Investigating TOUR006 for Thyroid Eye Disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Catalina Eye Care Site - 0121
  Tucson, Arizona, United States Recruiting
• Headlands Research - AMCR Site - 0131
  Escondido, California, United States Recruiting
• Cockerham Eye Consultants Site - 0114
  San Diego, California, United States Recruiting
• The Pacific Center for Oculofacial and Aesthetic Plastic Surgery Site - 0122
  San Francisco, California, United States Recruiting
• UC Hospital Sue Anschulz-Rodgers Eye Center Site - 0101
  Aurora, Colorado, United States Recruiting
• Bascom Palmer Eye Institute Site - 0115
  Miami, Florida, United States Recruiting

Study contacts

• Study coordinator: Tourmaline Bio
• Email: clinicaltrialinquiries@tourmalinebio.com
• Phone: 347-773-2627

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.