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

Summary
EudraCT number	2017-001489-53
Trial protocol	ES LT DE BG HU PL PT
Global end of trial date	05 Nov 2020

Results information
Results version number	v1(current)
This version publication date	21 May 2021
First version publication date	21 May 2021
Other versions

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

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Trial information

Top of page

Sponsor protocol code

CNTO1275SLE3001

ISRCTN number

-

US NCT number

NCT03517722

WHO universal trial number (UTN)

-

Sponsor organisation name

Janssen Research and Development, LLC

Sponsor organisation address

Welsh & McKean Roads, P.O. Box 776, Spring House, United States, PA 19477

Public contact

Clinical Registry Group, Janssen Research and Development, LLC, ClinicalTrialsEU@its.jnj.com

Scientific contact

Clinical Registry Group, Janssen Research and Development, LLC, ClinicalTrialsEU@its.jnj.com

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

No

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

No

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

Yes

Analysis stage

Final

Date of interim/final analysis

05 Nov 2020

Is this the analysis of the primary completion data?

No

Global end of trial reached?

Yes

Global end of trial date

05 Nov 2020

Was the trial ended prematurely?

Yes

Main objective of the trial

The main objective of this study was to evaluate the efficacy of ustekinumab in subjects with active systemic lupus erythematosus (SLE) who had not adequately responded to one or more standard-of-care treatments.

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. The safety assessments included vital signs, general and targeted physical examination, adverse events (AEs)/serious adverse events (SAEs), study agent administration reaction, concomitant medications, laboratory tests including pregnancy testing, chemistry, coagulation, hematology, and urinalysis, and immunogenicity.

Background therapy

-

Evidence for comparator

-

Actual start date of recruitment

03 May 2018

Long term follow-up planned

No

Independent data monitoring committee (IDMC) involvement?

Yes

Number of subjects enrolled per country

Country: Number of subjects enrolled

Argentina: 28

Country: Number of subjects enrolled

Bulgaria: 27

Country: Number of subjects enrolled

Canada: 2

Country: Number of subjects enrolled

China: 8

Country: Number of subjects enrolled

Colombia: 17

Country: Number of subjects enrolled

Germany: 19

Country: Number of subjects enrolled

Hungary: 14

Country: Number of subjects enrolled

Japan: 46

Country: Number of subjects enrolled

Lithuania: 21

Country: Number of subjects enrolled

Poland: 38

Country: Number of subjects enrolled

Portugal: 1

Country: Number of subjects enrolled

Korea, Republic of: 5

Country: Number of subjects enrolled

Russian Federation: 30

Country: Number of subjects enrolled

Serbia: 42

Country: Number of subjects enrolled

Spain: 10

Country: Number of subjects enrolled

South Africa: 12

Country: Number of subjects enrolled

Taiwan: 25

Country: Number of subjects enrolled

Thailand: 12

Country: Number of subjects enrolled

Ukraine: 30

Country: Number of subjects enrolled

United States: 129

Worldwide total number of subjects

516

EEA total number of subjects

130

Number of subjects enrolled per age group

In utero

0

Preterm newborn - gestational age < 37 wk

0

Newborns (0-27 days)

0

Infants and toddlers (28 days-23 months)

0

Children (2-11 years)

0

Adolescents (12-17 years)

4

Adults (18-64 years)

485

From 65 to 84 years

27

85 years and over

0

Subject disposition

Top of page

Recruitment details

-

Screening details

A total of 1029 subjects were screened, out of which 516 subjects were randomized to the study. Out of 516, 208 subjects were randomized to placebo and 308 subjects were randomized to ustekinumab.

Period 1 title

Through Week 52

Is this the baseline period?

