.6 )	2.4 ( 9.7 )	-1.1 ( 4.4 )	2.0 ( 10.1 )
Week 32 (44, 44, 42, 43)	-0.6 ( 10.8 )	-0.5 ( 13.5 )	-1.0 ( 5.4 )	4.1 ( 15.7 )
Week 40 (42, 43, 41, 44)	-1.6 ( 10.4 )	2.2 ( 19.8 )	1.4 ( 7.7 )	6.8 ( 30.9 )
Week 48 (38, 42, 40, 43)	-0.3 ( 8.9 )	10.8 ( 71.9 )	-1.0 ( 4.0 )	0.8 ( 5.3 )

No statistical analyses for this end point

Adverse events

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Timeframe for reporting adverse events

Adverse events were collected from Baseline (Week 1) until end of the study (Week 48)

Assessment type

Non-systematic

Dictionary name

MedDRA

Dictionary version

19.1

Reporting group title

SOC + Placebo iv Q4W (SS)

Reporting group description

Reporting group title

SOC + DZP 45mg/kg iv Q4W (SS)

Reporting group description

Reporting group title

SOC + DZP 24mg/kg iv Q4W (SS)

Reporting group description

Reporting group title

SOC + DZP 6mg/kg iv Q4W (SS)

Reporting group description

Serious adverse events	SOC + Placebo iv Q4W (SS)	SOC + DZP 45mg/kg iv Q4W (SS)	SOC + DZP 24mg/kg iv Q4W (SS)	SOC + DZP 6mg/kg iv Q4W (SS)
Total subjects affected by serious adverse events
subjects affected / exposed	6 / 45 (13.33%)	5 / 47 (10.64%)	6 / 45 (13.33%)	5 / 45 (11.11%)
number of deaths (all causes)	0	0	0	0
number of deaths resulting from adverse events	0	0	0	0
Injury, poisoning and procedural complications
Thoracic vertebral fracture
subjects affected / exposed	0 / 45 (0.00%)	0 / 47 (0.00%)	0 / 45 (0.00%)	1 / 45 (2.22%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Vascular disorders
Deep vein thrombosis
subjects affected / exposed	1 / 45 (2.22%)	0 / 47 (0.00%)	0 / 45 (0.00%)	0 / 45 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Cardiac disorders
Coronary artery disease
subjects affected / exposed	0 / 45 (0.00%)	0 / 47 (0.00%)	1 / 45 (2.22%)	0 / 45 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
subjects affected / exposed	0 / 45 (0.00%)	0 / 47 (0.00%)	0 / 45 (0.00%)	1 / 45 (2.22%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Blood and lymphatic system disorders
Anaemia
subjects affected / exposed	0 / 45 (0.00%)	0 / 47 (0.00%)	1 / 45 (2.22%)	0 / 45 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Antiphospholipid syndrome
subjects affected / exposed	1 / 45 (2.22%)	0 / 47 (0.00%)	0 / 45 (0.00%)	0 / 45 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Autoimmune haemolytic anaemia
subjects affected / exposed	0 / 45 (0.00%)	0 / 47 (0.00%)	0 / 45 (0.00%)	1 / 45 (2.22%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Haemorrhagic disorder
