VRDN-003 for Graves' Eye Disease

(REVEAL-2 Trial)

Recruiting at 37 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Viridian Therapeutics, Inc.

Must not be taking: Corticosteroids, Immunosuppressives

Disqualifiers: Pregnancy, Inflammatory bowel disease, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 6

Duration: 24 weeks

195 Participants Needed

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 chronic Thyroid Eye Disease (TED).

Will I have to stop taking my current medications?

The trial requires that you stop taking certain medications before joining. 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 chronic Thyroid Eye Disease (TED), a condition often associated with thyroid problems, where the eyes may become swollen, red, and painful. Specific eligibility criteria are not provided but typically include age range, disease severity, and overall health status.

Inclusion Criteria

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

I have had moderate to severe thyroid eye disease for over 15 months.

I am a woman and my pregnancy test was negative.

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 am not pregnant or breastfeeding.

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

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

Trial Overview The study is testing VRDN-003 to see if it's effective in treating TED symptoms compared to a placebo. Participants will be randomly assigned to receive either VRDN-003 or an inactive substance (placebo) without knowing which one they're getting.

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+