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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.

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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

FieldValue
Enrollment Target 134 participants
Start Date 2019-10-21
Est. Completion 2024-12-02
Phase Phase 3

Sponsor

CSL Behring

71 total trials

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.