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

Description

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.

Conditions

Thyroid Eye Disease

Talk to us

Study Overview

On this page

Study Details

Study overview

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.

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

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

Condition
Thyroid Eye Disease
Intervention / Treatment

-

Contacts and Locations

Tucson

Catalina Eye Care Site - 0121, Tucson, Arizona, United States, 85712

Pasadena

Foothill Eye Institute Site - 0116, Pasadena, California, United States, 91107

San Diego

Cockerham Eye Consultants Site - 0114, San Diego, California, United States, 92108

Aurora

UC Hospital Sue Anschulz-Rodgers Eye Center Site - 0101, Aurora, Colorado, United States, 80045

Miami

Bascom Palmer Eye Institute Site - 0115, Miami, Florida, United States, 33136

Miami

Cordova Research Institute - Site 0103, Miami, Florida, United States, 33174

Louisville

University of Louisville Health Eye Institute Site - 0108, Louisville, Kentucky, United States, 40202

Livonia

Kahana Oculoplastic and Orbital Surgery Site - 0112, Livonia, Michigan, United States, 48152

Rochester

Mayo Clinic - 0102, Rochester, Minnesota, United States, 55905

Chapel Hill

University of North Carolina at Chapel Hill Site - 0104, Chapel Hill, North Carolina, United States, 27517

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to 80 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Tourmaline Bio, Inc.,

Clinical Trials, STUDY_DIRECTOR, Tourmaline Bio

Study Record Dates

2026-02