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

Sponsor

Tourmaline Bio, Inc. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT06088979

Collaborator

(none)

Enrollment

Location

Arms

28.1

Anticipated Duration (Months)

2.9

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Thyroid Eye Disease	Drug: TOUR006 - 20 MG Other: Placebo Drug: TOUR006 - 50 MG	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

81 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Oct 1, 2023

Anticipated Primary Completion Date :

Feb 1, 2025

Anticipated Study Completion Date :

Feb 1, 2026

Arms and Interventions

Arm	Intervention/Treatment
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

Arm

Intervention/Treatment

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

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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