VRDN-001 for Thyroid Eye Disease

(THRIVE-2 Trial)

Recruiting at 105 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Viridian Therapeutics, Inc.

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial tests VRDN-001, a medicine that blocks a harmful protein, in people with long-term thyroid-related eye problems. The goal is to see if it is safe and effective in reducing symptoms.

Eligibility Criteria

This trial is for individuals with chronic thyroid eye disease (TED) who have had symptoms or signs for over 15 months. They must not be pregnant, agree to use effective contraception, and have a Clinical Activity Score of 0-7. People can't join if they've used certain medications recently, had prior TED treatments like surgery or radiation, or have other eye conditions that could affect the study.

Inclusion Criteria

I have had moderate to severe eye problems due to TED for over 15 months.

I am not pregnant.

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

Exclusion Criteria

I haven't taken oral steroids in the last 2 weeks.

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

I haven't taken rituximab, tocilizumab, or similar drugs in the last 8 weeks.

Treatment Details

Interventions

• VRDN-001 (Monoclonal Antibodies)

Trial Overview The trial is testing VRDN-001, a monoclonal antibody targeting the IGF-1 receptor. Participants will either receive this drug at a dose of 10 mg/kg or a placebo without knowing which one they're getting. The goal is to assess safety, tolerability, and effectiveness in treating TED.

Participant Groups

Group I: Veligrotug (VRDN-001)10 mg/kg Experimental Treatment 1 Intervention

Drug: 5 IV Infusions of veligrotug (VRDN-001)10 mg/kg

Group II: Placebo Drug Experimental Treatment 2 Interventions

Placebo Drug: 5 IV Infusions of placebo

Who Is Running the Clinical Trial?

Viridian Therapeutics, Inc.

Lead Sponsor

Trials

7

Recruited

1,200+