Yes

Allocation method

Randomised - controlled

Blinding used

Double blind

Roles blinded

Subject, Investigator

Are arms mutually exclusive

Yes

Placebo - Ustekinumab

Arm description

-

Arm type

Placebo

Investigational medicinal product name

Placebo

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for infusion

Routes of administration

Intravenous use, Subcutaneous use

Dosage and administration details

Subjects received matching placebo to ustekinumab IV at Week 0, followed by matching placebo to ustekinumab SC at Week 8 and q8w thereafter through Week 48 during double-blind period. Eligible subjects who entered the extension period will cross-over to receive 90 mg ustekinumab SC q8w through Week 160.

Ustekinumab

Arm description

-

Arm type

Experimental

Investigational medicinal product name

Ustekinumab

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for infusion

Routes of administration

Intravenous use, Subcutaneous use

Dosage and administration details

Subjects received ustekinumab approximately 6 milligram per kilogram (mg/kg) intravenously (IV) based on body weight-range at Week 0 followed by 90 mg ustekinumab subcutaneously (SC) at Week 8 and every 8 weeks (q8w) thereafter through Week 48 during double-blind period. Eligible subjects who will enter the extension period will continue to receive 90 mg ustekinumab SC q8w through Week 160.

Number of subjects in period 1	Placebo - Ustekinumab	Ustekinumab
Started	208	308
Completed	105	153
Not completed	103	155
Adverse event, serious fatal	1	4
Consent withdrawn by subject	11	11
Adverse event, non-fatal	2	3
Initiated prohibited medication	-	2
Other	4	3
Pregnancy	-	1
Study terminated by sponsor	76	120
Serious Adverse Event, non-fatal	6	8
Lack of efficacy	2	3
Protocol deviation	1	-

Period 2 title

After Week 52

Is this the baseline period?

No

Allocation method

Randomised - controlled

Blinding used

Double blind

Roles blinded

Subject, Investigator

Are arms mutually exclusive

Yes

Placebo - Ustekinumab

Arm description

-

Arm type

Placebo

Investigational medicinal product name

Placebo

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for infusion

Routes of administration

Intravenous use, Subcutaneous use

Dosage and administration details

Subjects received matching placebo to ustekinumab IV at Week 0, followed by matching placebo to ustekinumab SC at Week 8 and q8w thereafter through Week 48 during double-blind period. Eligible subjects who entered the extension period will cross-over to receive 90 mg ustekinumab SC q8w through Week 160.

Ustekinumab

Arm description

-

Arm type

Experimental

Investigational medicinal product name

Ustekinumab

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for infusion

Routes of administration

Intravenous use, Subcutaneous use

Dosage and administration details

Subjects received ustekinumab approximately 6 milligram per kilogram (mg/kg) intravenously (IV) based on body weight-range at Week 0 followed by 90 mg ustekinumab subcutaneously (SC) at Week 8 and every 8 weeks (q8w) thereafter through Week 48 during double-blind period. Eligible subjects who will enter the extension period will continue to receive 90 mg ustekinumab SC q8w through Week 160.

Number of subjects in period 2 ^[1]	Placebo - Ustekinumab	Ustekinumab
Started	88	137
Completed	0	0
Not completed	88	137
Consent withdrawn by subject	1	1
Study terminated by sponsor	87	134
Serious Adverse Event, non-fatal	-	1
Lack of efficacy	-	1

Notes
[1] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
Justification: These are the subjects who entered the extension phase at Week 52.

Baseline characteristics

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Reporting group title

Placebo - Ustekinumab

Reporting group description

-

Reporting group title

Ustekinumab

Reporting group description

-

Reporting group values	Placebo - Ustekinumab	Ustekinumab	Total
Number of subjects	208	308	516
Title for AgeCategorical
Units: subjects
Children (2-11 years)	0	0	0
Adolescents (12-17 years)	3	1	4
Adults (18-64 years)	191	294	485
From 65 to 84 years	14	13	27
85 years and over	0	0	0
Title for AgeContinuous
Units: years
arithmetic mean (standard deviation)	44.5 ± 12.31	42.9 ± 11.38	-
Title for Gender
Units: subjects
Female	191	291	482
Male	17	17	34

