Clinical trial NCT06088979: A Study to Investigate Efficacy and Safety of TOUR006 in Participants 18 to 80 Years of Age With Thyroid Eye Disease
Official title: A Multicenter Phase 2b Randomized, Double-Masked, Placebo-Controlled Dose-Ranging Study of TOUR006 in Participants With Thyroid Eye Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Thyroid Eye Disease
Keywords: TED
Graves' Disease
Thyroid Eye Disease
Exophthalmos
Eye Diseases
Thyroid Diseases
Graves' Ophthalmopathy
Hyperthyroidism
Lead sponsor: Tourmaline Bio, Inc.
Sponsor class: INDUSTRY
First posted: 2023-10-18
Enrollment: 81
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: 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).
timeFrame: 20 weeks
Secondary outcomes:
measure: Percentage of participants achieving a proptosis response with 20mg TOUR006 administered SC every 8 weeks or 50mg TOUR006 administered SC every 8 weeks.
timeFrame: 72 weeks
measure: Percentage of participants attaining a complete or near complete response on the 7-point Clinical Activity Score (CAS).
timeFrame: 72 weeks
measure: Percentage of participants attaining ≥1 grade decrease in diplopia.
timeFrame: 72 weeks
measure: Incidence of Treatment Emergent Adverse Events by severity and Serious Adverse Events through Week 72.
timeFrame: 72 weeks
measure: Mean change from baseline in serum trough concentration of TOUR006.
timeFrame: 72 weeks
measure: Mean change from baseline in serum TSI.
timeFrame: 72 weeks
measure: Percentage of participants with anti-drug antibodies.
timeFrame: 72 weeks
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Catalina Eye Care Site - 0121
state: Arizona
city: Escondido
country: United States
facility: Headlands Research - AMCR Site - 0131
state: California
city: Pasadena
country: United States
facility: Foothill Eye Institute Site - 0116
state: California
city: San Diego
country: United States
facility: Cockerham Eye Consultants Site - 0114
state: California
city: San Francisco
country: United States
facility: The Pacific Center for Oculofacial and Aesthetic Plastic Surgery Site - 0122
state: California
city: Aurora
country: United States
facility: UC Hospital Sue Anschulz-Rodgers Eye Center Site - 0101
state: Colorado
city: Miami
country: United States
facility: Bascom Palmer Eye Institute Site - 0115
state: Florida
city: Miami
country: United States
facility: Cordova Research Institute - Site 0103
state: Florida
city: Louisville
country: United States
facility: University of Louisville Health Eye Institute Site - 0108
state: Kentucky
city: Boston
country: United States
facility: Ophthalmic Consultants of Boston Site - 0128
state: Massachusetts
city: Livonia
country: United States
facility: Kahana Oculoplastic and Orbital Surgery Site - 0112
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic Site - 0102
state: Minnesota
city: Kansas City
country: United States
facility: University of Missouri-Kansas City School of Medicine
state: Missouri
city: Hackensack
country: United States
facility: Hackensack University Medical Center Site - 0105
state: New Jersey
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill Site - 0104
state: North Carolina
city: Fargo
country: United States
facility: Bergstrom Eye Research Site - 0134
state: North Dakota
city: Columbus
country: United States
facility: Eye Physicians, LLC Site - 0118
state: Ohio
city: Myrtle Beach
country: United States
facility: Headlands Research - TMA Site - 0132
state: South Carolina
city: El Paso
country: United States
facility: Academy of Diabetes, Thyroid, and Endocrine Site - 0129
state: Texas
city: Fort Worth
country: United States
facility: DCT Fort Worth Research Center Site - 0133
state: Texas
city: Houston
country: United States
facility: Neuro-Eye Clinical Trials, Inc Site - 0106
state: Texas
city: San Antonio
country: United States
facility: Sun Research Institute Site - 0120
state: Texas
city: Morgantown
country: United States
facility: University of West Virginia Site - 0113
state: West Virginia
city: Ottawa
country: Canada
facility: Ottawa Hospital Research Institute Site - 0202
state: Ontario
city: Montréal
country: Canada
facility: McGill University Health Center Site - 0201
state: Quebec
city: Amman
country: Jordan
facility: Al-Essra Hospital Site - 0401
city: Christchurch
country: New Zealand
facility: Southern Eye Specialists Ltd Site - 501
city: Madrid
country: Spain
facility: Hospital Universitario Ramon y Cajal Site - 803
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Macarena Site - 801
Study officials:
affiliation: Tourmaline Bio
name: Clinical Trials
role: STUDY_DIRECTOR
References: