Trial Outcomes & Findings for A Study of Ustekinumab in Participants With Active Polymyositis and Dermatomyositis Who Have Not Adequately Responded to One or More Standard-of-care Treatments (NCT NCT03981744)

Last Updated: 2025-04-29

Results Overview

Minimal improvement was defined as IMACS TIS greater than or equal to (\>=) 20 in participants with polymyositis (PM)/dermatomyositis (DM). Criteria used the 6 IMACS core set measures: physician global activity (PhGA)(0-10), patient global activity (PtGA)(0-10), manual muscle testing-8 (MMT-8)(0-80), muscle enzymes (creatine kinase, Aldolase, lactate dehydrogenase, aspartate aminotransferase, alanine aminotransferase), extramuscular assessment of myositis disease activity assessment tool (MDAAT)(0-10), and health assessment questionnaire disability index (HAQ-DI)(0-3). Absolute percent change in each core set measure was calculated as final value minus baseline value divided by range\*100. Total improvement score was calculated by sum of 6 core set improvement scores. Total improvement score ranged from 0 to 100 where higher scores indicated greater improvement. This was categorized into 3 categories (minimal \[improvement \>=20\], moderate \[improvement \>=40\] and major \[improvement \>=60\]).

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

51 participants

Primary outcome timeframe

Week 24

Results posted on

2025-04-29

Participant Flow

Participant milestones

Participant milestones
Measure	Placebo Participants received placebo (matching to ustekinumab) intravenously (IV) at Week 0, then placebo subcutaneously (SC) every 8 weeks (q8w) at Weeks 8 and 16.	Ustekinumab Participants received body weight-range based IV dose of ustekinumab 6 mg/kg at Week 0 followed by ustekinumab 90 mg as SC injection at Weeks 8 and 16.	Placebo to Ustekinumab Participants who received placebo (matching to ustekinumab) intravenously (IV) at Week 0, placebo subcutaneously (SC) every 8 weeks (q8w) at Weeks 8 and 16, then in order to gain benefit from this study participants received body weight-range based IV dose of ustekinumab 6 milligrams per kilograms (mg/kg) and placebo SC (to maintain blinding) at Week 24, followed by ustekinumab 90 milligrams (mg) SC q8w thereafter through Week 72.	Ustekinumab Through End of Study (EOS) Participants who received body weight-range based IV dose of ustekinumab 6 mg/kg at Week 0, ustekinumab 90 mg as SC injection at Weeks 8 and 16 then received placebo IV (to maintain blinding) and ustekinumab 90 mg SC at Week 24 and ustekinumab 90 mg SC q8w thereafter through Week 72.
First Intervention (Prior to Week 24) STARTED	26	25	0	0
First Intervention (Prior to Week 24) COMPLETED	26	23	0	0
First Intervention (Prior to Week 24) NOT COMPLETED	0	2	0	0
Second Intervention (Week 24 to Week 72) STARTED	0	0	26	23
Second Intervention (Week 24 to Week 72) COMPLETED	0	0	24	23
Second Intervention (Week 24 to Week 72) NOT COMPLETED	0	0	2	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Ustekinumab Participants received body weight-range based IV dose of ustekinumab 6 mg/kg at Week 0 followed by ustekinumab 90 mg as SC injection at Weeks 8 and 16.	Placebo to Ustekinumab Participants who received placebo (matching to ustekinumab) intravenously (IV) at Week 0, placebo subcutaneously (SC) every 8 weeks (q8w) at Weeks 8 and 16, then in order to gain benefit from this study participants received body weight-range based IV dose of ustekinumab 6 milligrams per kilograms (mg/kg) and placebo SC (to maintain blinding) at Week 24, followed by ustekinumab 90 milligrams (mg) SC q8w thereafter through Week 72.
First Intervention (Prior to Week 24) Withdrawal by Subject	2	0
Second Intervention (Week 24 to Week 72) Adverse Event	0	1
Second Intervention (Week 24 to Week 72) Withdrawal by Subject	0	1

