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Active (not recruiting) Phase 2 NCT06088979

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

Phase 2 – studying effectiveness and dosage
Conditions: Thyroid Eye Disease

Sponsor: Tourmaline Bio, Inc.

trial.available_in: БГ
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.
Who can participate
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.
Interventions
TOUR006 - 20 MG
DRUG
Placebo
OTHER
TOUR006 - 50 MG
DRUG
Locations 36
Brazil (8)
Freire Pesquisa Clinica - Site 076-773
Belo Horizonte
UFG - Hospital de Clinicas da Universidade Federal de Goias - Site 076-762
Goiânia
Santa Casa de Misericordia de Porto Alegre - Site 076-767
Porto Alegre
Universidade Federal do Rio Grande do Sul (UFRGS) - Site 076-775
Porto Alegre
NPCRS - Nucleo de Pesquisa Clinica do Rio Grande do Sul - Site 076-764
Porto Alegre
Centro Brasileiro de Pesquisa Clínica - Rio de Janeiro Ltd - Site 076-765
Rio de Janeiro
Irmandade da Santa Casa de Misericordia de Sao Paulo - Site 076-771
São Paulo
IPEPO - Instituto Paulista de Estudos e Pesquisas em Oftalmologia - Site 076-761
São Paulo
France (2)
CHU Angers - Site 250-252
Angers
CHU de Nantes - Hopital Nord Laennec - Site 250-251
Nantes
Italy (2)
Azienda Ospedaliera Universitaria Federico II - Site 390-382
Naples
Azienda Ospedaliero Universitaria Pisana - Site 380-381
Pisa
Jordan (1)
Al-Essra Hospital - Site 400-401
Amman
Latvia (2)
Riga East Clinical University Hospital, Clinic Bikernieki - Site 428-901
Riga
Ziemelkurzemes Regional Hospital - Site 428-902
Ventspils
New Zealand (1)
Southern Eye Specialists Ltd - Site 554-501
Christchurch
Puerto Rico (1)
University of Puerto Rico, Medical Sciences Campus - Site 630-602
San Juan
Slovakia (1)
Univerzitna nemocnica Bratislava - Nemocnica sv. Cyrila a Metoda - Site 703-211
Bratislava
South Korea (1)
Seoul National University Hospital - Site 410-002
Seoul
Spain (2)
Hospital Universitario Ramon y Cajal - Site 724-803
Madrid
Hospital Universitario Virgen Macarena - Site 724-801
Seville
United States (15)
UC Hospital Sue Anschulz-Rodgers Eye Center - Site 840-101
Aurora , Colorado
Ophthalmic Consultants of Boston - Site 840-128
Boston , Massachusetts
Academy of Diabetes, Thyroid, and Endocrine - Site 840-129
El Paso , Texas
DCT Fort Worth Research Center - Site 840-133
Fort Worth , Texas
Hackensack University Medical Center - Site 840-105
Hackensack , New Jersey
Ophthalmic Plastic, Reconstructive, Orbital & Cosmetic Surgery - Site 840-123
Las Vegas , Nevada
Kahana Oculoplastic and Orbital Surgery - Site 840-112
Livonia , Michigan
Bascom Palmer Eye Institute - Site 840-115
Miami , Florida
University of West Virginia - Site 840-113
Morgantown , West Virginia
Columbia University - Site 840-125
New York , New York
Foothill Eye Institute - Site 840-116
Pasadena , California
University of California Davis Eye Center - Site 840-119
Sacramento , California
Sun Research Institute - Site 840-120
San Antonio , Texas
The Pacific Center for Oculofacial and Aesthetic Plastic Surgery - Site 840-122
San Francisco , California
Catalina Eye Care - Site 840-121
Tucson , Arizona
Technical details
Status
Active (not recruiting)
Phase
Phase 2
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Maximum age
80 Years
Healthy volunteers
No
Start date
19.02.2024
Completion date
01.09.2027
Registry ID
NCT06088979
Source
clinicaltrials.gov
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