A Study to Evaluate the Efficacy Safety and Pharmacokinetics of IgPro20 in Adults With Dermatomyositis (DM)

  • STATUS
    Recruiting
  • End date
    Feb 14, 2024
  • participants needed
    126
  • sponsor
    CSL Behring
Updated on 14 June 2021
corticosteroids
prednisolone
a 10
rheumatism
rash
dermatomyositis
myopathy

Summary

This is a phase 3, multicenter, randomized, placebo-controlled, double-blind study of IgPro20 (subcutaneous Ig) treatment in adult subjects with dermatomyositis (DM). The primary objective of this study is to assess the efficacy of IgPro20 subcutaneous (SC) doses in comparison to placebo in adult subjects with DM, as measured by responder status based on Total Improvement Score (TIS) assessments.

Details
Condition Dermatomyositis, CONNECTIVE TISSUE DISEASE, Dermatosis, Polymyositis, Dermatomyositis (Connective Tissue Disease), Congenital Skin Diseases, Polymyositis (Inflammatory Muscle Disease), Skin Conditions, Connective Tissue Diseases
Treatment Placebo, human immunoglobulin G
Clinical Study IdentifierNCT04044690
SponsorCSL Behring
Last Modified on14 June 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Male or female subjects 18 years of age
Diagnosis of at least probable idiopathic inflammatory myopathies (IIM) per European League Against Rheumatism/American College of Rheumatology (EULAR/ACR) Classification Criteria which includes confirmation of dermatomyositis (DM) rash/manifestation, disease activity defined by presence of DM rash / manifestation or an objective disease activity measure
Disease severity defined by Physician global activity visual analog scale (VAS) with a minimum value of 2.0 cm on a 10 cm scale and MMT-8 142 or CDASI total activity score 14\
Corticosteroid daily dose less than that or equal to 20 mg prednisolone equivalent

Exclusion Criteria

Cancer-associated myositis
Evidence of active malignant disease or malignancies diagnosed within the previous 5 years
Physician Global Damage score 3, or clinically relevant improvement between Screening Visit and Baseline
Clear my responses

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