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RECRUITINGPhase 2INTERVENTIONAL

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

A Multicenter Phase 2b Randomized, Double-Masked, Placebo-Controlled Dose-Ranging Study of TOUR006 in Participants With Thyroid Eye Disease

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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. Who Should NOT Join This Trial: - 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

DRUG

TOUR006 - 20 MG

TOUR006 20 MG

OTHER

Placebo

Placebo

DRUG

TOUR006 - 50 MG

TOUR006 - 50 MG

Locations (20)

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
Aran Eye Associate
Sweetwater, 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