A Study to Investigate Efficacy and Safety of TOUR006 in Participants 18 to 80 Years of Age With Thyroid Eye Disease
NCT ID: NCT06088979
Last Updated: 2026-01-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
81 participants
INTERVENTIONAL
2024-02-19
2027-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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TOUR006 - 20 MG
In part A of the study, participants will receive a total of three 20 mg subcutaneous injections: 1 injection every 8 weeks (Day 1, Week 8, Week 16) followed by treatment in part B of the study based on proptosis response and rescue therapy use.
TOUR006 - 20 MG
TOUR006 20 MG
TOUR006 - 50 MG
In part A of the study, participants will receive a total of three 50 mg subcutaneous injections: 1 injection every 8 weeks (Day 1, Week 8, Week 16) followed by treatment in part B of the study based on proptosis response and rescue therapy use.
TOUR006 - 50 MG
TOUR006 - 50 MG
Placebo
In part A of the study, participants will receive a total of three Placebo subcutaneous injections: 1 injection every 8 weeks (Day 1, Week 8, Week 16) followed by treatment in part B of the study based on proptosis response and rescue therapy use.
Placebo
Placebo
Interventions
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TOUR006 - 20 MG
TOUR006 20 MG
Placebo
Placebo
TOUR006 - 50 MG
TOUR006 - 50 MG
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
80 Years
ALL
No
Sponsors
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Tourmaline Bio, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Tourmaline Bio
Locations
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Catalina Eye Care - Site 840-121
Tucson, Arizona, United States
Headlands Research - AMCR - Site 840-131
Escondido, California, United States
Foothill Eye Institute - Site 840-116
Pasadena, California, United States
University of California Davis Eye Center - Site 840-119
Sacramento, California, United States
Cockerham Eye Consultants - Site 840-114
San Diego, California, United States
The Pacific Center for Oculofacial and Aesthetic Plastic Surgery - Site 840-122
San Francisco, California, United States
UC Hospital Sue Anschulz-Rodgers Eye Center - Site 840-101
Aurora, Colorado, United States
Bascom Palmer Eye Institute - Site 840-115
Miami, Florida, United States
Cordova Research Institute - Site 840-103
Miami, Florida, United States
University of Louisville Health Eye Institute - Site 840-108
Louisville, Kentucky, United States
Ophthalmic Consultants of Boston - Site 840-128
Boston, Massachusetts, United States
W.K. Kellogg Eye Center - Site 840-126
Ann Arbor, Michigan, United States
Michigan State University - Site 840-127
East Lansing, Michigan, United States
Kahana Oculoplastic and Orbital Surgery - Site 840-112
Livonia, Michigan, United States
Mayo Clinic - Site 840-102
Rochester, Minnesota, United States
University of Missouri-Kansas City School of Medicine - Site 840-130
Kansas City, Missouri, United States
Ophthalmic Plastic, Reconstructive, Orbital & Cosmetic Surgery - Site 840-123
Las Vegas, Nevada, United States
Hackensack University Medical Center - Site 840-105
Hackensack, New Jersey, United States
Columbia University - Site 840-125
New York, New York, United States
University of North Carolina at Chapel Hill - Site 840-104
Chapel Hill, North Carolina, United States
Bergstrom Eye Research - Site 840-134
Fargo, North Dakota, United States
Eye Physicians, LLC - Site 840-118
Columbus, Ohio, United States
Headlands Research - TMA - Site 840-132
Myrtle Beach, South Carolina, United States
Academy of Diabetes, Thyroid, and Endocrine - Site 840-129
El Paso, Texas, United States
DCT Fort Worth Research Center - Site 840-133
Fort Worth, Texas, United States
Neuro-Eye Clinical Trials, Inc - Site 840-106
Houston, Texas, United States
Houston Methodist Hospital - Site 840-124
Houston, Texas, United States
Sun Research Institute - Site 840-120
San Antonio, Texas, United States
University of West Virginia - Site 840-113
Morgantown, West Virginia, United States
Ottawa Hospital Research Institute - Site 124-202
Ottawa, Ontario, Canada
McGill University Health Center - Site 124-201
Montreal, Quebec, Canada
CHU Angers - Site 250-252
Angers, , France
CHU de Nantes - Hopital Nord Laennec - Site 250-251
Nantes, , France
Azienda Ospedaliera Universitaria Federico II - Site 390-382
Napoli, , Italy
Azienda Ospedaliero Universitaria Pisana - Site 380-381
Pisa, , Italy
Al-Essra Hospital - Site 400-401
Amman, , Jordan
Riga East Clinical University Hospital, Clinic Bikernieki - Site 428-901
Riga, , Latvia
Ziemelkurzemes Regional Hospital - Site 428-902
Ventspils, , Latvia
Southern Eye Specialists Ltd - Site 554-501
Christchurch, , New Zealand
University of Puerto Rico, Medical Sciences Campus - Site 630-602
San Juan, , Puerto Rico
Seoul National University Hospital - Site 410-002
Seoul, , South Korea
Hospital La Arruzafa - Site 724-802
Córdoba, , Spain
Hospital Universitario Ramon y Cajal - Site 724-803
Madrid, , Spain
Hospital Universitario Virgen Macarena - Site 724-801
Seville, , Spain
Countries
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Central Contacts
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Other Identifiers
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U1111-1308-4718
Identifier Type: OTHER
Identifier Source: secondary_id
2024-514801-69-00
Identifier Type: OTHER
Identifier Source: secondary_id
TOUR006-T01
Identifier Type: -
Identifier Source: org_study_id
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