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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
79
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).
Time frame: 20 weeks
Percentage of participants achieving a proptosis response with 20mg TOUR006 administered SC every 8 weeks or 50mg TOUR006 administered SC every 8 weeks.
Time frame: 72 weeks
Percentage of participants attaining a complete or near complete response on the 7-point Clinical Activity Score (CAS).
Time frame: 72 weeks
Percentage of participants attaining ≥1 grade decrease in diplopia.
Time frame: 72 weeks
Incidence of Treatment Emergent Adverse Events by severity and Serious Adverse Events through Week 72.
Time frame: 72 weeks
Mean change from baseline in serum trough concentration of TOUR006.
Time frame: 72 weeks
Mean change from baseline in serum TSI.
Time frame: 72 weeks
Percentage of participants with anti-drug antibodies.
Time frame: 72 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Catalina Eye Care - Site 840-121
Tucson, Arizona, 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
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
Ophthalmic Consultants of Boston - Site 840-128
Boston, Massachusetts, United States
Kahana Oculoplastic and Orbital Surgery - Site 840-112
Livonia, Michigan, 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
...and 26 more locations