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

CSL Behring

Status and phase: Terminated; Phase 3

Conditions: Dermatomyositis

Treatments: Drug: human immunoglobulin G; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04044690

2018-003171-35 (EudraCT Number)

IgPro20_3007

Details and patient eligibility

About

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.

Enrollment: 126 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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126 participants in 2 patient groups, including a placebo group

IgPro20

Experimental group

Description:

human immunoglobulin G administered subcutaneously

Treatment:

Drug: human immunoglobulin G

Placebo

Placebo Comparator group

Description:

human albumin solution administered subcutaneously

Treatment:

Drug: Placebo