RECRUITING

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

Conditions

Thyroid Eye Disease TED Graves' Disease Exophthalmos Eye Diseases Thyroid Diseases Graves' Ophthalmopathy Hyperthyroidism

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2024-02-19

Study Completion:2026-02

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06088979

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.

Ages Eligible for Study:18 Years to 80 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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

Inclusion Criteria

Exclusion 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

Contacts and Locations

Study Contact

Tourmaline Bio

CONTACT

347-773-2627

clinicaltrialinquiries@tourmalinebio.com

Principal Investigator

Clinical Trials

STUDY_DIRECTOR

Tourmaline Bio

Study Locations (Sites)

Catalina Eye Care Site - 0121

Tucson, Arizona, 85712

United States

Foothill Eye Institute Site - 0116

Pasadena, California, 91107

United States

Cockerham Eye Consultants Site - 0114

San Diego, California, 92108

United States

UC Hospital Sue Anschulz-Rodgers Eye Center Site - 0101

Aurora, Colorado, 80045

United States

Bascom Palmer Eye Institute Site - 0115

Miami, Florida, 33136

United States

Cordova Research Institute - Site 0103

Miami, Florida, 33174

United States

University of Louisville Health Eye Institute Site - 0108

Louisville, Kentucky, 40202

United States

Kahana Oculoplastic and Orbital Surgery Site - 0112

Livonia, Michigan, 48152

United States

Mayo Clinic - 0102

Rochester, Minnesota, 55905

United States

University of North Carolina at Chapel Hill Site - 0104

Chapel Hill, North Carolina, 27517

United States

Eye Physicians, LLC Site - 0118

Columbus, Ohio, 43215

United States

Neuro-Eye Clinical Trials, Inc Site - 0106

Houston, Texas, 77004

United States

Sun Research Institute Site - 0120

San Antonio, Texas, 78215

United States

University of West Virginia Site - 0113

Morgantown, West Virginia, 26506

United States

Collaborators and Investigators

Sponsor: Tourmaline Bio, Inc.

Clinical Trials, STUDY_DIRECTOR, Tourmaline Bio

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-02-19

Study Completion Date2026-02

Study Record Updates

Study Start Date2024-02-19

Study Completion Date2026-02

Terms related to this study

Keywords Provided by Researchers

TED
Graves' Disease
Thyroid Eye Disease
Exophthalmos
Eye Diseases
Thyroid Diseases
Graves' Ophthalmopathy
Hyperthyroidism

Additional Relevant MeSH Terms

Thyroid Eye Disease