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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 is a Phase 3 study that was terminated before completion, run by CSL Behring. The registered enrollment target is 134 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04044690
The ClinicalTrials.gov registry entry for NCT04044690 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 134 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is CSL Behring, which has 71 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04044690 reports 0 study locations.
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.
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