TerminatedPhase 3

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

Stopped: Primary endpoint not attained

United States134 participantsStarted 2019-10-21

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Responder Rate

Timeframe: At Week 25

Trial details

NCT IDNCT04044690

SponsorCSL Behring

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-12-02

Results submitted2025-10-17