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Clinical Trial Results:
A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Guselkumab in Subjects with Active Lupus Nephritis

Summary
EudraCT number	2018-003155-38
Trial protocol	PL
Global end of trial date	01 Feb 2023

Results information
Results version number	v1(current)
This version publication date	17 Feb 2024
First version publication date	17 Feb 2024
Other versions

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

CNTO1959LUN2001

ISRCTN number

US NCT number

NCT04376827

WHO universal trial number (UTN)

Sponsor organisation name

Janssen Research & Development, LLC

Sponsor organisation address

920, US Highway, South Raritan, NJ, United States, 08869

Public contact

Clinical Registry Group, Janssen Research & Development, LLC, clinicaltrialsEU@its.jnj.com

Scientific contact

Clinical Registry Group, Janssen Research & Development, LLC, clinicaltrialsEU@its.jnj.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

01 Feb 2023

Is this the analysis of the primary completion data?

Global end of trial reached?

Yes

Global end of trial date

01 Feb 2023

Was the trial ended prematurely?

Yes

Main objective of the trial

The main objective of this trial was to evaluate the efficacy of guselkumab in subjects with active Lupus Nephritis (LN)

Protection of trial subjects

This study was conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki and that are consistent with Good Clinical Practices and applicable regulatory requirements.

Background therapy

Evidence for comparator

Actual start date of recruitment

18 Nov 2020

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Yes

Number of subjects enrolled per country

Country: Number of subjects enrolled

Argentina: 9

Country: Number of subjects enrolled

Mexico: 4

Country: Number of subjects enrolled

Russian Federation: 3

Country: Number of subjects enrolled

Thailand: 1

Country: Number of subjects enrolled

Taiwan: 3

Country: Number of subjects enrolled

Ukraine: 12

Country: Number of subjects enrolled

United States: 1

Worldwide total number of subjects

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)

From 65 to 84 years

85 years and over

Subject disposition

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Recruitment details

Screening details

Randomization was stratified by geographic region (North America, Latin America, Asia Pacific and Europe) and Urine Protein to Creatinine Ratio (UPCR) level (less than [<] 3 milligrams per milligram [mg/mg] and greater than or equal to [>=] 3 mg/mg).

Period 1 title

Double blind Period: Week 0 to Week 52

Is this the baseline period?

Yes

Allocation method

Randomised - controlled

Blinding used

Double blind

Roles blinded

Investigator, Subject

Are arms mutually exclusive

Yes

Placebo

Arm description

In double-blind period, subjects received placebo matched to guselkumab (400 milligrams [mg]) intravenous (IV) infusion at Weeks 0, 4 and 8 and placebo matched to guselkumab (200 mg) subcutaneous (SC) injection every 4 weeks (q4w) from Week 12 through Week 48 along with standard-of-care treatment of mycophenolate mofetil (MMF)/mycophenolic acid (MPA) and glucocorticoids. Subjects who achieved complete renal response (CRR) at Week 48 and 52, and completed the Week 52 assessments entered the long-term extension (LTE) phase and continued to receive placebo matched to guselkumab SC injection q4w from Week 52 through Week 84 (that is., up to LTE phase treatment termination).

Arm type

Experimental

Investigational medicinal product name

Placebo

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Subcutaneous use

Dosage and administration details

In double-blind period subjects received placebo matched to guselkumab 200 mg SC q4w from Week 12 through Week 48.

Investigational medicinal product name

Placebo

Investigational medicinal product code

Other name

Pharmaceutical forms

Infusion

Routes of administration

Intravenous use

Dosage and administration details

In double-blind period subjects received placebo matched to guselkumab 400 mg IV at Weeks 0, 4 and 8.

Guselkumab

Arm description

In double-blind period subjects received guselkumab 400 mg IV infusion at Weeks 0, 4 and 8 and guselkumab 200 mg SC injection q4w from Week 12 through Week 48 along with standard-of-care treatment of MMF/MPA and glucocorticoids. Subjects who achieved CRR at Week 48 and 52, and completed the Week 52 assessments entered LTE phase and continued to receive guselkumab 200 mg SC injection q4w from Week 52 through Week 84 (that is., up to LTE phase treatment termination).

Arm type

Experimental

Investigational medicinal product name

Guselkumab

Investigational medicinal product code

Other name

CNTO1959

Pharmaceutical forms

Infusion

Routes of administration

Intravenous use

Dosage and administration details

In double-blind period subjects received guselkumab 400 mg IV infusion at Weeks 0, 4 and 8.

Investigational medicinal product name

Guselkumab

Investigational medicinal product code

Other name

CNTO1959

Pharmaceutical forms

Injection

Routes of administration

Subcutaneous use

Dosage and administration details

In double-blind period subjects received guselkumab 200 mg SC injection q4w from Week 12 through Week 48.

Number of subjects in period 1	Placebo	Guselkumab
Started	16	17
Completed	9	8
Not completed	7	9
Consent withdrawn by subject	1	1
Study Terminated by Sponsor	6	8

Period 2 title

LTE Phase:Week 52 to 96(LTE termination)

Is this the baseline period?

Allocation method

Randomised - controlled

Blinding used

Double blind

Roles blinded

Subject, Investigator

Are arms mutually exclusive

Placebo

Arm description

Arm type

Experimental

Investigational medicinal product name

Placebo

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Subcutaneous use

Dosage and administration details

In LTE phase subjects received placebo matched to guselkumab 200 mg SC injection q4w from Week 52 through Week 84 (that is., up to LTE phase treatment termination).

Guselkumab

Arm description

In double-blind period subjects received guselkumab 400 mg IV infusion at Weeks 0, 4 and 8 and guselkumab 200 mg SC injection q4w from Week 12 through Week 48 along with standard-of-care treatment of MMF/MPA and glucocorticoids. Participants who achieved CRR at Week 48 and 52, and completed the Week 52 assessments entered LTE phase and continued to receive guselkumab 200 mg SC injection q4w from Week 52 through Week 84 (that is., up to LTE phase treatment termination).

Arm type

Experimental

Investigational medicinal product name

Guselkumab

Investigational medicinal product code

Other name

CNTO1959

Pharmaceutical forms

Injection

Routes of administration

Subcutaneous use

Dosage and administration details

In LTE phase subjects received guselkumab 200 mg SC injection q4w from Week 52 through Week 84 (that is., up to LTE phase treatment termination) LTE phase.

Number of subjects in period 2	Placebo	Guselkumab
Started	4	1
Completed	0	0
Not completed	4	1
Consent withdrawn by subject	-	1
Protocol-specified withdrawal criterion met	1	-
Study Terminated by Sponsor	3	-

Baseline characteristics

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Reporting group title

Placebo

Reporting group description

Reporting group title

Guselkumab

Reporting group description

Reporting group values	Placebo	Guselkumab	Total
Number of subjects	16	17	33
Age Categorical
Units: subjects
>= 55 years	1	1	2
< 55 years	15	16	31
Age continuous
Units: years
arithmetic mean (standard deviation)	38.8 ( 11.69 )	35.3 ( 10.07 )	-
Sex: Female, Male
Units: subjects
Female	14	15	29
Male	2	2	4
Race (NIH/OMB)
Units: Subjects
American Indian or Alaska Native	1	2	3
Asian	3	1	4
Black or African American	0	0	0
Native Hawaiian or Other Pacific Islander	0	0	0
White	12	14	26
More than one race	0	0	0
Unknown or Not Reported	0	0	0
Region of Enrollment
Units: Subjects
ARGENTINA	5	4	9
MEXICO	1	3	4
RUSSIAN FEDERATION	2	1	3
TAIWAN	3	0	3
THAILAND	0	1	1
UKRAINE	5	7	12
UNITED STATES	0	1	1
Ethnicity (NIH/OMB)
Units: Subjects
Hispanic or Latino	4	7	11
Not Hispanic or Latino	12	10	22
Unknown or Not Reported	0	0	0

End points

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Reporting group title

Placebo

Reporting group description

Reporting group title

Guselkumab

Reporting group description

Reporting group title

Placebo

Reporting group description

Reporting group title

Guselkumab

Reporting group description

In double-blind period subjects received guselkumab 400 mg IV infusion at Weeks 0, 4 and 8 and guselkumab 200 mg SC injection q4w from Week 12 through Week 48 along with standard-of-care treatment of MMF/MPA and glucocorticoids. Participants who achieved CRR at Week 48 and 52, and completed the Week 52 assessments entered LTE phase and continued to receive guselkumab 200 mg SC injection q4w from Week 52 through Week 84 (that is., up to LTE phase treatment termination).

Subject analysis set title

Guselkumab Vs Placebo

Subject analysis set type

Per protocol

Subject analysis set description

In double-blind period, placebo arm subjects received placebo matched to guselkumab (400 mg) IV infusion at Weeks 0, 4 and 8 and placebo matched to guselkumab (200 mg) SC injection q4w from Week 12 through Week 48; Guselkumab arm subjects received guselkumab 400 mg IV infusion at Weeks 0, 4 and 8 and guselkumab 200 mg SC injection q4w from Week 12 through Week 48. All (both arms) subjects received standard-of-care treatment of MMF/MPA and glucocorticoids. Subjects who achieved CRR at Weeks 48 and 52, and completed the Week 52 assessments entered the LTE phase. During the LTE phase, subjects received the same treatment, placebo or guselkumab that was assigned at randomization, SC q4w from Week 52 through Week 84 (that is, up to LTE phase treatment termination).

Primary: Percentage of Subjects Achieving at Least 50 Percent (%) Decrease From Baseline in Proteinuria at Week 24

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End point title

Percentage of Subjects Achieving at Least 50 Percent (%) Decrease From Baseline in Proteinuria at Week 24 ^[1]

End point description

Percentage of subjects achieving at least 50% decrease in proteinuria from baseline at Week 24 was reported. Proteinuria analysis was based on UPCR and was defined as the presence of an excess of serum proteins in the urine, which may be an early sign of kidney disease. Full analysis set (FAS) included all randomised subjects who received at least 1 dose of study intervention.

End point type

Primary

End point timeframe

Week 24

Notes
[1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: Descriptive statistics was done, no inferential statistical analysis was performed.

End point values	Placebo	Guselkumab
Number of subjects analysed	16	17
Units: percentage of subjects
number (not applicable)	56.3	35.3

No statistical analyses for this end point

Secondary: Time to Achievement of Complete Renal Response

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End point title

Time to Achievement of Complete Renal Response

End point description

Subject was considered as achieved CRR who did not discontinue study intervention for any reason excluding COVID-19 related discontinuations or met medication intercurrent event (exceeded baseline glucocorticoid dose, increase above 10 mg/d prednisone equivalent after Week 12, use of new or increased dose of concomitant medication related to lupus nephritis (LN) or other immunosuppressive agents, within 8 weeks prior to endpoint time point or initiation of prohibited medications at any time prior to endpoint time point. In below data table, measure type "Number"=hazard ratio and unit of measure is ratio for time to CRR.FAS population. For this endpoint, only summary measure (population-level summary) data were analyzed and reported as planned in study statistical analysis plan. Thus, data were presented for single comparative arm (guselkumab vs placebo). ‘N' (number of subjects analysed)=all subjects of both arms with available data for this endpoint.

