Phase
Condition
Lupus
Collagen Vascular Diseases
Idiopathic Inflammatory Myopathies
Treatment
Placebo IV
Placebo SC
Ustekinumab 90 mg
Clinical Study ID
Ages 18-75 All Genders
Study Summary
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
Connect with a study center
Tokyo Medical and Dental University Hospital
Bunkyo Ku, 113 8519
JapanSite Not Available
Tokyo Medical and Dental University Hospital
Bunkyo-Ku, 113-8510
JapanSite Not Available
Fukushima Medical University Hospital
Fukushima, 960 1295
JapanSite Not Available
University of Occupational and Environmental Health
Hukuoka, 807-8555
JapanSite Not Available
Shinko Hospital
Hyogo, 651-0072
JapanSite Not Available
Tokai University Hospital
Isehara, 259-1193
JapanSite Not Available
Kagoshima University Hospital
Kagoshima City, 890-8544
JapanSite Not Available
St Marianna University Hospital
Kanagawa, 216 8511
JapanSite Not Available
St.Marianna University Hospital
Kanagawa, 216-8511
JapanSite Not Available
National Hospital Organization Osaka Minami Medical Center
Kawachi Nagano, 586 8521
JapanSite Not Available
National Hospital Organization Osaka Minami Medical Center
Kawachi-Nagano, 586-8521
JapanSite Not Available
Hospital of the University of Occupational and Enviromental Health
Kita-kyushu, 807-8555
JapanSite Not Available
Hospital of the University of Occupational and Environmental Health
Kita-kyushu, 807-8555
JapanSite Not Available
Kumamoto University Hospital
Kumamoto, 860-8556
JapanSite Not Available
Kurashiki Central Hospital
Kurashiki, 710-8602
JapanSite Not Available
Shinshu University Hospital
Matsumoto, 390-8621
JapanSite Not Available
Minaminagano Medical Center Shinonoi General Hospital
Nagano, 388-8004
JapanSite Not Available
Nagasaki University Hospital
Nagasaki, 852-8501
JapanSite Not Available
Nagasaki University Hospital
Nagasaki-shi, 852-8501
JapanSite Not Available
National Hospital Organization Nagoya Medical Center
Nagoya, 460-0001
JapanSite Not Available
National Hospital Organization Nagoya Medical Center
Nagoya-shi, 460-0001
JapanSite Not Available
Niigata University Medical & Dental Hospital
Niigata, 951-8520
JapanSite Not Available
Niigata University Medical And Dental Hospital
Niigata, 951 8520
JapanSite Not Available
Okayama City General Medical Center Okayama City Hospital
Okayama, 700-8557
JapanSite Not Available
Saga University Hospital
Saga, 849-8501
JapanSite Not Available
Kitasato University Hospital
Sagamihara, 252-0375
JapanSite Not Available
Sakai City Medical Center
Sakai City, 593-8304
JapanSite Not Available
Tohoku Medical And Pharmaceutical University Hospital
Sendai, 983-8512
JapanSite Not Available
Tohoku University Hospital
Sendai shi, 980 8574
JapanSite Not Available
Tohoku University Hospital
Sendai-shi, 980-8574
JapanSite Not Available
Dokkyo Medical University Hospital
Shimotsuga Gun, 321 0293
JapanSite Not Available
Dokkyo Medical University Hospital
Shimotsuga-gun, 321-0293
JapanSite Not Available
Tokyo Women's Medical University Hospital
Shinjuku-ku, 162-8666
JapanSite Not Available
Center Hospital of the National Center for Global Health and Medicine
Tokyo, 162-8655
JapanSite Not Available
Juntendo University Hospital
Tokyo, 113-8431
JapanSite Not Available
National Center for Global Health and Medicine
Tokyo, 162-8655
JapanSite Not Available
Nippon Medical School Hospital
Tokyo, 113 8603
JapanSite Not Available
The Jikei University Hospital
Tokyo, 105 8471
JapanSite Not Available
Tokyo Medical University Hospital
Tokyo, 160-0023
JapanSite Not Available
Ehime University Hospital
Toon, 791-0295
JapanSite Not Available
Fujita Health University Hospital
Toyoake, 470-1192
JapanSite Not Available
University of Tsukuba Hospital
Tsukuba, 305 8576
JapanSite Not Available
Yamaguchi University Hospital
Ube, 755-8505
JapanSite Not Available
Yokohama Rosai Hospital
Yokohama, 222-0036
JapanSite Not Available
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