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New injection every 8 weeks shows promise for thyroid eye disease

NCT ID NCT06088979

Disease control Sponsor: Tourmaline Bio, Inc., a Novartis Company 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 This study
Running, but no longer taking on new participants.
Completed
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This study tests a drug called TOUR006 in 79 people with active thyroid eye disease, a condition that causes eye bulging and inflammation. Participants receive either a low dose, high dose, or placebo injection every 8 weeks. The main goal is to see if the drug can reduce eye bulging by at least 2 millimeters without worsening 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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

79 people

The number who actually took part.

Started

Feb 2024

Expected to finish

Sep 2027

An estimate. End dates often move.

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 to 80 years

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.

Inclusion Criteria: * Clinical diagnosis of Graves' disease associated with moderate to severe active TED * Onset of active TED symptoms within approximately 15 months * Proptosis (exophthalmos) ≥3 mm above the normal range per investigator judgment (based upon race and gender) for the study eye * CAS ≥4 (on the 7-item scale) for the study eye * Presence of TSI \>130% of the normal reference standard or \>0.55 IU/L (depending on assay method) and laboratory reference ranges Additional inclusion criteria are defined in the study protocol. Exclusion Criteria: * Anticipated need for intervention due to sight-threatening complications or other significant and acute deterioration in vision * Any previous treatment with teprotumumab or other agent that inhibits the IGF-1 receptor * History of systemic (eg, oral or IV) steroid use with a cumulative dose equivalent to \>1 g of methylprednisolone for the treatment of TED. Previous oral steroid use with a cumulative dose of ≤1g methylprednisolone (or equivalent dosage for other systemic corticosteroid) for the treatment of TED, however, is allowed if the corticosteroid was discontinued at least 6 weeks before baseline (Day 1) and completely tapered by Baseline (if applicable). * Systemic (oral or IV) corticosteroid use for conditions other than TED within 6 weeks of baseline (Day 1) or not completely tapered by baseline (if applicable). * Any major illness/condition or evidence of an unstable clinical condition that, in the investigator's judgment, will substantially increase the risk to the participant, or confound the interpretation of safety assessments, if they were to participate in the study * Any other condition that, in the opinion of the investigator, would impair the ability of the participant to comply with the study procedures or impair the ability to interpret data from the participant's participation in the study * Pregnant or lactating Additional exclusion criteria are defined in the study protocol.

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Conditions

The condition(s) this trial relates to.

endocrine exophthalmos exophthalmos eye disorder Graves disease Graves Ophthalmopathy hyperthyroidism thyroid gland disorder

As listed by the trial registrant

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

Thyroid eye disease

Contacts and locations

Locations

  • Academy of Diabetes, Thyroid, and Endocrine - Site 840-129

    El Paso, Texas, 79935, United States

  • Al-Essra Hospital - Site 400-401

    Amman, Jordan

  • Azienda Ospedaliera Universitaria Federico II - Site 390-382

    Naples, 80131, Italy

  • Azienda Ospedaliero Universitaria Pisana - Site 380-381

    Pisa, 56124, Italy

  • Bascom Palmer Eye Institute - Site 840-115

    Miami, Florida, 33136, United States

  • CHU Angers - Site 250-252

    Angers, 49933, France

  • CHU de Nantes - Hopital Nord Laennec - Site 250-251

    Nantes, 44800, France

  • Catalina Eye Care - Site 840-121

    Tucson, Arizona, 85712, United States

  • Centro Brasileiro de Pesquisa Clínica - Rio de Janeiro Ltd - Site 076-765

    Rio de Janeiro, 22410-000, Brazil

  • Columbia University - Site 840-125

    New York, New York, 10032, United States

  • DCT Fort Worth Research Center - Site 840-133

    Fort Worth, Texas, 76132, United States

  • Foothill Eye Institute - Site 840-116

    Pasadena, California, 91107, United States

  • Freire Pesquisa Clinica - Site 076-773

    Belo Horizonte, 13334-290, Brazil

  • Hackensack University Medical Center - Site 840-105

    Hackensack, New Jersey, 07601, United States

  • Hospital Universitario Ramon y Cajal - Site 724-803

    Madrid, 28034, Spain

  • Hospital Universitario Virgen Macarena - Site 724-801

    Seville, 41009, Spain

  • IPEPO - Instituto Paulista de Estudos e Pesquisas em Oftalmologia - Site 076-761

    São Paulo, 04038-032, Brazil

  • Irmandade da Santa Casa de Misericordia de Sao Paulo - Site 076-771

    São Paulo, 01221-020, Brazil

  • Kahana Oculoplastic and Orbital Surgery - Site 840-112

    Livonia, Michigan, 48152, United States

  • NPCRS - Nucleo de Pesquisa Clinica do Rio Grande do Sul - Site 076-764

    Porto Alegre, 90430-001, Brazil

  • Ophthalmic Consultants of Boston - Site 840-128

    Boston, Massachusetts, 02114, United States

  • Ophthalmic Plastic, Reconstructive, Orbital & Cosmetic Surgery - Site 840-123

    Las Vegas, Nevada, 89144, United States

  • Riga East Clinical University Hospital, Clinic Bikernieki - Site 428-901

    Riga, LV1006, Latvia, Latvia

  • Santa Casa de Misericordia de Porto Alegre - Site 076-767

    Porto Alegre, 90020-090, Brazil

  • Seoul National University Hospital - Site 410-002

    Seoul, 03080, South Korea

  • Southern Eye Specialists Ltd - Site 554-501

    Christchurch, 8013, New Zealand

  • Sun Research Institute - Site 840-120

    San Antonio, Texas, 78215, United States

  • The Pacific Center for Oculofacial and Aesthetic Plastic Surgery - Site 840-122

    San Francisco, California, 94115, United States

  • UC Hospital Sue Anschulz-Rodgers Eye Center - Site 840-101

    Aurora, Colorado, 80045, United States

  • UFG - Hospital de Clinicas da Universidade Federal de Goias - Site 076-762

    Goiânia, 74605-050, Brazil

  • Universidade Federal do Rio Grande do Sul (UFRGS) - Site 076-775

    Porto Alegre, 90410-000, Brazil

  • University of California Davis Eye Center - Site 840-119

    Sacramento, California, 95817, United States

  • University of Puerto Rico, Medical Sciences Campus - Site 630-602

    San Juan, 00921, Puerto Rico

  • University of West Virginia - Site 840-113

    Morgantown, West Virginia, 26506, United States

  • Univerzitna nemocnica Bratislava - Nemocnica sv. Cyrila a Metoda - Site 703-211

    Bratislava, 851 07, Slovakia

  • Ziemelkurzemes Regional Hospital - Site 428-902

    Ventspils, Latvia

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