End points

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Reporting group title

Placebo - Ustekinumab

Reporting group description

-

Reporting group title

Ustekinumab

Reporting group description

-

Reporting group title

Placebo - Ustekinumab

Reporting group description

-

Reporting group title

Ustekinumab

Reporting group description

-

Primary: Percentage of Subjects Achieving an Systemic Lupus Erythematosus Responder Index-4 (SRI-4) Composite Response at Week 52

Top of page

End point title

Percentage of Subjects Achieving an Systemic Lupus Erythematosus Responder Index-4 (SRI-4) Composite Response at Week 52 ^[1]

End point description

End point type

Primary

End point timeframe

Week 52

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: No formal statistical hypothesis testing was planned for this study due to the descriptive nature of this study.

End point values	Placebo - Ustekinumab	Ustekinumab
Number of subjects analysed	116	173
Units: percentage of subjects
number (not applicable)	65	76

No statistical analyses for this end point

Adverse events

Top of page

Timeframe for reporting adverse events

Up to Week 182

Assessment type

Non-systematic

Dictionary name

MedDRA

Dictionary version

23.0

Reporting group title

Placebo (Prior to entering LTE)

Reporting group description

Subjects only received placebo administration through Week 52 double blinded period. Data prior to the first administration of ustekinumab, or through the last follow-up if the subject did not receive any ustekinumab, were included.

Reporting group title

Placebo to Ustekinumab (After entering LTE)

Reporting group description

Subjects only received placebo administration through Week 52 double blinded period, and crossed over to ustekinumab in the extension period. Data from the first administration of ustekinumab through the last follow-up were included.

Reporting group title

Ustekinumab (Through Week 176)

Reporting group description

Subjects received ustekinumab administration through Week 52 double blinded period, and continued to receive ustekinumab in the extension period. Data from the first administration of ustekinumab through the last follow-up were included.

