Trials / Terminated
TerminatedNCT04044690
A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of IgPro20 in Adults With Dermatomyositis (DM)
A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of IgPro20 (Subcutaneous Immunoglobulin, Hizentra®) in Adults With Dermatomyositis (DM) - The RECLAIIM Study
- Status
- Terminated
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 134 (actual)
- Sponsor
- CSL Behring · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | human immunoglobulin G | human immunoglobulin G administered subcutaneously |
| DRUG | Placebo | contains 2% human albumin, similar excipients as IgPro20 (Hizentra), same volume, same duration, administered subcutaneously |
Timeline
- Start date
- 2019-10-21
- Primary completion
- 2024-12-02
- Completion
- 2024-12-02
- First posted
- 2019-08-05
- Last updated
- 2025-12-09
- Results posted
- 2025-12-09
Locations
76 sites across 14 countries: United States, Argentina, Belgium, France, Germany, Hungary, Italy, Japan, Mexico, Poland, Russia, Spain, Switzerland, Ukraine
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04044690. Inclusion in this directory is not an endorsement.