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Can a targeted antibody calm thyroid eye disease?

NCT ID NCT05176639

Disease control Sponsor: Viridian Therapeutics, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 13, 2026 · Last updated Aug 14, 2026 · Updated 1 time

Summary

This trial tests whether veligrotug, an antibody that blocks a receptor involved in inflammation, can reduce eye bulging and swelling in people with active thyroid eye disease. Participants receive five infusions of the drug or a placebo. The study measures how many people see a meaningful reduction in eye protrusion, along with safety and tolerability.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
veligrotug (VRDN-001), a humanized monoclonal antibody that blocks the insulin-like growth factor-1 receptor (IGF-1R) to reduce inflammation and tissue swelling in thyroid eye disease.
What this could lead to
If successful, veligrotug could offer a new treatment to reduce eye bulging and inflammation in people with active thyroid eye disease, potentially improving vision and appearance.
What could go wrong
This is a Phase 3 trial, but results are not yet known. The drug may not prove more effective than placebo, and there could be side effects from blocking IGF-1R.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

113 people

The number who actually took part.

Started

Nov 2022

Finished

Mar 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Key Inclusion Criteria for Active TED Participants (THRIVE): * Must have moderate to severe active TED with documented evidence of ocular symptoms or signs that began within 15 months prior to screening * Must have Clinical Activity Score (CAS) of ≥ 3 on the 7-item scale for the study eye * Must agree to use highly effective contraception as specified in the protocol * Female TED participants must have a negative serum pregnancy test at screening Key Exclusion Criteria for Active TED Participants (THRIVE): * Must not have received prior treatment with another anti-IGF-1R therapy or any investigational agent for TED * Must not have used systemic corticosteroids or selenium within 2 weeks prior to Day 1 * Must not have received rituximab, tocilizumab or other immunosuppressive agents or any other therapy for TED within 8 weeks prior to Day 1 * Must not have received an investigational agent for any condition within 8 weeks prior to Day 1 * Must not have a pre-existing ophthalmic condition in the study eye that in the opinion of the Investigator would confound interpretation of the study results * Must not have had previous orbital irradiation or surgery for TED in the study eye * Must not have a history of inflammatory bowel disease * Must not have a history of or screening audiometry assessment of clinically significant (as determined by investigator) ear pathology, relevant ear surgery, or hearing loss * Female TED participants must not be pregnant or lactating Note: Prior thyroidectomy, radioactive iodine (RAI) treatment, or orbital decompression surgery limited to bone only are NOT exclusions.

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Conditions

The condition(s) this trial relates to.

endocrine exophthalmos Graves disease Graves Ophthalmopathy

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Thyroid eye disease

Contacts and locations

Locations

  • 4 Wojskowy Szpital Kliniczny z Polikinika SP ZOZ

    Wroclaw, 53-114, Poland

  • AP-HP- Hopital de la Pitie Salpetriere

    Paris, 75013, France

  • Advanced Research International, LLC

    Las Vegas, Nevada, 89144, United States

  • Amy Patel Jain, MD

    Newport Beach, California, 92260, United States

  • Baylor College of Medicine (BCM)-Ophthalmology

    Houston, Texas, 77030, United States

  • Byers Eye Institute/Stanford University

    Palo Alto, California, 94303, United States

  • CH Nice

    Nice, 06000, France

  • CHU d'Angers

    Angers, 49100, France

  • Centre Hospitalier National D'ophtalmologie

    Paris, 75012, France

  • Clinica Bonanova de Cirugia Ocular

    Barcelona, 08022, Spain

  • Clinica Universidad de Navarra

    Madrid, 28027, Spain

  • Clinica Universidad de Navarra

    Pamplona, 31008, Spain

  • Complexo Hospiralario Universitario de Santiago-Hospital Medico-Ciruxico de Conxo

    Santiago, 15706, Spain

  • Edward Jenner Research Group Center LLC

    Plantation, Florida, 33317, United States

  • Fraser Eye Care Center

    Fraser, Michigan, 48026, United States

  • Guy's and St. Thomas NHS Trust

    London, United Kingdon, SE1 7EH, United Kingdom

  • Hospital Arruzafa

    Córdoba, 14012, Spain

  • Hospital Universitario Miguel Servet, Servicio de Paseo Isabel La Catdlica1

    Zaragoza, 50009, Spain

  • Hospital Universitario Ramon y Cajal

    Madrid, 28034, Spain

  • Hospital Universitatio Virgen De La Macarena, Servicio de Oftalmologia

    Seville, 41071, Spain

  • Johannes Gutenberg-University Medical Center

    Mainz, 55131, Germany

  • KU Medical Center, University of Kansas

    Kansas City, Kansas, 66103, United States

  • Kahana Oculoplastic & Orbital Surgery

    Livonia, Michigan, 48152, United States

  • MACRO Trials, Inc.

    Los Angeles, California, 90049, United States

  • Massachusetts Eye and Ear

    Boston, Massachusetts, 02114, United States

  • Med-Care Research Inc.

    Miami, Florida, 33125, United States

  • NZOZ E-Vita

    Bialystok, 15-879, Poland

  • Neuro-Eye Clinical Trials

    Houston, Texas, 77074, United States

  • Neuro-Ophthalmology of Texas PLLC

    Houston, Texas, 77074, United States

  • New York Eye Ear Infirmary of Mount Sinai

    New York, New York, 10003, United States

  • North Shore Eye Surgery

    Sydney, 2065, Australia

  • Northwick Park Hospital

    London, United Kingdon, HA13UJ, United Kingdom

  • Ophthalmic Consultants of Boston

    Weymouth, Massachusetts, 02189, United States

  • Panstwowy Instytut Medycsny MSWiA

    Warsaw, 02-507, Poland

  • Rutgers-New Jersey Medical School-Newark

    Newark, New Jersey, 07103, United States

  • Santa Familia PTG Lodz

    Lodz, 90-302, Poland

  • Sarasota Retina Institute

    Sarasota, Florida, 34231, United States

  • Senta Clinic

    San Diego, California, 95207, United States

  • Sina Medical Center

    Homestead, Florida, 33034, United States

  • Specjakistyczny Osrodek Okulistyczny Oculomedica

    Bydgoszcz, 85-870, Poland

  • Sydney Eye Hospital

    Sydney, 2000, Australia

  • The Private Office of Raymond Douglas

    Beverly Hills, California, 90210, United States

  • USC Roski Eye Institute

    Los Angeles, California, 90033, United States

  • Universitatsmedizin Gottingen

    Göttingen, 37075, Germany

  • University Health Diabetes, Endocrinology & Nephrology Center

    Kansas City, Kansas, 64108, United States

  • University of California, San Francisco

    San Francisco, California, 94158, United States

  • University of Colorado

    Aurora, Colorado, 80045, United States

  • University of Colorado - Department of Ophthalmology

    Aurora, California, 80045, United States

  • University of Minnesota, Department of Ophthalmology and Visual Neurosciences

    Minneapolis, Minnesota, 55455, United States

  • University of Vermont Medical Center

    Burlington, Vermont, 05401, United States

  • Vision Medical Research Inc.

    Orland Park, Illinois, 60462, United States

  • West Virgina University Eye Institute

    Morgantown, West Virginia, 26506, United States

  • Western Eye Hospital Imperial College NHS trust

    London, United Kingdon, NW1 5QH, United Kingdom

More trials for these conditions

Other studies related to the condition(s) this trial covers.