Serious adverse events	Placebo (Prior to entering LTE)	Placebo to Ustekinumab (After entering LTE)	Ustekinumab (Through Week 176)
Total subjects affected by serious adverse events
subjects affected / exposed	28 / 208 (13.46%)	5 / 88 (5.68%)	44 / 307 (14.33%)
number of deaths (all causes)	1	0	5
number of deaths resulting from adverse events
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acoustic Neuroma
subjects affected / exposed	0 / 208 (0.00%)	0 / 88 (0.00%)	1 / 307 (0.33%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Diffuse Large B-Cell Lymphoma
subjects affected / exposed	1 / 208 (0.48%)	0 / 88 (0.00%)	0 / 307 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Gastric Cancer
subjects affected / exposed	0 / 208 (0.00%)	0 / 88 (0.00%)	1 / 307 (0.33%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Vascular disorders
Aortic Aneurysm
subjects affected / exposed	0 / 208 (0.00%)	1 / 88 (1.14%)	0 / 307 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Deep Vein Thrombosis
subjects affected / exposed	0 / 208 (0.00%)	1 / 88 (1.14%)	0 / 307 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Hypotension
subjects affected / exposed	0 / 208 (0.00%)	0 / 88 (0.00%)	1 / 307 (0.33%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Hypovolaemic Shock
subjects affected / exposed	0 / 208 (0.00%)	0 / 88 (0.00%)	1 / 307 (0.33%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 1
Lupus Vasculitis
subjects affected / exposed	0 / 208 (0.00%)	0 / 88 (0.00%)	1 / 307 (0.33%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Pregnancy, puerperium and perinatal conditions
Hyperemesis Gravidarum
subjects affected / exposed	0 / 208 (0.00%)	0 / 88 (0.00%)	1 / 307 (0.33%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Reproductive system and breast disorders
Benign Prostatic Hyperplasia
subjects affected / exposed	1 / 208 (0.48%)	0 / 88 (0.00%)	0 / 307 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Ovarian Cyst
subjects affected / exposed	0 / 208 (0.00%)	0 / 88 (0.00%)	1 / 307 (0.33%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Failure
subjects affected / exposed	0 / 208 (0.00%)	0 / 88 (0.00%)	2 / 307 (0.65%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Lupus Pleurisy
subjects affected / exposed	0 / 208 (0.00%)	0 / 88 (0.00%)	1 / 307 (0.33%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Pleural Effusion
subjects affected / exposed	0 / 208 (0.00%)	0 / 88 (0.00%)	1 / 307 (0.33%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Pneumonitis
subjects affected / exposed	1 / 208 (0.48%)	0 / 88 (0.00%)	0 / 307 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Pulmonary Hypertension
subjects affected / exposed	1 / 208 (0.48%)	0 / 88 (0.00%)	0 / 307 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Respiratory Failure
subjects affected / exposed	0 / 208 (0.00%)	0 / 88 (0.00%)	1 / 307 (0.33%)
occurrences causally related to treatment / all	0 / 0	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Injury, poisoning and procedural complications
Fall
subjects affected / exposed	1 / 208 (0.48%)	0 / 88 (0.00%)	0 / 307 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Implantation Complication
subjects affected / exposed	1 / 208 (0.48%)	0 / 88 (0.00%)	0 / 307 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Infusion Related Reaction
subjects affected / exposed	0 / 208 (0.00%)	0 / 88 (0.00%)	1 / 307 (0.33%)
occurrences causally related to treatment / all	0 / 0	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Patella Fracture
subjects affected / exposed	0 / 208 (0.00%)	0 / 88 (0.00%)	1 / 307 (0.33%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Post Procedural Fever
subjects affected / exposed	0 / 208 (0.00%)	1 / 88 (1.14%)	0 / 307 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Post Procedural Haemorrhage
subjects affected / exposed	1 / 208 (0.48%)	0 / 88 (0.00%)	0 / 307 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Splenic Rupture
subjects affected / exposed	1 / 208 (0.48%)	0 / 88 (0.00%)	0 / 307 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0	0 / 0
Ulna Fracture
subjects affected / exposed	1 / 208 (0.48%)	0 / 88 (0.00%)	0 / 307 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Cardiac disorders
Acute Myocardial Infarction
subjects affected / exposed	2 / 208 (0.96%)	1 / 88 (1.14%)	0 / 307 (0.00%)
occurrences causally related to treatment / all	1 / 2	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Bradycardia
subjects affected / exposed	0 / 208 (0.00%)	1 / 88 (1.14%)	0 / 307 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Cardiac Failure
