## Protocol Section
### Identification Module
**NCT ID:** NCT06088979

**Acronym:** spiriTED

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

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

#### Organization Study ID Info
**ID:** TOUR006-T01
#### Organization
**Class:** INDUSTRY
**Full Name:** Tourmaline Bio, Inc.
### Status Module
#### Completion Date
**Date:** 2026-02

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-04-11

**Type:** ACTUAL

**Last Update Submit Date:** 2024-04-10

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2025-02

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-02-19

**Type:** ACTUAL

**Status Verified Date:** 2024-04

#### Study First Post Date
**Date:** 2023-10-18
**Type:** ACTUAL
**Study First Submit Date:** 2023-10-03
**Study First Submit QC Date:** 2023-10-11
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Tourmaline Bio, Inc.

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** True

**Oversight Has DMC:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Thyroid Eye Disease

**Keywords:**

- TED

- Graves' Disease

- Thyroid Eye Disease

- Exophthalmos

- Eye Diseases

- Thyroid Diseases

- Graves' Ophthalmopathy

- Hyperthyroidism

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** QUADRUPLE

**Who Masked:**

- PARTICIPANT

- CARE_PROVIDER

- INVESTIGATOR

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 81

**Type:** ESTIMATED

**Phases:**

- PHASE2

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**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.

**Intervention Names:**

- Drug: TOUR006 - 20 MG

**Label:** TOUR006 - 20 MG

**Type:** EXPERIMENTAL

#### Arm Group 2

**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.

**Intervention Names:**

- Drug: TOUR006 - 50 MG

**Label:** TOUR006 - 50 MG

**Type:** EXPERIMENTAL

#### Arm Group 3

**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 Names:**

- Other: Placebo

**Label:** Placebo

**Type:** PLACEBO_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- TOUR006 - 20 MG

**Description:** TOUR006 20 MG

**Name:** TOUR006 - 20 MG

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- Placebo

**Description:** Placebo

**Name:** Placebo

**Type:** OTHER

#### Intervention 3

**Arm Group Labels:**

- TOUR006 - 50 MG

**Description:** TOUR006 - 50 MG

**Name:** TOUR006 - 50 MG

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Measure:** 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 Outcomes

**Measure:** 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

**Measure:** Percentage of participants attaining a complete or near complete response on the 7-point Clinical Activity Score (CAS).

**Time Frame:** 72 weeks

**Measure:** Percentage of participants attaining ≥1 grade decrease in diplopia.

**Time Frame:** 72 weeks

**Measure:** Incidence of Treatment Emergent Adverse Events by severity and Serious Adverse Events through Week 72.

**Time Frame:** 72 weeks

**Measure:** Mean change from baseline in serum trough concentration of TOUR006.

**Time Frame:** 72 weeks

**Measure:** Mean change from baseline in serum TSI.

**Time Frame:** 72 weeks

**Measure:** Percentage of participants with anti-drug antibodies.

**Time Frame:** 72 weeks

### Eligibility Module

**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.

**Maximum Age:** 75 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** clinicaltrialinquiries@tourmalinebio.com

**Name:** Tourmaline Bio

**Phone:** 347-773-2627

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Pasadena

**Country:** United States

**Facility:** Site - 0116

**State:** California

**Status:** RECRUITING

**Zip:** 91107

**Location 2:**

**City:** San Diego

**Country:** United States

**Facility:** Site - 0114

**State:** California

**Status:** RECRUITING

**Zip:** 92108

**Location 3:**

**City:** Aurora

**Country:** United States

**Facility:** Site - 0101

**State:** Colorado

**Status:** RECRUITING

**Zip:** 80045

**Location 4:**

**City:** Miami

**Country:** United States

**Facility:** Site - 0103

**State:** Florida

**Status:** RECRUITING

**Zip:** 33174

**Location 5:**

**City:** Louisville

**Country:** United States

**Facility:** Site - 0108

**State:** Kentucky

**Status:** RECRUITING

**Zip:** 40202

**Location 6:**

**City:** Livonia

**Country:** United States

**Facility:** Site - 0112

**State:** Michigan

**Status:** RECRUITING

**Zip:** 48152

**Location 7:**

**City:** Chapel Hill

**Country:** United States

**Facility:** Site - 0104

**State:** North Carolina

**Status:** RECRUITING

**Zip:** 27517

**Location 8:**

**City:** Houston

**Country:** United States

**Facility:** Site - 0106

**State:** Texas

**Status:** RECRUITING

**Zip:** 77004

**Location 9:**

**City:** Morgantown

**Country:** United States

**Facility:** Site - 0113

**State:** West Virginia

**Status:** RECRUITING

**Zip:** 26506

**Location 10:**

**City:** Amman

**Country:** Jordan

**Facility:** Site - 0401

**Status:** RECRUITING

#### Overall Officials

**Official 1:**

**Affiliation:** Tourmaline Bio

**Name:** Clinical Trials

**Role:** STUDY_DIRECTOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000004700

- Term: Endocrine System Diseases

- ID: D000015785

- Term: Eye Diseases, Hereditary

- ID: D000006111

- Term: Graves Disease

- ID: D000005094

- Term: Exophthalmos

- ID: D000009916

- Term: Orbital Diseases

- ID: D000030342

- Term: Genetic Diseases, Inborn

- ID: D000006042

- Term: Goiter

- ID: D000006980

- Term: Hyperthyroidism

- ID: D000001327

- Term: Autoimmune Diseases

- ID: D000007154

- Term: Immune System Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC11

- Name: Eye Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC19

- Name: Gland and Hormone Related Diseases

- Abbrev: BC20

- Name: Immune System Diseases

- Abbrev: BC16

- Name: Diseases and Abnormalities at or Before Birth

### Condition Browse Module - Browse Leaves

- ID: M8271

- Name: Eye Diseases

- Relevance: HIGH

- As Found: Eye Disease

- ID: M9214

- Name: Graves Disease

- Relevance: LOW

- As Found: Unknown

- ID: M10031

- Name: Hyperthyroidism

- Relevance: LOW

- As Found: Unknown

- ID: M16718

- Name: Thyroid Diseases

- Relevance: HIGH

- As Found: Thyroid

- ID: M26148

- Name: Graves Ophthalmopathy

- Relevance: HIGH

- As Found: Thyroid Eye Disease

- ID: M8237

- Name: Exophthalmos

- Relevance: LOW

- As Found: Unknown

- ID: M7862

- Name: Endocrine System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M18339

- Name: Eye Diseases, Hereditary

- Relevance: LOW

- As Found: Unknown

- ID: M12845

- Name: Orbital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M23686

- Name: Genetic Diseases, Inborn

- Relevance: LOW

- As Found: Unknown

- ID: M9147

- Name: Goiter

- Relevance: LOW

- As Found: Unknown

- ID: M4629

- Name: Autoimmune Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M10200

- Name: Immune System Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000005128

- Term: Eye Diseases

- ID: D000049970

- Term: Graves Ophthalmopathy

- ID: D000013959

- Term: Thyroid Diseases

### Misc Info Module

- Version Holder: 2024-05-24