Baseline Characteristics

A Study of Ustekinumab in Participants With Active Polymyositis and Dermatomyositis Who Have Not Adequately Responded to One or More Standard-of-care Treatments

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=26 Participants Participants received placebo (matching to ustekinumab) intravenously (IV) at Week 0, then placebo subcutaneously (SC) every 8 weeks (q8w) at Weeks 8 and 16.	Ustekinumab n=25 Participants Participants received body weight-range based IV dose of ustekinumab 6 mg/kg at Week 0 followed by ustekinumab 90 mg as SC injection at Weeks 8 and 16.	Total n=51 Participants Total of all reporting groups
Age, Continuous	54.5 years STANDARD_DEVIATION 13.41 • n=5 Participants	54.2 years STANDARD_DEVIATION 11.62 • n=7 Participants	54.4 years STANDARD_DEVIATION 12.44 • n=5 Participants
Sex: Female, Male Female	16 Participants n=5 Participants	20 Participants n=7 Participants	36 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	5 Participants n=7 Participants	15 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	26 Participants n=5 Participants	25 Participants n=7 Participants	51 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment JAPAN	26 Participants n=5 Participants	25 Participants n=7 Participants	51 Participants n=5 Participants

PRIMARY outcome

Timeframe: Week 24

Population: All randomized analysis set included all participants who were randomized in this study.

Outcome measures

Outcome measures
Measure	Placebo n=26 Participants Participants received placebo (matching to ustekinumab) intravenously (IV) at Week 0, then placebo subcutaneously (SC) every 8 weeks (q8w) at Weeks 8 and 16.	Ustekinumab n=25 Participants Participants received body weight-range based IV dose of ustekinumab 6 mg/kg at Week 0 followed by ustekinumab 90 mg as SC injection at Weeks 8 and 16.
Percentage of Participants Who Achieved Minimal Improvement in International Myositis Assessment and Clinical Studies Total Improvement Score (IMACS TIS) at Week 24	61.5 Percentage of participants	64.0 Percentage of participants

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: All randomized analysis set included all participants who were randomized in this study. Here, 'n' (number analyzed) signifies participants who were evaluable for this outcome measure for given categories.

Change from baseline in FI-2 at Week 24 was reported. The FI-2 was a functional outcome developed for participants with adult PM or DM to assess muscle endurance in 7 muscle groups (shoulder flexion \[0-60\], shoulder abduction \[0-60\], head lift \[0-60\], hip flexion \[0-60\], step test \[0-60\], heel lift \[0-120\], and toe lift \[0-120\]). Each muscle group was scored as the number of correctly performed repetitions with 60 or 120 maximal number of repetitions depending on muscle group. The FI-2 was performed unilaterally, preferably on the participant's dominant side for muscle groups of shoulder, hip, and step test. The FI-2 score ranged from 0-60 or 0-120 depending on the muscle group. Higher score indicated better muscle endurance.

