A Study to Investigate Efficacy and Safety of TOUR006 in Participants 18 to 80 Years of Age With Thyroid Eye Disease

Last updated: January 28, 2026
Sponsor: Tourmaline Bio, Inc.
Overall Status: Active - Recruiting

Phase

2

Condition

Thyroid Disease

Thyroid Disorders

Female Hormonal Deficiencies/abnormalities

Treatment

Placebo

TOUR006 - 20 MG

TOUR006 - 50 MG

Clinical Study ID

NCT06088979
TOUR006-T01
U1111-1308-4718
2024-514801-69-00
  • Ages 18-80
  • All Genders

Study 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 Criteria

Inclusion

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 onassay method) and laboratory reference ranges

Additional inclusion criteria are defined in the study protocol.

Exclusion

Exclusion Criteria:

  • Anticipated need for intervention due to sight-threatening complications or othersignificant and acute deterioration in vision

  • Any previous treatment with teprotumumab or other agent that inhibits the IGF-1receptor

  • History of systemic (eg, oral or IV) steroid use with a cumulative dose equivalentto >1 g of methylprednisolone for the treatment of TED. Previous oral steroid usewith a cumulative dose of ≤1g methylprednisolone (or equivalent dosage for othersystemic corticosteroid) for the treatment of TED, however, is allowed if thecorticosteroid was discontinued at least 6 weeks before baseline (Day 1) andcompletely tapered by Baseline (if applicable).

  • Systemic (oral or IV) corticosteroid use for conditions other than TED within 6weeks of baseline (Day 1) or not completely tapered by baseline (if applicable).

  • Any major illness/condition or evidence of an unstable clinical condition that, inthe investigator's judgment, will substantially increase the risk to theparticipant, or confound the interpretation of safety assessments, if they were toparticipate in the study

  • Any other condition that, in the opinion of the investigator, would impair theability of the participant to comply with the study procedures or impair the abilityto interpret data from the participant's participation in the study

  • Pregnant or lactating

Additional exclusion criteria are defined in the study protocol.

Study Design

Total Participants: 81
Treatment Group(s): 3
Primary Treatment: Placebo
Phase: 2
Study Start date:
February 19, 2024
Estimated Completion Date:
September 30, 2027

Connect with a study center

  • Freire Pesquisa Clinica - Site 076-773

    Belo Horizonte 3470127, 13334-290
    Brazil

    Active - Recruiting

  • UFG - Hospital de Clinicas da Universidade Federal de Goias - Site 076-762

    Goiânia 3462377, 74605-050
    Brazil

    Active - Recruiting

  • NPCRS - Nucleo de Pesquisa Clinica do Rio Grande do Sul - Site 076-764

    Porto Alegre 3452925, 90430-001
    Brazil

    Active - Recruiting

  • Santa Casa de Misericordia de Porto Alegre - Site 076-767

    Porto Alegre 3452925, 90020-090
    Brazil

    Active - Recruiting

  • Universidade Federal do Rio Grande do Sul (UFRGS) - Site 076-775

    Porto Alegre 3452925, 90410-000
    Brazil

    Active - Recruiting

  • Centro Brasileiro de Pesquisa Clínica - Rio de Janeiro Ltd - Site 076-765

    Rio de Janeiro 3451190, 22410-000
    Brazil

    Active - Recruiting

  • IPEPO - Instituto Paulista de Estudos e Pesquisas em Oftalmologia - Site 076-761