End point type

Secondary

End point timeframe

Up to Week 24

End point values	Guselkumab Vs Placebo
Number of subjects analysed	33
Units: ratio
number (confidence interval 80%)	0.62 (0.27 to 1.41)

No statistical analyses for this end point

Secondary: Percentage of Subjects who Achieved Complete Renal Response (CRR) at Week 24

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End point title

Percentage of Subjects who Achieved Complete Renal Response (CRR) at Week 24

End point description

CRR was defined as UPCR less than (<) 0.5 mg/mg, estimated glomerular filtration rate (eGFR) greater than or equal to (>=) 60 milliliter per minute per 1.73 meter square (mL/min/1.73m^2) or no confirmed decrease >=20% from baseline and prednisone dose less than or equal to (<=) 10 milligrams per day (mg/d). Subject was considered as achieved CRR who did not discontinue study intervention for any reason excluding COVID-19 related discontinuations or met the medication intercurrent event (exceeded baseline glucocorticoid dose, increase above 10 mg/d prednisone equivalent after Week 12, use of new or increased dose of concomitant medication related to LN or other immunosuppressive agents, within 8 weeks prior to the endpoint time point or initiation of prohibited medications at any time prior to the endpoint time point. FAS included all randomised subjects who received at least 1 dose of study intervention.

End point type

Secondary

End point timeframe

Week 24

End point values	Placebo	Guselkumab
Number of subjects analysed	16	17
Units: percentage of subjects
number (not applicable)	18.8	17.6

No statistical analyses for this end point

Secondary: Time to Treatment Failure (TF)

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End point title

Time to Treatment Failure (TF)

End point description

TF:time to first occurrence of TF from baseline. Subject was considered have treatment failure, who did not continue study intervention for any reason excluding COVID-19 related discontinuations or met medication intercurrent event (exceeded baseline glucocorticoid dose, increase above 10 mg/d prednisone equivalent after Week 12, use of new or increased dose of concomitant medication related to LN or other immunosuppressive agents, within 8 weeks prior to endpoint time point or initiation of prohibited medications at any time prior to endpoint time point. In below data table, measure type "Number"= hazard ratio and unit of measure is ratio for time to TF. FAS population. For this endpoint, only summary measure (population-level summary) data were analyzed and reported as planned in study statistical analysis plan. Thus, data were presented for single comparative arm. ‘N' (number of subjects analysed) signifies all subjects of both arms with available data for this endpoint.

End point type

Secondary

End point timeframe

Through Week 52

End point values	Guselkumab Vs Placebo
Number of subjects analysed	33
Units: ratio
number (confidence interval 80%)	1.54 (0.62 to 3.85)

No statistical analyses for this end point

Secondary: Serum Concentration of Guselkumab

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End point title

Serum Concentration of Guselkumab ^[2]

End point description

Serum Concentration of guselkumab were reported. Data for this endpoint was not planned to be collected and analysed for the placebo arm. Pharmacokinetic analysis set included all subjects who received at least 1 administration of guselkumab and had at least one post-dose sample collection. Here (number analysed) signifies number of subjects evaluable at specific timepoints. Since a small number of subjects only entered LTE period than the planned enrollment count, planned serum concentration analysis was not performed for the LTE phase for this endpoint.

End point type

Secondary

End point timeframe

Predose: Weeks 0,4,8,12,16,20,24, 36; Post-dose: Weeks 0 (1 hour after intravenous administration), Day 2, Week 52 and 60

Notes
[2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This endpoint was planned to be reported for specified arms only.

End point values	Guselkumab
Number of subjects analysed	16
Units: microgram per milliliter
arithmetic mean (standard deviation)
Week 0, predose (n=16)	0.00 ( 0.000 )
Week 0, 1h after IV administration (n=16)	146.20 ( 41.273 )
Day 2 post-dose (n=16)	96.55 ( 33.805 )
Week 4, predose (n=16)	11.20 ( 7.175 )
Week 8, predose (n=15)	12.85 ( 9.549 )
Week 12, predose (n=14)	18.17 ( 11.784 )
Week 20, predose (n=14)	7.63 ( 4.689 )
Week 24, predose (n=12)	6.42 ( 3.447 )
Week 36, predose (n=10)	6.57 ( 1.827 )
Week 52 post-dose (n=6)	6.13 ( 3.262 )
Week 60 post-dose (n=4)	0.39 ( 0.641 )

No statistical analyses for this end point

Secondary: Percentage of Subjects Achieving a Sustained Reduction in Steroid Dose <=10 mg/d of Prednisone or Equivalent From Week 16 through Week 24

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End point title

Percentage of Subjects Achieving a Sustained Reduction in Steroid Dose <=10 mg/d of Prednisone or Equivalent From Week 16 through Week 24

End point description

Percentage of subjects achieving a sustained reduction in steroid dose less than or equal to (<=) 10 mg/day of prednisone or equivalent from week 16 through Week 24 were reported. FAS included all randomised subjects who received at least 1 dose of study intervention.

End point type

Secondary

End point timeframe

From Week 16 through Week 24

End point values	Placebo	Guselkumab
Number of subjects analysed	16	17
Units: percentage of subjects
number (not applicable)	87.5	94.1

No statistical analyses for this end point

Secondary: Percentage of Subjects Achieving at Least 50% Decrease in Proteinuria From Baseline at Week 52

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End point title

Percentage of Subjects Achieving at Least 50% Decrease in Proteinuria From Baseline at Week 52

End point description

Percentage of subjects achieving at least 50% decrease in proteinuria from baseline at Week 52 were reported.FAS included all randomised subjects who received at least 1 dose of study intervention.

End point type

Secondary

End point timeframe

Week 52

End point values	Placebo	Guselkumab
Number of subjects analysed	16	17
Units: percentage of subjects
number (not applicable)	18.8	17.6

No statistical analyses for this end point

Secondary: Percentage of Subjects with Urine Protein to Creatinine Ratio (UPCR) < 0.5 mg/mg at Week 24

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End point title

Percentage of Subjects with Urine Protein to Creatinine Ratio (UPCR) < 0.5 mg/mg at Week 24

End point description

Percentage of subjects with UPCR <0.5 mg/mg at Week 24 were reported. FAS included all randomised subjects who received at least 1 dose of study intervention.

End point type

Secondary

End point timeframe

Week 24

End point values	Placebo	Guselkumab
Number of subjects analysed	16	17
Units: percentage of subjects
number (not applicable)	25.0	29.4

No statistical analyses for this end point

Secondary: Percentage of Subjects with UPCR < 0.75 mg/mg at Week 24

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End point title

Percentage of Subjects with UPCR < 0.75 mg/mg at Week 24

End point description

Percentage of subjects with UPCR less than (<) 0.75 mg/mg at Week 24 were reported. FAS included all randomised subjects who received at least 1 dose of study intervention.

End point type

Secondary

End point timeframe

Week 24

End point values	Placebo	Guselkumab
Number of subjects analysed	16	17
Units: percentage of subjects
number (not applicable)	37.5	35.3

No statistical analyses for this end point

Secondary: Number of Subjects with AE Leading to Discontinuation of Study Intervention

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End point title

Number of Subjects with AE Leading to Discontinuation of Study Intervention

End point description

Number of subjects with AE leading to discontinuation of study intervention were reported. SAS included all subjects who received at least one dose of study intervention. Since a small number of subjects only entered the LTE phase than the planned enrollment count, no separate adverse events analysis was performed for the LTE phase subjects and thus, data of both DB period and LTE phase were presented together for this endpoint under the arms: placebo and guselkumab.

End point type

Secondary

End point timeframe

DB period: From Week 0 up to 12 week safety follow-up (i.e., up to Week 60); LTE phase: From Week 52 up to LTE phase termination (i.e., up to Week 96)

End point values	Placebo	Guselkumab
Number of subjects analysed	16	17
Units: subjects	1	2

No statistical analyses for this end point

Secondary: Number of Subjects with Related AEs

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End point title

Number of Subjects with Related AEs

End point description

Number of subjects with related AEs were reported. An AE was defined as any untoward medical occurrence in a clinical study subject administered a medicinal (investigational or non-investigational) product did not necessarily have a causal relationship with the treatment. Therefore, it could be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to that medicinal product. Related AE was defined as the AE assessed by the investigator related to study agent. SAS included all subjects who received at least one dose of study intervention. Since a small number of subjects only entered the LTE phase than the planned enrollment count, no separate adverse events analysis was performed for the LTE phase subjects and thus, data of both DB period and LTE phase were presented together for this endpoint under the arms: placebo and guselkumab.

End point type

Secondary

End point timeframe

DB period: From Week 0 up to 12 week safety follow-up (i.e., up to Week 60); LTE phase: From Week 52 up to LTE phase termination (i.e., up to Week 96)

End point values	Placebo	Guselkumab
Number of subjects analysed	16	17
Units: subjects	2	2

No statistical analyses for this end point

Secondary: Number of Subjects with Serious Adverse Events (SAEs)

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End point title

Number of Subjects with Serious Adverse Events (SAEs)

End point description

Number of subjects with AEs were reported. A SAE was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening, required inpatient hospitalisation or prolongation of existing hospitalisation, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a suspected transmission of any infectious agent via a medicinal product, or was medically important. SAS included all subjects who received at least one dose of study intervention. Since a small number of subjects only entered the LTE phase than the planned enrollment count, no separate adverse events analysis was performed for the LTE phase participants and thus, data of both DB period and LTE phase were presented together for this endpoint under the arms: placebo and guselkumab.

End point type

Secondary

End point timeframe

DB period: From Week 0 up to 12 week safety follow-up (i.e., up to Week 60); LTE phase: From Week 52 up to LTE phase termination (i.e., up to Week 96)

End point values	Placebo	Guselkumab
Number of subjects analysed	16	17
Units: subjects	1	1

No statistical analyses for this end point

Secondary: Number of Subjects with Adverse Events (AEs)

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End point title

Number of Subjects with Adverse Events (AEs)

End point description

Number of subjects with AEs were reported. An AE was defined as any untoward medical occurrence in a clinical study subject administered a medicinal (investigational or non-investigational) product did not necessarily have a causal relationship with the treatment. Therefore, it could be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to that medicinal product. Safety analysis set (SAS) included all subjects who received at least one dose of study intervention. Since a small number of subjects only entered the LTE phase than the planned enrollment count, no separate adverse events analysis was performed for the LTE phase subjects and thus, data of both DB period and LTE phase were presented together for this endpoint under the arms: placebo and guselkumab.

