A Phase 3 interventional study of Ustekinumab 6 mg/kg and Ustekinumab 90 mg in Polymyositis and Dermatomyositis, sponsored by Janssen Pharmaceutical K.K.. Terminated at 32 sites in Japan. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-04-29.
Sponsored by Janssen Pharmaceutical K.K. (part of Johnson & Johnson) · Phase 3, Interventional, and Treatment
The purpose of this study is to evaluate the efficacy of ustekinumab in participants with active polymyositis (PM)/dermatomyositis (DM) despite receiving 1 or more standard-of-care treatments (for example, glucocorticoids and/or immunomodulators).
184 studies on the registry are indexed under Dermatomyositis; 63 are open to participants now.
This study's enrollment of 51 is above the median of 35 across 130 interventional studies indexed under Dermatomyositis.
Browse Dermatomyositis studies →Janssen Pharmaceutical K.K. is the lead sponsor of 126 studies on the registry; none are open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 7 (50%) have results posted.
Compared within Dermatomyositis, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Polymyositis. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive body weight-range based IV dosing of approximately 6 milligram per kilogram (mg/kg) of ustekinumab at Week 0 followed by ustekinumab 90 milligram (mg) subcutaneously (SC) at Week 8 and every 8 Weeks (q8w) administrations through Week 72. At Week 24, participants will receive IV dosing of placebo.
Drug: Ustekinumab 6 mg/kg · Drug: Ustekinumab 90 mg · Drug: Placebo IV
Participants will receive IV dosing of placebo at Week 0 followed by placebo SC administrations at Weeks 8,16 and 24. At Week 24, participants will receive body weight-range based IV dosing of approximately 6 mg/kg of ustekinumab, followed by ustekinumab 90 mg SC q8w administrations Week 32 through Week 72.
Drug: Ustekinumab 6 mg/kg · Drug: Ustekinumab 90 mg · Drug: Placebo IV · Drug: Placebo SC
Drug page: Ustekinumab
Participants will receive body weight-range based IV dosing of 6 mg/kg of ustekinumab at Week 0 in Group 1 and at Week 24 in Group 2.
Also known as: STELARA
Participants will receive ustekinumab 90 mg SC at Week 8 and every 8 Weeks (q8w) through Week 72 in Group 1 and q8w Week 32 through Week 72 in Group 2.
Also known as: STELARA
Participants will receive IV dosing of placebo at Week 24 in Group 1 and at Week 0 in Group 2.
Participants will receive SC dosing of placebo at Weeks 8,16 and 24.
Percentage of Participants Who Achieved Minimal Improvement in International Myositis Assessment and Clinical Studies Total Improvement Score (IMACS TIS) at Week 24
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 \[improvement \>=60\]).
Time frame: Week 24
Change From Baseline in Functional Index-2 (FI-2) at Week 24
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.
Time frame: Baseline, Week 24
Percentage of Participants Who Experienced Disease Worsening Up to Week 24 Based on Consensus Criteria for Worsening
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.
Time frame: Up to Week 24
Change From Baseline in Manual Muscle Testing (MMT)-8 Score at Week 24
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.
Time frame: Baseline, Week 24
Change From Baseline in Physician Global Activity (PhGA) at Week 24
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.
Time frame: Baseline, Week 24
Change From Baseline in Extramuscular Assessment by Myositis Disease Activity Assessment Tool (MDAAT) at Week 24
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.
Time frame: Baseline, Week 24
Change From Baseline in Muscle Enzyme Levels at Week 24
Change from baseline in muscle enzyme levels (creatine kinase, lactate dehydrogenase) at Week 24 was reported.
Time frame: Baseline, Week 24
| Milestone | Placebo | Ustekinumab | Placebo to Ustekinumab | Ustekinumab Through End of Study (EOS) |
|---|---|---|---|---|
| Started | 26 | 25 | 0 | 0 |
| Completed | 26 | 23 | 0 | 0 |
| Not completed | 0 | 2 | 0 | 0 |
| Withdrew: Withdrawal by subject | 0 | 2 | 0 | 0 |
| Milestone | Placebo | Ustekinumab | Placebo to Ustekinumab | Ustekinumab Through End of Study (EOS) |
|---|---|---|---|---|
| Started | 0 | 0 | 26 | 23 |
| Completed | 0 | 0 | 24 | 23 |
| Not completed | 0 | 0 | 2 | 0 |
| Withdrew: Adverse event | 0 | 0 | 1 | 0 |
| Withdrew: Withdrawal by subject | 0 | 0 | 1 | 0 |
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 \[improvement \>=60\]).
| Percentage of participants | Placebo | Ustekinumab |
|---|---|---|
| Percentage of Participants Who Achieved Minimal Improvement in International Myositis Assessment and Clinical Studies Total Improvement Score (IMACS TIS) at Week 24 | 61.5 | 64.0 |
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.
| Scores on a scale | Placebo | Ustekinumab |
|---|---|---|
| Change in Shoulder Flexion | 2.92 ± 14.672 | 6.88 ± 14.284 |
| Change in Head Lift | 2.00 ± 11.331 | 5.56 ± 13.364 |
| Change in Hip Flexion | 2.54 ± 6.819 | 5.84 ± 13.184 |
| Change in Step Test | 4.15 ± 10.806 | 3.76 ± 16.674 |
| Change in Heel Lift | 1.27 ± 20.232 | 5.38 ± 29.315 |
| Change in Toe Lift | -0.62 ± 17.422 | 10.60 ± 33.800 |
| Change in Shoulder abduction | -0.69 ± 11.589 | 9.00 ± 15.419 |
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.
| Percentage of participants | Placebo | Ustekinumab |
|---|---|---|
| Percentage of Participants Who Experienced Disease Worsening Up to Week 24 Based on Consensus Criteria for Worsening | 38.5 | 28.0 |
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.
| Scores on a scale | Placebo | Ustekinumab |
|---|---|---|
| Change From Baseline in Manual Muscle Testing (MMT)-8 Score at Week 24 | 5.27 ± 5.647 | 5.88 ± 5.207 |
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.
| Scores on a scale | Placebo | Ustekinumab |
|---|---|---|
| Change From Baseline in Physician Global Activity (PhGA) at Week 24 | -1.15 ± 1.623 | -1.22 ± 2.193 |
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.
| Scores on a scale | Placebo | Ustekinumab |
|---|---|---|
| Change From Baseline in Extramuscular Assessment by Myositis Disease Activity Assessment Tool (MDAAT) at Week 24 | -0.68 ± 1.645 | -1.02 ± 1.437 |
Change from baseline in muscle enzyme levels (creatine kinase, lactate dehydrogenase) at Week 24 was reported.
| Enzyme units per liter (Enzyme U/L) | Placebo | Ustekinumab |
|---|---|---|
| Creatine Kinase | 140.42 ± 365.562 | 134.80 ± 498.102 |
| Lactate Dehydrogenase | -10.77 ± 68.577 | -0.67 ± 64.513 |
Collected over Up to Week 88. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo | 0/26 (0%) | 1/26 (3.8%) | 16/26 (61.5%) |
| Placebo to Ustekinumab | 0/26 (0%) | 6/26 (23.1%) | 15/26 (57.7%) |
| Ustekinumab Through End of Study (EOS) | 0/25 (0%) | 8/25 (32%) | 24/25 (96%) |
| Event | Placebo | Placebo to Ustekinumab | Ustekinumab Through End of Study (EOS) |
|---|---|---|---|
| Herpes ZosterInfections and infestations | 1/26 | 0/26 | 2/25 |
| PolymyositisMusculoskeletal and connective tissue disorders | 0/26 | 2/26 | 2/25 |
| Cerebral InfarctionNervous system disorders | 0/26 | 2/26 | 0/25 |
| SchizophreniaPsychiatric disorders | 0/26 | 2/26 | 0/25 |
| Large Intestine PolypGastrointestinal disorders | 0/26 | 0/26 | 1/25 |
| DiverticulitisInfections and infestations | 0/26 | 0/26 | 1/25 |
| Intervertebral Disc ProtrusionMusculoskeletal and connective tissue disorders | 0/26 | 0/26 | 1/25 |
| OsteonecrosisMusculoskeletal and connective tissue disorders | 0/26 | 0/26 | 1/25 |
| Respiratory FailureRespiratory, thoracic and mediastinal disorders | 0/26 | 0/26 | 1/25 |
| GlaucomaEye disorders | 0/26 | 1/26 | 0/25 |
| Event | Placebo | Placebo to Ustekinumab | Ustekinumab Through End of Study (EOS) |
|---|---|---|---|
| NasopharyngitisInfections and infestations | 2/26 | 4/26 | 4/25 |
| PolymyositisMusculoskeletal and connective tissue disorders | 1/26 | 1/26 | 4/25 |
| DiarrhoeaGastrointestinal disorders | 4/26 | 0/26 | 2/25 |
| DermatomyositisSkin and subcutaneous tissue disorders | 4/26 | 0/26 | 2/25 |
| Lymphocyte Count DecreasedInvestigations | 2/26 | 0/26 | 3/25 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 0/26 | 0/26 | 3/25 |
| Iron Deficiency AnaemiaBlood and lymphatic system disorders | 0/26 | 0/26 | 2/25 |
| VertigoEar and labyrinth disorders | 0/26 | 2/26 | 2/25 |
| Vitreous FloatersEye disorders | 0/26 | 0/26 | 2/25 |
| Dental CariesGastrointestinal disorders | 0/26 | 1/26 | 2/25 |
| Age, Continuous(years) | Placebo | Ustekinumab | Total |
|---|---|---|---|
| Mean | 54.5 ± 13.41 | 54.2 ± 11.62 | 54.4 ± 12.44 |
| Sex: Female, Male(Participants) | Placebo | Ustekinumab | Total |
|---|---|---|---|
| Female | 16 | 20 | 36 |
| Male | 10 | 5 | 15 |
| Race (NIH/OMB)(Participants) | Placebo | Ustekinumab | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 26 | 25 | 51 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 0 | 0 | 0 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(Participants) | Placebo | Ustekinumab | Total |
|---|---|---|---|
| JAPAN | 26 | 25 | 51 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale open Data Access (YODA) Project site at yoda.yale.edu
Data sharing details ↗ · www.janssen.com
Ran from Jul 2019 to primary completion in Jan 2022, 29 months.
Results were first posted in May 2024, 2 years 3 months after primary completion.
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This study is terminated, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Ustekinumab