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

Thyroid Eye Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06179875
• Other study ID #: VRDN-001-302
• Status: Recruiting
• Phase: Phase 3
• Start date: February 1, 2023
• Est. completion date: March 2026

Study information

• Verified date: April 2024
• Source: Viridian Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 143
• Est. completion date: March 2026
• Est. primary completion date: July 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Eye Diseases
• Graves Ophthalmopathy
• Thyroid Eye Disease

Intervention

Drug:
• Intervention/Treatment
VRDN-001 10 mg/kg (5 infusions of VRDN-001 10 mg/kg)

Locations

Country	Name	City	State
United States	University of Vermont Medical Center	Burlington	Vermont
United States	Ophthalmic Consultants of Boston	E. Weymouth	Massachusetts
United States	Neuro-eye Clinical Trials	Houston	Texas
United States	Kahana Oculoplastic & Orbital Surgery	Livonia	Michigan
United States	MACRO Trials, Inc.	Los Angeles	California
United States	Amy Patel Jain, MD Inc	Newport Beach	California
United States	Byers Eye Institute	Palo Alto	California
United States	Cockerham Eye Consultants, PC	San Diego	California
United States	Sarasota Retina Institute	Sarasota	Florida
United States	The Center for Eye and Facial Plastic Surgery	Somerset	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Viridian Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proptosis Responder Rate in the study eye	Proptosis Responder Rate in the study eye (i.e., reduction of proptosis of =2 mm from baseline [without a corresponding increase of =2 mm in the fellow eye] as measured by exophthalmometer) at 3 weeks post the fifth infusion (i.e., Week 15)	3 weeks post the fifth infusion
Secondary	Change from Baseline in proptosis in the study eye at Week 15	Change from Baseline in proptosis in the study eye as measured by exophthalmometer at Week 15	Week 15
Secondary	Clinical Activity Responder Rate in the study eye	Clinical Activity Responder Rate in the study eye at Week 15	Week 15
Secondary	Change from baseline in Clinical Activity Score in the study eye	Change from baseline in Clinical Activity Score in the study eye at Week 15	Week 15
Secondary	Overall Responder Rate in the study eye	Overall Responder Rate in the study eye at Week 15	Week 15
Secondary	Diplopia Resolution Rate	Diplopia Resolution Rate (i.e., reduction in Diplopia Score to 0 from baseline for participants with baseline Diplopia Score >0) at Week 15	Week 15