subjects affected / exposed	1 / 45 (2.22%)	0 / 47 (0.00%)	0 / 45 (0.00%)	0 / 45 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Gastrointestinal disorders
Anastomotic ulcer perforation
subjects affected / exposed	0 / 45 (0.00%)	1 / 47 (2.13%)	0 / 45 (0.00%)	0 / 45 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Respiratory, thoracic and mediastinal disorders
Pneumothorax
subjects affected / exposed	0 / 45 (0.00%)	0 / 47 (0.00%)	1 / 45 (2.22%)	0 / 45 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Pulmonary embolism
subjects affected / exposed	1 / 45 (2.22%)	0 / 47 (0.00%)	0 / 45 (0.00%)	0 / 45 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Renal and urinary disorders
Lupus nephritis
subjects affected / exposed	0 / 45 (0.00%)	1 / 47 (2.13%)	0 / 45 (0.00%)	0 / 45 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Nephrosclerosis
subjects affected / exposed	0 / 45 (0.00%)	0 / 47 (0.00%)	0 / 45 (0.00%)	1 / 45 (2.22%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Renal tubular necrosis
subjects affected / exposed	0 / 45 (0.00%)	0 / 47 (0.00%)	0 / 45 (0.00%)	1 / 45 (2.22%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Musculoskeletal and connective tissue disorders
Systemic lupus erythematosus
subjects affected / exposed	1 / 45 (2.22%)	1 / 47 (2.13%)	0 / 45 (0.00%)	0 / 45 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 2	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Infections and infestations
Cellulitis
subjects affected / exposed	0 / 45 (0.00%)	0 / 47 (0.00%)	1 / 45 (2.22%)	0 / 45 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Herpes zoster
subjects affected / exposed	0 / 45 (0.00%)	0 / 47 (0.00%)	0 / 45 (0.00%)	1 / 45 (2.22%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Influenza
subjects affected / exposed	1 / 45 (2.22%)	0 / 47 (0.00%)	0 / 45 (0.00%)	0 / 45 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Pseudomonal bacteraemia
subjects affected / exposed	0 / 45 (0.00%)	0 / 47 (0.00%)	1 / 45 (2.22%)	0 / 45 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Pyelonephritis
subjects affected / exposed	0 / 45 (0.00%)	1 / 47 (2.13%)	0 / 45 (0.00%)	0 / 45 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Urinary tract infection
subjects affected / exposed	0 / 45 (0.00%)	1 / 47 (2.13%)	0 / 45 (0.00%)	0 / 45 (0.00%)
occurrences causally related to treatment / all	0 / 0	1 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Appendicitis
subjects affected / exposed	0 / 45 (0.00%)	0 / 47 (0.00%)	1 / 45 (2.22%)	0 / 45 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0

