--- title: A Study to Investigate Efficacy and Safety of TOUR006 in Participants 18 to 80 Years of Age With Thyroid Eye Disease nct_id: NCT06088979 overall_status: ACTIVE_NOT_RECRUITING phase: PHASE2 sponsor: Tourmaline Bio, Inc. study_type: INTERVENTIONAL primary_condition: Thyroid Eye Disease countries: United States, Brazil, France, Italy, Jordan, Latvia, New Zealand, Puerto Rico, Slovakia, South Korea, Spain canonical_url: "https://parkinsonspathways.com/agent/trials/NCT06088979.md" clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT06088979" ct_last_update_post_date: 2026-04-23 last_seen_at: "2026-05-12T06:13:07.214Z" source: ClinicalTrials.gov (mirrored, no enrichment) --- # A Study to Investigate Efficacy and Safety of TOUR006 in Participants 18 to 80 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 **NCT ID:** [NCT06088979](https://clinicaltrials.gov/study/NCT06088979) ## Key Facts - **Status:** ACTIVE_NOT_RECRUITING - **Phase:** PHASE2 - **Study Type:** INTERVENTIONAL - **Target Enrollment:** 79 - **Lead Sponsor:** Tourmaline Bio, Inc. - **Conditions:** Thyroid Eye Disease - **Start Date:** 2024-02-19 - **Completion Date:** 2027-09 - **CT.gov Last Update:** 2026-04-23 ## 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. ## Eligibility - **Minimum age:** 18 Years - **Maximum age:** 80 Years - **Sex:** ALL - **Healthy Volunteers:** No ``` Inclusion Criteria: * Clinical diagnosis of Graves' disease associated with moderate to severe active TED * Onset of active TED symptoms within approximately 15 months * Proptosis (exophthalmos) ≥3 mm above the normal range per investigator judgment (based upon race and gender) for the study eye * CAS ≥4 (on the 7-item scale) for the study eye * Presence of TSI \>130% of the normal reference standard or \>0.55 IU/L (depending on assay method) and laboratory reference ranges 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 (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 ≤1g 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). * 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). * 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. ``` ## Arms - **TOUR006 - 20 MG** (EXPERIMENTAL) — 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. - **TOUR006 - 50 MG** (EXPERIMENTAL) — 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. - **Placebo** (PLACEBO_COMPARATOR) — 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. ## Interventions - **TOUR006 - 20 MG** (DRUG) — TOUR006 20 MG - **Placebo** (OTHER) — Placebo - **TOUR006 - 50 MG** (DRUG) — TOUR006 - 50 MG ## Primary Outcomes - **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 - **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)_ - **Percentage of participants attaining a complete or near complete response on the 7-point Clinical Activity Score (CAS).** _(time frame: 72 weeks)_ - **Percentage of participants attaining ≥1 grade decrease in diplopia.** _(time frame: 72 weeks)_ - **Incidence of Treatment Emergent Adverse Events by severity and Serious Adverse Events through Week 72.** _(time frame: 72 weeks)_ - **Mean change from baseline in serum trough concentration of TOUR006.** _(time frame: 72 weeks)_ - **Mean change from baseline in serum TSI.** _(time frame: 72 weeks)_ - **Percentage of participants with anti-drug antibodies.