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

Last updated: March 29, 2025
Sponsor: Janssen Pharmaceutical K.K.
Overall Status: Terminated

Phase

3

Condition

Lupus

Collagen Vascular Diseases

Idiopathic Inflammatory Myopathies

Treatment

Placebo IV

Placebo SC

Ustekinumab 90 mg

Clinical Study ID

NCT03981744
CR108618
CNTO1275DMY3001
  • Ages 18-75
  • All Genders

Study Summary

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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Has a diagnosis of polymyositis (PM)/ dermatomyositis (DM) made or confirmed by aphysician (such as a rheumatologist, neurologist, or dermatologist) experienced intreatment of PM/DM at least 6 weeks prior to first dose of the study drug

  • Has PM or DM which is considered active despite receiving at least 1standard-of-care treatment by the investigator

  • Must be receiving 1 or more of the following protocol-permitted, systemicstandard-of-care treatments: i) glucocorticoids, ii) 1 or 2 of the followingimmunomodulatory drugs: mycophenolate mofetil, azathioprine, oral methotrexate, oraltacrolimus, or oral cyclosporine A

  • Regular or as needed treatment with topical use of glucocorticoids are permitted totreat skin lesions on a stable dose for greater than or equal to (>=) 2 weeks priorto first dose of the study drug

  • Contraceptive (birth control) use by men or women should be consistent with localregulations regarding the acceptable methods of contraception for thoseparticipating in clinical studies

  • Must be medically stable on the basis of clinical laboratory tests performed atscreening. If the results of the clinical laboratory tests are outside the normalreference ranges, the participant may be included only if the investigator judgesthe abnormalities or deviations from normal to be not clinically significant

  • Demonstrable muscle weakness at screening and Week 0 measured by the Manual MuscleTesting (MMT)-8 less than or equal to (<=)135 units

  • Demonstrable muscle weakness at screening measured by any 2 or more of thefollowings: (i) PhGA greater than or equal to (>=) 1.5 centimeter (cm), (ii) 1 ormore muscle enzymes (Creatine kinase [CK], and aldolase) >=1.4*upper limit of normal (ULN), (iii) Myositis disease activity assessment tool (MDAAT)-Extramuscular GlobalAssessment >=1.5 cm

Exclusion

Exclusion Criteria:

  • Has myositis other than PM/DM, including but not limited to amyopathicdermatomyositis (ADM), clinically amyopathic DM, juvenile DM, inclusion bodymyositis (IBM) immune-mediated necrotizing myopathy diagnosed based on muscle biopsyfindings and positive anti-SRP or anti-HMGCR antibody, drug-induced myositis, PMassociated with human immunodeficiency virus (HIV), and muscular dystrophy,congenital myopathy, metabolic myopathy, and mitochondrial myopathy

  • Has other inflammatory diseases that might confound the evaluations of efficacy,including but not limited to rheumatoid arthritis (RA), psoriatic arthritis (PsA),systemic lupus erythematosus (SLE), psoriasis, or Crohn's disease

  • Has severe respiratory muscle weakness confirmed by the investigator based on theconsultation with a pulmonologist and the measures of respiratory muscle strengthsuch as maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP)and/or maximal voluntary ventilation (MVV) measurements and lung capacity such asforced vital capacity (FVC). The results need to be within population appropriatenormal limits

  • Has severe muscle damage (Myositis Damage Index-VAS [Muscle Damage] greater than (>) 7 centimeter [cm]), permanent weakness due to a non-IIM cause, or myositis withcardiac dysfunction

  • Has glucocorticoid-induced myopathy which the investigator considers the primarycause of muscle weakness

  • Has positive test result of anti-melanoma differentiation-associated protein 5 (MDA5) antibody (anti clinically amyopathic dermatomyositis (C-ADM)-140 antibody).

  • Has had a nontuberculous mycobacterial infection or opportunistic infection

  • Has a history of, or ongoing, chronic or recurrent infectious disease

  • Has past history of severe Interstitial lung disease (ILD) flare, severenon-infectious lung inflammation which required active intervention, or multiplerelapses of these conditions

  • Presence or history of malignancy within 5 years before screening

Study Design

Total Participants: 51
Treatment Group(s): 4
Primary Treatment: Placebo IV
Phase: 3
Study Start date:
July 26, 2019
Estimated Completion Date:
July 12, 2022

Connect with a study center

  • Tokyo Medical and Dental University Hospital

    Bunkyo Ku, 113 8519
    Japan

    Site Not Available

  • Tokyo Medical and Dental University Hospital

    Bunkyo-Ku, 113-8510
    Japan

    Site Not Available

  • Fukushima Medical University Hospital

    Fukushima, 960 1295
    Japan

    Site Not Available

  • University of Occupational and Environmental Health

    Hukuoka, 807-8555
    Japan

    Site Not Available

  • Shinko Hospital

    Hyogo, 651-0072
    Japan

    Site Not Available

  • Tokai University Hospital

    Isehara, 259-1193
    Japan

    Site Not Available

  • Kagoshima University Hospital

    Kagoshima City, 890-8544
    Japan

    Site Not Available

  • St Marianna University Hospital

    Kanagawa, 216 8511
    Japan

    Site Not Available

  • St.Marianna University Hospital

    Kanagawa, 216-8511
    Japan

    Site Not Available

  • National Hospital Organization Osaka Minami Medical Center

    Kawachi Nagano, 586 8521
    Japan

    Site Not Available

  • National Hospital Organization Osaka Minami Medical Center

    Kawachi-Nagano, 586-8521
    Japan

    Site Not Available

  • Hospital of the University of Occupational and Enviromental Health

    Kita-kyushu, 807-8555
    Japan

    Site Not Available

  • Hospital of the University of Occupational and Environmental Health

    Kita-kyushu, 807-8555
    Japan

    Site Not Available

  • Kumamoto University Hospital

    Kumamoto, 860-8556
    Japan

    Site Not Available

  • Kurashiki Central Hospital

    Kurashiki, 710-8602
    Japan

    Site Not Available

  • Shinshu University Hospital

    Matsumoto, 390-8621
    Japan

    Site Not Available

  • Minaminagano Medical Center Shinonoi General Hospital

    Nagano, 388-8004
    Japan

    Site Not Available

  • Nagasaki University Hospital

    Nagasaki, 852-8501
    Japan

    Site Not Available

  • Nagasaki University Hospital

    Nagasaki-shi, 852-8501
    Japan

    Site Not Available

  • National Hospital Organization Nagoya Medical Center

    Nagoya, 460-0001
    Japan

    Site Not Available

  • National Hospital Organization Nagoya Medical Center

    Nagoya-shi, 460-0001
    Japan

    Site Not Available

  • Niigata University Medical & Dental Hospital

    Niigata, 951-8520
    Japan

    Site Not Available

  • Niigata University Medical And Dental Hospital

    Niigata, 951 8520
    Japan

    Site Not Available

  • Okayama City General Medical Center Okayama City Hospital

    Okayama, 700-8557
    Japan

    Site Not Available

  • Saga University Hospital

    Saga, 849-8501
    Japan

    Site Not Available

  • Kitasato University Hospital

    Sagamihara, 252-0375
    Japan

    Site Not Available

  • Sakai City Medical Center

    Sakai City, 593-8304
    Japan

    Site Not Available

  • Tohoku Medical And Pharmaceutical University Hospital

    Sendai, 983-8512
    Japan

    Site Not Available

  • Tohoku University Hospital

    Sendai shi, 980 8574
    Japan

    Site Not Available

  • Tohoku University Hospital

    Sendai-shi, 980-8574
    Japan

    Site Not Available

  • Dokkyo Medical University Hospital

    Shimotsuga Gun, 321 0293
    Japan

    Site Not Available

  • Dokkyo Medical University Hospital

    Shimotsuga-gun, 321-0293
    Japan

    Site Not Available

  • Tokyo Women's Medical University Hospital

    Shinjuku-ku, 162-8666
    Japan

    Site Not Available

  • Center Hospital of the National Center for Global Health and Medicine

    Tokyo, 162-8655
    Japan

    Site Not Available

  • Juntendo University Hospital

    Tokyo, 113-8431
    Japan

    Site Not Available

  • National Center for Global Health and Medicine

    Tokyo, 162-8655
    Japan

    Site Not Available

  • Nippon Medical School Hospital

    Tokyo, 113 8603
    Japan

    Site Not Available

  • The Jikei University Hospital

    Tokyo, 105 8471
    Japan

    Site Not Available

  • Tokyo Medical University Hospital

    Tokyo, 160-0023
    Japan

    Site Not Available

  • Ehime University Hospital

    Toon, 791-0295
    Japan

    Site Not Available

  • Fujita Health University Hospital

    Toyoake, 470-1192
    Japan

    Site Not Available

  • University of Tsukuba Hospital

    Tsukuba, 305 8576
    Japan

    Site Not Available

  • Yamaguchi University Hospital

    Ube, 755-8505
    Japan

    Site Not Available

  • Yokohama Rosai Hospital

    Yokohama, 222-0036
    Japan

    Site Not Available

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