subjects affected / exposed	0 / 208 (0.00%)	0 / 88 (0.00%)	2 / 307 (0.65%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 1
Pericardial Effusion
subjects affected / exposed	0 / 208 (0.00%)	0 / 88 (0.00%)	1 / 307 (0.33%)
occurrences causally related to treatment / all	0 / 0	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Nervous system disorders
Amnesia
subjects affected / exposed	1 / 208 (0.48%)	0 / 88 (0.00%)	0 / 307 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Embolic Stroke
subjects affected / exposed	0 / 208 (0.00%)	0 / 88 (0.00%)	1 / 307 (0.33%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Facial Paralysis
subjects affected / exposed	0 / 208 (0.00%)	0 / 88 (0.00%)	1 / 307 (0.33%)
occurrences causally related to treatment / all	0 / 0	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Haemorrhagic Stroke
subjects affected / exposed	0 / 208 (0.00%)	0 / 88 (0.00%)	1 / 307 (0.33%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 1
Neuropsychiatric Lupus
subjects affected / exposed	0 / 208 (0.00%)	0 / 88 (0.00%)	2 / 307 (0.65%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Seizure
subjects affected / exposed	0 / 208 (0.00%)	0 / 88 (0.00%)	1 / 307 (0.33%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Blood and lymphatic system disorders
Thrombocytopenia
subjects affected / exposed	2 / 208 (0.96%)	0 / 88 (0.00%)	1 / 307 (0.33%)
occurrences causally related to treatment / all	0 / 2	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Eye disorders
Retinal Detachment
subjects affected / exposed	1 / 208 (0.48%)	0 / 88 (0.00%)	0 / 307 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Visual Impairment
subjects affected / exposed	0 / 208 (0.00%)	1 / 88 (1.14%)	0 / 307 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Gastrointestinal disorders
Abdominal Hernia
subjects affected / exposed	0 / 208 (0.00%)	0 / 88 (0.00%)	1 / 307 (0.33%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Abdominal Pain
subjects affected / exposed	1 / 208 (0.48%)	0 / 88 (0.00%)	0 / 307 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Colitis
subjects affected / exposed	0 / 208 (0.00%)	0 / 88 (0.00%)	1 / 307 (0.33%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Gastritis
subjects affected / exposed	0 / 208 (0.00%)	0 / 88 (0.00%)	1 / 307 (0.33%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Pancreatitis Acute
subjects affected / exposed	0 / 208 (0.00%)	0 / 88 (0.00%)	1 / 307 (0.33%)
occurrences causally related to treatment / all	0 / 0	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Small Intestinal Obstruction
subjects affected / exposed	1 / 208 (0.48%)	0 / 88 (0.00%)	0 / 307 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Hepatobiliary disorders
Hepatorenal Syndrome
subjects affected / exposed	0 / 208 (0.00%)	0 / 88 (0.00%)	1 / 307 (0.33%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Skin and subcutaneous tissue disorders
Dermal Cyst
subjects affected / exposed	0 / 208 (0.00%)	0 / 88 (0.00%)	1 / 307 (0.33%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Hypersensitivity Vasculitis
subjects affected / exposed	0 / 208 (0.00%)	0 / 88 (0.00%)	1 / 307 (0.33%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Pemphigoid
subjects affected / exposed	1 / 208 (0.48%)	0 / 88 (0.00%)	0 / 307 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Toxic Epidermal Necrolysis
subjects affected / exposed	0 / 208 (0.00%)	0 / 88 (0.00%)	1 / 307 (0.33%)
occurrences causally related to treatment / all	0 / 0	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Renal and urinary disorders
Haematuria
subjects affected / exposed	1 / 208 (0.48%)	0 / 88 (0.00%)	0 / 307 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Hydronephrosis
subjects affected / exposed	1 / 208 (0.48%)	0 / 88 (0.00%)	0 / 307 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Lupus Nephritis
subjects affected / exposed	0 / 208 (0.00%)	0 / 88 (0.00%)	1 / 307 (0.33%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Nephritic Syndrome
subjects affected / exposed	1 / 208 (0.48%)	0 / 88 (0.00%)	0 / 307 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Nephrolithiasis
subjects affected / exposed	0 / 208 (0.00%)	0 / 88 (0.00%)	2 / 307 (0.65%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Neurogenic Bladder
subjects affected / exposed	1 / 208 (0.48%)	0 / 88 (0.00%)	0 / 307 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Renal Colic
