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

April 22, 2026 updated by: Tourmaline Bio, Inc.

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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
79

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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).
Time Frame: 20 weeks
20 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.
Time Frame: 72 weeks
72 weeks
Percentage of participants attaining a complete or near complete response on the 7-point Clinical Activity Score (CAS).
Time Frame: 72 weeks
72 weeks
Percentage of participants attaining ≥1 grade decrease in diplopia.
Time Frame: 72 weeks
72 weeks
Incidence of Treatment Emergent Adverse Events by severity and Serious Adverse Events through Week 72.
Time Frame: 72 weeks
72 weeks
Mean change from baseline in serum trough concentration of TOUR006.
Time Frame: 72 weeks
72 weeks
Mean change from baseline in serum TSI.
Time Frame: 72 weeks
72 weeks
Percentage of participants with anti-drug antibodies.
Time Frame: 72 weeks
72 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Tourmaline Bio, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Clinical Trials, Tourmaline Bio

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 19, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 3, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 11, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 18, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 23, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 22, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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