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NCT04044690 · ClinicalTrials.gov registry record · Phase 3
A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of IgPro20 in Adults With Dermatomyositis (DM)
A Phase 3 study, sponsored by CSL Behring.
- Terminated
- Registry status
- Phase 3
- Development phase
- 134
- Enrollment target
NCT04044690: Clinical Trial Phase 3 study, sponsored by CSL Behring.
NCT04044690 is a Phase 3 study that was terminated before completion, run by CSL Behring. The registered enrollment target is 134 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04044690, a Phase 3 study, was terminated before completion, sponsored by CSL Behring.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 134 participants
- Enrollment target
Study 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.
Primary Outcome
A responder was defined as a participant with a TIS \>= 20 points at Week 25 and at least 1 of the previous scheduled visits (Week 17 or 21), who completes 24 weeks of randomized IMP treatment without the use of rescue corticosteroid treatment. The TIS was a sum response criterion which incorporates 6 weighted international myositis assessment and clinical studies (IMACS) core set measures (CSMs) including Physician and Patient Global Disease Activity (PGA), Manual Muscle Testing-8 (MMT-8), Heal
Interventions
- DRUG Placebo
- DRUG human immunoglobulin G
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 134 participants |
| Start Date | 2019-10-21 |
| Est. Completion | 2024-12-02 |
| Phase | Phase 3 |
Why NCT04044690 stopped before completion
NCT04044690 is an interventional study that assigns participants to a tested intervention. The registered 134 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (83% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04044690 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04044690 about?
NCT04044690 is a clinical study titled "A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of IgPro20 in Adults With Dermatomyositis (DM)". 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 su...
What is the current status of trial NCT04044690?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 134 participants. The study started on 2019-10-21. Estimated completion is 2024-12-02.
What interventions are being tested in trial NCT04044690?
The interventions under investigation include: Placebo (DRUG), human immunoglobulin G (DRUG).
Who is sponsoring clinical trial NCT04044690?
This trial is sponsored by CSL Behring, which has 71 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04044690's enrollment target sits among peer trials
134 1585th of 2000 higher than 413 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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