VRDN-003 for Thyroid Eye Disease

Recruiting at 18 trial locations

Overseen By Stephen Director, Clinical Operations

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Viridian Therapeutics, Inc.

Must not be taking: Corticosteroids, Immunosuppressives, Selenium, others

Disqualifiers: Anti-IGF-1R therapy, Orbital surgery, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

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: 3

Duration: 24 weeks

284 Participants Needed

Trial Summary

What is the purpose of this trial?

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

Eligibility Criteria

This trial is for individuals with Thyroid Eye Disease (TED), regardless of the severity. Participants should not need immediate eye surgery and women must test negative for pregnancy. All participants must agree to use effective contraception as outlined in the study.

Inclusion Criteria

I agree to use effective birth control as required.

I am female and have a negative pregnancy test.

I have been diagnosed with thyroid eye disease and might benefit from VRDN-003.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive subcutaneous administrations of VRDN-003 every 4 or 8 weeks

24 weeks

3-6 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

28 weeks

Treatment Details

Interventions

• VRDN-003

Trial Overview The trial is testing VRDN-003, a new drug, against a placebo to see how safe it is and how well people can tolerate it when treating TED. It's designed to compare outcomes between those receiving the actual drug and those given a non-active substance.

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

Who Is Running the Clinical Trial?

Viridian Therapeutics, Inc.

Lead Sponsor

Trials

7

Recruited

1,200+