VRDN-003 for Graves' Eye Disease

(REVEAL-2 Trial)

Not currently recruiting at 38 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new drug, VRDN-003, to evaluate its effectiveness and safety for individuals with chronic Thyroid Eye Disease (TED). The study compares different groups: some receive VRDN-003 injections every 4 weeks, others every 8 weeks, and one group receives a placebo (an inactive substance). Candidates for this trial have moderate to severe TED with symptoms persisting for more than 15 months. As a Phase 3 trial, this study represents the final step before FDA approval, providing participants an opportunity to contribute to the potential availability of a new treatment.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that VRDN-003 has been generally safe in earlier studies. In one study, patients did not experience any serious unexpected medical issues after receiving the treatment. Another study examined the safety and tolerability of VRDN-003, noting that it is administered as an injection every four weeks. While these studies suggest that VRDN-003 is well-tolerated, participants should remember that the treatment is still under investigation and not yet approved for general use. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Unlike the standard treatments for Graves' Eye Disease, which often involve steroids or surgery, VRDN-003 works by targeting and blocking the IGF-1 receptor, a mechanism that could offer more precise symptom control. Researchers are excited because VRDN-003 might reduce inflammation and eye bulging more effectively, with fewer side effects. Plus, it's administered subcutaneously, potentially making it easier and less invasive than surgical options.

What evidence suggests that VRDN-003 might be an effective treatment for Thyroid Eye Disease?

Research has shown that VRDN-003 might help treat Thyroid Eye Disease (TED), also known as Graves' Eye Disease. Earlier studies found that similar treatments, like VRDN-001, greatly reduced eye bulging and improved scores measuring disease activity. VRDN-003 remains active in the body longer, potentially increasing its effectiveness with fewer doses. The current study tests VRDN-003 in different treatment arms, with some participants receiving it every 4 weeks and others every 8 weeks. Although more information is needed, early results suggest VRDN-003 could offer promising relief for people with TED. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06625398

An Efficacy, Safety, and Tolerability Study of VRDN-003 in ... The key objectives of this study are to determine if VRDN-003 is efficacious, safe and tolerable when administered as subcutaneous/SC injections every 4 weeks ...

2. investors.viridiantherapeutics.com investors.viridiantherapeutics.com/news/news-details/2024/Viridian-Therapeutics-Announces-Details-of-Subcutaneous-VRDN-003-Phase-3-Clinical-Program-for-Patients-with-Active-and-Chronic-Moderate-to-Severe-Thyroid-Eye-Disease/default.aspx

Viridian Therapeutics Announces Details of Subcutaneous ... Phase 1 results in healthy volunteers showed a VRDN-003 half-life of 40-50 days which is 4-5x the half-life of VRDN-001.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11182121/

Emerging therapies in the medical management of thyroid ... In this study, two infusions led to substantial reductions in proptosis and clinical activity scores. No patients treated with VRDN-001 achieve completed ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06812325

A Safety and Tolerability Study of VRDN-003 in ... The key objectives of this study are to determine if VRDN-003 is safe and tolerable when administered as a series of subcutaneous (SC) injections every 4 weeks ...

5. healio.com healio.com/news/endocrinology/20251010/treatment-for-thyroid-eye-disease-in-an-exciting-era-of-growth

Treatment for thyroid eye disease in an exciting era of growth Viridian is also working on a subcutaneous agent called VRDN-003, and it initiated two phase 3 trials in 2024. Bhan said the availability of a ...

6. clinicaltrials.eu clinicaltrials.eu/trial/study-on-the-effects-of-vrdn-003-for-patients-with-active-thyroid-eye-disease/

Study on the Effects of VRDN-003 for Patients with Active ... This study investigates the efficacy and safety of VRDN-003, an injectable treatment under trial for reducing symptoms in patients with active Thyroid Eye ...