What is the mechanism of action of this treatment?

Graves' Ophthalmopathy (GO) treatments often include corticosteroids to reduce inflammation and immune response, and monoclonal antibodies targeting specific pathways involved in the disease. VRDN-001, a monoclonal antibody against the IGF-1 receptor, exemplifies this approach. These antibodies inhibit molecules or receptors crucial in the inflammatory process of GO, potentially offering more effective and safer treatment options compared to broad-spectrum immunosuppressants. This targeted mechanism is important for patients as it promises better outcomes with fewer side effects.

What side effects are associated with this type of intervention?

Common treatments for Graves' Ophthalmopathy, particularly monoclonal antibodies like VRDN-001 targeting the IGF-1 receptor, often include teprotumumab. Known side effects of these treatments can include muscle spasms, nausea, alopecia, diarrhea, fatigue, hyperglycemia, and hearing impairment. Other treatments, such as corticosteroids, can cause side effects like weight gain, mood swings, and increased risk of infections. It's important to discuss these potential side effects with a healthcare provider to manage and mitigate risks effectively.

What prior FDA approvals exist?

Currently, the FDA has approved Teprotumumab (Tepezza), a monoclonal antibody that targets the IGF-1 receptor, for the treatment of Thyroid Eye Disease (TED), also known as Graves' Ophthalmopathy. This approval is significant as it represents a targeted biologic therapy similar to VRDN-001, which is also a monoclonal antibody directed against the IGF-1 receptor. Other treatments for Graves' Ophthalmopathy have included corticosteroids and orbital irradiation, but these are not monoclonal antibodies.

What other types of research exist?

Promising novel alternatives to VRDN-001 for Graves' Ophthalmopathy patients include: 1) Teprotumumab, another monoclonal antibody targeting the IGF-1 receptor, which has shown efficacy in treating Thyroid Eye Disease. 2) Anti-VEGF therapies, such as aflibercept, bevacizumab, and ranibizumab, which are used in other ocular conditions and may offer potential benefits. 3) Emerging treatments like longer-acting biologics, gene therapies, and sustained release systems that aim to reduce the frequency of injections and improve patient compliance. These alternatives are in various stages of clinical trials and development, showing promise for future treatment options.

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Monoclonal Antibodies

VRDN-001 for Thyroid Eye Disease (THRIVE-2 Trial)

Phase 3

Waitlist Available

Research Sponsored by Viridian Therapeutics, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Female TED participants must have a negative serum pregnancy test

Be older than 18 years old

Must not have

Must not have used oral corticosteroids within 2 weeks prior to Day 1

Female TED participants must not be pregnant or lactating

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 15

Awards & highlights

Pivotal Trial

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include reactions related to the immune system due to the action of VRDN-001 on growth factors involved in inflammation but specific side effects are not listed here as it's under investigation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am not pregnant.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I am not pregnant or breastfeeding.

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I have never been treated with anti-IGF-1R monoclonal antibody.

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I have never had inflammatory bowel disease.

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I have not had eye radiation or surgery for TED in the affected eye.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 15

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 15

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 15 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Proptosis Responder Rate in the most proptotic eye

Secondary study objectives

Change from baseline in proptosis in the most proptotic eye

Clinical Activity Responder Rate in the most proptotic eye

Diplopia Resolution Rate

+2 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Veligrotug (VRDN-001)10 mg/kgExperimental Treatment1 Intervention

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

Group II: Placebo DrugExperimental Treatment2 Interventions

Placebo Drug: 5 IV Infusions of placebo

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Placebo

1995

Completed Phase 3

~2670

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Graves' Ophthalmopathy (GO) treatments often include corticosteroids to reduce inflammation and immune response, and monoclonal antibodies targeting specific pathways involved in the disease. VRDN-001, a monoclonal antibody against the IGF-1 receptor, exemplifies this approach. These antibodies inhibit molecules or receptors crucial in the inflammatory process of GO, potentially offering more effective and safer treatment options compared to broad-spectrum immunosuppressants. This targeted mechanism is important for patients as it promises better outcomes with fewer side effects.

Tocilizumab for thyroid eye disease.