Outcome measures

Outcome measures
Measure	Placebo n=26 Participants Participants received placebo (matching to ustekinumab) intravenously (IV) at Week 0, then placebo subcutaneously (SC) every 8 weeks (q8w) at Weeks 8 and 16.	Ustekinumab n=25 Participants Participants received body weight-range based IV dose of ustekinumab 6 mg/kg at Week 0 followed by ustekinumab 90 mg as SC injection at Weeks 8 and 16.
Change From Baseline in Functional Index-2 (FI-2) at Week 24 Change in Shoulder Flexion	2.92 Scores on a scale Standard Deviation 14.672	6.88 Scores on a scale Standard Deviation 14.284
Change From Baseline in Functional Index-2 (FI-2) at Week 24 Change in Head Lift	2.00 Scores on a scale Standard Deviation 11.331	5.56 Scores on a scale Standard Deviation 13.364
Change From Baseline in Functional Index-2 (FI-2) at Week 24 Change in Hip Flexion	2.54 Scores on a scale Standard Deviation 6.819	5.84 Scores on a scale Standard Deviation 13.184
Change From Baseline in Functional Index-2 (FI-2) at Week 24 Change in Step Test	4.15 Scores on a scale Standard Deviation 10.806	3.76 Scores on a scale Standard Deviation 16.674
Change From Baseline in Functional Index-2 (FI-2) at Week 24 Change in Heel Lift	1.27 Scores on a scale Standard Deviation 20.232	5.38 Scores on a scale Standard Deviation 29.315
Change From Baseline in Functional Index-2 (FI-2) at Week 24 Change in Toe Lift	-0.62 Scores on a scale Standard Deviation 17.422	10.60 Scores on a scale Standard Deviation 33.800
Change From Baseline in Functional Index-2 (FI-2) at Week 24 Change in Shoulder abduction	-0.69 Scores on a scale Standard Deviation 11.589	9.00 Scores on a scale Standard Deviation 15.419

SECONDARY outcome

Timeframe: Up to Week 24

Population: All randomized analysis set included all participants who were randomized in this study.

Percentage of participants who experienced disease worsening up to Week 24 based on consensus criteria for worsening was reported. Criteria for disease worsening in a clinical trial were based on international consensus guideline developed by the IMACS. The worsening of disease was defined as 1 of the following criteria: Worsening of the Physician Global Activity by \>=2 centimeter (cm) on a 10-cm visual analogue scale (VAS) and worsening of findings of MMT-8 by \>= 20 percent (%) from baseline; worsening of MDAAT-global extramuscular organ disease activity (a composite of constitutional, cutaneous, skeletal, gastrointestinal, pulmonary, and cardiac activity) by \>=2 cm on a 10-cm VAS from baseline; worsening of any 3 of 6 IMACS core set (PhGA, PtGA, MMT-8, muscle enzymes, MDAAT, and HAQ-D) activity measures by \>= 30% from baseline.

Outcome measures

Outcome measures
Measure	Placebo n=26 Participants Participants received placebo (matching to ustekinumab) intravenously (IV) at Week 0, then placebo subcutaneously (SC) every 8 weeks (q8w) at Weeks 8 and 16.	Ustekinumab n=25 Participants Participants received body weight-range based IV dose of ustekinumab 6 mg/kg at Week 0 followed by ustekinumab 90 mg as SC injection at Weeks 8 and 16.
Percentage of Participants Who Experienced Disease Worsening Up to Week 24 Based on Consensus Criteria for Worsening	38.5 Percentage of participants	28.0 Percentage of participants

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: All randomized analysis set included all participants who were randomized in this study.

Change from baseline in MMT-8 score at Week 24 was reported. Manual Muscle Testing was a partially validated tool to assess muscle strength. MMT-8 total score ranged from 0-80, where maximal score was sum of scores from 8 muscle groups (Deltoid middle \[left/right\], Biceps brachii \[left/right\], Gluteus maximus \[left/right\], Gluteus medius \[left/right\], Quadriceps \[left/right\], Wrist extensors \[left/right\], Ankle dorsiflexors \[left/right\], Neck flexors \[axial\]) and each muscle group was scored on a 0 to 10-point scale. The sides (right or left) used for calculating the total score. Higher score indicated greater muscle strength, that is, less impairment of muscle.

Outcome measures

Outcome measures
Measure	Placebo n=26 Participants Participants received placebo (matching to ustekinumab) intravenously (IV) at Week 0, then placebo subcutaneously (SC) every 8 weeks (q8w) at Weeks 8 and 16.	Ustekinumab n=25 Participants Participants received body weight-range based IV dose of ustekinumab 6 mg/kg at Week 0 followed by ustekinumab 90 mg as SC injection at Weeks 8 and 16.
Change From Baseline in Manual Muscle Testing (MMT)-8 Score at Week 24	5.27 Scores on a scale Standard Deviation 5.647	5.88 Scores on a scale Standard Deviation 5.207

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: All randomized analysis set included all participants who were randomized in this study.

