An Open-label Study for Participants Who Are Non-responders at the End of Treatment Assessment on the VRDN-001-101 and VRDN-001-301 Pivotal Studies

• Status: Recruiting
• Trial end date: 2026-03-01
• Target enrollment: 0
• Participant gender: All

Summary

An open-label study for participants who are non-responders at end of the treatment period assessment (i.e., 15 weeks) in the VRND-001-101 (THRIVE) and VRDN-001-301 (THRIVE-2) pivotal studies

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Viridian Therapeutics, Inc.

Criteria

Inclusion Criteria:

• Have completed at least 5 infusions and assessments required to determine proptosis responder status as measured by exophthalmometer 3 weeks post the fifth infusion (i.e., Week 15) as defined in either the VRDN-001-101 or VRDN-001-301 pivotal studies

• Been a participant in either the VRDN-001-101 or VRDN-001-301 pivotal studies and found to be non-responder

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

• Female Thyroid Eye Disease (TED) participants must have a negative urine pregnancy test

Exclusion Criteria:

• Must not have received prior treatment with another anti-IGF-1R monoclonal antibody or any other investigational agent for TED

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

• Must not have received an investigational agent for any condition (other than VRDN-001 or placebo associated with the VRDN-001-101 or VRDN-001-301 pivotal studies) within 8 weeks prior to Day 1