A Multicenter Phase 2b Randomized, Double-Masked, Placebo-Controlled Dose-Ranging Study of TOUR006 in Participants With Thyroid Eye Disease
Status: Recruiting
Location: See all (44) locations...
Intervention Type: Drug, Other
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
Phase 2b trial of TOUR006 in Thyroid Eye Disease (TED) to evaluate 20mg and 50mg doses against placebo given by a subcutaneous injection every eight weeks to TED patients who are in the active inflammatory phase of disease.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:
• 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.
Locations
United States
Arizona
Catalina Eye Care - Site 840-121
RECRUITING
Tucson
California
Headlands Research - AMCR - Site 840-131
RECRUITING
Escondido
Foothill Eye Institute - Site 840-116
TERMINATED
Pasadena
University of California Davis Eye Center - Site 840-119
RECRUITING
Sacramento
Cockerham Eye Consultants - Site 840-114
RECRUITING
San Diego
The Pacific Center for Oculofacial and Aesthetic Plastic Surgery - Site 840-122
RECRUITING
San Francisco
Colorado
UC Hospital Sue Anschulz-Rodgers Eye Center - Site 840-101
RECRUITING
Aurora
Florida
Bascom Palmer Eye Institute - Site 840-115
RECRUITING
Miami
Cordova Research Institute - Site 840-103
RECRUITING
Miami
Kentucky
University of Louisville Health Eye Institute - Site 840-108
RECRUITING
Louisville
Massachusetts
Ophthalmic Consultants of Boston - Site 840-128
RECRUITING
Boston
Michigan
W.K. Kellogg Eye Center - Site 840-126
RECRUITING
Ann Arbor
Michigan State University - Site 840-127
RECRUITING
East Lansing
Kahana Oculoplastic and Orbital Surgery - Site 840-112
RECRUITING
Livonia
Minnesota
Mayo Clinic - Site 840-102
WITHDRAWN
Rochester
Missouri
University of Missouri-Kansas City School of Medicine - Site 840-130
RECRUITING
Kansas City
North Carolina
University of North Carolina at Chapel Hill - Site 840-104
RECRUITING
Chapel Hill
North Dakota
Bergstrom Eye Research - Site 840-134
RECRUITING
Fargo
New Jersey
Hackensack University Medical Center - Site 840-105
RECRUITING
Hackensack
Nevada
Ophthalmic Plastic, Reconstructive, Orbital & Cosmetic Surgery - Site 840-123
RECRUITING
Las Vegas
New York
Columbia University - Site 840-125
RECRUITING
New York
Ohio
Eye Physicians, LLC - Site 840-118
RECRUITING
Columbus
South Carolina
Headlands Research - TMA - Site 840-132
RECRUITING
Myrtle Beach
Texas
Academy of Diabetes, Thyroid, and Endocrine - Site 840-129
RECRUITING
El Paso
DCT Fort Worth Research Center - Site 840-133
RECRUITING
Fort Worth
Houston Methodist Hospital - Site 840-124
RECRUITING
Houston
Neuro-Eye Clinical Trials, Inc - Site 840-106
RECRUITING
Houston
Sun Research Institute - Site 840-120
RECRUITING
San Antonio
West Virginia
University of West Virginia - Site 840-113
RECRUITING
Morgantown
Other Locations
Canada
McGill University Health Center - Site 124-201
RECRUITING
Montreal
Ottawa Hospital Research Institute - Site 124-202
NOT_YET_RECRUITING
Ottawa
France
CHU Angers - Site 250-252
RECRUITING
Angers
CHU de Nantes - Hopital Nord Laennec - Site 250-251
RECRUITING
Nantes
Italy
Azienda Ospedaliera Universitaria Federico II - Site 390-382
RECRUITING
Napoli
Azienda Ospedaliero Universitaria Pisana - Site 380-381
RECRUITING
Pisa
Jordan
Al-Essra Hospital - Site 400-401
RECRUITING
Amman
Latvia
Riga East Clinical University Hospital, Clinic Bikernieki - Site 428-901
RECRUITING
Riga
Ziemelkurzemes Regional Hospital - Site 428-902
RECRUITING
Ventspils
New Zealand
Southern Eye Specialists Ltd - Site 554-501
RECRUITING
Christchurch
Puerto Rico
University of Puerto Rico, Medical Sciences Campus - Site 630-602
RECRUITING
San Juan
Republic of Korea
Seoul National University Hospital - Site 410-002
RECRUITING
Seoul
Spain
Hospital La Arruzafa - Site 724-802
RECRUITING
Córdoba
Hospital Universitario Ramon y Cajal - Site 724-803
RECRUITING
Madrid
Hospital Universitario Virgen Macarena - Site 724-801
RECRUITING
Seville
Contact Information
Primary
Tourmaline Bio
clinicaltrialinquiries@tourmalinebio.com
347-773-2627
Time Frame
Start Date: 2024-02-19
Estimated Completion Date: 2026-11
Participants
Target number of participants: 81
Treatments
Experimental: 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.
Experimental: 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.
Placebo_comparator: 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.
Related Therapeutic Areas
Sponsors
Leads: Tourmaline Bio, Inc.