subjects affected / exposed	0 / 208 (0.00%)	0 / 88 (0.00%)	1 / 307 (0.33%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Musculoskeletal and connective tissue disorders
Intervertebral Disc Protrusion
subjects affected / exposed	0 / 208 (0.00%)	0 / 88 (0.00%)	1 / 307 (0.33%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Osteonecrosis
subjects affected / exposed	0 / 208 (0.00%)	0 / 88 (0.00%)	1 / 307 (0.33%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Systemic Lupus Erythematosus
subjects affected / exposed	4 / 208 (1.92%)	0 / 88 (0.00%)	2 / 307 (0.65%)
occurrences causally related to treatment / all	0 / 4	0 / 0	1 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Infections and infestations
Bronchitis
subjects affected / exposed	1 / 208 (0.48%)	0 / 88 (0.00%)	0 / 307 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Covid-19
subjects affected / exposed	0 / 208 (0.00%)	0 / 88 (0.00%)	4 / 307 (1.30%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 1
Diverticulitis
subjects affected / exposed	1 / 208 (0.48%)	0 / 88 (0.00%)	0 / 307 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Endocarditis Staphylococcal
subjects affected / exposed	0 / 208 (0.00%)	0 / 88 (0.00%)	1 / 307 (0.33%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 1
Gastroenteritis
subjects affected / exposed	0 / 208 (0.00%)	0 / 88 (0.00%)	2 / 307 (0.65%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Herpes Zoster
subjects affected / exposed	1 / 208 (0.48%)	0 / 88 (0.00%)	0 / 307 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Infected Bite
subjects affected / exposed	0 / 208 (0.00%)	0 / 88 (0.00%)	1 / 307 (0.33%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Nosocomial Infection
subjects affected / exposed	0 / 208 (0.00%)	0 / 88 (0.00%)	1 / 307 (0.33%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Pneumonia
subjects affected / exposed	1 / 208 (0.48%)	0 / 88 (0.00%)	4 / 307 (1.30%)
occurrences causally related to treatment / all	1 / 1	0 / 0	2 / 4
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Pulmonary Tuberculosis
subjects affected / exposed	0 / 208 (0.00%)	0 / 88 (0.00%)	1 / 307 (0.33%)
occurrences causally related to treatment / all	0 / 0	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Sepsis
subjects affected / exposed	1 / 208 (0.48%)	0 / 88 (0.00%)	0 / 307 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Tonsillitis
subjects affected / exposed	0 / 208 (0.00%)	0 / 88 (0.00%)	1 / 307 (0.33%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Urinary Tract Infection
subjects affected / exposed	2 / 208 (0.96%)	0 / 88 (0.00%)	1 / 307 (0.33%)
occurrences causally related to treatment / all	0 / 2	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Urosepsis
subjects affected / exposed	1 / 208 (0.48%)	0 / 88 (0.00%)	0 / 307 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Viral Infection
subjects affected / exposed	1 / 208 (0.48%)	0 / 88 (0.00%)	0 / 307 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Vulval Cellulitis
subjects affected / exposed	0 / 208 (0.00%)	0 / 88 (0.00%)	1 / 307 (0.33%)
occurrences causally related to treatment / all	0 / 0	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Metabolism and nutrition disorders
Electrolyte Imbalance
subjects affected / exposed	1 / 208 (0.48%)	0 / 88 (0.00%)	1 / 307 (0.33%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0

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

Non-serious adverse events	Placebo (Prior to entering LTE)	Placebo to Ustekinumab (After entering LTE)	Ustekinumab (Through Week 176)
Total subjects affected by non serious adverse events
subjects affected / exposed	60 / 208 (28.85%)	3 / 88 (3.41%)	79 / 307 (25.73%)
Nervous system disorders
Headache
subjects affected / exposed	14 / 208 (6.73%)	1 / 88 (1.14%)	19 / 307 (6.19%)
occurrences all number	15	1	42
Infections and infestations
Nasopharyngitis
subjects affected / exposed	19 / 208 (9.13%)	2 / 88 (2.27%)	24 / 307 (7.82%)
occurrences all number	23	2	32
Upper Respiratory Tract Infection
subjects affected / exposed	17 / 208 (8.17%)	0 / 88 (0.00%)	25 / 307 (8.14%)
occurrences all number	21	0	31
Urinary Tract Infection
subjects affected / exposed	20 / 208 (9.62%)	0 / 88 (0.00%)	26 / 307 (8.47%)
occurrences all number	25	0	34

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Were there any global substantial amendments to the protocol? No

Were there any global interruptions to the trial? No

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

Study was early terminated for futility.

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