A Study to Investigate Efficacy and Safety of TOUR006 in Participants 18 to 80 Years of Age With Thyroid Eye Disease

Purpose

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.

Condition

  • Thyroid Eye Disease

Eligibility

Eligible Ages
Between 18 Years and 80 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
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.
  • Drug: TOUR006 - 20 MG
    TOUR006 20 MG
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.
  • Drug: TOUR006 - 50 MG
    TOUR006 - 50 MG
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.
  • Other: Placebo
    Placebo

Recruiting Locations

Catalina Eye Care - Site 840-121
Tucson 5318313, Arizona 5551752 85712

Headlands Research - AMCR - Site 840-131
Escondido 5346827, California 5332921 92025

University of California Davis Eye Center - Site 840-119
Sacramento 5389489, California 5332921 95817

The Pacific Center for Oculofacial and Aesthetic Plastic Surgery - Site 840-122
San Francisco 5391959, California 5332921 94115

Bascom Palmer Eye Institute - Site 840-115
Miami 4164138, Florida 4155751 33136

Cordova Research Institute - Site 840-103
Miami 4164138, Florida 4155751 33174

University of Louisville Health Eye Institute - Site 840-108
Louisville 4299276, Kentucky 6254925 40202

Ophthalmic Consultants of Boston - Site 840-128
Boston 4930956, Massachusetts 6254926 02114

W.K. Kellogg Eye Center - Site 840-126
Ann Arbor 4984247, Michigan 5001836 48105

Michigan State University - Site 840-127
East Lansing 4991640, Michigan 5001836 48824

Kahana Oculoplastic and Orbital Surgery - Site 840-112
Livonia 4999837, Michigan 5001836 48152

University of Missouri-Kansas City School of Medicine - Site 840-130
Kansas City 4393217, Missouri 4398678 64108

Ophthalmic Plastic, Reconstructive, Orbital & Cosmetic Surgery - Site 840-123
Las Vegas 5506956, Nevada 5509151 89144

Hackensack University Medical Center - Site 840-105
Hackensack 5098706, New Jersey 5101760 07601

Columbia University - Site 840-125
New York 5128581, New York 5128638 10032

University of North Carolina at Chapel Hill - Site 840-104
Chapel Hill 4460162, North Carolina 4482348 27517

Bergstrom Eye Research - Site 840-134
Fargo 5059163, North Dakota 5690763 58103

Headlands Research - TMA - Site 840-132
Myrtle Beach 4588718, South Carolina 4597040 29572

Academy of Diabetes, Thyroid, and Endocrine - Site 840-129
El Paso 5520993, Texas 4736286 79935

DCT Fort Worth Research Center - Site 840-133
Fort Worth 4691930, Texas 4736286 76132

Houston Methodist Hospital - Site 840-124
Houston 4699066, Texas 4736286 77030

Sun Research Institute - Site 840-120
San Antonio 4726206, Texas 4736286 78215

University of West Virginia - Site 840-113
Morgantown 4815352, West Virginia 4826850 26506

University of Puerto Rico, Medical Sciences Campus - Site 630-602
San Juan 4568127, Puerto Rico 00921

More Details

NCT ID
NCT06088979
Status
Recruiting
Sponsor
Tourmaline Bio, Inc.

Study Contact

Tourmaline Bio
347-773-2627
clinicaltrialinquiries@tourmalinebio.com

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ResearchMatch is funded in part by the National Institutes of Health (NIH) Clinical and Translational Science Award (CTSA) program, led by the NIH’s National Center for Advancing Translational Sciences (NCATS), grants UL1TR000445 and 1U54RR032646-01, and grant U24TR001579 from NCATS and the National Library of Medicine. The content of this website is solely the responsibility of ResearchMatch and Vanderbilt University and does not necessarily represent the official views of the NIH, NCATS, or NLM.

Vanderbilt University Medical Center