    São Paulo 3448439, 04038-032
    Brazil

    Active - Recruiting

  • Irmandade da Santa Casa de Misericordia de Sao Paulo - Site 076-771

    São Paulo 3448439, 01221-020
    Brazil

    Active - Recruiting

  • Ottawa Hospital Research Institute - Site 124-202

    Ottawa, Ontario
    Canada

    Site Not Available

  • Ottawa Hospital Research Institute Site - 0202

    Ottawa, Ontario
    Canada

    Site Not Available

  • Site - 0202

    Ottawa, Ontario
    Canada

    Site Not Available

  • Ottawa Hospital Research Institute - Site 124-202

    Ottawa 6094817, Ontario 6093943
    Canada

    Site Not Available

  • McGill University Health Center - Site 124-201

    Montréal, Quebec QC H4A 3S5
    Canada

    Site Not Available

  • McGill University Health Center Site - 0201

    Montréal, Quebec QC H4A 3S5
    Canada

    Active - Recruiting

  • McGill University Health Center - Site 124-201

    Montreal 6077243, Quebec 6115047 QC H4A 3S5
    Canada

    Site Not Available

  • CHU Angers - Site 250-252

    Angers 3037656, 49933
    France

    Active - Recruiting

  • CHU Angers - Site 250-252

    Angers Cedex 09, 49933
    France

    Site Not Available

  • CHU de Nantes - Hopital Nord Laennec - Site 250-251

    NANTES cedex 1, 44800
    France

    Site Not Available

  • CHU de Nantes - Hopital Nord Laennec - Site 250-251

    Nantes 2990969, 44800
    France

    Active - Recruiting

  • Azienda Ospedaliera Universitaria Federico II - Site 390-382

    Napoli, 80131
    Italy

    Site Not Available

  • Azienda Ospedaliera Universitaria Federico II - Site 380-382

    Napoli 9031661, 80131
    Italy

    Active - Recruiting

  • Azienda Ospedaliera Universitaria Federico II - Site 390-382

    Napoli 9031661, 80131
    Italy

    Active - Recruiting

  • Azienda Ospedaliero Universitaria Pisana - Site 380-381

    Pisa, 56124
    Italy

    Site Not Available

  • Azienda Ospedaliero Universitaria Pisana - Site 380-381

    Pisa 3170647, 56124
    Italy

    Active - Recruiting

  • Al-Essra Hospital - Site 400-401

    Amman,
    Jordan

    Site Not Available

  • Al-Essra Hospital Site - 0401

    Amman,
    Jordan

    Active - Recruiting

  • Site - 0401

    Amman,
    Jordan

    Active - Recruiting

  • Al-Essra Hospital - Site 400-401

    Amman 250441,
    Jordan

    Active - Recruiting

  • Seoul National University Hospital - Site 410-002

    Seoul, 03080
    Korea, Republic of

    Site Not Available

  • Riga East Clinical University Hospital, Clinic Bikernieki - Site 428-901

    Riga, LV1006, Latvia
    Latvia

    Site Not Available

  • Riga East Clinical University Hospital, Clinic Bikernieki - Site 428-901

    Riga 456172, LV1006, Latvia
    Latvia

    Active - Recruiting

  • Ziemelkurzemes Regional Hospital - Site 428-902

    Ventspils,
    Latvia

    Site Not Available

  • Ziemelkurzemes Regional Hospital - Site 428-902

    Ventspils 454310,
    Latvia

    Active - Recruiting

  • Southern Eye Specialists Ltd - Site 554-501

    Christchurch, 8013
    New Zealand

    Site Not Available

  • Southern Eye Specialists Ltd Site - 501

    Christchurch, 8013
    New Zealand

    Active - Recruiting

  • Southern Eye Specialists Ltd - Site 554-501

    Christchurch 2192362, 8013
    New Zealand

    Active - Recruiting

  • University of Puerto Rico, Medical Sciences Campus - Site 630-602

    San Juan, 00921
    Puerto Rico

    Site Not Available

  • University of Puerto Rico, Medical Sciences Campus - Site 630-602

    San Juan 4568127, 00921
    Puerto Rico

    Active - Recruiting

  • Univerzitna nemocnica Bratislava - Nemocnica sv. Cyrila a Metoda - Site 703-211