End point type

Secondary

End point timeframe

DB period: From Week 0 up to 12 week safety follow-up (i.e., up to Week 60); LTE phase: From Week 52 up to LTE phase termination (i.e., up to Week 96)

End point values	Placebo	Guselkumab
Number of subjects analysed	16	17
Units: subjects	12	12

No statistical analyses for this end point

Secondary: Number of Subjects with Infections

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End point title

Number of Subjects with Infections

End point description

Number of subjects with infections as assessed by the investigator were reported. SAS included all subjects who received at least one dose of study intervention. Since a small number of subjects only entered the LTE phase than the planned enrollment count, no separate adverse events analysis was performed for the LTE phase subjects and thus, data of both DB period and LTE phase were presented together for this endpoint under the arms: placebo and guselkumab.

End point type

Secondary

End point timeframe

DB period: From Week 0 up to 12 week safety follow-up (i.e., up to Week 60); LTE phase: From Week 52 up to LTE phase termination (i.e., up to Week 96)

End point values	Placebo	Guselkumab
Number of subjects analysed	16	17
Units: subjects	5	6

No statistical analyses for this end point

Secondary: Number of Subjects With Serious Infections

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End point title

Number of Subjects With Serious Infections

End point description

Number of subjects with serious infections as assessed by the investigator were reported. SAS included all subjects who received at least one dose of study intervention. Since a small number of subjects only entered the LTE phase than the planned enrollment count, no separate adverse events analysis was performed for the LTE phase subjects and thus, data of both DB period and LTE phase were presented together for this endpoint under the arms: placebo and guselkumab.

End point type

Secondary

End point timeframe

DB period: From Week 0 up to 12 week safety follow-up (i.e., up to Week 60); LTE phase: From Week 52 up to LTE phase termination (i.e., up to Week 96)

End point values	Placebo	Guselkumab
Number of subjects analysed	16	17
Units: subjects	0	0

No statistical analyses for this end point

Secondary: Number of Subjects with Infections Requiring Oral or Parenteral Antimicrobial Treatment

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End point title

Number of Subjects with Infections Requiring Oral or Parenteral Antimicrobial Treatment

End point description

Number of subjects with infections requiring oral or parenteral antimicrobial treatment were reported. For this endpoint, no data was collected and analysed due to premature termination of the study.

End point type

Secondary

End point timeframe

DB period: From Week 0 up to 12 week safety follow-up (i.e., up to Week 60); LTE phase: From Week 52 up to LTE phase termination (i.e., up to Week 96)

End point values	Placebo	Guselkumab
Number of subjects analysed	16	17
Units: subjects	9999	9999

No statistical analyses for this end point

Secondary: Number of Subjects With AEs Temporally Associated with an Infusion

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End point title

Number of Subjects With AEs Temporally Associated with an Infusion

End point description

Number of subjects with AEs temporally (a reaction that occurred during of within 1 hour after infusion) associated with an infusion were reported. AE is any untoward medical occurrence in a clinical study subject administered a medicinal (investigational or non-investigational) product does not necessarily have a causal relationship with the treatment. Therefore, it can be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to that medicinal product. SAS included all subjects who received at least one dose of study intervention. Since a small number of subjects only entered the LTE phase than the planned enrollment count, no separate adverse events analysis was performed for the LTE phase subjects and thus, data of both DB period and LTE phase were presented together for this endpoint under the arms: placebo and guselkumab.

End point type

Secondary

End point timeframe

DB period: From Week 0 up to 12 week safety follow-up (i.e., up to Week 60); LTE phase: From Week 52 up to LTE phase termination (i.e., up to Week 96)

End point values	Placebo	Guselkumab
Number of subjects analysed	16	17
Units: subjects	1	0

No statistical analyses for this end point

Secondary: Number of Subjects With AEs with Injection-site Reactions

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End point title

Number of Subjects With AEs with Injection-site Reactions

End point description

Number of subjects with injection-site reactions as assessed by the investigator were reported. An injection-site reaction is any adverse reaction at a SC study intervention injection-site. SAS included all subjects who received at least one dose of study intervention. Since a small number of subjects only entered the LTE phase than the planned enrollment count, no separate adverse events analysis was performed for the LTE phase subjects and thus, data of both DB period and LTE phase were presented together for this endpoint under the arms: placebo and guselkumab.

End point type

Secondary

End point timeframe

DB period: From Week 0 up to 12 week safety follow-up (i.e., up to Week 60); LTE phase: From Week 52 up to LTE phase termination (i.e., up to Week 96)

End point values	Placebo	Guselkumab
Number of subjects analysed	16	17
Units: subjects	1	0

No statistical analyses for this end point

Secondary: Number of Subjects with Treatment-boosted Anti-drug antibodies (ADA) Response

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End point title

Number of Subjects with Treatment-boosted Anti-drug antibodies (ADA) Response ^[3]

End point description

Treatment-boosted ADA positive subjects: subjects who were positive at baseline and whose titers increased 2-fold at any time after treatment. Titer values were categorised as<=1:10, 10 to 100, 100 to 1000, >1000. Immunogenecity analysis set inlcuded all subjects who received at least 1 administration of guselkumab and had at least one post-dose sample collection. Here 'n' (number analysed) signifies number of subjects evaluable at specified timepoints. Data for this endpoint was not planned to be collected and analyzed for the placebo arm.

End point type

Secondary

End point timeframe

From Baseline (Week 0) through Week 24 and Week 60

Notes
[3] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This endpoint was planned to be reported for specified arms only.

End point values	Guselkumab
Number of subjects analysed	17
Units: subjects
Week 24 (n = 17)	1
Week 60 (n= 16)	1

No statistical analyses for this end point

Secondary: Percentage of Subjects with Abnormal Vital Signs: Systolic and Diastolic Blood Pressure

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End point title

Percentage of Subjects with Abnormal Vital Signs: Systolic and Diastolic Blood Pressure

End point description

Percentage of subjects with abnormal vital signs: Systolic and Diastolic blood pressure were reported. SAS included all subjects who received at least one dose of study intervention. Here "mmHg" refers to millimeter(s) of mercury.

End point type

Secondary

End point timeframe

Up to Week 60

End point values	Placebo	Guselkumab
Number of subjects analysed	16	17
Units: percentage of subjects
number (not applicable)
Systolic Blood Pressure: <85 mmHg	0	0
Systolic Blood Pressure::>180 mmHg	6.3	5.9
Diastolic Blood Pressure: <55 mmHg	6.3	0
Diastolic Blood Pressure: >115 mmHg	6.3	0

No statistical analyses for this end point

Secondary: Change from Baseline in Hematology Parameter: Hematocrit

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End point title

Change from Baseline in Hematology Parameter: Hematocrit

End point description

Change from baseline in hematology parameter: hematocrit was reported. SAS population. Here 'n' (number analysed) signifies number of subjects evaluable at specified timepoints. Here 'N' (number of subjects analysed) signifies to number of subjects with available data for this endpoint. Since a small number of subjects only entered the LTE phase than the planned enrollment count, the planned analysis of change from baseline for the safety parameters was not performed for the LTE phase for this endpoint. 9999=mean and standard deviation (SD) was not evaluated because no subjects were available for analysis.

End point type

Secondary

End point timeframe

Baseline (Week 0), Week 24, and Week 52

End point values	Placebo	Guselkumab
Number of subjects analysed	13	12
Units: fraction of 1
arithmetic mean (standard deviation)
Week 24 (n=13,12)	-0.013 ( 0.0411 )	-0.004 ( 0.0356 )
Week 52 (n=2,0)	-0.055 ( 0.0495 )	9999 ( 9999 )

No statistical analyses for this end point

Secondary: Change from Baseline in Hematology Parameter: Hemoglobin

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End point title

Change from Baseline in Hematology Parameter: Hemoglobin

End point description

Change from baseline in hematology parameter: hemoglobin was reported. SAS included all subjects who received at least one dose of study intervention. Here 'n' refers to the number of subjects evaluable at specified timepoints. Here 'N' refers to the number of subjects of both with available data for this endpoint. Since a small number of subjects only entered the LTE phase than the planned enrollment count, the planned analysis of change from baseline for the safety parameters was not performed for the LTE phase for this endpoint.9999=mean and SD was not evaluated because no subjects were available for analysis.

End point type

Secondary

End point timeframe

Baseline (Week 0), Week 24, and Week 52

End point values	Placebo	Guselkumab
Number of subjects analysed	16	15
Units: grams per liter (g/L)
arithmetic mean (standard deviation)
Week 24 (n=13,12)	-5.2 ( 15.57 )	-0.3 ( 14.82 )
Week 52 (n=2,0)	-17.0 ( 22.63 )	9999 ( 9999 )

No statistical analyses for this end point

Secondary: Change from Baseline in Clinical Laboratory Parameter:: Leukocytes

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End point title

Change from Baseline in Clinical Laboratory Parameter:: Leukocytes

End point description

Change from baseline in clinical laboratory parameter: leukocytes was reported. SAS population. Here 'n' (number analysed) signifies number of subjects evaluable at specified timepoints. Here 'N' (number of subjects analysed) signifies to number of subjects with available data for this endpoint. Since a small number of subjects only entered the LTE phase than the planned enrollment count, the planned analysis of change from baseline for the safety parameters was not performed for the LTE phase for this endpoint. 9999=mean and SD was not evaluated because no subjects were available for analysis.

End point type

Secondary

End point timeframe

Baseline (Week 0), Week 24, and Week 52

End point values	Placebo	Guselkumab
Number of subjects analysed	16	17
Units: 10*9 cells per liter
arithmetic mean (standard deviation)
Week 24 (n=13,12)	-0.622 ( 3.8729 )	-1.157 ( 3.1246 )
Week 52 (n=2,0)	-5.120 ( 7.7499 )	9999 ( 9999 )

No statistical analyses for this end point

Secondary: Change from Baseline in Clinical Laboratory Parameter: Lymphocytes

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End point title

Change from Baseline in Clinical Laboratory Parameter: Lymphocytes

End point description

Change from baseline in hematology parameter: lymphocytes was reported. SAS population. Here 'n' (number analysed) signifies number of subjects evaluable at specified timepoints. Here 'N' (number of subjects analysed) signifies to number of subjects with available data for this endpoint. Since a small number of subjects only entered the LTE phase than the planned enrollment count, the planned analysis of change from baseline for the safety parameters was not performed for the LTE phase for this endpoint. 9999= mean and SD was not evaluated because no subjects were available for analysis.

End point type

Secondary

End point timeframe

Baseline (Week 0), Week 24, and Week 52

End point values	Placebo	Guselkumab
Number of subjects analysed	13	12
Units: 10*9 cells per Liter
arithmetic mean (standard deviation)
Week 24 (n=13,12)	0.006 ( 0.5213 )	-0.032 ( 0.3860 )
Week 52 (n=2,0)	-0.545 ( 1.0960 )	9999 ( 9999 )

No statistical analyses for this end point

Secondary: Change from Baseline in Clinical Laboratory Parameter: Monocytes

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End point title

Change from Baseline in Clinical Laboratory Parameter: Monocytes

End point description

Change from baseline in hematology parameter: monocytes was reported. SAS population. Here 'n' (number analysed) signifies number of subjects evaluable at specified timepoints. Here 'N' (number of subjects analysed) signifies to number of subjects with available data for this endpoint. Since a small number of subjects only entered the LTE phase than the planned enrollment count, the planned analysis of change from baseline for the safety parameters was not performed for the LTE phase for this endpoint. 9999=mean and SD was not evaluated because no subjects were available for analysis.

End point type

Secondary

End point timeframe

Baseline (Week 0), Week 24, and Week 52

End point values	Placebo	Guselkumab
Number of subjects analysed	13	12
Units: 10*9 cells per liter
arithmetic mean (standard deviation)
Week 24 (n=13,12)	-0.014 ( 0.3277 )	-0.002 ( 0.1268 )
Week 52 (n=2,0)	-0.510 ( 0.7354 )	99999 ( 99999 )

No statistical analyses for this end point

Secondary: Change from Baseline in Clinical Laboratory Parameter: Hematology Parameter: Neutrophils, Segmented

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End point title

Change from Baseline in Clinical Laboratory Parameter: Hematology Parameter: Neutrophils, Segmented

End point description

Change from baseline in hematology parameter: neutrophils, segmented was reported. SAS population. Here 'n' (number analysed) signifies number of subjects evaluable at specified timepoints. Here 'N' (number of subjects analysed) signifies to number of subjects with available data for this endpoint. Since a small number of subjects only entered the LTE phase than the planned enrollment count, the planned analysis of change from baseline for the safety parameters was not performed for the LTE phase for this endpoint. Here, 9999=mean and standard deviation (SD) was not evaluated because no subjects were available for analysis.

End point type

Secondary

End point timeframe

Baseline (Week 0), Week 24, and Week 52

End point values	Placebo	Guselkumab
Number of subjects analysed	13	12
Units: 10*9 cells per liter
arithmetic mean (standard deviation)
Week 24 (n=13,12)	-0.630 ( 3.2494 )	-1.074 ( 2.9652 )
Week 52 (n=2,0)	-3.990 ( 5.8548 )	99999 ( 99999 )

No statistical analyses for this end point

Secondary: Change from Baseline in Clinical Laboratory Parameter: Platelets

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End point title

Change from Baseline in Clinical Laboratory Parameter: Platelets

End point description

Change from baseline in hematology parameter: platelets was reported. SAS population. Here 'n' (number analysed) signifies number of subjects evaluable at specified timepoints. Here 'N' (number of subjects analysed) signifies to number of subjects with available data for this endpoint. Since a small number of subjects only entered the LTE phase than the planned enrollment count, the planned analysis of change from baseline for the safety parameters was not performed for the LTE phase for this endpoint. Here '9999' signifies that mean and standard deviation (SD) was not evaluated because no subjects were available for analysis.

End point type

Secondary

End point timeframe

Baseline (Week 0), Week 24, and Week 52

End point values	Placebo	Guselkumab
Number of subjects analysed	13	12
Units: 10*9 cells per liter
arithmetic mean (standard deviation)
Week 24 (n=13,12)	-36.7 ( 61.43 )	-17.8 ( 61.89 )
Week 52 (n=2,0)	-70.5 ( 67.18 )	99999 ( 99999 )

No statistical analyses for this end point

Secondary: Change from Baseline in Clinical Laboratory Parameter: Prothrombin International Normalised Ratio

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End point title

Change from Baseline in Clinical Laboratory Parameter: Prothrombin International Normalised Ratio

End point description

Change from baseline in hematology parameter: prothrombin international normalized ratio was reported. SAS population. Here 'n' (number analysed) signifies number of subjects evaluable at specified timepoints. Here 'N' (number of subjects analysed) signifies to number of subjects with available data for this endpoint. Since a small number of subjects only entered the LTE phase than the planned enrollment count, the planned analysis of change from baseline for the safety parameters was not performed for the LTE phase for this endpoint. Here '9999' signifies that mean and standard deviation (SD) was not evaluated because no subjects were available for analysis.

End point type

Secondary

End point timeframe

Baseline (Week 0), Week 24, and Week 52

End point values	Placebo	Guselkumab
Number of subjects analysed	13	13
Units: RATIO
arithmetic mean (standard deviation)
Week 24 (n=13,13)	0.02 ( 0.090 )	0.01 ( 0.064 )
Week 52 (n=4,0)	0.00 ( 0.000 )	9999 ( 9999 )

No statistical analyses for this end point

Secondary: Change from Baseline in Clinical Laboratory Parameter: Prothrombin Time

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End point title

Change from Baseline in Clinical Laboratory Parameter: Prothrombin Time

End point description

Change from baseline in hematology parameter: prothrombin time was reported. SAS population. Here 'n' (number analysed) signifies number of subjects evaluable at specified timepoints. Here 'N' (number of subjects analysed) signifies to number of subjects with available data for this endpoint. Since a small number of subjects only entered the LTE phase than the planned enrollment count, the planned analysis of change from baseline for the safety parameters was not performed for the LTE phase for this endpoint. Here '9999' signifies that mean and standard deviation (SD) was not evaluated because no subjects were available for analysis.

End point type

Secondary

End point timeframe

Baseline (Week 0), Week 24, and Week 52

End point values	Placebo	Guselkumab
Number of subjects analysed	13	13
Units: second
arithmetic mean (standard deviation)
Week 24 (n=13,13)	0.18 ( 0.766 )	0.16 ( 0.425 )
Week 52(n=4,0)	-0.03 ( 0.359 )	9999 ( 9999 )

No statistical analyses for this end point

Secondary: Change from Baseline in Clinical Laboratory Parameter: Reticulocytes/Erythrocytes

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End point title

Change from Baseline in Clinical Laboratory Parameter: Reticulocytes/Erythrocytes

End point description

Change from baseline in hematology parameter:reticulocytes/erythrocytes was reported. SAS population. Here 'n' (number analysed) signifies number of subjects evaluable at specified timepoints. Here 'N' (number of subjects analysed) signifies to number of subjects with available data for this endpoint. Since a small number of subjects only entered the LTE phase than the planned enrollment count, the planned analysis of change from baseline for the safety parameters was not performed for the LTE phase for this endpoint. Here '9999' signifies that mean and standard deviation (SD) was not evaluated because no subjects were available for analysis.

End point type

Secondary

End point timeframe

Baseline (Week 0), Week 24, and Week 52

End point values	Placebo	Guselkumab
Number of subjects analysed	13	11
Units: fraction of 1
arithmetic mean (standard deviation)
Week 24 (n=13,11)	-0.0007 ( 0.00485 )	-0.0001 ( 0.00541 )
Week 52 (2,0)	0.0000 ( 0.01414 )	9999 ( 9999 )

No statistical analyses for this end point

Secondary: Change from Baseline in Clinical Laboratory Parameter: Albumin

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End point title

Change from Baseline in Clinical Laboratory Parameter: Albumin

End point description

Change from baseline in hematology parameter: albumin was reported. SAS population. Here 'n' (number analysed) signifies number of subjects evaluable at specified timepoints. Here 'N' (number of subjects analysed) signifies to number of subjects with available data for this endpoint. Since a small number of subjects only entered the LTE phase than the planned enrollment count, the planned analysis of change from baseline for the safety parameters was not performed for the LTE phase for this endpoint. Here '9999' signifies that SD was not evaluated because only 1 subject was available for analysis.

End point type

Secondary

End point timeframe

Baseline (Week 0), Week 24, and Week 52

End point values	Placebo	Guselkumab
Number of subjects analysed	14	16
Units: Grams per Liter (g/L)
arithmetic mean (standard deviation)
Week 24 (n=14,16)	2.4 ( 5.57 )	1.9 ( 4.58 )
Week 52 (n=4,1)	3.5 ( 5.32 )	-3.0 ( 9999 )

No statistical analyses for this end point

Secondary: Change from Baseline in Clinical Laboratory Parameter: Alanine Aminotransferase

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End point title

Change from Baseline in Clinical Laboratory Parameter: Alanine Aminotransferase

End point description

Change from baseline in hematology parameter: alanine aminotransferase was reported. SAS population. Here 'n' (number analysed) signifies number of subjects evaluable at specified timepoints. Here 'N' (number of subjects analysed) signifies to number of subjects with available data for this endpoint. Since a small number of subjects only entered the LTE phase than the planned enrollment count, the planned analysis of change from baseline for the safety parameters was not performed for the LTE phase for this endpoint. Here '9999' signifies that mean and standard deviation (SD) was not evaluated because no subjects were available for analysis.

End point type

Secondary

End point timeframe

Baseline (Week 0), Week 24, and Week 52

End point values	Placebo	Guselkumab
Number of subjects analysed	14	16
Units: Enzyme U/L
arithmetic mean (standard deviation)
Week 24 (n=14,16)	2.6 ( 10.98 )	-3.1 ( 6.57 )
Week 52 (n=4,0)	2.3 ( 4.92 )	9999 ( 9999 )

No statistical analyses for this end point

Secondary: Change from Baseline in Clinical Laboratory Parameter: Alkaline Phosphatase

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End point title

Change from Baseline in Clinical Laboratory Parameter: Alkaline Phosphatase

End point description

Change from baseline in hematology parameter: alkaline phosphatase was reported. SAS population. Here 'n' (number analysed) signifies number of subjects evaluable at specified timepoints. Here 'N' (number of subjects analysed) signifies to number of subjects with available data for this endpoint. Since a small number of subjects only entered the LTE phase than the planned enrollment count, the planned analysis of change from baseline for the safety parameters was not performed for the LTE phase for this endpoint. Here '9999' signifies that SD was not evaluated because only 1 subject was available for analysis.

End point type

Secondary

End point timeframe

Baseline (Week 0), Week 24, and Week 52

End point values	Placebo	Guselkumab
Number of subjects analysed	16	16
Units: Enzyme U/L
arithmetic mean (standard deviation)
Week 24 (n=14,16)	1.9 ( 16.75 )	1.7 ( 8.07 )
Week 52 (n=4,1)	6.5 ( 5.00 )	6.0 ( 9999 )

No statistical analyses for this end point

Secondary: Change from Baseline in Clinical Laboratory Parameter: Aspartate Aminotransferase

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End point title

Change from Baseline in Clinical Laboratory Parameter: Aspartate Aminotransferase

End point description

Change from baseline in hematology parameter: aspartate aminotransferase was reported. SAS population. Here 'n' (number analysed) signifies number of subjects evaluable at specified timepoints. Here 'N' (number of subjects analysed) signifies to number of subjects with available data for this endpoint. Since a small number of subjects only entered the LTE phase than the planned enrollment count, the planned analysis of change from baseline for the safety parameters was not performed for the LTE phase for this endpoint. Here '9999' signifies that SD was not evaluated because only 1 subject was available for analysis.

End point type

Secondary

End point timeframe

Baseline (Week 0), Week 24, and Week 52

End point values	Placebo	Guselkumab
Number of subjects analysed	13	13
Units: Enzyme U/L
arithmetic mean (standard deviation)
Week 24 (n=13,13)	0.0 ( 4.97 )	-0.7 ( 5.41 )
Week 52 (n=4,1)	1.5 ( 2.38 )	1.0 ( 9999 )

No statistical analyses for this end point

Secondary: Change from Baseline in Clinical Laboratory Parameter: Bicarbonate

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End point title

Change from Baseline in Clinical Laboratory Parameter: Bicarbonate

End point description

Change from baseline in hematology parameter: bicarbonate was reported. SAS population. Here 'n' (number analysed) signifies number of subjects evaluable at specified timepoints. Here 'N' (number of subjects analysed) signifies to number of subjects with available data for this endpoint. Since a small number of subjects only entered the LTE phase than the planned enrollment count, the planned analysis of change from baseline for the safety parameters was not performed for the LTE phase for this endpoint. Here '9999' signifies that mean SD was not evaluated because no subjects were available for analysis.

End point type

Secondary

End point timeframe

Baseline (Week 0), Week 24, and Week 52

End point values	Placebo	Guselkumab
Number of subjects analysed	13	12
Units: mmol/L
arithmetic mean (standard deviation)
Week 24 (n=13,12)	-0.78 ( 4.97 )	0.21 ( 5.41 )
Week 52 (n=2,0)	-2.20 ( 2.38 )	9999 ( 9999 )

No statistical analyses for this end point

Secondary: Change from Baseline in Clinical Laboratory Parameter: Bilirubin

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End point title

Change from Baseline in Clinical Laboratory Parameter: Bilirubin

End point description

Change from baseline in chemistry parameter: bilirubin was reported. SAS population. Here 'n' (number analysed) signifies number of subjects evaluable at specified timepoints. Here 'N' (number of subjects analysed) signifies to number of subjects with available data for this endpoint. Since a small number of subjects only entered the LTE phase than the planned enrollment count, the planned analysis of change from baseline for the safety parameters was not performed for the LTE phase for this endpoint. Here '9999' signifies that mean and SD was not evaluated because only one subject was available for analysis.

End point type

Secondary

End point timeframe

Baseline (Week 0), Week 24, and Week 52

End point values	Placebo	Guselkumab
Number of subjects analysed	16	16
Units: micromole per liter
arithmetic mean (standard deviation)
Week 24 (n=14,16)	0.1 ( 1.98 )	0.3 ( 2.46 )
Week 52 (n=4,1)	-0.3 ( 2.06 )	4.0 ( 9999 )

No statistical analyses for this end point

Secondary: Change from Baseline in Clinical Laboratory Parameter: Chloride

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End point title

Change from Baseline in Clinical Laboratory Parameter: Chloride

End point description

Change from baseline in chemistry parameter: chloride was reported. SAS population. Here 'n' (number analysed) signifies number of subjects evaluable at specified timepoints. Here 'N' (number of subjects analysed) signifies to number of subjects with available data for this endpoint. Since a small number of subjects only entered the LTE phase than the planned enrollment count, the planned analysis of change from baseline for the safety parameters was not performed for the LTE phase for this endpoint. Here '9999' signifies that mean SD was not evaluated because only 1 subject was available for analysis.

End point type

Secondary

End point timeframe

Baseline (Week 0), Week 24, and Week 52

End point values	Placebo	Guselkumab
Number of subjects analysed	14	16
Units: mmol/L
arithmetic mean (standard deviation)
Week 24 (n=14,16)	0.1 ( 4.50 )	0.7 ( 0.0958 )
Week 52 (n=4,1)	2.0 ( 4.83 )	2.0 ( 9999 )

No statistical analyses for this end point

Secondary: Change from Baseline in Clinical Laboratory Parameters: Calcium

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End point title

Change from Baseline in Clinical Laboratory Parameters: Calcium

End point description

Change from baseline in chemistry parameter: calcium was reported. SAS population. Here 'n' (number analysed) signifies number of subjects evaluable at specified timepoints. Here 'N' (number of subjects analysed) signifies to number of subjects with available data for this endpoint. Since a small number of subjects only entered the LTE phase than the planned enrollment count, the planned analysis of change from baseline for the safety parameters was not performed for the LTE phase for this endpoint. Here '9999' signifies that mean and SD was not evaluated because only 1 subjects was available for analysis.

End point type

Secondary

End point timeframe

Baseline (Week 0), Week 24, and Week 52

End point values	Placebo	Guselkumab
Number of subjects analysed	14	16
Units: mmol/L
arithmetic mean (standard deviation)
Week 24 (n=14,16)	0.039 ( 0.1172 )	0.073 ( 0.0958 )
Week 52 (n=4,1)	0.000 ( 0.1871 )	0.010 ( 9999 )

No statistical analyses for this end point

Secondary: Change from Baseline in Clinical Laboratory Parameters: Cholesterol

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End point title

Change from Baseline in Clinical Laboratory Parameters: Cholesterol

End point description

Change from baseline in chemistry parameter: cholesterol was reported. mean and SD was not evaluated because no subject was available for the analysis. Since a small number of subjects only entered the LTE phase than the planned enrollment count, the planned analysis of change from baseline for the safety parameters was not performed for the LTE phase for this endpoint. Here '9999' signifies that SD was not evaluated because only 1 subject was available for analysis.

End point type

Secondary

End point timeframe

Baseline (Week 0), Week 24, and Week 52

End point values	Placebo	Guselkumab
Number of subjects analysed	14	15
Units: mmol/L
arithmetic mean (standard deviation)
Week 24 (n=14,15)	-1.325 ( 1.3026 )	0.017 ( 0.7818 )
Week 52 (n=4,1)	-2.235 ( 1.6588 )	0.210 ( 9999 )

No statistical analyses for this end point

Secondary: Change from Baseline in Clinical Laboratory Parameter: Activated Partial Thromboplastin Time

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End point title

Change from Baseline in Clinical Laboratory Parameter: Activated Partial Thromboplastin Time

End point description

Change from baseline in hematology parameter: activated partial thromboplastin time was reported. SAS population. Here 'n' (number analysed) signifies number of subjects evaluable at specified timepoints. Here 'N' (number of subjects analysed) signifies to number of subjects with available data for this endpoint. Since a small number of subjects only entered the LTE phase than the planned enrollment count, the planned analysis of change from baseline for the safety parameters was not performed for the LTE phase for this endpoint.9999=signifies that mean and SD was not evaluated because no subject was available for the analysis.

End point type

Secondary

End point timeframe

Baseline (Week 0), Week 24, and Week 52

End point values	Placebo	Guselkumab
Number of subjects analysed	12	13
Units: Seconds
arithmetic mean (standard deviation)
Week 24 (n=12,13)	0.78 ( 1.734 )	0.96 ( 3.869 )
Week 52 (n=4,0)	0.88 ( 1.387 )	99999 ( 99999 )

No statistical analyses for this end point

Secondary: Change from Baseline in Clinical Laboratory Parameter: Creatine Kinase

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End point title

Change from Baseline in Clinical Laboratory Parameter: Creatine Kinase

End point description

Change from baseline in chemistry parameter: creatine kinase was reported. mean and SD was not evaluated because no subject was available for the analysis. Since a small number of subjects only entered the LTE phase than the planned enrollment count, the planned analysis of change from baseline for the safety parameters was not performed for the LTE phase for this endpoint. Here '9999' signifies that SD was not evaluated because only 1 subject was available for analysis.

End point type

Secondary

End point timeframe

Baseline (Week 0), Week 24, and Week 52

End point values	Placebo	Guselkumab
Number of subjects analysed	14	16
Units: Enzyme U/L
arithmetic mean (standard deviation)
Week 24 (n=14,16)	3.3 ( 42.22 )	-0.5 ( 53.94 )
Week 52 (n=4,1)	-8.8 ( 36.65 )	-2.0 ( 9999 )

No statistical analyses for this end point

Secondary: Change from Baseline in Clinical Laboratory Parameter: Basophils

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End point title

Change from Baseline in Clinical Laboratory Parameter: Basophils

End point description

Change from baseline in hematology parameter: basophils was reported. mean and SD was not evaluated because no subject was available for the analysis. Since a small number of subjects only entered the LTE phase than the planned enrollment count, the planned analysis of change from baseline for the safety parameters was not performed for the LTE phase for this endpoint. Here '9999' signifies that mean and SD was not evaluated because no subjects were available for analysis.

End point type

Secondary

End point timeframe

Baseline (Week 0), Week 24, and Week 52

End point values	Placebo	Guselkumab
Number of subjects analysed	13	12
Units: 10*9 cells per liter
arithmetic mean (standard deviation)
Week 24 (n=13,12)	-0.009 ( 0.0512 )	-0.009 ( 0.0502 )
Week 52 (n=2,0)	-0.070 ( 0.0990 )	9999 ( 9999 )

No statistical analyses for this end point

Secondary: Percentage of Subjects who Achieved CRR at Week 52

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End point title

Percentage of Subjects who Achieved CRR at Week 52

End point description

CRR was defined as UPCR less than (<) 0.5 mg/mg, eGFR >= 60 mL/min/1.73m^2 or no confirmed decrease >=20% from baseline and prednisone dose <= 10 mg/d. Subject was considered as achieved CRR who did not discontinue study intervention for any reason excluding COVID-19 related discontinuations or met the medication intercurrent event (exceeded baseline glucocorticoid dose, increase above 10 mg/d prednisone equivalent after Week 12, use of new or increased dose of concomitant medication related to LN or other immunosuppressive agents, within 8 weeks prior to the endpoint time point (Week 52) or initiation of prohibited medications at any time prior to the endpoint time point (Week 52). The Full Analyses Set for Week 52 (FASC52) includes all randomized subjects who received at least 1 dose of any study intervention and have the opportunity to complete the Week 52 visit prior to study termination. Here 'N' (number of subjects analyzed) signifies subjects evaluable for this endpoint.

End point type

Secondary

End point timeframe

Week 52

End point values	Placebo	Guselkumab
Number of subjects analysed	12	11
Units: percentage of subjects
number (not applicable)	25.0	9.1

No statistical analyses for this end point

Secondary: Change from Baseline in Clinical Laboratory Parameter: Creatinine

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End point title

Change from Baseline in Clinical Laboratory Parameter: Creatinine

End point description

Change from baseline in clinical laboratory parameter: creatinine was reported. mean and SD was not evaluated because no subject was available for the analysis. Since a small number of subjects only entered the LTE phase than the planned enrollment count, the planned analysis of change from baseline for the safety parameters was not performed for the LTE phase for this endpoint. Here '9999' signifies that SD was not evaluated because only 1 subject was available for analysis.

End point type

Secondary

End point timeframe

Baseline (Week 0), Week 24, and Week 52

End point values	Placebo	Guselkumab
Number of subjects analysed	14	16
Units: micromole per liter
arithmetic mean (standard deviation)
Week 24 (n=14,16)	0.6 ( 18.30 )	6.7 ( 16.78 )
Week 52 (n=4,1)	-3.3 ( 7.54 )	-5.0 ( 9999 )

No statistical analyses for this end point

Secondary: Change from Baseline in Clinical Laboratory Parameter: Protein

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End point title

Change from Baseline in Clinical Laboratory Parameter: Protein

End point description

Change from baseline in clinical laboratory parameter: protein was reported. mean and SD was not evaluated because no subject was available for the analysis. Since a small number of subjects only entered the LTE phase than the planned enrollment count, the planned analysis of change from baseline for the safety parameters was not performed for the LTE phase for this endpoint. Here '9999' signifies that SD was not evaluated because only 1 subject was available for analysis.

