A Randomized, Double-masked, Placebo-controlled Safety, Tolerability, and Efficacy Study of VRDN-001, a Humanized Monoclonal Antibody Directed Against the IGF-1 Receptor, in Participants With Chronic Thyroid Eye Disease (TED)

• Status: Recruiting
• Trial end date: 2025-09-01
• Target enrollment: 0
• Participant gender: All

Summary

A randomized, double-masked, placebo-controlled safety, tolerability and efficacy study of VRDN-001 in participants with chronic thyroid eye disease (TED)

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Viridian Therapeutics, Inc.

Criteria

Inclusion Criteria:

• Must have moderate to severe chronic TED with documented evidence of ocular symptoms or signs that began > 15 months prior to screening

• Must have Clinical Activity Score (CAS) of (0-7) item scale for the study (more proptotic) eye

• Must agree to use highly effective contraception as specified in the protocol

• Female TED participants must have a negative serum pregnancy test

Key Exclusion Criteria:

• Must not have received prior treatment with another anti-IGF-1R monoclonal antibody

• Must not have used oral corticosteroids within 2 weeks prior to Day 1

• Must not have received rituximab, tocilizumab or other immunosuppressive agents within 8 weeks prior to Day 1

• Must not have a pre-existing ophthalmic condition in the study eye that in the opinion of the Investigator would confound interpretation of the study results

• Must not have had previous orbital irradiation or surgery for TED in the study eye

• Must not have a history inflammatory bowel disease

• Must not have a history or screening audiometry assessment of clinically significant (as determined by investigator) ear pathology, relevant ear surgery, or hearing l loss

• Must not have received an investigational agent for any condition

• Female TED participants must not be pregnant or lactating