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Investigating TOUR006 for Thyroid Eye Disease

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

PHASE2 · Tourmaline Bio, Inc. · NCT06088979

This study is testing a new treatment called TOUR006 to see if it can help adults with moderate to severe Thyroid Eye Disease feel better by reducing their symptoms.

Quick facts

PhasePHASE2
Study typeInterventional
Enrollment81 (estimated)
Ages18 Years to 80 Years
SexAll
SponsorTourmaline Bio, Inc. (industry)
Drugs / interventionsteprotumumab
Locations29 sites (Tucson, Arizona and 28 other locations)
Trial IDNCT06088979 on ClinicalTrials.gov

What this trial studies

This Phase 2b trial evaluates the efficacy and safety of TOUR006 in patients aged 18 to 80 with moderate to severe active Thyroid Eye Disease (TED). Participants will receive either 20mg or 50mg doses of TOUR006 or a placebo via subcutaneous injection every eight weeks. The study focuses on patients experiencing the active inflammatory phase of TED, characterized by symptoms such as proptosis and elevated clinical activity scores. The goal is to determine the effectiveness of TOUR006 in reducing TED symptoms compared to placebo.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 to 80 with a clinical diagnosis of Graves' disease and moderate to severe active TED.

Not a fit: Patients with sight-threatening complications or those who have previously received certain treatments for TED may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve the quality of life for patients suffering from Thyroid Eye Disease.

How similar studies have performed: While there have been studies on TED treatments, the specific approach with TOUR006 is novel and has not been extensively tested in prior trials.

Eligibility criteria

Show full inclusion / exclusion criteria 
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 ≤1 g 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.

Where this trial is running

Tucson, Arizona and 28 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Thyroid Eye Disease, TED, Graves' Disease, Exophthalmos, Eye Diseases, Thyroid Diseases, Graves' Ophthalmopathy, Hyperthyroidism

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.