** _(time frame: 72 weeks)_ ## Locations (36) - Catalina Eye Care - Site 840-121, Tucson, Arizona, United States - Foothill Eye Institute - Site 840-116, Pasadena, California, United States - University of California Davis Eye Center - Site 840-119, Sacramento, California, United States - The Pacific Center for Oculofacial and Aesthetic Plastic Surgery - Site 840-122, San Francisco, California, United States - UC Hospital Sue Anschulz-Rodgers Eye Center - Site 840-101, Aurora, Colorado, United States - Bascom Palmer Eye Institute - Site 840-115, Miami, Florida, United States - Ophthalmic Consultants of Boston - Site 840-128, Boston, Massachusetts, United States - Kahana Oculoplastic and Orbital Surgery - Site 840-112, Livonia, Michigan, United States - Ophthalmic Plastic, Reconstructive, Orbital & Cosmetic Surgery - Site 840-123, Las Vegas, Nevada, United States - Hackensack University Medical Center - Site 840-105, Hackensack, New Jersey, United States - Columbia University - Site 840-125, New York, New York, United States - Academy of Diabetes, Thyroid, and Endocrine - Site 840-129, El Paso, Texas, United States - DCT Fort Worth Research Center - Site 840-133, Fort Worth, Texas, United States - Sun Research Institute - Site 840-120, San Antonio, Texas, United States - University of West Virginia - Site 840-113, Morgantown, West Virginia, United States - Freire Pesquisa Clinica - Site 076-773, Belo Horizonte, Brazil - UFG - Hospital de Clinicas da Universidade Federal de Goias - Site 076-762, Goiânia, Brazil - Santa Casa de Misericordia de Porto Alegre - Site 076-767, Porto Alegre, Brazil - Universidade Federal do Rio Grande do Sul (UFRGS) - Site 076-775, Porto Alegre, Brazil - NPCRS - Nucleo de Pesquisa Clinica do Rio Grande do Sul - Site 076-764, Porto Alegre, Brazil - Centro Brasileiro de Pesquisa Clínica - Rio de Janeiro Ltd - Site 076-765, Rio de Janeiro, Brazil - Irmandade da Santa Casa de Misericordia de Sao Paulo - Site 076-771, São Paulo, Brazil - IPEPO - Instituto Paulista de Estudos e Pesquisas em Oftalmologia - Site 076-761, São Paulo, Brazil - CHU Angers - Site 250-252, Angers, France - CHU de Nantes - Hopital Nord Laennec - Site 250-251, Nantes, France - Azienda Ospedaliera Universitaria Federico II - Site 390-382, Naples, Italy - Azienda Ospedaliero Universitaria Pisana - Site 380-381, Pisa, Italy - Al-Essra Hospital - Site 400-401, Amman, Jordan - Riga East Clinical University Hospital, Clinic Bikernieki - Site 428-901, Riga, Latvia - Ziemelkurzemes Regional Hospital - Site 428-902, Ventspils, Latvia - Southern Eye Specialists Ltd - Site 554-501, Christchurch, New Zealand - University of Puerto Rico, Medical Sciences Campus - Site 630-602, San Juan, Puerto Rico - Univerzitna nemocnica Bratislava - Nemocnica sv. Cyrila a Metoda - Site 703-211, Bratislava, Slovakia - Seoul National University Hospital - Site 410-002, Seoul, South Korea - Hospital Universitario Ramon y Cajal - Site 724-803, Madrid, Spain - Hospital Universitario Virgen Macarena - Site 724-801, Seville, Spain ## Recent Field Changes (last 30 days) - `eligibility.minAge` — added _(2026-05-12)_ - `eligibility.maxAge` — added _(2026-05-12)_ - `eligibility.sex` — added _(2026-05-12)_ - `outcomes.primary` — added _(2026-05-12)_ - `status.overallStatus` — added _(2026-05-12)_ - `status.primaryCompletionDate` — added _(2026-05-12)_ - `status.completionDate` — added _(2026-05-12)_ - `status.lastUpdatePostDate` — added _(2026-05-12)_ - `design.phases` — added _(2026-05-12)_ - `design.enrollmentCount` — added _(2026-05-12)_ - `eligibility.criteria` — added _(2026-05-12)_ - `outcomes.secondary` — added _(2026-05-12)_ - `armsInterventions.arms` — added _(2026-05-12)_ - `armsInterventions.interventions` — added _(2026-05-12)_ - `sponsor.lead` — added _(2026-05-12)_ - `results.hasResults` — added _(2026-05-12)_ - `locations.catalina eye care - site 840-121|tucson|arizona|united states` — added _(2026-05-12)_ - `locations.foothill eye institute - site 840-116|pasadena|california|united states` — added _(2026-05-12)_ - `locations.university of california davis eye center - site 840-119|sacramento|california|united states` — added _(2026-05-12)_ - `locations.the pacific center for oculofacial and aesthetic plastic surgery - site 840-122|san francisco|california|united states` — added _(2026-05-12)_ - `locations.uc hospital sue anschulz-rodgers eye center - site 840-101|aurora|colorado|united states` — added _(2026-05-12)_ - `locations.bascom palmer eye institute - site 840-115|miami|florida|united states` — added _(2026-05-12)_ - `locations.ophthalmic consultants of boston - site 840-128|boston|massachusetts|united states` — added _(2026-05-12)_ - `locations.kahana oculoplastic and orbital surgery - site 840-112|livonia|michigan|united states` — added _(2026-05-12)_ - `locations.ophthalmic plastic, reconstructive, orbital & cosmetic surgery - site 840-123|las vegas|nevada|united states` — added _(2026-05-12)_ - `locations.hackensack university medical center - site 840-105|hackensack|new jersey|united states` — added _(2026-05-12)_ - `locations.columbia university - site 840-125|new york|new york|united states` — added _(2026-05-12)_ - `locations.academy of diabetes, thyroid, and endocrine - site 840-129|el paso|texas|united states` — added _(2026-05-12)_ - `locations.dct fort worth research center - site 840-133|fort worth|texas|united states` — added _(2026-05-12)_ - `locations.sun research institute - site 840-120|san antonio|texas|united states` — added _(2026-05-12)_ - `locations.university of west virginia - site 840-113|morgantown|west virginia|united states` — added _(2026-05-12)_ - `locations.freire pesquisa clinica - site 076-773|belo horizonte||brazil` — added _(2026-05-12)_ - `locations.ufg - hospital de clinicas da universidade federal de goias - site 076-762|goiânia||brazil` — added _(2026-05-12)_ - `locations.santa casa de misericordia de porto alegre - site 076-767|porto alegre||brazil` — added _(2026-05-12)_ - `locations.universidade federal do rio grande do sul (ufrgs) - site 076-775|porto alegre||brazil` — added _(2026-05-12)_ - `locations.npcrs - nucleo de pesquisa clinica do rio grande do sul - site 076-764|porto alegre||brazil` — added _(2026-05-12)_ - `locations.centro brasileiro de pesquisa clínica - rio de janeiro ltd - site 076-765|rio de janeiro||brazil` — added _(2026-05-12)_ - `locations.irmandade da santa casa de misericordia de sao paulo - site 076-771|são paulo||brazil` — added _(2026-05-12)_ - `locations.ipepo - instituto paulista de estudos e pesquisas em oftalmologia - site 076-761|são paulo||brazil` — added _(2026-05-12)_ - `locations.chu angers - site 250-252|angers||france` — added _(2026-05-12)_ - `locations.chu de nantes - hopital nord laennec - site 250-251|nantes||france` — added _(2026-05-12)_ - `locations.azienda ospedaliera universitaria federico ii - site 390-382|naples||italy` — added _(2026-05-12)_ - `locations.azienda ospedaliero universitaria pisana - site 380-381|pisa||italy` — added _(2026-05-12)_ - `locations.al-essra hospital - site 400-401|amman||jordan` — added _(2026-05-12)_ - `locations.riga east clinical university hospital, clinic bikernieki - site 428-901|riga||latvia` — added _(2026-05-12)_ - `locations.ziemelkurzemes regional hospital - site 428-902|ventspils||latvia` — added _(2026-05-12)_ - `locations.southern eye specialists ltd - site 554-501|christchurch||new zealand` — added _(2026-05-12)_ - `locations.university of puerto rico, medical sciences campus - site 630-602|san juan||puerto rico` — added _(2026-05-12)_ - `locations.univerzitna nemocnica bratislava - nemocnica sv. cyrila a metoda - site 703-211|bratislava||slovakia` — added _(2026-05-12)_ - `locations.seoul national university hospital - site 410-002|seoul||south korea` — added _(2026-05-12)_ --- *Canonical: https://parkinsonspathways.com/agent/trials/NCT06088979.md* *Source data (authoritative): https://clinicaltrials.gov/study/NCT06088979* *This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*