End point type

Secondary

End point timeframe

Baseline (Week 0), Week 24, and Week 52

End point values	Placebo	Guselkumab
Number of subjects analysed	14	16
Units: g/L
arithmetic mean (standard deviation)
Week 24 (n=14,16)	3.0 ( 8.83 )	2.9 ( 16.78 )
Week 52 (n=4,1)	7.0 ( 7.39 )	1.0 ( 9999 )

No statistical analyses for this end point

Secondary: Change from Baseline in Clinical Laboratory Parameter: Phosphate

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End point title

Change from Baseline in Clinical Laboratory Parameter: Phosphate

End point description

Change from baseline in clinical laboratory parameter: phosphate was reported. mean and SD was not evaluated because no subject was available for the analysis. Since a small number of subjects only entered the LTE phase than the planned enrollment count, the planned analysis of change from baseline for the safety parameters was not performed for the LTE phase for this endpoint. Here '9999' signifies that SD was not evaluated because only 1 subject was available for analysis.

End point type

Secondary

End point timeframe

Baseline (Week 0), Week 24, and Week 52

End point values	Placebo	Guselkumab
Number of subjects analysed	14	16
Units: mmol/L
arithmetic mean (standard deviation)
Week 24 (n=14,16)	0.060 ( 0.1498 )	0.030 ( 0.2916 )
Week 52 (n=4,1)	-0.035 ( 0.2213 )	0.220 ( 9999 )

No statistical analyses for this end point

Secondary: Change from Baseline in Clinical Laboratory Parameter: Sodium

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End point title

Change from Baseline in Clinical Laboratory Parameter: Sodium

End point description

Change from baseline in clinical laboratory parameter: sodium was reported. mean and SD was not evaluated because no subject was available for the analysis. Since a small number of subjects only entered the LTE phase than the planned enrollment count, the planned analysis of change from baseline for the safety parameters was not performed for the LTE phase for this endpoint. Here '9999' signifies that SD was not evaluated because only 1 subject was available for analysis.

End point type

Secondary

End point timeframe

Baseline (Week 0), Week 24, and Week 52

End point values	Placebo	Guselkumab
Number of subjects analysed	14	16
Units: mmol/L
arithmetic mean (standard deviation)
Week 24 (n=14,16)	-0.7 ( 2.30 )	0.4 ( 4.24 )
Week 52 (n=4,1)	1.0 ( 1.41 )	3.0 ( 9999 )

No statistical analyses for this end point

Secondary: Change from Baseline in Clinical Laboratory Parameter: Erythrocytes

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End point title

Change from Baseline in Clinical Laboratory Parameter: Erythrocytes

End point description

Change from baseline in clinical laboratory parameter: erythrocytes was reported. mean and SD was not evaluated because no subject was available for the analysis. Since a small number of subjects only entered the LTE phase than the planned enrollment count, the planned analysis of change from baseline for the safety parameters was not performed for the LTE phase for this endpoint. Here '9999' signifies that mean and SD was not evaluated because no subjects were available for analysis.

End point type

Secondary

End point timeframe

Baseline (Week 0), Week 24, and Week 52

End point values	Placebo	Guselkumab
Number of subjects analysed	13	12
Units: 10*12 cells per liter
arithmetic mean (standard deviation)
Week 24 (n=13,12)	-0.16 ( 0.582 )	0.12 ( 0.577 )
Week 52 (n=2,0)	-0.40 ( 0.566 )	9999 ( 9999 )

No statistical analyses for this end point

Secondary: Change from Baseline in Clinical Laboratiory Parameters: Potassium

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End point title

Change from Baseline in Clinical Laboratiory Parameters: Potassium

End point description

Change from baseline in clinical laboratory parameter: potassium was reported. mean and SD was not evaluated because no subject was available for the analysis. Since a small number of subjects only entered the LTE phase than the planned enrollment count, the planned analysis of change from baseline for the safety parameters was not performed for the LTE phase for this endpoint. Here '9999' signifies that SD was not evaluated because only 1 subject was available for analysis.

End point type

Secondary

End point timeframe

Baseline (Week 0), Week 24, and Week 52

End point values	Placebo	Guselkumab
Number of subjects analysed	14	16
Units: mmol/L
arithmetic mean (standard deviation)
Week 24 (n=14,16)	0.19 ( 0.704 )	0.13 ( 0.402 )
Week 52 (n=4,1)	0.03 ( 0.457 )	0.00 ( 9999 )

No statistical analyses for this end point

Secondary: Change from Baseline in Clinical Laboratory Parameters: Urea Nitrogen

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End point title

Change from Baseline in Clinical Laboratory Parameters: Urea Nitrogen

End point description

Change from baseline in chemistry parameter: urea nitrogen was reported. mean and SD was not evaluated because no subject was available for the analysis. Since a small number of subjects only entered the LTE phase than the planned enrollment count, the planned analysis of change from baseline for the safety parameters was not performed for the LTE phase for this endpoint. Here '9999' signifies that SD was not evaluated because only 1 subject was available for analysis

End point type

Secondary

End point timeframe

Baseline (Week 0), Week 24, and Week 52

End point values	Placebo	Guselkumab
Number of subjects analysed	14	16
Units: mmol/L
arithmetic mean (standard deviation)
Week 24 (n=14,16)	-1.23 ( 3.106 )	0.71 ( 2.177 )
Week 52 (n=4,1)	-1.60 ( 1.564 )	0.50 ( 9999 )

No statistical analyses for this end point

Secondary: Change from Baseline in Clinical Laboratory Parameter: Glomerular Filtration Rate (GFR) from Creatinine Adjusted for Body Surface Area (BSA)

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End point title

Change from Baseline in Clinical Laboratory Parameter: Glomerular Filtration Rate (GFR) from Creatinine Adjusted for Body Surface Area (BSA)

End point description

Change from baseline in clinical laboratory parameter: GFR from Creatinine Adjusted for BSA was reported. mean and SD was not evaluated because no subject was available for the analysis. Since a small number of subjects only entered the LTE phase than the planned enrollment count, the planned analysis of change from baseline for the safety parameters was not performed for the LTE phase for this endpoint. Here '9999' signifies that SD was not evaluated because only 1 subject was available for analysis.

End point type

Secondary

End point timeframe

Baseline (Week 0), Weeks 24 and 52

End point values	Placebo	Guselkumab
Number of subjects analysed	14	16
Units: millilter/minute/1.73 meter square
arithmetic mean (standard deviation)
Week 24 (n=14,16)	0.44 ( 21.639 )	-5.87 ( 17.150 )
Week 52 (n=4,1)	6.75 ( 22.588 )	5.60 ( 9999 )

No statistical analyses for this end point

Secondary: Change from Baseline in Clinical Laboratory Parameter: Gamma Glutamyl and Transferase Lactate Dehydrogenase

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End point title

Change from Baseline in Clinical Laboratory Parameter: Gamma Glutamyl and Transferase Lactate Dehydrogenase

End point description

Change from baseline in clinical laboratory parameter: gamma glutamyl transferase and lactate dehydrogenase were reported. mean and SD was not evaluated because no subject was available for the analysis. Since a small number of subjects only entered the LTE phase than the planned enrollment count, the planned analysis of change from baseline for the safety parameters was not performed for the LTE phase for this endpoint. Here '9999' signifies that SD was not evaluated because only 1 subject was available for analysis.

End point type

Secondary

End point timeframe

Baseline (Week 0), Weeks 24 and 52

End point values	Placebo	Guselkumab
Number of subjects analysed	14	16
Units: Enzyme units per liter (U/L)
arithmetic mean (standard deviation)
gamma glutamyl transferase: Week 24 (n=14,16)	-0.6 ( 15.01 )	-3.0 ( 9.70 )
gamma glutamyl transferase: Week 52 (n=4,1)	1.0 ( 8.60 )	-2.0 ( 99999 )
Lactate dehrdogenase: Week 24 (n=13,12)	-14.5 ( 47.90 )	-2.5 ( 17.52 )
Lactate dehrdogenase: Week 24 (n=2,1)	-62.5 ( 40.31 )	7.0 ( 99999 )

No statistical analyses for this end point

Secondary: Change from Baseline in Clinical Laboratory Parameter: Glucose and Magnesium

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End point title

Change from Baseline in Clinical Laboratory Parameter: Glucose and Magnesium

End point description

Change from baseline in clinical laboratory parameter: glucose and magnesium werereported. mean and SD was not evaluated because no subject was available for the analysis. Since a small number of subjects only entered the LTE phase than the planned enrollment count, the planned analysis of change from baseline for the safety parameters was not performed for the LTE phase for this endpoint. Here '9999' signifies that SD was not evaluated because only 1 subject was available for analysis.

End point type

Secondary

End point timeframe

Baseline (Week 0), Weeks 24 and 52

End point values	Placebo	Guselkumab
Number of subjects analysed	14	16
Units: millimoles per liter (mmol/L)
arithmetic mean (standard deviation)
Glucose: Week 24 (n=14,16)	-0.23 ( 1.041 )	-0.04 ( 0.908 )
Glucose:: Week 52 (n=4,1)	-0.03 ( 0.126 )	0.20 ( 9999 )
Magnesium: Week 24 (n=14,16)	-0.024 ( 0.0696 )	-0.022 ( 0.0607 )
Magnesium: Week 24 (n=4,1)	-0.068 ( 0.0842 )	-0.010 ( 9999 )

No statistical analyses for this end point

Secondary: Change from Baseline in Clinical Laboratory Parameter: Protein/Creatinine

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End point title

Change from Baseline in Clinical Laboratory Parameter: Protein/Creatinine

End point description

Change from baseline in clinical labpratory parameter: protein/creatinine was reported. mean and SD was not evaluated because no subject was available for the analysis. Since a small number of subjects only entered the LTE phase than the planned enrollment count, the planned analysis of change from baseline for the safety parameters was not performed for the LTE phase for this endpoint.

End point type

Secondary

End point timeframe

Baseline (Week 0), Weeks 24 and 52

End point values	Placebo	Guselkumab
Number of subjects analysed	15	16
Units: milligrams per milligram (mg/mg)
arithmetic mean (standard deviation)
Week 24 (n=15,16)	-1.509 ( 1.9494 )	-0.821 ( 2.4250 )
Week 52 (n=6,7)	-1.586 ( 1.7966 )	-0.352 ( 1.6960 )

No statistical analyses for this end point

Secondary: Double-blind Period: Change from Baseline in Clinical Laboratory Parameter: Urate

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End point title

Double-blind Period: Change from Baseline in Clinical Laboratory Parameter: Urate

End point description

Change from baseline in clinical laboratory parameter: urate was reported. mean and SD was not evaluated because no subject was available for the analysis. Since a small number of subjects only entered the LTE phase than the planned enrollment count, the planned analysis of change from baseline for the safety parameters was not performed for the LTE phase for this endpoint.Here '9999' signifies that SD was not evaluated because only 1 subject was available for analysis.

