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

Phase 2

Recruiting

Brief 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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
TOUR006 - 20 MG	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.
Placebo	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.
TOUR006 - 50 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.

Primary Outcome Measures

Name	Time	Method
Percentage of participants achieving a proptosis response defined as a ≥2 mm reduction in proptosis from baseline in the study eye without deterioration [≥2 mm increase] of proptosis in the fellow eye and without need for rescue therapy/intervention).	20 weeks

Secondary Outcome Measures

Name	Time	Method
Percentage of participants achieving a proptosis response with 20mg TOUR006 administered SC every 8 weeks or 50mg TOUR006 administered SC every 8 weeks.	72 weeks
Percentage of participants attaining ≥1 grade decrease in diplopia.	72 weeks
Mean change from baseline in serum trough concentration of TOUR006.	72 weeks
Percentage of participants with anti-drug antibodies.	72 weeks
Mean change from baseline in serum TSI.	72 weeks
Percentage of participants attaining a complete or near complete response on the 7-point Clinical Activity Score (CAS).	72 weeks
Incidence of Treatment Emergent Adverse Events by severity and Serious Adverse Events through Week 72.	72 weeks

Locations (17): Mayo Clinic Site - 0102
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Rochester, Minnesota, United States
Hackensack University Medical Center Site - 0105
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Hackensack, New Jersey, United States
Catalina Eye Care Site - 0121
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Tucson, Arizona, United States
Foothill Eye Institute Site - 0116
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Pasadena, California, United States
Cockerham Eye Consultants Site - 0114
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San Diego, California, United States
UC Hospital Sue Anschulz-Rodgers Eye Center Site - 0101
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Aurora, Colorado, United States
Bascom Palmer Eye Institute Site - 0115
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Miami, Florida, United States
Cordova Research Institute - Site 0103
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Miami, Florida, United States
University of Louisville Health Eye Institute Site - 0108
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Louisville, Kentucky, United States
Kahana Oculoplastic and Orbital Surgery Site - 0112
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Livonia, Michigan, United States
University of North Carolina at Chapel Hill Site - 0104
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Chapel Hill, North Carolina, United States
Eye Physicians, LLC Site - 0118
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Columbus, Ohio, United States
Neuro-Eye Clinical Trials, Inc Site - 0106
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Houston, Texas, United States
Sun Research Institute Site - 0120
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San Antonio, Texas, United States
University of West Virginia Site - 0113
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Morgantown, West Virginia, United States
Ottawa Hospital Research Institute Site - 0202
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Ottawa, Ontario, Canada
Al-Essra Hospital Site - 0401
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Amman, Jordan