Frequency threshold for reporting non-serious adverse events: 5%

Non-serious adverse events	SOC + Placebo iv Q4W (SS)	SOC + DZP 45mg/kg iv Q4W (SS)	SOC + DZP 24mg/kg iv Q4W (SS)	SOC + DZP 6mg/kg iv Q4W (SS)
Total subjects affected by non serious adverse events
subjects affected / exposed	22 / 45 (48.89%)	25 / 47 (53.19%)	24 / 45 (53.33%)	26 / 45 (57.78%)
Investigations
Hepatic enzyme increased
subjects affected / exposed	3 / 45 (6.67%)	0 / 47 (0.00%)	0 / 45 (0.00%)	0 / 45 (0.00%)
occurrences all number	3	0	0	0
Vascular disorders
Hypertension
subjects affected / exposed	1 / 45 (2.22%)	2 / 47 (4.26%)	3 / 45 (6.67%)	3 / 45 (6.67%)
occurrences all number	1	2	4	3
Nervous system disorders
Headache
subjects affected / exposed	6 / 45 (13.33%)	3 / 47 (6.38%)	4 / 45 (8.89%)	6 / 45 (13.33%)
occurrences all number	6	3	6	14
Migraine
subjects affected / exposed	0 / 45 (0.00%)	3 / 47 (6.38%)	1 / 45 (2.22%)	0 / 45 (0.00%)
occurrences all number	0	3	1	0
Gastrointestinal disorders
Diarrhoea
subjects affected / exposed	3 / 45 (6.67%)	3 / 47 (6.38%)	4 / 45 (8.89%)	4 / 45 (8.89%)
occurrences all number	3	3	4	4
Nausea
subjects affected / exposed	2 / 45 (4.44%)	2 / 47 (4.26%)	3 / 45 (6.67%)	1 / 45 (2.22%)
occurrences all number	2	2	3	1
Dyspepsia
subjects affected / exposed	5 / 45 (11.11%)	0 / 47 (0.00%)	0 / 45 (0.00%)	1 / 45 (2.22%)
occurrences all number	5	0	0	2
Abdominal pain upper
subjects affected / exposed	3 / 45 (6.67%)	0 / 47 (0.00%)	0 / 45 (0.00%)	0 / 45 (0.00%)
occurrences all number	3	0	0	0
Psychiatric disorders
Anxiety
subjects affected / exposed	2 / 45 (4.44%)	0 / 47 (0.00%)	3 / 45 (6.67%)	1 / 45 (2.22%)
occurrences all number	2	0	3	1
Musculoskeletal and connective tissue disorders
Back pain
subjects affected / exposed	2 / 45 (4.44%)	2 / 47 (4.26%)	0 / 45 (0.00%)	5 / 45 (11.11%)
occurrences all number	3	2	0	6
Infections and infestations
Nasopharyngitis
subjects affected / exposed	2 / 45 (4.44%)	5 / 47 (10.64%)	6 / 45 (13.33%)	5 / 45 (11.11%)
occurrences all number	2	5	7	7
Upper respiratory tract infection
subjects affected / exposed	4 / 45 (8.89%)	7 / 47 (14.89%)	3 / 45 (6.67%)	5 / 45 (11.11%)
occurrences all number	5	9	5	5
Pharyngitis
subjects affected / exposed	3 / 45 (6.67%)	5 / 47 (10.64%)	4 / 45 (8.89%)	4 / 45 (8.89%)
occurrences all number	3	6	6	5
Urinary tract infection
subjects affected / exposed	2 / 45 (4.44%)	2 / 47 (4.26%)	4 / 45 (8.89%)	7 / 45 (15.56%)
occurrences all number	3	2	4	7
Bronchitis
subjects affected / exposed	0 / 45 (0.00%)	3 / 47 (6.38%)	2 / 45 (4.44%)	3 / 45 (6.67%)
occurrences all number	0	3	2	5
Influenza
subjects affected / exposed	1 / 45 (2.22%)	3 / 47 (6.38%)	3 / 45 (6.67%)	3 / 45 (6.67%)
occurrences all number	1	3	3	3

More information

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Were there any global substantial amendments to the protocol? No

Were there any global interruptions to the trial? No

Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.

None reported

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Clinical trials

Clinical Trial Results: A MULTI-CENTER, RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, DOSE RANGING STUDY FOLLOWED BY AN OBSERVATIONAL PERIOD TO EVALUATE THE EFFICACY AND SAFETY OF DAPIROLIZUMAB PEGOL IN SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Percentage of participants with British Isles Lupus Assessment Group Disease Activity Index 2004 (BILAG 2004)-based Composite Lupus Assessment (BICLA) (mNRI) response across 3 doses of dapirolizumab pegol (DZP) and placebo (PBO) at Week 24

Primary: Percentage of participants with British Isles Lupus Assessment Group Disease Activity Index 2004 (BILAG 2004)-based Composite Lupus Assessment (BICLA) (mNRI) response across 3 doses of dapirolizumab pegol (DZP) and placebo (PBO) at Week 24

Secondary: The percentage of participants with BICLA (mNRI) response in the individual dose groups at Week 24

Secondary: The percentage of participants with BICLA (mNRI) response in the individual dose groups at Week 24

Secondary: Percentage of participants with at least one Adverse Events (AEs)

Secondary: Percentage of participants with at least one Adverse Events (AEs)

Secondary: Percentage of participants with a Serious Adverse Event (SAE)

Secondary: Percentage of participants with a Serious Adverse Event (SAE)

Secondary: Percentage of participants with at least one Adverse Events (AEs) of interest

Secondary: Percentage of participants with at least one Adverse Events (AEs) of interest

Secondary: Percentage of participants who permanently withdrew of study drug due to an Adverse Event (AE)

Secondary: Percentage of participants who permanently withdrew of study drug due to an Adverse Event (AE)