Change from baseline in PhGA at Week 24 was reported. Physician Global Activity was a partially validated tool to measure the global evaluation by the physician of the participant's overall disease activity at the time of assessment using a 0-10 cm VAS, where 0 cm= no evidence of disease activity and 10 cm= extremely active or severe disease activity. Negative values indicated improvement from baseline.

Outcome measures

Outcome measures
Measure	Placebo n=26 Participants Participants received placebo (matching to ustekinumab) intravenously (IV) at Week 0, then placebo subcutaneously (SC) every 8 weeks (q8w) at Weeks 8 and 16.	Ustekinumab n=25 Participants Participants received body weight-range based IV dose of ustekinumab 6 mg/kg at Week 0 followed by ustekinumab 90 mg as SC injection at Weeks 8 and 16.
Change From Baseline in Physician Global Activity (PhGA) at Week 24	-1.15 Scores on a scale Standard Deviation 1.623	-1.22 Scores on a scale Standard Deviation 2.193

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: All randomized analysis set included all participants who were randomized in this study.

Change from baseline in extramuscular assessment by MDAAT at Week 24 was reported. This validated tool measure the degree of disease activity of extramuscular organ systems and muscle on a 0-10 cm VAS. Extramuscular activity ranged between 0 and 10 via VAS where, 0 cm = absent and 10 cm = maximum disease activity.

Outcome measures

Outcome measures
Measure	Placebo n=26 Participants Participants received placebo (matching to ustekinumab) intravenously (IV) at Week 0, then placebo subcutaneously (SC) every 8 weeks (q8w) at Weeks 8 and 16.	Ustekinumab n=25 Participants Participants received body weight-range based IV dose of ustekinumab 6 mg/kg at Week 0 followed by ustekinumab 90 mg as SC injection at Weeks 8 and 16.
Change From Baseline in Extramuscular Assessment by Myositis Disease Activity Assessment Tool (MDAAT) at Week 24	-0.68 Scores on a scale Standard Deviation 1.645	-1.02 Scores on a scale Standard Deviation 1.437

SECONDARY outcome

Timeframe: Baseline, Week 24

Change from baseline in muscle enzyme levels (creatine kinase, lactate dehydrogenase) at Week 24 was reported.

Outcome measures

Outcome measures
Measure	Placebo n=26 Participants Participants received placebo (matching to ustekinumab) intravenously (IV) at Week 0, then placebo subcutaneously (SC) every 8 weeks (q8w) at Weeks 8 and 16.	Ustekinumab n=25 Participants Participants received body weight-range based IV dose of ustekinumab 6 mg/kg at Week 0 followed by ustekinumab 90 mg as SC injection at Weeks 8 and 16.
Change From Baseline in Muscle Enzyme Levels at Week 24 Lactate Dehydrogenase	-10.77 Enzyme units per liter (Enzyme U/L) Standard Deviation 68.577	-0.67 Enzyme units per liter (Enzyme U/L) Standard Deviation 64.513
Change From Baseline in Muscle Enzyme Levels at Week 24 Creatine Kinase	140.42 Enzyme units per liter (Enzyme U/L) Standard Deviation 365.562	134.80 Enzyme units per liter (Enzyme U/L) Standard Deviation 498.102

Adverse Events

Placebo

Serious events: 1 serious events

Other events: 16 other events

Deaths: 0 deaths

Placebo to Ustekinumab

Serious events: 6 serious events

Other events: 15 other events

Deaths: 0 deaths

Ustekinumab Through End of Study (EOS)

Serious events: 8 serious events

Other events: 24 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Placebo n=26 participants at risk Participants received placebo (matching to ustekinumab) intravenously (IV) at Week 0, then placebo subcutaneously (SC) every 8 weeks (q8w) at Weeks 8 and 16.	Placebo to Ustekinumab n=26 participants at risk Participants who received placebo (matching to ustekinumab) intravenously (IV) at Week 0, placebo subcutaneously (SC) every 8 weeks (q8w) at Weeks 8 and 16, then in order to gain benefit from this study participants received body weight-range based IV dose of ustekinumab 6 milligrams per kilograms (mg/kg) and placebo SC (to maintain blinding) at Week 24, followed by ustekinumab 90 milligrams (mg) SC q8w thereafter through Week 72.	Ustekinumab Through End of Study (EOS) n=25 participants at risk Participants who received body weight-range based IV dose of ustekinumab 6 mg/kg at Week 0, ustekinumab 90 mg as SC injection at Weeks 8 and 16 then received placebo IV (to maintain blinding) and ustekinumab 90 mg SC at Week 24 and ustekinumab 90 mg SC q8w thereafter through Week 72.
Eye disorders Glaucoma	0.00% 0/26 • Up to Week 88 The safety analysis set included all randomized participants who received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of study agent.	3.8% 1/26 • Up to Week 88 The safety analysis set included all randomized participants who received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of study agent.	0.00% 0/25 • Up to Week 88 The safety analysis set included all randomized participants who received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of study agent.
Gastrointestinal disorders Large Intestine Polyp	0.00% 0/26 • Up to Week 88 The safety analysis set included all randomized participants who received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of study agent.	0.00% 0/26 • Up to Week 88 The safety analysis set included all randomized participants who received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of study agent.	4.0% 1/25 • Up to Week 88 The safety analysis set included all randomized participants who received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of study agent.
Gastrointestinal disorders Pneumatosis Intestinalis	0.00% 0/26 • Up to Week 88 The safety analysis set included all randomized participants who received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of study agent.	3.8% 1/26 • Up to Week 88 The safety analysis set included all randomized participants who received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of study agent.	0.00% 0/25 • Up to Week 88 The safety analysis set included all randomized participants who received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of study agent.
Infections and infestations Bacteraemia	0.00% 0/26 • Up to Week 88 The safety analysis set included all randomized participants who received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of study agent.	3.8% 1/26 • Up to Week 88 The safety analysis set included all randomized participants who received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of study agent.	0.00% 0/25 • Up to Week 88 The safety analysis set included all randomized participants who received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of study agent.
Infections and infestations Diverticulitis	0.00% 0/26 • Up to Week 88 The safety analysis set included all randomized participants who received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of study agent.	0.00% 0/26 • Up to Week 88 The safety analysis set included all randomized participants who received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of study agent.	4.0% 1/25 • Up to Week 88 The safety analysis set included all randomized participants who received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of study agent.
Infections and infestations Herpes Zoster	3.8% 1/26 • Up to Week 88 The safety analysis set included all randomized participants who received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of study agent.	0.00% 0/26 • Up to Week 88 The safety analysis set included all randomized participants who received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of study agent.	8.0% 2/25 • Up to Week 88 The safety analysis set included all randomized participants who received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of study agent.
