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

  • End date
    Feb 13, 2024
  • participants needed
  • sponsor
    CSL Behring
Updated on 13 July 2022
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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.

Condition Dermatomyositis
Treatment Placebo, human immunoglobulin G
Clinical Study IdentifierNCT04044690
SponsorCSL Behring
Last Modified on13 July 2022


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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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