Secondary: Mean change from baseline in Systolic Blood Pressure

Secondary: Mean change from baseline in Systolic Blood Pressure

Secondary: Mean change from baseline in Diastolic Blood Pressure

Secondary: Mean change from baseline in Diastolic Blood Pressure

Secondary: Mean change from baseline in Pulse Rate

Secondary: Mean change from baseline in Pulse Rate

Secondary: Mean change from baseline in Temperature

Secondary: Mean change from baseline in Temperature

Secondary: Mean change from baseline in Weight

Secondary: Mean change from baseline in Weight

Secondary: Mean change from baseline in Height

Secondary: Mean change from baseline in Height

Secondary: Number of participants with 12-Lead electrocardiogram (ECG) abnormal findings

Secondary: Number of participants with 12-Lead electrocardiogram (ECG) abnormal findings

Secondary: Mean change from baseline in Hemoglobin

Secondary: Mean change from baseline in Hemoglobin

Secondary: Mean change from baseline in Hematocrit

Secondary: Mean change from baseline in Hematocrit

Secondary: Mean change from baseline in Erythrocytes

Secondary: Mean change from baseline in Erythrocytes

Secondary: Mean change from baseline in Erythrocytes Mean Corpuscular Volume

Secondary: Mean change from baseline in Erythrocytes Mean Corpuscular Volume

Secondary: Mean change from baseline in Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration

Secondary: Mean change from baseline in Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration

Secondary: Mean change from baseline in Erythrocytes Mean Corpuscular Hemoglobin

Secondary: Mean change from baseline in Erythrocytes Mean Corpuscular Hemoglobin

Secondary: Mean change from baseline in Leukocytes

Secondary: Mean change from baseline in Leukocytes

Secondary: Mean change from baseline in Basophils

Secondary: Mean change from baseline in Basophils

Secondary: Mean change from baseline in Basophils/Leukocytes

Secondary: Mean change from baseline in Basophils/Leukocytes

Secondary: Mean change from baseline in Eosinophils

Secondary: Mean change from baseline in Eosinophils

Secondary: Mean change from baseline in Eosinophils/Leukocytes

Secondary: Mean change from baseline in Eosinophils/Leukocytes

Secondary: Mean change from baseline in Lymphocytes

Secondary: Mean change from baseline in Lymphocytes

Secondary: Mean change from baseline in Lymphocytes/Leukocytes

Secondary: Mean change from baseline in Lymphocytes/Leukocytes

Secondary: Mean change from baseline in Monocytes

Secondary: Mean change from baseline in Monocytes

Secondary: Mean change from baseline in Monocytes/Leukocytes

Secondary: Mean change from baseline in Monocytes/Leukocytes

Secondary: Mean change from baseline in Neutrophils

Secondary: Mean change from baseline in Neutrophils

Secondary: Mean change from baseline in Neutrophils/Leukocytes

Secondary: Mean change from baseline in Neutrophils/Leukocytes

Secondary: Mean change from baseline in Platelets

Secondary: Mean change from baseline in Platelets

Secondary: Mean change from baseline in cluster of differentiation 3 (CD3)

Secondary: Mean change from baseline in cluster of differentiation 3 (CD3)

Secondary: Mean change from baseline in CD3/Lymphocytes

Secondary: Mean change from baseline in CD3/Lymphocytes

Secondary: Mean change from baseline in cluster of differentiation 19 (CD19)

Secondary: Mean change from baseline in cluster of differentiation 19 (CD19)

Secondary: Mean change from baseline in CD19/Lymphocytes

Secondary: Mean change from baseline in CD19/Lymphocytes

Clinical Trial Results:
A MULTI-CENTER, RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, DOSE RANGING STUDY FOLLOWED BY AN OBSERVATIONAL PERIOD TO EVALUATE THE EFFICACY AND SAFETY OF DAPIROLIZUMAB PEGOL IN SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS