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

  • STATUS
    Recruiting
  • End date
    Jan 18, 2023
  • participants needed
    50
  • sponsor
    Janssen Pharmaceutical K.K.
Updated on 31 December 2020
Investigator
The Medical Research Network, LLC
Primary Contact
Dokkyo Medical University Hospital (6.5 mi away) Contact
+37 other location
tacrolimus
mycophenolate mofetil
cyclosporine
methotrexate
ustekinumab
glucocorticoids
weakness
creatine kinase
azathioprine
dermatomyositis
mycophenolate
polymyositis
aldolase

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).

Details
Treatment Placebo SC, Ustekinumab 90 mg, Placebo IV, Ustekinumab 6 mg/kg
Clinical Study IdentifierNCT03981744
SponsorJanssen Pharmaceutical K.K.
Last Modified on31 December 2020

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Eligibility

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Inclusion Criteria

Is your age between 18 yrs and 75 yrs?
Gender: Male or Female
Do you have any of these conditions: CONNECTIVE TISSUE DISEASE or Dermatomyositis or Skin Conditions or Dermatomyositis (Connective Tissue Disease) or Dermatosis or Congenital Skin Diseas...?
Do you have any of these conditions: Dermatosis or Dermatomyositis or Dermatomyositis (Connective Tissue Disease) or Congenital Skin Diseases or Polymyositis (Inflammatory Muscle Disease)...?
Do you have any of these conditions: CONNECTIVE TISSUE DISEASE or Dermatomyositis (Connective Tissue Disease) or Connective Tissue Diseases or Myositis or Polymyositis or Congenital Skin ...?
Has a diagnosis of polymyositis (PM)/ dermatomyositis (DM) made or confirmed by a physician (such as a rheumatologist, neurologist, or dermatologist) experienced in treatment 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 1 standard-of-care treatment by the investigator
Must be receiving 1 or more of the following protocol-permitted, systemic standard-of-care treatments: i) glucocorticoids, ii) 1 or 2 of the following immunomodulatory drugs: mycophenolate mofetil, azathioprine, oral methotrexate, oral tacrolimus, or oral cyclosporine A
Regular or as needed treatment with topical use of glucocorticoids are permitted to treat skin lesions on a stable dose for greater than or equal to (>=) 2 weeks prior to first dose of the study drug
Contraceptive (birth control) use by men or women should be consistent with local regulations regarding the acceptable methods of contraception for those participating in clinical studies
Must be medically stable on the basis of clinical laboratory tests performed at screening. If the results of the clinical laboratory tests are outside the normal reference ranges, the participant may be included only if the investigator judges the abnormalities or deviations from normal to be not clinically significant
Demonstrable muscle weakness at screening and Week 0 measured by the Manual Muscle Testing (MMT)-8 less than or equal to (<=)135 units
Demonstrable muscle weakness at screening measured by any 2 or more of the followings: (i) PhGA greater than or equal to (>=) 1.5 centimeter (cm), (ii) 1 or more muscle enzymes (Creatine kinase [CK], and aldolase) >=1.4upper limit of normal (ULN), (iii) Myositis disease activity assessment tool (MDAAT)-Extramuscular Global Assessment >=1.5 cm

Exclusion Criteria

Has myositis other than PM/DM, including but not limited to amyopathic dermatomyositis (ADM), clinically amyopathic DM, juvenile DM, inclusion body myositis (IBM) immune-mediated necrotizing myopathy diagnosed based on muscle biopsy findings and positive anti-SRP or anti-HMGCR antibody, drug-induced myositis, PM associated 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 the consultation with a pulmonologist and the measures of respiratory muscle strength such as maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP) and/or maximal voluntary ventilation (MVV) measurements and lung capacity such as forced vital capacity (FVC). The results need to be within population appropriate normal 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 with cardiac dysfunction
Has glucocorticoid-induced myopathy which the investigator considers the primary cause 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, severe non-infectious lung inflammation which required active intervention, or multiple relapses of these conditions
Presence or history of malignancy within 5 years before screening
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