Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 2INTERVENTIONAL

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

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

A Study to Investigate Efficacy and Safety of TOUR006 in Participants 18 to 80 Years of Age With Thyroid Eye Disease (NCT06088979) is a Phase 2 interventional studying Thyroid Eye Disease, sponsored by Tourmaline Bio, Inc.. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Thyroid Eye Disease and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 81 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Thyroid Eye Disease subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: - 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. Who Should NOT Join This Trial: - 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. Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

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.

Treatments Being Tested

DRUG

TOUR006 - 20 MG

TOUR006 20 MG

OTHER

Placebo

DRUG

TOUR006 - 50 MG

Locations (20)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Catalina Eye Care - Site 840-121

Tucson, Arizona, United States

Headlands Research - AMCR - Site 840-131

Escondido, California, United States

Foothill Eye Institute - Site 840-116

Pasadena, California, United States

University of California Davis Eye Center - Site 840-119

Sacramento, California, United States

Cockerham Eye Consultants - Site 840-114

San Diego, California, United States

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

San Francisco, California, United States

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

Aurora, Colorado, United States

Bascom Palmer Eye Institute - Site 840-115

Miami, Florida, United States

Cordova Research Institute - Site 840-103

Miami, Florida, United States

Aran Eye Associate

Sweetwater, Florida, United States

University of Louisville Health Eye Institute - Site 840-108

Louisville, Kentucky, United States

Ophthalmic Consultants of Boston - Site 840-128

Boston, Massachusetts, United States

W.K. Kellogg Eye Center - Site 840-126

Ann Arbor, Michigan, United States

Michigan State University - Site 840-127

East Lansing, Michigan, United States

Kahana Oculoplastic and Orbital Surgery - Site 840-112

Livonia, Michigan, United States

Mayo Clinic - Site 840-102

Rochester, Minnesota, United States

University of Missouri-Kansas City School of Medicine - Site 840-130

Kansas City, Missouri, United States

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

Las Vegas, Nevada, United States

Hackensack University Medical Center - Site 840-105

Hackensack, New Jersey, United States

Columbia University - Site 840-125

New York, New York, United States

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06088979), the sponsor (Tourmaline Bio, Inc.), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06088979 clinical trial studying?

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. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT06088979?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06088979?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06088979. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06088979. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.