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

Thyroid Eye Disease Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06384547
• Other study ID #: VRDN-001-303
• Status: Recruiting
• Phase: Phase 3
• Start date: May 23, 2024
• Est. completion date: January 2026

Study information

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

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 212
• Est. completion date: January 2026
• Est. primary completion date: May 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• VRDN-001 10 mg/kg
5 infusions of VRDN-001 10 mg/kg
• VRDN-001 3 mg/kg
5 infusions of VRDN-001 3 mg/kg

Locations

Country	Name	City	State
United States	United Medical Research Institute	Inglewood	California

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	Treatment Emergent Adverse Event (TEAE) incidence rate		Week 52
Secondary	Change from baseline in proptosis in the study eye as measured by exophthalmometer at Week 15		Week 15