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Clinical Trials in the USA / NCT06088979
Active, not recruiting Phase 2

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

NCT06088979 · tracked via the Priya Life Science USA tracker
Sponsor
Tourmaline Bio, Inc., a Novartis Company
Phase
Phase 2
Started
2024-02-19
Last updated
2026-04-23

Condition(s) studied

Thyroid Eye Disease

Investigational drug(s) / intervention(s)

TOUR006 - 20 MGPlaceboTOUR006 - 50 MG

TOUR006 - 20 MG: TOUR006 20 MG

Placebo: Placebo

TOUR006 - 50 MG: TOUR006 - 50 MG

Study 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

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
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 ≤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.

Primary outcome measure(s)

Trial sites (36)

FacilityCityRegionStatus
Catalina Eye Care - Site 840-121 Tucson Arizona
Foothill Eye Institute - Site 840-116 Pasadena California
University of California Davis Eye Center - Site 840-119 Sacramento California
The Pacific Center for Oculofacial and Aesthetic Plastic Surgery - Site 840-122 San Francisco California
UC Hospital Sue Anschulz-Rodgers Eye Center - Site 840-101 Aurora Colorado
Bascom Palmer Eye Institute - Site 840-115 Miami Florida
Ophthalmic Consultants of Boston - Site 840-128 Boston Massachusetts
Kahana Oculoplastic and Orbital Surgery - Site 840-112 Livonia Michigan
Ophthalmic Plastic, Reconstructive, Orbital & Cosmetic Surgery - Site 840-123 Las Vegas Nevada
Hackensack University Medical Center - Site 840-105 Hackensack New Jersey
Columbia University - Site 840-125 New York New York
Academy of Diabetes, Thyroid, and Endocrine - Site 840-129 El Paso Texas
DCT Fort Worth Research Center - Site 840-133 Fort Worth Texas
Sun Research Institute - Site 840-120 San Antonio Texas
University of West Virginia - Site 840-113 Morgantown West Virginia
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
Azienda Ospedaliera Universitaria Federico II - Site 390-382 Naples Italy
Azienda Ospedaliero Universitaria Pisana - Site 380-381 Pisa Italy
Al-Essra Hospital - Site 400-401 Amman Jordan
Riga East Clinical University Hospital, Clinic Bikernieki - Site 428-901 Riga Latvia
Ziemelkurzemes Regional Hospital - Site 428-902 Ventspils Latvia
Southern Eye Specialists Ltd - Site 554-501 Christchurch New Zealand
University of Puerto Rico, Medical Sciences Campus - Site 630-602 San Juan Puerto Rico
Univerzitna nemocnica Bratislava - Nemocnica sv. Cyrila a Metoda - Site 703-211 Bratislava Slovakia
Seoul National University Hospital - Site 410-002 Seoul South Korea
Hospital Universitario Ramon y Cajal - Site 724-803 Madrid Spain
Hospital Universitario Virgen Macarena - Site 724-801 Seville Spain

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06088979 on ClinicalTrials.gov ↗ ← All trials in the USA