Musculoskeletal and connective tissue disorders Intervertebral Disc Protrusion	0.00% 0/26 • Up to Week 88 The safety analysis set included all randomized participants who received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of study agent.	0.00% 0/26 • Up to Week 88 The safety analysis set included all randomized participants who received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of study agent.	4.0% 1/25 • Up to Week 88 The safety analysis set included all randomized participants who received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of study agent.
Musculoskeletal and connective tissue disorders Osteonecrosis	0.00% 0/26 • Up to Week 88 The safety analysis set included all randomized participants who received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of study agent.	0.00% 0/26 • Up to Week 88 The safety analysis set included all randomized participants who received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of study agent.	4.0% 1/25 • Up to Week 88 The safety analysis set included all randomized participants who received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of study agent.
Musculoskeletal and connective tissue disorders Polymyositis	0.00% 0/26 • Up to Week 88 The safety analysis set included all randomized participants who received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of study agent.	7.7% 2/26 • Up to Week 88 The safety analysis set included all randomized participants who received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of study agent.	8.0% 2/25 • Up to Week 88 The safety analysis set included all randomized participants who received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of study agent.
Nervous system disorders Cerebral Infarction	0.00% 0/26 • Up to Week 88 The safety analysis set included all randomized participants who received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of study agent.	7.7% 2/26 • Up to Week 88 The safety analysis set included all randomized participants who received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of study agent.	0.00% 0/25 • Up to Week 88 The safety analysis set included all randomized participants who received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of study agent.
Nervous system disorders Neuroleptic Malignant Syndrome	0.00% 0/26 • Up to Week 88 The safety analysis set included all randomized participants who received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of study agent.	3.8% 1/26 • Up to Week 88 The safety analysis set included all randomized participants who received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of study agent.	0.00% 0/25 • Up to Week 88 The safety analysis set included all randomized participants who received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of study agent.
Psychiatric disorders Anxiety Disorder	0.00% 0/26 • Up to Week 88 The safety analysis set included all randomized participants who received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of study agent.	3.8% 1/26 • Up to Week 88 The safety analysis set included all randomized participants who received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of study agent.	0.00% 0/25 • Up to Week 88 The safety analysis set included all randomized participants who received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of study agent.
Psychiatric disorders Schizophrenia	0.00% 0/26 • Up to Week 88 The safety analysis set included all randomized participants who received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of study agent.	7.7% 2/26 • Up to Week 88 The safety analysis set included all randomized participants who received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of study agent.	0.00% 0/25 • Up to Week 88 The safety analysis set included all randomized participants who received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of study agent.
Respiratory, thoracic and mediastinal disorders Respiratory Failure	0.00% 0/26 • Up to Week 88 The safety analysis set included all randomized participants who received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of study agent.	0.00% 0/26 • Up to Week 88 The safety analysis set included all randomized participants who received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of study agent.	4.0% 1/25 • Up to Week 88 The safety analysis set included all randomized participants who received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of study agent.

Other adverse events

Additional Information

PRODUCT DEVELOPMENT PORTFOLIO LEADER

Janssen Pharmaceutical K.K.

Phone: 844-434-4210

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days.
Publication restrictions are in place

Restriction type: OTHER

Measure	Placebo n=26 participants at risk Participants received placebo (matching to ustekinumab) intravenously (IV) at Week 0, then placebo subcutaneously (SC) every 8 weeks (q8w) at Weeks 8 and 16.	Placebo to Ustekinumab n=26 participants at risk Participants who received placebo (matching to ustekinumab) intravenously (IV) at Week 0, placebo subcutaneously (SC) every 8 weeks (q8w) at Weeks 8 and 16, then in order to gain benefit from this study participants received body weight-range based IV dose of ustekinumab 6 milligrams per kilograms (mg/kg) and placebo SC (to maintain blinding) at Week 24, followed by ustekinumab 90 milligrams (mg) SC q8w thereafter through Week 72.	Ustekinumab Through End of Study (EOS) n=25 participants at risk Participants who received body weight-range based IV dose of ustekinumab 6 mg/kg at Week 0, ustekinumab 90 mg as SC injection at Weeks 8 and 16 then received placebo IV (to maintain blinding) and ustekinumab 90 mg SC at Week 24 and ustekinumab 90 mg SC q8w thereafter through Week 72.
Blood and lymphatic system disorders Iron Deficiency Anaemia	0.00% 0/26 • Up to Week 88 The safety analysis set included all randomized participants who received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of study agent.	0.00% 0/26 • Up to Week 88 The safety analysis set included all randomized participants who received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of study agent.	8.0% 2/25 • Up to Week 88 The safety analysis set included all randomized participants who received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of study agent.
Ear and labyrinth disorders Vertigo	0.00% 0/26 • Up to Week 88 The safety analysis set included all randomized participants who received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of study agent.	7.7% 2/26 • Up to Week 88 The safety analysis set included all randomized participants who received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of study agent.	8.0% 2/25 • Up to Week 88 The safety analysis set included all randomized participants who received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of study agent.
Eye disorders Vitreous Floaters	0.00% 0/26 • Up to Week 88 The safety analysis set included all randomized participants who received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of study agent.	0.00% 0/26 • Up to Week 88 The safety analysis set included all randomized participants who received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of study agent.	8.0% 2/25 • Up to Week 88 The safety analysis set included all randomized participants who received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of study agent.
Gastrointestinal disorders Abdominal Pain	3.8% 1/26 • Up to Week 88 The safety analysis set included all randomized participants who received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of study agent.	7.7% 2/26 • Up to Week 88 The safety analysis set included all randomized participants who received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of study agent.	4.0% 1/25 • Up to Week 88 The safety analysis set included all randomized participants who received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of study agent.
Gastrointestinal disorders Constipation	0.00% 0/26 • Up to Week 88 The safety analysis set included all randomized participants who received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of study agent.	7.7% 2/26 • Up to Week 88 The safety analysis set included all randomized participants who received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of study agent.	0.00% 0/25 • Up to Week 88 The safety analysis set included all randomized participants who received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of study agent.
Gastrointestinal disorders Dental Caries	0.00% 0/26 • Up to Week 88 The safety analysis set included all randomized participants who received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of study agent.	3.8% 1/26 • Up to Week 88 The safety analysis set included all randomized participants who received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of study agent.	8.0% 2/25 • Up to Week 88 The safety analysis set included all randomized participants who received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of study agent.
Gastrointestinal disorders Diarrhoea	15.4% 4/26 • Up to Week 88 The safety analysis set included all randomized participants who received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of study agent.	0.00% 0/26 • Up to Week 88 The safety analysis set included all randomized participants who received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of study agent.	8.0% 2/25 • Up to Week 88 The safety analysis set included all randomized participants who received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of study agent.
General disorders Oedema Peripheral	3.8% 1/26 • Up to Week 88 The safety analysis set included all randomized participants who received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of study agent.	0.00% 0/26 • Up to Week 88 The safety analysis set included all randomized participants who received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of study agent.	8.0% 2/25 • Up to Week 88 The safety analysis set included all randomized participants who received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of study agent.
General disorders Vaccination Site Reaction	7.7% 2/26 • Up to Week 88 The safety analysis set included all randomized participants who received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of study agent.	3.8% 1/26 • Up to Week 88 The safety analysis set included all randomized participants who received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of study agent.	8.0% 2/25 • Up to Week 88 The safety analysis set included all randomized participants who received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of study agent.
Infections and infestations Cellulitis	7.7% 2/26 • Up to Week 88 The safety analysis set included all randomized participants who received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of study agent.	0.00% 0/26 • Up to Week 88 The safety analysis set included all randomized participants who received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of study agent.	0.00% 0/25 • Up to Week 88 The safety analysis set included all randomized participants who received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of study agent.
Infections and infestations Covid-19	0.00% 0/26 • Up to Week 88 The safety analysis set included all randomized participants who received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of study agent.	7.7% 2/26 • Up to Week 88 The safety analysis set included all randomized participants who received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of study agent.	4.0% 1/25 • Up to Week 88 The safety analysis set included all randomized participants who received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of study agent.
