VRDN-003 for Graves' Eye Disease

(REVEAL-1 Trial)

Recruiting at 32 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Recruiting

Sponsor: Viridian Therapeutics, Inc.

Must not be taking: Corticosteroids, Immunosuppressives

Disqualifiers: Ophthalmic condition, Ear conditions, IBD, others

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This is a clinical trial assessing the efficacy, safety, and tolerability of an investigational drug, VRDN-003, in participants with active Thyroid Eye Disease (TED).

Will I have to stop taking my current medications?

The trial requires that you stop taking certain medications before participating. You must not have taken systemic corticosteroids within 2 weeks or other immunosuppressive drugs within 8 weeks before the first dose.

Eligibility Criteria

This trial is for individuals with active Thyroid Eye Disease (TED), a condition associated with thyroid problems that affects the eyes. Specific eligibility criteria are not provided, but typically participants must meet certain health standards and may be excluded based on factors like other medical conditions or treatments that could interfere with the study.

Inclusion Criteria

Must have a Clinical Activity Score (CAS) of ≥ 4 on the 7-item scale for the study eye

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

My eye condition started less than 15 months ago and is moderate to severe.

Exclusion Criteria

Must not have a pre-existing ophthalmic condition in the study eye which in the study doctor's opinion, would interfere with interpretation of study results

Must not have abnormal hearing test before first dose. Must also not have a history of ear conditions considered significant by study doctor

I have never had inflammatory bowel disease.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive subcutaneous injections of VRDN-003 or placebo every 4 or 8 weeks for up to 24 weeks

24 weeks

6 visits (in-person) for every 4 weeks group, 3 visits (in-person) for every 8 weeks group

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Extension

Participants who do not have a meaningful response at Week 24 may receive additional subcutaneous injections of VRDN-003

Treatment Details

Interventions

• VRDN-003 (Monoclonal Antibodies)

Trial Overview The trial is testing VRDN-003, an investigational drug, against a placebo to see if it's effective in treating TED. Participants will either receive VRDN-003 or a placebo without knowing which one they're getting to fairly measure the drug's effects.

Participant Groups

Group I: VRDN-003 every 8 weeks Experimental Treatment 2 Interventions

3 subcutaneous administrations of VRDN-003 and 3 subcutaneous administrations of placebo

Group II: VRDN-003 every 4 weeks Experimental Treatment 1 Intervention

6 subcutaneous administrations of VRDN-003

Group III: Placebo every 4 weeks Placebo Group 1 Intervention

6 subcutaneous administrations of placebo

Who Is Running the Clinical Trial?

Viridian Therapeutics, Inc.

Lead Sponsor

Trials

7

Recruited

1,200+