A Study to Investigate Efficacy and Safety of TOUR006 in Participants 18 to 75 Years of Age With Thyroid Eye Disease

Thyroid Eye Disease Clinical Trial

— spiriTED  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06088979
• Other study ID #: TOUR006-T01
• Status: Recruiting
• Phase: Phase 2
• Start date: February 19, 2024
• Est. completion date: February 2026

Study information

• Verified date: April 2024
• Source: Tourmaline Bio, Inc.
• Contact: Tourmaline Bio
• Phone: 347-773-2627
• Email: clinicaltrialinquiries[@]tourmalinebio.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 81
• Est. completion date: February 2026
• Est. primary completion date: February 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Clinical diagnosis of Graves' disease associated with moderate to severe active TED
• Onset of active TED symptoms within approximately 12 months
• Proptosis (exophthalmos) =3 mm above the normal range (based upon race and gender) for the study eye
• CAS =4 (on the 7-item scale) for the study eye
• Presence of thyroid stimulating immunoglobulin (TSI) above the upper limit of normal 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 steroid (oral or IV) 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 is allowed if the corticosteroid is discontinued at least 6 weeks before screening.
• Systemic (oral or IV) corticosteroid use for conditions other than TED within 3 months before screening.
• 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.

Related Conditions & MeSH terms

• Eye Diseases
• Graves Ophthalmopathy
• Thyroid Diseases
• Thyroid Eye Disease

Intervention

Drug:
• TOUR006 - 20 MG
TOUR006 20 MG

Other:
• Placebo
Placebo

Drug:
• TOUR006 - 50 MG
TOUR006 - 50 MG

Locations

Country	Name	City	State
Jordan	Site - 0401	Amman
United States	Site - 0101	Aurora	Colorado
United States	Site - 0104	Chapel Hill	North Carolina
United States	Site - 0106	Houston	Texas
United States	Site - 0112	Livonia	Michigan
United States	Site - 0108	Louisville	Kentucky
United States	Site - 0103	Miami	Florida
United States	Site - 0113	Morgantown	West Virginia
United States	Site - 0116	Pasadena	California
United States	Site - 0114	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
Tourmaline Bio, Inc.

Countries where clinical trial is conducted

United States,  Jordan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Percentage of participants attaining a complete or near complete response on the 7-point Clinical Activity Score (CAS).		72 weeks
Secondary	Percentage of participants attaining =1 grade decrease in diplopia.		72 weeks
Secondary	Incidence of Treatment Emergent Adverse Events by severity and Serious Adverse Events through Week 72.		72 weeks
Secondary	Mean change from baseline in serum trough concentration of TOUR006.		72 weeks
Secondary	Mean change from baseline in serum TSI.		72 weeks
Secondary	Percentage of participants with anti-drug antibodies.		72 weeks