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)

Thyroid Eye Disease Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06021054
• Other study ID #: VRDN-001-301
• Status: Recruiting
• Phase: Phase 3
• Start date: November 14, 2023
• Est. completion date: September 2025

Study information

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

Clinical Trial Summary

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

Description:

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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 159
• Est. completion date: September 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Eye Diseases
• Graves Ophthalmopathy
• Thyroid Diseases
• Thyroid Eye Disease

Intervention

Drug:
• VRDN-001 10 mg/kg Drug:
Drug: 5 Infusions of VRDN-001 10mg/ Placebo: 5 Infusions of placebo

Locations

Country	Name	City	State
Turkey	Gazi Oniversitesi Tip FakOltesi Hastanesi	Ankara
Turkey	Hacettepe Universitesi Tip Fak0ltesi	Ankara
Turkey	Akdeniz Oniversitesi T,p FakOltesi. Goz Hastal,k.an	Konya
United States	Eye Wellness Center- Neuro-Eye Clinical Trials, Inc.	Bellaire	Texas
United States	Ophthalmic Consultants of Boston	Boston	Massachusetts
United States	Michigan State University Department of Neurology and Ophthalmology	East Lansing	Michigan
United States	Kahana Oculoplastic and Orbital Surgery	Livonia	Michigan
United States	MACRO Trials, Inc	Los Angeles	California
United States	Rutgers New Jersey Medical	Newark	New Jersey
United States	Amy Patel Jain, MD Inc	Newport Beach	California
United States	Vision Medical Research, INC	Oak Lawn	Illinois
United States	Byers Eye Institute	Palo Alto	California
United States	Senta Clinic	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.

Countries where clinical trial is conducted

United States,  Turkey, 

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	Week 15
Secondary	Change from baseline in CAS in the study eye	Change from baseline in CAS in the study eye	Week 15
Secondary	Overall Response Rate in the study eye	Overall Response Rate in the study eye	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