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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Thyroid Eye Disease
• Intervention / Treatment: Other: Placebo; Drug: TOUR006 - 20 MG; Drug: TOUR006 - 50 MG

• Study Type: Interventional
• Enrollment (Actual): 79
• Phase: Phase 2

Contacts and Locations

Study Locations

• Brazil
  • Belo Horizonte, Brazil, 13334-290
    • Freire Pesquisa Clinica - Site 076-773
  • Goiânia, Brazil, 74605-050
    • UFG - Hospital de Clinicas da Universidade Federal de Goias - Site 076-762
  • Porto Alegre, Brazil, 90020-090
    • Santa Casa de Misericordia de Porto Alegre - Site 076-767
  • Porto Alegre, Brazil, 90410-000
    • Universidade Federal do Rio Grande do Sul (UFRGS) - Site 076-775
  • Porto Alegre, Brazil, 90430-001
    • NPCRS - Nucleo de Pesquisa Clinica do Rio Grande do Sul - Site 076-764
  • Rio de Janeiro, Brazil, 22410-000
    • Centro Brasileiro de Pesquisa Clínica - Rio de Janeiro Ltd - Site 076-765
  • São Paulo, Brazil, 01221-020
    • Irmandade da Santa Casa de Misericordia de Sao Paulo - Site 076-771
  • São Paulo, Brazil, 04038-032
    • IPEPO - Instituto Paulista de Estudos e Pesquisas em Oftalmologia - Site 076-761
• France
  • Angers, France, 49933
    • CHU Angers - Site 250-252
  • Nantes, France, 44800
    • CHU de Nantes - Hopital Nord Laennec - Site 250-251
• Italy
  • Naples, Italy, 80131
    • Azienda Ospedaliera Universitaria Federico II - Site 390-382
  • Pisa, Italy, 56124
    • Azienda Ospedaliero Universitaria Pisana - Site 380-381
• Jordan
  • Amman, Jordan
    • Al-Essra Hospital - Site 400-401
• Latvia
  • Riga, Latvia, LV1006, Latvia
    • Riga East Clinical University Hospital, Clinic Bikernieki - Site 428-901
  • Ventspils, Latvia
    • Ziemelkurzemes Regional Hospital - Site 428-902
• New Zealand
  • Christchurch, New Zealand, 8013
    • Southern Eye Specialists Ltd - Site 554-501
• Puerto Rico
  • San Juan, Puerto Rico, 00921
    • University of Puerto Rico, Medical Sciences Campus - Site 630-602
• Slovakia
  • Bratislava, Slovakia, 851 07
    • Univerzitna nemocnica Bratislava - Nemocnica sv. Cyrila a Metoda - Site 703-211
• South Korea
  • Seoul, South Korea, 03080
    • Seoul National University Hospital - Site 410-002
• Spain
  • Madrid, Spain, 28034
    • Hospital Universitario Ramon y Cajal - Site 724-803
  • Seville, Spain, 41009
    • Hospital Universitario Virgen Macarena - Site 724-801
• United States
  • Arizona
    • Tucson, Arizona, United States, 85712
      • Catalina Eye Care - Site 840-121
  • California
    • Pasadena, California, United States, 91107
      • Foothill Eye Institute - Site 840-116
    • Sacramento, California, United States, 95817
      • University of California Davis Eye Center - Site 840-119
    • San Francisco, California, United States, 94115
      • The Pacific Center for Oculofacial and Aesthetic Plastic Surgery - Site 840-122
  • Colorado
    • Aurora, Colorado, United States, 80045
      • UC Hospital Sue Anschulz-Rodgers Eye Center - Site 840-101
  • Florida
    • Miami, Florida, United States, 33136
      • Bascom Palmer Eye Institute - Site 840-115
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Ophthalmic Consultants of Boston - Site 840-128
  • Michigan
    • Livonia, Michigan, United States, 48152
      • Kahana Oculoplastic and Orbital Surgery - Site 840-112
  • Nevada
    • Las Vegas, Nevada, United States, 89144
      • Ophthalmic Plastic, Reconstructive, Orbital & Cosmetic Surgery - Site 840-123
  • New Jersey
    • Hackensack, New Jersey, United States, 07601
      • Hackensack University Medical Center - Site 840-105
  • New York
    • New York, New York, United States, 10032
      • Columbia University - Site 840-125
  • Texas
    • El Paso, Texas, United States, 79935
      • Academy of Diabetes, Thyroid, and Endocrine - Site 840-129
    • Fort Worth, Texas, United States, 76132
      • DCT Fort Worth Research Center - Site 840-133
    • San Antonio, Texas, United States, 78215
      • Sun Research Institute - Site 840-120
  • West Virginia
    • Morgantown, West Virginia, United States, 26506
      • University of West Virginia - Site 840-113

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TOUR006 - 20 MG; 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 20 MG
Experimental: TOUR006 - 50 MG; 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; TOUR006 - 50 MG
Placebo Comparator: Placebo; 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; Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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
Mean change from baseline in serum TSI.	72 weeks
Percentage of participants with anti-drug antibodies.	72 weeks

Collaborators and Investigators

• Sponsor: Tourmaline Bio, Inc.
• Investigators: Study Director: Clinical Trials, Tourmaline Bio

Study record dates

Study Major Dates

• Study Start (Actual): February 19, 2024
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2027

Study Registration Dates

• First Submitted: October 3, 2023
• First Submitted That Met QC Criteria: October 11, 2023
• First Posted (Actual): October 18, 2023

Study Record Updates

• Last Update Posted (Actual): April 23, 2026
• Last Update Submitted That Met QC Criteria: April 22, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Graves' Ophthalmopathy; Eye Diseases; Thyroid Eye Disease; Hyperthyroidism; Graves' Disease; TED; Exophthalmos; Thyroid Diseases
• Additional Relevant MeSH Terms: Endocrine System Diseases; Genetic Diseases, Inborn; Autoimmune Diseases; Immune System Diseases; Eye Diseases, Hereditary; Orbital Diseases; Goiter; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Thyroid Diseases; Eye Diseases; Graves Ophthalmopathy; Graves Disease; Hyperthyroidism; Exophthalmos
• Other Study ID Numbers: TOUR006-T01; U1111-1308-4718 (Other Identifier: WHO Universal Trial Number (UTN)); 2024-514801-69-00 (Other Identifier: EU CTN)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No