End point type

Secondary

End point timeframe

Baseline (Week 0), Weeks 24 and 52

End point values	Placebo	Guselkumab
Number of subjects analysed	14	16
Units: micromole per liter
arithmetic mean (standard deviation)
Week 24 (n=14,16)	-73.4 ( 104.11 )	8.4 ( 48.61 )
Week 52 (n=4,7)	-79.5 ( 79.38 )	-2.0 ( 9999 )

No statistical analyses for this end point

Secondary: Double-blind Period: Change from Baseline in Clinical Laboratory Parameter: Urine Protein

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End point title

Double-blind Period: Change from Baseline in Clinical Laboratory Parameter: Urine Protein

End point description

Change from baseline in clinical labpratory parameter: urine protein was reported. mean and SD was not evaluated because no subject was available for the analysis. Since a small number of subjects only entered the LTE phase than the planned enrollment count, the planned analysis of change from baseline for the safety parameters was not performed for the LTE phase for this endpoint.

End point type

Secondary

End point timeframe

Baseline (Week 0), Weeks 24 and 52

End point values	Placebo	Guselkumab
Number of subjects analysed	15	16
Units: milligrams per liter (mg/L)
arithmetic mean (standard deviation)
Week 24 (n=15,16)	-1322.1 ( 1865.82 )	-310.3 ( 1494.58 )
Week 52 (n=6,7)	-1821.7 ( 2334.78 )	-166.4 ( 1099.54 )

No statistical analyses for this end point

Secondary: Number of Subjects with Maximum US National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) Toxicity Grade (Grade 4) in Clinical Laboratory Parameters: Hematology and Chemistry

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End point title

Number of Subjects with Maximum US National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) Toxicity Grade (Grade 4) in Clinical Laboratory Parameters: Hematology and Chemistry

End point description

Number of subjects with maximum US NCI-CTCAE toxicity grade (Grade 4) in clinical laboratory parameters: hematology and chemistry were reported. Toxicity were graded as Grade 1: Mild, Grade 2: Moderate; Grade 3: Severe. Grade 4: Life-threatening and Grade 5: Death. SAS included all subjects who received at least one dose of study intervention. Since a small number of subjects only entered the LTE period than the planned enrollment count, no separate adverse events analysis was performed for the LTE phase subjects and thus, data of both DB period and LTE phase were presented together for this endpoint under the arms: placebo and guselkumab.

End point type

Secondary

End point timeframe

DB period: From Week 0 up to 12 week safety follow-up (i.e., up to Week 60); LTE phase: From Week 52 up to LTE phase termination (i.e., up to Week 96)

End point values	Placebo	Guselkumab
Number of subjects analysed	16	17
Units: subjects
number (not applicable)
Alanine Aminotransferase Increased	0	0
Alkaline Phosphatase Increased	0	0
Aspartate Aminotransferase Increased	0	0
Blood Bilirubin Increased	0	0
CPK Increased	0	0
Cholesterol High	0	0
Creatinine Increase	0	0
Gamma-glutamyl transferase (GGT) Increased	0	0
Hypermagnesemia	0	0
Hypernatremia	0	0
Hypertriglyceridemia	0	0
Hypoalbuminemia	0	0
Hypoglycemia	0	0
Hypokalemia	0	0
Hypomagnesemia	0	0
Hyponatremia	0	0
Activated Partial Thromboplastin Time Prolonged	0	0
Anemia	0	0
Hemoglobin Increased	0	0
Leukocytosis	0	0
Lymphocyte Count Decreased	0	0
Lymphocyte Count Increased	0	0
Neutrophil Count Decreased	0	0
Platelet Count Decreased	0	0
White Blood Cell Decreased	0	0

No statistical analyses for this end point

Adverse events

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Timeframe for reporting adverse events

DB period: From Week 0 up to 12 week safety follow-up (i.e., up to Week 60); LTE phase: From Week 52 up to LTE phase termination (i.e., up to Week 96)

Adverse event reporting additional description

SAS: all subjects who received at least 1 dose of study drug. Since small number of subjects only entered LTE period than planned enrollment, no separate AEs analysis was performed for LTE phase subjects and thus, data of both DB and LTE period were presented together for AEs (SAEs and non- SAEs) and death data under arms: placebo and guselkumab.

Assessment type

Non-systematic

Dictionary name

MedDRA

Dictionary version

25.1

Reporting group title

Guselkumab

Reporting group description

Reporting group title

Placebo

Reporting group description

Serious adverse events	Guselkumab	Placebo
Total subjects affected by serious adverse events
subjects affected / exposed	1 / 17 (5.88%)	1 / 16 (6.25%)
number of deaths (all causes)	0	0
number of deaths resulting from adverse events
Nervous system disorders
Basal Ganglia Stroke
subjects affected / exposed	0 / 17 (0.00%)	1 / 16 (6.25%)
occurrences causally related to treatment / all	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Renal and urinary disorders
Lupus Nephritis
subjects affected / exposed	1 / 17 (5.88%)	0 / 16 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0

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

Non-serious adverse events	Guselkumab	Placebo
Total subjects affected by non serious adverse events
subjects affected / exposed	12 / 17 (70.59%)	12 / 16 (75.00%)
Vascular disorders
Hypotension
subjects affected / exposed	0 / 17 (0.00%)	1 / 16 (6.25%)
occurrences all number	0	0
Hypertension
subjects affected / exposed	2 / 17 (11.76%)	2 / 16 (12.50%)
occurrences all number	0	0
General disorders and administration site conditions
Pyrexia
subjects affected / exposed	0 / 17 (0.00%)	1 / 16 (6.25%)
occurrences all number	0	0
Injection Site Erythema
subjects affected / exposed	0 / 17 (0.00%)	1 / 16 (6.25%)
occurrences all number	0	0
Fatigue
subjects affected / exposed	0 / 17 (0.00%)	1 / 16 (6.25%)
occurrences all number	0	0
Investigations
Alanine Aminotransferase Increased
subjects affected / exposed	1 / 17 (5.88%)	0 / 16 (0.00%)
occurrences all number	0	0
White Blood Cell Count Increased
subjects affected / exposed	1 / 17 (5.88%)	0 / 16 (0.00%)
occurrences all number	0	0
Liver Function Test Increased
subjects affected / exposed	1 / 17 (5.88%)	0 / 16 (0.00%)
occurrences all number	0	0
Heart Rate Increased
subjects affected / exposed	1 / 17 (5.88%)	0 / 16 (0.00%)
occurrences all number	0	0
Blood Pressure Increased
subjects affected / exposed	1 / 17 (5.88%)	0 / 16 (0.00%)
occurrences all number	0	0
Blood Creatine Phosphokinase Increased
subjects affected / exposed	0 / 17 (0.00%)	1 / 16 (6.25%)
occurrences all number	0	0
Blood Bicarbonate Decreased
subjects affected / exposed	0 / 17 (0.00%)	1 / 16 (6.25%)
occurrences all number	0	0
Injury, poisoning and procedural complications
Skin Laceration
subjects affected / exposed	0 / 17 (0.00%)	1 / 16 (6.25%)
occurrences all number	0	0
Medication Error
subjects affected / exposed	2 / 17 (11.76%)	0 / 16 (0.00%)
occurrences all number	0	0
Cardiac disorders
Left Ventricular Hypertrophy
subjects affected / exposed	1 / 17 (5.88%)	0 / 16 (0.00%)
occurrences all number	0	0
Nervous system disorders
Tension Headache
subjects affected / exposed	0 / 17 (0.00%)	1 / 16 (6.25%)
occurrences all number	0	0
Sciatica
subjects affected / exposed	0 / 17 (0.00%)	1 / 16 (6.25%)
occurrences all number	0	0
Post Herpetic Neuralgia
subjects affected / exposed	1 / 17 (5.88%)	0 / 16 (0.00%)
occurrences all number	0	0
Hypoaesthesia
subjects affected / exposed	0 / 17 (0.00%)	1 / 16 (6.25%)
occurrences all number	0	0
Headache
subjects affected / exposed	2 / 17 (11.76%)	0 / 16 (0.00%)
occurrences all number	0	0
Blood and lymphatic system disorders
Anaemia
subjects affected / exposed	3 / 17 (17.65%)	1 / 16 (6.25%)
occurrences all number	0	0
Iron Deficiency Anaemia
subjects affected / exposed	0 / 17 (0.00%)	1 / 16 (6.25%)
occurrences all number	0	0
Leukopenia
subjects affected / exposed	0 / 17 (0.00%)	2 / 16 (12.50%)
occurrences all number	0	0
Lymphopenia
subjects affected / exposed	0 / 17 (0.00%)	3 / 16 (18.75%)
occurrences all number	0	0
Thrombocytopenia
subjects affected / exposed	0 / 17 (0.00%)	1 / 16 (6.25%)
occurrences all number	0	0
Eye disorders
Ocular Myasthenia
subjects affected / exposed	1 / 17 (5.88%)	0 / 16 (0.00%)
occurrences all number	0	0
Gastrointestinal disorders
Toothache
subjects affected / exposed	0 / 17 (0.00%)	1 / 16 (6.25%)
occurrences all number	0	0
Nausea
subjects affected / exposed	0 / 17 (0.00%)	1 / 16 (6.25%)
occurrences all number	0	0
Gastrooesophageal Reflux Disease
subjects affected / exposed	2 / 17 (11.76%)	0 / 16 (0.00%)
occurrences all number	0	0
Diarrhoea
subjects affected / exposed	0 / 17 (0.00%)	1 / 16 (6.25%)
occurrences all number	0	0
Chronic Gastritis
subjects affected / exposed	1 / 17 (5.88%)	0 / 16 (0.00%)
occurrences all number	0	0
Abdominal Pain Upper
subjects affected / exposed	0 / 17 (0.00%)	2 / 16 (12.50%)
occurrences all number	0	0
Skin and subcutaneous tissue disorders
Urticaria
subjects affected / exposed	1 / 17 (5.88%)	0 / 16 (0.00%)
occurrences all number	0	0
Skin Striae
subjects affected / exposed	1 / 17 (5.88%)	0 / 16 (0.00%)
occurrences all number	0	0
Dry Skin
subjects affected / exposed	0 / 17 (0.00%)	1 / 16 (6.25%)
occurrences all number	0	0
Renal and urinary disorders
Lupus Nephritis
subjects affected / exposed	5 / 17 (29.41%)	2 / 16 (12.50%)
occurrences all number	0	0
Endocrine disorders
Hypothyroidism
subjects affected / exposed	1 / 17 (5.88%)	0 / 16 (0.00%)
occurrences all number	0	0
Musculoskeletal and connective tissue disorders
Arthralgia
subjects affected / exposed	0 / 17 (0.00%)	1 / 16 (6.25%)
occurrences all number	0	0
Back Pain
subjects affected / exposed	0 / 17 (0.00%)	1 / 16 (6.25%)
occurrences all number	0	0
Muscular Weakness
subjects affected / exposed	0 / 17 (0.00%)	1 / 16 (6.25%)
occurrences all number	0	0
Systemic Lupus Erythematosus
subjects affected / exposed	1 / 17 (5.88%)	0 / 16 (0.00%)
occurrences all number	0	0
Sle Arthritis
subjects affected / exposed	0 / 17 (0.00%)	1 / 16 (6.25%)
occurrences all number	0	0
Pain in Extremity
subjects affected / exposed	0 / 17 (0.00%)	1 / 16 (6.25%)
occurrences all number	0	0
Muscle Spasms
subjects affected / exposed	0 / 17 (0.00%)	1 / 16 (6.25%)
occurrences all number	0	0
Infections and infestations
Bacterial Vaginosis
subjects affected / exposed	1 / 17 (5.88%)	0 / 16 (0.00%)
occurrences all number	0	0
Bronchitis
subjects affected / exposed	1 / 17 (5.88%)	0 / 16 (0.00%)
occurrences all number	0	0
Urinary Tract Infection
subjects affected / exposed	2 / 17 (11.76%)	2 / 16 (12.50%)
occurrences all number	0	0
Upper Respiratory Tract Infection
subjects affected / exposed	0 / 17 (0.00%)	1 / 16 (6.25%)
occurrences all number	0	0
Pyelonephritis Chronic
subjects affected / exposed	1 / 17 (5.88%)	0 / 16 (0.00%)
occurrences all number	0	0
Pneumonia Bacterial
subjects affected / exposed	0 / 17 (0.00%)	1 / 16 (6.25%)
occurrences all number	0	0
Influenza
subjects affected / exposed	2 / 17 (11.76%)	0 / 16 (0.00%)
occurrences all number	0	0
Herpes Zoster
subjects affected / exposed	1 / 17 (5.88%)	2 / 16 (12.50%)
occurrences all number	0	0
Gastroenteritis
subjects affected / exposed	0 / 17 (0.00%)	1 / 16 (6.25%)
occurrences all number	0	0
Covid-19
subjects affected / exposed	0 / 17 (0.00%)	3 / 16 (18.75%)
occurrences all number	0	0
Metabolism and nutrition disorders
Vitamin D Deficiency
subjects affected / exposed	0 / 17 (0.00%)	1 / 16 (6.25%)
occurrences all number	0	0
Hypokalaemia
subjects affected / exposed	0 / 17 (0.00%)	1 / 16 (6.25%)
occurrences all number	0	0
Hyperuricaemia
subjects affected / exposed	1 / 17 (5.88%)	2 / 16 (12.50%)
occurrences all number	0	0
Hyperlipidaemia
subjects affected / exposed	1 / 17 (5.88%)	0 / 16 (0.00%)
occurrences all number	0	0
Hyperkalaemia
subjects affected / exposed	1 / 17 (5.88%)	1 / 16 (6.25%)
occurrences all number	0	0
Dyslipidaemia
subjects affected / exposed	1 / 17 (5.88%)	0 / 16 (0.00%)
occurrences all number	0	0