Infections and infestations Nasopharyngitis	7.7% 2/26 • Up to Week 88 The safety analysis set included all randomized participants who received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of study agent.	15.4% 4/26 • Up to Week 88 The safety analysis set included all randomized participants who received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of study agent.	16.0% 4/25 • Up to Week 88 The safety analysis set included all randomized participants who received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of study agent.
Infections and infestations Sinusitis	7.7% 2/26 • Up to Week 88 The safety analysis set included all randomized participants who received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of study agent.	0.00% 0/26 • Up to Week 88 The safety analysis set included all randomized participants who received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of study agent.	0.00% 0/25 • Up to Week 88 The safety analysis set included all randomized participants who received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of study agent.
Injury, poisoning and procedural complications Contusion	7.7% 2/26 • Up to Week 88 The safety analysis set included all randomized participants who received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of study agent.	0.00% 0/26 • Up to Week 88 The safety analysis set included all randomized participants who received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of study agent.	4.0% 1/25 • Up to Week 88 The safety analysis set included all randomized participants who received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of study agent.
Investigations Blood Creatine Phosphokinase Increased	0.00% 0/26 • Up to Week 88 The safety analysis set included all randomized participants who received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of study agent.	7.7% 2/26 • Up to Week 88 The safety analysis set included all randomized participants who received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of study agent.	0.00% 0/25 • Up to Week 88 The safety analysis set included all randomized participants who received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of study agent.
Investigations Lymphocyte Count Decreased	7.7% 2/26 • Up to Week 88 The safety analysis set included all randomized participants who received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of study agent.	0.00% 0/26 • Up to Week 88 The safety analysis set included all randomized participants who received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of study agent.	12.0% 3/25 • Up to Week 88 The safety analysis set included all randomized participants who received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of study agent.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/26 • Up to Week 88 The safety analysis set included all randomized participants who received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of study agent.	0.00% 0/26 • Up to Week 88 The safety analysis set included all randomized participants who received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of study agent.	12.0% 3/25 • Up to Week 88 The safety analysis set included all randomized participants who received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of study agent.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/26 • Up to Week 88 The safety analysis set included all randomized participants who received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of study agent.	0.00% 0/26 • Up to Week 88 The safety analysis set included all randomized participants who received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of study agent.	8.0% 2/25 • Up to Week 88 The safety analysis set included all randomized participants who received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of study agent.
Musculoskeletal and connective tissue disorders Polymyositis	3.8% 1/26 • Up to Week 88 The safety analysis set included all randomized participants who received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of study agent.	3.8% 1/26 • Up to Week 88 The safety analysis set included all randomized participants who received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of study agent.	16.0% 4/25 • Up to Week 88 The safety analysis set included all randomized participants who received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of study agent.
Nervous system disorders Headache	7.7% 2/26 • Up to Week 88 The safety analysis set included all randomized participants who received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of study agent.	0.00% 0/26 • Up to Week 88 The safety analysis set included all randomized participants who received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of study agent.	8.0% 2/25 • Up to Week 88 The safety analysis set included all randomized participants who received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of study agent.
Skin and subcutaneous tissue disorders Acne	7.7% 2/26 • Up to Week 88 The safety analysis set included all randomized participants who received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of study agent.	0.00% 0/26 • Up to Week 88 The safety analysis set included all randomized participants who received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of study agent.	4.0% 1/25 • Up to Week 88 The safety analysis set included all randomized participants who received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of study agent.
Skin and subcutaneous tissue disorders Dermatomyositis	15.4% 4/26 • Up to Week 88 The safety analysis set included all randomized participants who received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of study agent.	0.00% 0/26 • Up to Week 88 The safety analysis set included all randomized participants who received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of study agent.	8.0% 2/25 • Up to Week 88 The safety analysis set included all randomized participants who received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of study agent.
Skin and subcutaneous tissue disorders Hyperkeratosis	0.00% 0/26 • Up to Week 88 The safety analysis set included all randomized participants who received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of study agent.	3.8% 1/26 • Up to Week 88 The safety analysis set included all randomized participants who received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of study agent.	8.0% 2/25 • Up to Week 88 The safety analysis set included all randomized participants who received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of study agent.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/26 • Up to Week 88 The safety analysis set included all randomized participants who received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of study agent.	0.00% 0/26 • Up to Week 88 The safety analysis set included all randomized participants who received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of study agent.	8.0% 2/25 • Up to Week 88 The safety analysis set included all randomized participants who received at least 1 dose (partial or complete, intravenously \[IV\] or subcutaneously \[SC\]) of study agent.