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

NCT06088979 | Active Not Recruiting Phase 2 FDA Drug

• 3 other identifiers: TOUR006-T01U1111-1308-47182024-514801-69-00
• Study Type: interventional
• Target: 79
• Locations: 11 countries
• Sites: 36

Brief 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.

Conditions

Thyroid Eye Disease

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Percentage of participants achieving a proptosis response defined as a ≥2 mm reduction in proptosis from baseline in the study eye without deterioration [≥2 mm increase] of proptosis in the fellow eye and without need for rescue therapy/intervention).

  20 weeks

Secondary Outcomes (7)

• Percentage of participants achieving a proptosis response with 20mg TOUR006 administered SC every 8 weeks or 50mg TOUR006 administered SC every 8 weeks.

  72 weeks

• Percentage of participants attaining a complete or near complete response on the 7-point Clinical Activity Score (CAS).

  72 weeks

• Percentage of participants attaining ≥1 grade decrease in diplopia.

  72 weeks

• Incidence of Treatment Emergent Adverse Events by severity and Serious Adverse Events through Week 72.

  72 weeks

• Mean change from baseline in serum trough concentration of TOUR006.

  72 weeks

Study Arms (3)

TOUR006 - 20 MG

EXPERIMENTAL

In part A of the study, participants will receive a total of three 20 mg subcutaneous injections: 1 injection every 8 weeks (Day 1, Week 8, Week 16) followed by treatment in part B of the study based on proptosis response and rescue therapy use.

Drug: TOUR006 - 20 MG

TOUR006 - 50 MG

EXPERIMENTAL

In part A of the study, participants will receive a total of three 50 mg subcutaneous injections: 1 injection every 8 weeks (Day 1, Week 8, Week 16) followed by treatment in part B of the study based on proptosis response and rescue therapy use.

Drug: TOUR006 - 50 MG

Placebo

PLACEBO COMPARATOR

In part A of the study, participants will receive a total of three Placebo subcutaneous injections: 1 injection every 8 weeks (Day 1, Week 8, Week 16) followed by treatment in part B of the study based on proptosis response and rescue therapy use.

Other: Placebo

Interventions

TOUR006 - 20 MG DRUG

TOUR006 20 MG

TOUR006 - 20 MG

Placebo OTHER

Placebo

Placebo

TOUR006 - 50 MG DRUG

TOUR006 - 50 MG

TOUR006 - 50 MG

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

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

Sponsors & Collaborators

• Tourmaline Bio, Inc.: lead

Study Sites (36)

Catalina Eye Care - Site 840-121

Tucson, Arizona, 85712, United States

Location

Foothill Eye Institute - Site 840-116

Pasadena, California, 91107, United States

Location

University of California Davis Eye Center - Site 840-119

Sacramento, California, 95817, United States

Location

The Pacific Center for Oculofacial and Aesthetic Plastic Surgery - Site 840-122

San Francisco, California, 94115, United States

Location

UC Hospital Sue Anschulz-Rodgers Eye Center - Site 840-101

Aurora, Colorado, 80045, United States

Location

Bascom Palmer Eye Institute - Site 840-115

Miami, Florida, 33136, United States

Location

Ophthalmic Consultants of Boston - Site 840-128

Boston, Massachusetts, 02114, United States

Location

Kahana Oculoplastic and Orbital Surgery - Site 840-112

Livonia, Michigan, 48152, United States

Location

Ophthalmic Plastic, Reconstructive, Orbital & Cosmetic Surgery - Site 840-123

Las Vegas, Nevada, 89144, United States

Location

Hackensack University Medical Center - Site 840-105

Hackensack, New Jersey, 07601, United States

Location

Columbia University - Site 840-125

New York, New York, 10032, United States

Location

Academy of Diabetes, Thyroid, and Endocrine - Site 840-129

El Paso, Texas, 79935, United States

Location

DCT Fort Worth Research Center - Site 840-133

Fort Worth, Texas, 76132, United States

Location

Sun Research Institute - Site 840-120

San Antonio, Texas, 78215, United States

Location

University of West Virginia - Site 840-113

Morgantown, West Virginia, 26506, United States

Location

Freire Pesquisa Clinica - Site 076-773

Belo Horizonte, 13334-290, Brazil

Location

UFG - Hospital de Clinicas da Universidade Federal de Goias - Site 076-762

Goiânia, 74605-050, Brazil

Location

Santa Casa de Misericordia de Porto Alegre - Site 076-767

Porto Alegre, 90020-090, Brazil

Location

Universidade Federal do Rio Grande do Sul (UFRGS) - Site 076-775

Porto Alegre, 90410-000, Brazil

Location

NPCRS - Nucleo de Pesquisa Clinica do Rio Grande do Sul - Site 076-764

Porto Alegre, 90430-001, Brazil

Location

Centro Brasileiro de Pesquisa Clínica - Rio de Janeiro Ltd - Site 076-765

Rio de Janeiro, 22410-000, Brazil

Location

Irmandade da Santa Casa de Misericordia de Sao Paulo - Site 076-771

São Paulo, 01221-020, Brazil

Location

IPEPO - Instituto Paulista de Estudos e Pesquisas em Oftalmologia - Site 076-761

São Paulo, 04038-032, Brazil

Location

CHU Angers - Site 250-252

Angers, 49933, France

Location

CHU de Nantes - Hopital Nord Laennec - Site 250-251

Nantes, 44800, France

Location

Azienda Ospedaliera Universitaria Federico II - Site 390-382

Naples, 80131, Italy

Location

Azienda Ospedaliero Universitaria Pisana - Site 380-381

Pisa, 56124, Italy

Location

Al-Essra Hospital - Site 400-401

Amman, Jordan

Location

Riga East Clinical University Hospital, Clinic Bikernieki - Site 428-901

Riga, LV1006, Latvia, Latvia

Location

Ziemelkurzemes Regional Hospital - Site 428-902

Ventspils, Latvia

Location

Southern Eye Specialists Ltd - Site 554-501

Christchurch, 8013, New Zealand

Location

University of Puerto Rico, Medical Sciences Campus - Site 630-602

San Juan, 00921, Puerto Rico

Location

Univerzitna nemocnica Bratislava - Nemocnica sv. Cyrila a Metoda - Site 703-211

Bratislava, 851 07, Slovakia

Location

Seoul National University Hospital - Site 410-002

Seoul, 03080, South Korea

Location

Hospital Universitario Ramon y Cajal - Site 724-803

Madrid, 28034, Spain

Location

Hospital Universitario Virgen Macarena - Site 724-801

Seville, 41009, Spain

Location

MeSH Terms

Conditions

Graves Ophthalmopathy; Graves Disease; Exophthalmos; Eye Diseases; Thyroid Diseases; Hyperthyroidism

Condition Hierarchy (Ancestors)

Eye Diseases, Hereditary; Orbital Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Goiter; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Clinical Trials

  Tourmaline Bio

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 3, 2023
• First Posted: October 18, 2023
• Study Start: February 19, 2024
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2027
• Last Updated: April 23, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

JO (1); FR (2); PR (1); LA (2); ES (2); KR (1); US (15); SL (1); BR (8); NZ (1); IT (2)