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Second chance: new drug offers hope for thyroid eye disease Non-Responders

NCT ID NCT06179875

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Aug 14, 2026 · Updated 1 time

Summary

This study tested an investigational drug called VRDN-001 in 143 people with thyroid eye disease who did not improve in earlier studies. The drug aims to reduce inflammation and eye bulging by blocking a specific receptor. Researchers measured how many participants had at least a 2-millimeter reduction in eye protrusion without worsening in the other eye.

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

139 people

The number who actually took part.

Started

Jan 2024

Finished

Jun 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: 1. Be able to understand the study procedures and the risks involved and be willing to provide written informed consent before the first study-related activity 2. Have completed at least 5 IV infusions and assessments required to determine proptosis responder status 3 weeks post the fifth IV infusion (i.e., Week 15) as defined in either the VRDN-001-101 or VRDN-001-301 pivotal studies 3. Been a participant in either the VRDN-001-101 or VRDN-001-301 studies and found to be a non-responder as defined within the VRDN-001-101 or VRDN-001-301 study 4. Not require immediate surgical ophthalmological or orbital surgery in the study eye for any reason 5. Must agree to use highly effective contraception as specified in the protocol 6. Female TED participants must have a negative urine pregnancy test at screening 7. Be willing and able to comply with all the requirements of the protocol for the entire duration of the study Key Exclusion Criteria: Participants must not: 1. Have received prior treatment with another anti-IGF-1R agent 2. Have received systemic corticosteroids for any condition, including TED, or selenium within 2 weeks prior to first dose 3. Have received other immunosuppressive drugs or another investigational agent for any condition, including TED (other than VRDN-001 or placebo associated with the VRDN-001-101 or VRDN-001-301 pivotal studies), or any other therapy for TED, within 8 weeks prior to first dose 4. Have received radioactive iodine (RAI) treatment within 8 weeks prior to first dose 5. Have had previous orbital irradiation or decompression surgery involving excision of fat for TED to the study eye's orbit 6. Have abnormal hearing test before first dose. Have a history of ear conditions considered significant by study doctor

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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

  • Advancing Research International, LLC

    Los Angeles, California, 90023, United States

  • Advancing Research International, LLC

    Newport Beach, California, 90023, United States

  • Akdeniz University Medical Faculty Hospital

    Antalya, 7070, Turkey (Türkiye)

  • Amsterdam UMC

    Amsterdam, Netherlands

  • Baylor College of Medicine

    Houston, Texas, 77030, United States

  • CHU Angers

    Angers, 49933, France

  • Centre Hospitalier Universitaire De Nantes G.R. Laenne

    Saint-Herblain, Loire-Atlantique, 44800, France

  • Centre Hospitalier Universitaire de Montpellier Hopital Lapeyronie

    Montpellier, Hérault, 34295, France

  • Centrum Medyczne Piasta

    Wałbrzych, Piasta, 58-304, Poland

  • Centrum Medyczne Pulawska

    Piaseczno, 05-500, Poland

  • Charite - Universitatsmedizin Berlin KoR, Campus Virchow Klinikum, Klinik tor Augenheilkunde

    Berlin, Germany

  • Cockerham Eye Consultants, PC

    San Diego, California, 92108, United States

  • Gazi University Medical Faculty Hospital

    Ankara, 06560, Turkey (Türkiye)

  • Guy's and St. Thomas Trust

    London, SE17EH, United Kingdom

  • Hacettepe Universitesi Tip Fakultesi

    Ankara, 06230, Turkey (Türkiye)

  • Hospital Arruzafa. Servicio de Oftalmologia

    Córdoba, 14012, Spain

  • Hospital Clinico San Carlos

    Madrid, Spain

  • Hospital Universitario Miguel Servel

    Zaragoza, 50009, Spain

  • Hospital Universitario Ramon y Cajal

    Madrid, 28034, Spain

  • Hospital Universitario Virgen de la Macarena

    Seville, 41009, Spain

  • Hospital of the University of Pennsylvania Perleman Center

    Philadelphia, Pennsylvania, 19104, United States

  • Imperial College Healthcare NHS Trust Western Eye Hospital

    London, NW15QH, United Kingdom

  • Kahana Oculoplastic & Orbital Surgery

    Livonia, Michigan, 48152, United States

  • Marmara University Faculty of Medicine

    Istanbul, 34899, Turkey (Türkiye)

  • Neuro-Eye Clinical Trials

    Houston, Texas, 77074, United States

  • Newcastle Eye Centre

    Newcastle, United Kingdom

  • Norfolk and Norwich University Hospital NHS Foundation Trust

    Norwich, London, United Kingdom

  • Ophthalmic Consultants of Boston

    East Weymouth, Massachusetts, 02189, United States

  • Ophthalmic Plastic, Reconstructive, Orbital and Cosmetic Surgery

    Las Vegas, Nevada, 89144, United States

  • Optimum Profesorskie Centrum Okulistyki

    Gdansk, 80809, Poland

  • Rutgers New Jersey Medical School

    Newark, New Jersey, 07103, United States

  • Sarasota Retina Institute

    Sarasota, Florida, 34239, United States

  • Stanford Byers Eye Institute

    Palo Alto, California, 94303, United States

  • The Center for Eye and Facial Plastic Surgery

    Somerset, New Jersey, 08873, United States

  • USC Eye Institute

    Los Angeles, California, 90033, United States

  • Universitatmedizin Gottingen

    Göttingen, Lower Saxony, 37075, Germany

  • Universitatsklinikum Carl Gustav Carus

    Dresden, Germany

  • Universitatsklinikum Essen AoR - Klinik fur Augenheilkunde

    Essen, Germany

  • University Hospital Bristol and Weston NHS Foundation Trust- Bristol Eye Hospital

    Bristol, United Kingdom

  • University Medical Center Freiburg

    Freiburg im Breisgau, Germany

  • University of Miami Miller School of Medicine, Bascom Palmer Eye Institute

    Miami, Florida, 33136, United States

  • University of Vermont Medical Center

    Burlington, Vermont, 05401, United States

  • University of Washington Medical Center

    Seattle, Washington, 98104-2430, United States

  • Uniwersytecki Szpital Kliniczny w Bialymstoku

    Bialystok, 15-276, Poland

  • Vision Medical Research

    Oak Lawn, Illinois, 60453, United States

More trials for these conditions

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