What side effects are associated with this type of intervention?

The investigational drug VRDN-001, which inhibits IGF-1R, aims to reduce inflammation and tissue swelling in Graves' Ophthalmopathy. Similar treatments, such as monoclonal antibodies targeting IGF-1R, may have side effects including infusion reactions, increased risk of infections, and potential impacts on glucose metabolism. Broadly, common treatments for Graves' Ophthalmopathy, such as corticosteroids, can cause side effects like hyperglycemia, increased susceptibility to infections, bone loss, and neuropsychiatric effects. Other treatments like rituximab may lead to infusion reactions and immunosuppression.

What prior FDA approvals exist?

Currently, there are no FDA-approved treatments specifically targeting IGF-1R for Graves' Ophthalmopathy. However, other treatments for Graves' Ophthalmopathy include glucocorticoids, which reduce inflammation, and rituximab, a monoclonal antibody targeting B cells. These treatments aim to manage symptoms and reduce inflammation associated with the disease.

What other types of research exist?

Promising novel alternatives to VRDN-001 for Graves' Ophthalmopathy patients include Teprotumumab, another monoclonal antibody that inhibits IGF-1R, and emerging therapies targeting different inflammatory pathways such as TNF-alpha inhibitors or IL-6 inhibitors. Additionally, small molecule inhibitors targeting specific signaling pathways involved in inflammation and tissue remodeling in TED are also under investigation.

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Monoclonal Antibodies

VRDN-001 for Thyroid Eye Disease (THRIVE 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 volunteers must not be of child-bearing potential

Be older than 18 years old

Must not have

Must not have received prior treatment with another anti-IGF-1R monoclonal antibody

Must not have received rituximab, tocilizumab or other immunosuppressive agents within 8 weeks prior to Day 1

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 6 for ted mad participants, and week 15 for phase 3 participants

Awards & highlights

Pivotal Trial

Summary

This trial is testing VRDN-001, a medicine that blocks a part of cells causing inflammation, in patients with thyroid eye disease. The goal is to see if it can reduce eye swelling and inflammation.

Who is the study for?

This trial is for healthy individuals and those with Thyroid Eye Disease (TED), specifically moderate to severe cases. Participants should not have certain medical conditions like diabetes, recent kidney issues, or hearing loss. They must not have used specific medications recently and agree to use effective contraception.

What is being tested?

The study tests VRDN-001, a monoclonal antibody targeting the IGF-1R receptor which could reduce inflammation in TED patients. It's being compared against a placebo in different phases of trials to assess safety, tolerability, and how it's processed by the body.

What are the potential side effects?

Potential side effects are not detailed here but may include reactions typical of monoclonal antibodies such as infusion-related reactions, immune system effects or allergic responses due to inhibition of the IGF-1R pathway.

Eligibility Criteria

Inclusion Criteria

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

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I am not able to become pregnant.

Exclusion Criteria

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

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

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I haven't taken rituximab, tocilizumab, or similar drugs in the last 8 weeks.

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

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I do not have diabetes, kidney issues, inflammatory bowel disease, or significant ear problems.

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

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My eye condition responds to treatment.

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I have never had inflammatory bowel disease.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 6 for ted mad participants, and week 15 for phase 3 participants

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 6 for ted mad participants, and week 15 for phase 3 participants

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 6 for ted mad participants, and week 15 for phase 3 participants 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 study eye

Secondary study objectives

Change from baseline in Clinical Activity Score (CAS)

Diplopia Resolution Rate

Diplopia Responder Rate

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: Phase 3 Cohort (THRIVE)Experimental Treatment2 Interventions

Participants with TED will be randomized to either veligrotug (VRDN-001) 10mg/kg or placebo.

Group II: Phase 1/2 MAD (HV and TED)Experimental Treatment1 Intervention

Healthy volunteers and participants with TED will be randomized to receive two intravenous infusions of veligrotug (VRDN-001) or placebo with an interval of 3

0 / 8Eligibility 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

The investigational drug VRDN-001 works by inhibiting the insulin-like growth factor-1 receptor (IGF-1R), which may help reduce inflammation and tissue swelling in patients with Graves' Ophthalmopathy. Other common treatments include glucocorticoids, which reduce inflammation and inhibit thyroid hormone secretion, and rituximab, a monoclonal antibody that depletes peripheral B cells and may induce remission. These treatments are crucial for managing the symptoms of Graves' Ophthalmopathy, such as proptosis and diplopia, by targeting the underlying inflammatory processes and immune responses.