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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 Genders: 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 ≤1 g 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

Arm	Description	Assigned 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 - 0121
Tucson, Arizona 85712

Headlands Research - AMCR Site - 0131
Escondido, California 92025

Cockerham Eye Consultants Site - 0114
San Diego, California 92108

The Pacific Center for Oculofacial and Aesthetic Plastic Surgery Site - 0122
San Francisco, California 94115

UC Hospital Sue Anschulz-Rodgers Eye Center Site - 0101
Aurora, Colorado 80045

Bascom Palmer Eye Institute Site - 0115
Miami, Florida 33136

Cordova Research Institute - Site 0103
Miami, Florida 33174

University of Louisville Health Eye Institute Site - 0108
Louisville, Kentucky 40202

Ophthalmic Consultants of Boston Site - 0128
Boston, Massachusetts 02114

Kahana Oculoplastic and Orbital Surgery Site - 0112
Livonia, Michigan 48152

Hackensack University Medical Center Site - 0105
Hackensack, New Jersey 07601

University of North Carolina at Chapel Hill Site - 0104
Chapel Hill, North Carolina 27517

Bergstrom Eye Research Site - 0134
Fargo, North Dakota 58103

Eye Physicians, LLC Site - 0118
Columbus, Ohio 43215

Headlands Research - TMA Site - 0132
Myrtle Beach, South Carolina 29572

Academy of Diabetes, Thyroid, and Endocrine Site - 0129
El Paso, Texas 79935

DCT Fort Worth Research Center Site - 0133
Fort Worth, Texas 76132

Neuro-Eye Clinical Trials, Inc Site - 0106
Houston, Texas 77004

Sun Research Institute Site - 0120
San Antonio, Texas 78215

University of West Virginia Site - 0113
Morgantown, West Virginia 26506

More Details

NCT ID: NCT06088979
Status: Recruiting
Sponsor: Tourmaline Bio, Inc.

Study Contact

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