HUMAN IGG2 MONOCLONAL ANTIBODY AGAINST IL-6 for Thyroid eye disease

Inclusion criteria

• {"criterion_text":"- 1. Clinical diagnosis of Graves' disease associated with moderate to severe active TED"}
• {"criterion_text":"- 2. Onset of active TED symptoms within approximately 15 months"}
• {"criterion_text":"- 3. Proptosis (exophthalmos) ≥3 mm above the normal range per investigator judgment (based upon race and gender) for the study eye."}
• {"criterion_text":"- 4. CAS ≥4 (on the 7-item scale) for the study eye."}
• {"criterion_text":"- 5. Presence of TSI >130% of the normal reference standard or >0.55 IU/L (depending on assay method) and laboratory reference ranges"}

Exclusion criteria

• {"criterion_text":"- 1. Anticipated need for intervention due to sight-threatening complications or other significant and acute deterioration in vision"}
• {"criterion_text":"- 2. Any previous treatment with teprotumumab or other agent that inhibits the IGF-1 receptor"}
• {"criterion_text":"- 3. 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)"}
• {"criterion_text":"- 4. 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)"}
• {"criterion_text":"- 5. 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"}
• {"criterion_text":"- 6. 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"}
• {"criterion_text":"- 7. Pregnant or lactating"}

Primary endpoints

• {"endpoint_text":"- Percentage of participants achieving proptosis response (defined as a ≥2 mm reduction from baseline in the study eye without deterioration [≥2 mm increase] of proptosis in the fellow eye and without need for rescue therapy/intervention) in the TOUR006 treatment arms compared with the placebo arm at Week 20.","definition_or_measurement_approach":"Proptosis response defined as a ≥2 mm reduction from baseline in the study eye without ≥2 mm increase in fellow eye and without need for rescue therapy/intervention; assessed at Week 20."}

Secondary endpoints

• {"endpoint_text":"- 1. Percentage of participants achieving a proptosis response in the TOUR006 treatment arms at Week 8, Week 16, Week 24, Week 32, Week 40, Week 44, Week 48, Week 56, Week 64, and Week 72.","definition_or_measurement_approach":"Same proptosis response definition as primary; measured at multiple timepoints (Weeks 8,16,24,32,40,44,48,56,64,72)."}
• {"endpoint_text":"- 2. Mean change from baseline in proptosis in the study eye at Week 8, Week 16, Week 20, Week 24, Week 32, Week 40, Week 44, Week 48, Week 56, Week 64, and Week 72.","definition_or_measurement_approach":"Mean change from baseline in proptosis in study eye measured at specified weeks."}
• {"endpoint_text":"- 3. Percentage of participants attaining a complete or near-complete CAS response (defined as CAS ≤1 in the study eye, without ≥2 point increase in CAS from baseline in the fellow eye, and without need for rescue therapy/intervention) at Week 8, Week 16, Week 20, Week 24, Week 32, Week 40, Week 44, Week 48, Week 56, Week 64, and Week 72.","definition_or_measurement_approach":"Complete/near-complete CAS response defined as CAS ≤1 in study eye, without ≥2 point increase in fellow eye and no rescue therapy; measured at listed weeks."}
• {"endpoint_text":"- 4. Mean change from baseline in CAS in the study eye at Week 8, Week 16, Week 20, Week 24, Week 32, Week 40, Week 44, Week 48, Week 56, Week 64, and Week 72.","definition_or_measurement_approach":"Mean change from baseline in Clinical Activity Score (CAS) in study eye at specified weeks."}
• {"endpoint_text":"- 5. Percentage of participants attaining ≥1 grade decrease in diplopia at Week 8, Week 16, Week 20, Week 24, Week 32, Week 40, Week 44, Week 48, Week 56, Week 64, and Week 72.","definition_or_measurement_approach":"Proportion achieving ≥1 grade decrease in diplopia assessed at listed weeks."}
• {"endpoint_text":"- 6. Percentage of participants attaining resolution in diplopia at Week 8, Week 16, Week 20, Week 24, Week 32, Week 40, Week 44, Week 48, Week 56, Week 64, and Week 72.","definition_or_measurement_approach":"Proportion achieving resolution of diplopia at listed weeks."}
• {"endpoint_text":"- 7. Percentage of participants with inconstant diplopia at baseline attaining resolution of inconstant diplopia at Week 8, Week 16, Week 20, Week 24, Week 32, Week 40, Week 44, Week 48, Week 56, Week 64, and Week 72.","definition_or_measurement_approach":"Proportion of those with inconstant diplopia at baseline who achieve resolution at listed weeks."}
• {"endpoint_text":"- 8. Percentage of participants with constant diplopia at baseline attaining resolution of constant diplopia at Week 8, Week 16, Week 20, Week 24, Week 32, Week 40, Week 44, Week 48, Week 56, Week 64, and Week 72.","definition_or_measurement_approach":"Proportion of those with constant diplopia at baseline who achieve resolution at listed weeks."}
• {"endpoint_text":"- 9. Incidence of TEAEs by severity and SAEs through Week 72.","definition_or_measurement_approach":"Incidence and severity of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) collected through Week 72."}