More information

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Were there any global substantial amendments to the protocol? Yes

07 May 2020

It was recognized that the Coronavirus Disease 2019 (COVID-19) pandemic may have an impact on the conduct of this clinical study. In alignment with recent health authority guidance, the Sponsor was providing options for study related subject management in the event of COVID-19 related disruption to the conduct of the study.

20 May 2021

Added a LTE to the study for an additional 2 years in order to evaluate long-term efficacy and safety of guselkumab treatment in lupus nephritis. Eligible subjects must have achieved complete renal response (CRR) at Weeks 48 and 52. This amendment also addressesed the use of oral contraceptives (using oral contraceptives with a second method of contraception) with concomitant mycophenolate mofetil (MMF)/mycophenolic acid (MPA) due to changes in their label.

29 Mar 2022

Revised the inclusion and exclusion criteria on the use of glucocorticoids and cyclophosphamide to better align with standard of care treatment for lupus nephritis and to enhance enrollment in the study without affecting the Sponsor’s ability to fulfill the objectives of the study. The requirement for collection of plasma biomarkers samples in the long-term extension (LTE) was removed. In addition, Cystatin C testing was now required. Additional changes are also listed in the amendment table below.

24 May 2022

Revised the protocol to reflect the sponsor’s decision to stop screening of new subjects and terminate the study early, as a result of enrollment challenges.

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.

Due to enrollment challenges,Sponsor decided to stop screening of new subjects and stop study early. Since small number of subjects entered LTE phase than planned enrollment, some of planned safety analyses were not performed for LTE phase subjects.

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Clinical trials

Clinical Trial Results: A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Guselkumab in Subjects with Active Lupus Nephritis

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Percentage of Subjects Achieving at Least 50 Percent (%) Decrease From Baseline in Proteinuria at Week 24

Primary: Percentage of Subjects Achieving at Least 50 Percent (%) Decrease From Baseline in Proteinuria at Week 24

Secondary: Time to Achievement of Complete Renal Response

Secondary: Time to Achievement of Complete Renal Response

Secondary: Percentage of Subjects who Achieved Complete Renal Response (CRR) at Week 24

Secondary: Percentage of Subjects who Achieved Complete Renal Response (CRR) at Week 24

Secondary: Time to Treatment Failure (TF)

Secondary: Time to Treatment Failure (TF)

Secondary: Serum Concentration of Guselkumab

Secondary: Serum Concentration of Guselkumab

Secondary: Percentage of Subjects Achieving a Sustained Reduction in Steroid Dose <=10 mg/d of Prednisone or Equivalent From Week 16 through Week 24

Secondary: Percentage of Subjects Achieving a Sustained Reduction in Steroid Dose <=10 mg/d of Prednisone or Equivalent From Week 16 through Week 24

Secondary: Percentage of Subjects Achieving at Least 50% Decrease in Proteinuria From Baseline at Week 52

Secondary: Percentage of Subjects Achieving at Least 50% Decrease in Proteinuria From Baseline at Week 52

Secondary: Percentage of Subjects with Urine Protein to Creatinine Ratio (UPCR) < 0.5 mg/mg at Week 24

Secondary: Percentage of Subjects with Urine Protein to Creatinine Ratio (UPCR) < 0.5 mg/mg at Week 24

Secondary: Percentage of Subjects with UPCR < 0.75 mg/mg at Week 24

Secondary: Percentage of Subjects with UPCR < 0.75 mg/mg at Week 24

Secondary: Number of Subjects with AE Leading to Discontinuation of Study Intervention

Secondary: Number of Subjects with AE Leading to Discontinuation of Study Intervention

Secondary: Number of Subjects with Related AEs

Secondary: Number of Subjects with Related AEs

Secondary: Number of Subjects with Serious Adverse Events (SAEs)

Secondary: Number of Subjects with Serious Adverse Events (SAEs)

Secondary: Number of Subjects with Adverse Events (AEs)

Secondary: Number of Subjects with Adverse Events (AEs)

Secondary: Number of Subjects with Infections

Secondary: Number of Subjects with Infections

Secondary: Number of Subjects With Serious Infections

Secondary: Number of Subjects With Serious Infections

Secondary: Number of Subjects with Infections Requiring Oral or Parenteral Antimicrobial Treatment

Secondary: Number of Subjects with Infections Requiring Oral or Parenteral Antimicrobial Treatment

Secondary: Number of Subjects With AEs Temporally Associated with an Infusion

Secondary: Number of Subjects With AEs Temporally Associated with an Infusion

Secondary: Number of Subjects With AEs with Injection-site Reactions

Secondary: Number of Subjects With AEs with Injection-site Reactions

Secondary: Number of Subjects with Treatment-boosted Anti-drug antibodies (ADA) Response

Secondary: Number of Subjects with Treatment-boosted Anti-drug antibodies (ADA) Response

Secondary: Percentage of Subjects with Abnormal Vital Signs: Systolic and Diastolic Blood Pressure

Secondary: Percentage of Subjects with Abnormal Vital Signs: Systolic and Diastolic Blood Pressure

Secondary: Change from Baseline in Hematology Parameter: Hematocrit

Secondary: Change from Baseline in Hematology Parameter: Hematocrit

Secondary: Change from Baseline in Hematology Parameter: Hemoglobin

Secondary: Change from Baseline in Hematology Parameter: Hemoglobin

Secondary: Change from Baseline in Clinical Laboratory Parameter:: Leukocytes

Secondary: Change from Baseline in Clinical Laboratory Parameter:: Leukocytes

Secondary: Change from Baseline in Clinical Laboratory Parameter: Lymphocytes

Secondary: Change from Baseline in Clinical Laboratory Parameter: Lymphocytes

Secondary: Change from Baseline in Clinical Laboratory Parameter: Monocytes

Secondary: Change from Baseline in Clinical Laboratory Parameter: Monocytes

Secondary: Change from Baseline in Clinical Laboratory Parameter: Hematology Parameter: Neutrophils, Segmented

Secondary: Change from Baseline in Clinical Laboratory Parameter: Hematology Parameter: Neutrophils, Segmented

Secondary: Change from Baseline in Clinical Laboratory Parameter: Platelets

Secondary: Change from Baseline in Clinical Laboratory Parameter: Platelets

Secondary: Change from Baseline in Clinical Laboratory Parameter: Prothrombin International Normalised Ratio

Secondary: Change from Baseline in Clinical Laboratory Parameter: Prothrombin International Normalised Ratio

Secondary: Change from Baseline in Clinical Laboratory Parameter: Prothrombin Time

Secondary: Change from Baseline in Clinical Laboratory Parameter: Prothrombin Time

Secondary: Change from Baseline in Clinical Laboratory Parameter: Reticulocytes/Erythrocytes

Secondary: Change from Baseline in Clinical Laboratory Parameter: Reticulocytes/Erythrocytes

Secondary: Change from Baseline in Clinical Laboratory Parameter: Albumin

Secondary: Change from Baseline in Clinical Laboratory Parameter: Albumin

Secondary: Change from Baseline in Clinical Laboratory Parameter: Alanine Aminotransferase

Secondary: Change from Baseline in Clinical Laboratory Parameter: Alanine Aminotransferase

Secondary: Change from Baseline in Clinical Laboratory Parameter: Alkaline Phosphatase

Secondary: Change from Baseline in Clinical Laboratory Parameter: Alkaline Phosphatase

Secondary: Change from Baseline in Clinical Laboratory Parameter: Aspartate Aminotransferase

Secondary: Change from Baseline in Clinical Laboratory Parameter: Aspartate Aminotransferase

Secondary: Change from Baseline in Clinical Laboratory Parameter: Bicarbonate

Secondary: Change from Baseline in Clinical Laboratory Parameter: Bicarbonate

Clinical Trial Results:
A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Guselkumab in Subjects with Active Lupus Nephritis