Status:
RECRUITING
A Study to Investigate Efficacy and Safety of TOUR006 in Participants 18 to 80 Years of Age With Thyroid Eye Disease
Lead Sponsor:
Tourmaline Bio, Inc.
Conditions:
Thyroid Eye Disease
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
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 inflamm...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 19 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2027
Estimated Enrollment :
81 Patients enrolled
Trial Details
Trial ID
NCT06088979
Start Date
February 19 2024
End Date
September 1 2027
Last Update
January 9 2026
Active Locations (44)
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1
Catalina Eye Care - Site 840-121
Tucson, Arizona, United States, 85712
2
Headlands Research - AMCR - Site 840-131
Escondido, California, United States, 92025
3
Foothill Eye Institute - Site 840-116
Pasadena, California, United States, 91107
4
University of California Davis Eye Center - Site 840-119
Sacramento, California, United States, 95817