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

Running, not enrolling · Phase 2 · Has a placebo group

Conditions studied: Thyroid Eye Disease

In brief

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.

Key facts

Study ID

NCT06088979

Run by

Tourmaline Bio, Inc., a Novartis Company

People needed

79

Starts

2024-02-19

Expected to finish

2027-09-01

Last updated by the study team

2026-04-23

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• 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
• Columbia University - Site 840-125 — New York, New York, United States
• Academy of Diabetes, Thyroid, and Endocrine - Site 840-129 — El Paso, Texas, United States
• DCT Fort Worth Research Center - Site 840-133 — Fort Worth, Texas, United States
• Sun Research Institute - Site 840-120 — San Antonio, Texas, United States
• University of West Virginia - Site 840-113 — Morgantown, West Virginia, United States
• Freire Pesquisa Clinica - Site 076-773 — Belo Horizonte, Brazil
• UFG - Hospital de Clinicas da Universidade Federal de Goias - Site 076-762 — Goiânia, Brazil
• Santa Casa de Misericordia de Porto Alegre - Site 076-767 — Porto Alegre, Brazil
• Universidade Federal do Rio Grande do Sul (UFRGS) - Site 076-775 — Porto Alegre, Brazil
• NPCRS - Nucleo de Pesquisa Clinica do Rio Grande do Sul - Site 076-764 — Porto Alegre, Brazil
• Centro Brasileiro de Pesquisa Clínica - Rio de Janeiro Ltd - Site 076-765 — Rio de Janeiro, Brazil
• Irmandade da Santa Casa de Misericordia de Sao Paulo - Site 076-771 — São Paulo, Brazil
• IPEPO - Instituto Paulista de Estudos e Pesquisas em Oftalmologia - Site 076-761 — São Paulo, Brazil
• CHU Angers - Site 250-252 — Angers, France
• CHU de Nantes - Hopital Nord Laennec - Site 250-251 — Nantes, France

Full record on ClinicalTrials.gov

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