Methods

• Doctor-to-Doctor letters / physician referral (documents: K2_DoctorToDoctorLetter; country-specific versions present) — channel: physician communication to encourage referrals; countries with dedicated materials include France, Spain, Italy, Latvia, Slovakia, Poland.
• Doctor-to-Participant letters (K2_Recruitment material_DoctorToParticipantLetter) — channel: clinician-led direct invitation to potential participants at sites.
• Patient brochures, brochures and participant brochures (K2_Recruitment material_ParticipantBrochure, K2_Brochure) — channel: printed informational materials for patients; country-specific versions present.
• Flyers and patient recruitment flyers (K2_PatientRecruitmentFlyer, K2_Flyer) — channel: printed/handout materials aimed at patients.
• Participant FAQs and Participant Brochure/StudyGuide (K2_Recruitment material_ParticipantFAQs, StudyGuide) — channel: informational materials for prospective participants to answer common questions.
• Study visit guides, visit assessments flowcharts, visit reminder cards and appointment reminders (K2_VisitAssessmentsFlowchart, VisitReminderCard, AppointmentReminder) — channel: logistical support materials to facilitate retention and attendance.
• PAG to Participant letter (K2_Recruitment material_PAGtoParticipantLetter) — engagement channel via patient advocacy groups (country-specific PAG letters exist).
• PE card / Participant Emergency Contact Card — printed wallet cards for participants.
• Doctor/GP letters and GP engagement materials (L2 Other subject information material_GP Letter) — channel: primary care engagement (documented for e.g., Latvia).

Poland

Earliest CTIS Part Ii Submission Date

17-02-2025

Latest Decision Or Authorization Date

17-03-2025

Processing Time Days

28

Number Of Sites

5

Number Of Participants

12

Slovakia

Earliest CTIS Part Ii Submission Date

10-03-2025

Latest Decision Or Authorization Date

05-12-2025

Processing Time Days

270

Number Of Sites

1

Number Of Participants

4

France

Earliest CTIS Part Ii Submission Date

17-12-2024

Latest Decision Or Authorization Date

04-12-2025

Processing Time Days

352

Number Of Sites

2

Number Of Participants

8

Latvia

Earliest CTIS Part Ii Submission Date

20-02-2025

Latest Decision Or Authorization Date

03-12-2025

Processing Time Days

286

Number Of Sites

2

Number Of Participants

8

Italy

Earliest CTIS Part Ii Submission Date

07-03-2025

Latest Decision Or Authorization Date

22-01-2026

Processing Time Days

321

Number Of Sites

2

Number Of Participants

8

Spain

Earliest CTIS Part Ii Submission Date

31-01-2025

Latest Decision Or Authorization Date

10-12-2025

Processing Time Days

313

Number Of Sites

3

Number Of Participants

8

Primary sponsor

Full Name

Tourmaline Bio Inc.

Organisation Type

Pharmaceutical company

Country Of Registered Address

United States

Contract research organisations

Name

Medpace Inc.

Responsibilities

patient recruitment and retention, site contracting, clinical monitoring

Name

Syneos Health Inc.

Responsibilities

PK testing

Name

Bioclinica Inc.

Responsibilities

ECG

Name

PPD Global Central Labs

Responsibilities

central laboratory services

Name

Quest Diagnostics Inc.

Responsibilities

laboratory/testing services

Third parties

• {"country":"United States","full_name":"Quest Diagnostics Inc.","duties_or_roles":"3PLL","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"United States","full_name":"Bioclinica Inc.","duties_or_roles":"ECG","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"United States","full_name":"Medpace Inc.","duties_or_roles":"patient recruitment and retention, site contracting, clinical monitoring","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Scout Clinical","duties_or_roles":"Subjects' consierge services","organisation_type":"Hospital/Clinic/Other health care facility"}
• {"country":"India","full_name":"Qinecsa Solutions India Private Limited","duties_or_roles":"other","organisation_type":"Non-Pharmaceutical company"}
• {"country":"Belgium","full_name":"PPD Global Central Labs","duties_or_roles":"lab/central laboratory services","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Eclinical Solutions LLC","duties_or_roles":"electronic clinical solutions / eCOA","organisation_type":"Pharmaceutical company"}
• {"country":"Netherlands","full_name":"Emsere B.V.","duties_or_roles":"study equipment delivery (syringes)","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"electronic data capture / study systems","organisation_type":"Non-Pharmaceutical company"}
• {"country":"Belgium","full_name":"MEDPACE LABORATORIES","duties_or_roles":"TSI testing and laboratory services","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"Lithuania","full_name":"Biomapas UAB","duties_or_roles":"regulatory / local services","organisation_type":"Pharmaceutical company"}
• {"country":"Germany","full_name":"PCI Pharma Services Germany GmbH","duties_or_roles":"packaging/labeling/distribution (logistics)","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Syneos Health Inc.","duties_or_roles":"PK testing and related services","organisation_type":"Pharmaceutical company"}