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NCT06179875 · ClinicalTrials.gov registry record · Phase 3

An Open-label Study (OLE) for Non-responders of VRDN-001-101 (NCT05176639) and VRDN-001-301 (NCT06021054)

A Phase 3 study, sponsored by Viridian Therapeutics.

Completed
Registry status
Phase 3
Development phase
143
Enrollment target

NCT06179875 is a Phase 3 study that has completed, run by Viridian Therapeutics. The registered enrollment target is 143 participants.

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The verdict

NCT06179875, a Phase 3 study, has completed, sponsored by Viridian Therapeutics.

COMPLETED
Registry status
Phase 3
Development phase
143 participants
Enrollment target

Study Summary

The investigational drug, VRDN-001, is a monoclonal antibody that inhibits the activity of a cell surface receptor called insulin-like growth factor-1 receptor (IGF-1R). Inhibition of IGF-1R may help to reduce the inflammation and associated tissue swelling that occurs in patients with thyroid eye disease (TED). The primary objectives of this clinical trial are to provide open-label access to VRDN-001 for participants who were previously non-responders at 3 weeks post the fifth IV infusion (i.e., 15 weeks) in the VRDN-001-101 (THRIVE) and VRDN-001-301 (THRIVE-2) pivotal studies and assess the safety and efficacy of VRDN-001 in participants who were previously treated with VRDN-001 or placebo.

Interventions

  • DRUG Veligrotug

Trial Details

FieldValue
Enrollment Target 143 participants
Start Date 2024-01-31
Est. Completion 2025-06-23
Phase Phase 3

Sponsor

Viridian Therapeutics

8 total trials

What the Registry Record Tells You About NCT06179875

The ClinicalTrials.gov registry entry for NCT06179875 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 143 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Viridian Therapeutics, which has 8 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which Veligrotug is the first listed.

NCT06179875 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT06179875 about?

NCT06179875 is a clinical study titled "An Open-label Study (OLE) for Non-responders of VRDN-001-101 (NCT05176639) and VRDN-001-301 (NCT06021054)". The investigational drug, VRDN-001, is a monoclonal antibody that inhibits the activity of a cell surface receptor called insulin-like growth factor-1 receptor (IGF-1R). Inhibition of IGF-1R may help to reduce the inflammation and associated tissue swelling that occurs in patients with thyroid eye d...

What is the current status of trial NCT06179875?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 143 participants. The study started on 2024-01-31. Estimated completion is 2025-06-23.

What interventions are being tested in trial NCT06179875?

The interventions under investigation include: Veligrotug (DRUG).

Who is sponsoring clinical trial NCT06179875?

This trial is sponsored by Viridian Therapeutics, which has 8 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.