search
Back to results

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

Primary Purpose

Thyroid Eye Disease

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
TOUR006 - 20 MG
Placebo
TOUR006 - 50 MG
Sponsored by
Tourmaline Bio, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Thyroid Eye Disease focused on measuring TED, Graves' Disease, Thyroid Eye Disease, Exophthalmos, Eye Diseases, Thyroid Diseases, Graves' Ophthalmopathy, Hyperthyroidism

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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 Additional exclusion criteria are defined in the study protocol.

Sites / Locations

  • Site - 0103Recruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

TOUR006 - 20 MG

TOUR006 - 50 MG

Placebo

Arm Description

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.

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.

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.

Outcomes

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).

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

Full Information

First Posted
October 3, 2023
Last Updated
October 11, 2023
Sponsor
Tourmaline Bio, Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT06088979
Brief Title
A Study to Investigate Efficacy and Safety of TOUR006 in Participants 18 to 75 Years of Age With Thyroid Eye Disease
Acronym
spiriTED
Official Title
A Multicenter Phase 2b Randomized, Double-Masked, Placebo-Controlled Dose-Ranging Study of TOUR006 in Participants With Thyroid Eye Disease
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 2023 (Anticipated)
Primary Completion Date
February 2025 (Anticipated)
Study Completion Date
February 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tourmaline Bio, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thyroid Eye Disease
Keywords
TED, Graves' Disease, Thyroid Eye Disease, Exophthalmos, Eye Diseases, Thyroid Diseases, Graves' Ophthalmopathy, Hyperthyroidism

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
81 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
TOUR006 - 20 MG
Arm Type
Experimental
Arm Description
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.
Arm Title
TOUR006 - 50 MG
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
TOUR006 - 20 MG
Intervention Description
TOUR006 20 MG
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo
Intervention Type
Drug
Intervention Name(s)
TOUR006 - 50 MG
Intervention Description
TOUR006 - 50 MG
Primary Outcome Measure Information:
Title
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).
Time Frame
20 weeks
Secondary Outcome Measure Information:
Title
Percentage of participants achieving a proptosis response with 20mg TOUR006 administered SC every 8 weeks or 50mg TOUR006 administered SC every 8 weeks.
Time Frame
72 weeks
Title
Percentage of participants attaining a complete or near complete response on the 7-point Clinical Activity Score (CAS).
Time Frame
72 weeks
Title
Percentage of participants attaining ≥1 grade decrease in diplopia.
Time Frame
72 weeks
Title
Incidence of Treatment Emergent Adverse Events by severity and Serious Adverse Events through Week 72.
Time Frame
72 weeks
Title
Mean change from baseline in serum trough concentration of TOUR006.
Time Frame
72 weeks
Title
Mean change from baseline in serum TSI.
Time Frame
72 weeks
Title
Percentage of participants with anti-drug antibodies.
Time Frame
72 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tourmaline Bio
Phone
347-773-2627
Email
clinicaltrialinquiries@tourmalinebio.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Tourmaline Bio
Official's Role
Study Director
Facility Information:
Facility Name
Site - 0103
City
Miami
State/Province
Florida
ZIP/Postal Code
33174
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs