A Randomized, Active Controlled, Safety and Tolerability Study of VRDN-001 in Participants With Thyroid Eye Disease (TED)

Phase 3

Recruiting

• Conditions: Thyroid Eye Disease
• Interventions: Drug: VRDN-001 10 mg/kg; Drug: VRDN-001 3 mg/kg

• Registration Number: NCT06384547
• Lead Sponsor: Viridian Therapeutics, Inc.

Brief 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 objective of this clinical trial is to evaluate the safety and tolerability of VRDN-001 in patients with TED.

Detailed Description

A randomized, active controlled, safety and tolerability study of VRDN-001, a humanized monoclonal antibody directed against the IGF-1 receptor, in participants with thyroid eye disease (TED)

Study Timeline

• Study First Submitted: 2024-04-22
• Study First Submitted QC: 2024-04-22
• Study First Posted: 2024-04-25
• Study Start: 2024-05-23
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-01
• Last Update Posted: 2024-07-03
• Primary Completion: 2025-05
• Study Completion: 2026-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 212

Inclusion Criteria

• Have a clinical diagnosis of TED with or without proptosis and with any CAS (0 - 7) and in the opinion of the investigator may benefit from treatment
• Must agree to use highly effective contraception method as specified in the protocol
• Female TED participants must have a negative serum pregnancy test

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Exclusion Criteria

• Must not have received prior treatment with another anti-IGF-1R therapy or any 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 received any other therapy for TED 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 decompression surgery involving excision of fat for TED in the study eye's orbit
• Must not have inflammatory bowel disease
• Must not have a history or screening audiometry assessment of significant (as determined by investigator) ear pathology, relevant ear surgery, or hearing loss
• Must not have received an investigational agent for any condition within 8 weeks prior to Day 1
• Female TED participants must not be pregnant or lactating

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
VRDN-001 10 mg/kg	VRDN-001 10 mg/kg	5 infusions of VRDN-001 10 mg/kg
5 infusions of VRDN-001 3 mg/kg	VRDN-001 3 mg/kg	5 infusions of VRDN-001 3 mg/kg

Primary Outcome Measures

Name	Time	Method
Treatment Emergent Adverse Event (TEAE) incidence rate	Week 52

Secondary Outcome Measures

Name	Time	Method
Change from baseline in proptosis in the study eye as measured by exophthalmometer at Week 15	Week 15

Trial Locations

Locations (3)

Central Coast Retina; 🇺🇸 Santa Maria, California, United States

United Medical Research Institute; 🇺🇸 Inglewood, California, United States

Med-Care Research Corp.; 🇺🇸 Miami, Florida, United States