    Bratislava 3060972, 851 07
    Slovakia

    Active - Recruiting

  • Seoul National University Hospital - Site 410-002

    Seoul 1835848, 03080
    South Korea

    Active - Recruiting

  • Seoul St. Mary's Hospital Site 410-001

    Seoul 1835848, 06591
    South Korea

    Active - Recruiting

  • Hospital La Arruzafa - Site 724-802

    Córdoba, 14012
    Spain

    Site Not Available

  • Hospital La Arruzafa - Site 724-802

    Córdoba 2519240, 14012
    Spain

    Active - Recruiting

  • Hospital Universitario Ramon y Cajal - Site 724-803

    Madrid, 28034
    Spain

    Site Not Available

  • Hospital Universitario Ramon y Cajal Site - 803

    Madrid, 28034
    Spain

    Active - Recruiting

  • Hospital Universitario Ramon y Cajal - Site 724-803

    Madrid 3117735, 28034
    Spain

    Active - Recruiting

  • Hospital Universitario Virgen Macarena - Site 724-801

    Sevilla, 41009
    Spain

    Site Not Available

  • Hospital Universitario Virgen Macarena Site - 801

    Sevilla, 41009
    Spain

    Active - Recruiting

  • Hospital Universitario Virgen Macarena - Site 724-801

    Seville 2510911, 41009
    Spain

    Active - Recruiting

  • Catalina Eye Care - Site 840-121

    Tucson, Arizona 85712
    United States

    Site Not Available

  • Catalina Eye Care Site - 0121

    Tucson, Arizona 85712
    United States

    Active - Recruiting

  • Site - 0121

    Tucson, Arizona 85712
    United States

    Active - Recruiting

  • Catalina Eye Care - Site 840-121

    Tucson 5318313, Arizona 5551752 85712
    United States

    Active - Recruiting

  • Headlands Research - AMCR - Site 840-131

    Escondido, California 92025
    United States

    Site Not Available

  • Headlands Research - AMCR Site - 0131

    Escondido, California 92025
    United States

    Active - Recruiting

  • Foothill Eye Institute - Site 840-116

    Pasadena, California 91107
    United States

    Site Not Available

  • Foothill Eye Institute Site - 0116

    Pasadena, California 91107
    United States

    Terminated

  • Site - 0116

    Pasadena, California 91107
    United States

    Active - Recruiting

  • University of California Davis Eye Center - Site 840-119

    Sacramento, California 95817
    United States

    Site Not Available

  • Cockerham Eye Consultants - Site 840-114

    San Diego, California 92108
    United States

    Site Not Available

  • Cockerham Eye Consultants Site - 0114

    San Diego, California 92108
    United States

    Active - Recruiting

  • Site - 0114

    San Diego, California 92108
    United States

    Active - Recruiting

  • The Pacific Center for Oculofacial and Aesthetic Plastic Surgery - Site 840-122

    San Francisco, California 94115
    United States

    Site Not Available

  • The Pacific Center for Oculofacial and Aesthetic Plastic Surgery Site - 0122

    San Francisco, California 94115
    United States

    Active - Recruiting

  • Headlands Research - AMCR - Site 840-131

    Escondido 5346827, California 5332921 92025
    United States

    Active - Recruiting

  • Foothill Eye Institute - Site 840-116

    Pasadena 5381396, California 5332921 91107
    United States

    Terminated

  • University of California Davis Eye Center - Site 840-119

    Sacramento 5389489, California 5332921 95817
    United States

    Active - Recruiting

  • Cockerham Eye Consultants - Site 840-114

    San Diego 5391811, California 5332921 92108
    United States

    Site Not Available

  • The Pacific Center for Oculofacial and Aesthetic Plastic Surgery - Site 840-122

    San Francisco 5391959, California 5332921 94115
    United States

    Active - Recruiting

  • Site - 0101

    Aurora, Colorado 80045
    United States

    Active - Recruiting

  • UC Hospital Sue Anschulz-Rodgers Eye Center - Site 840-101

    Aurora, Colorado 80045
    United States

    Site Not Available

  • UC Hospital Sue Anschulz-Rodgers Eye Center Site - 0101

    Aurora, Colorado 80045
    United States

    Active - Recruiting

  • UC Hospital Sue Anschulz-Rodgers Eye Center - Site 840-101

    Aurora 5412347, Colorado 5417618 80045
    United States

    Site Not Available

  • Bascom Palmer Eye Institute - Site 840-115

    Miami, Florida 33136
    United States

    Active - Recruiting

  • Bascom Palmer Eye Institute Site - 0115

    Miami, Florida 33136
    United States

    Active - Recruiting

  • Cordova Research Institute - Site 0103

    Miami, Florida 33174
    United States

    Active - Recruiting

  • Cordova Research Institute - Site 840-103

    Miami, Florida 33174
    United States

    Site Not Available

  • Site - 0103

    Miami, Florida 33174
    United States

    Active - Recruiting

  • Site - 0115

    Miami, Florida 33136
    United States

    Active - Recruiting

  • Bascom Palmer Eye Institute - Site 840-115

    Miami 4164138, Florida 4155751 33136
    United States

    Active - Recruiting

  • Cordova Research Institute - Site 840-103

    Miami 4164138, Florida 4155751 33174
    United States

    Active - Recruiting

  • Aran Eye Associate

    Sweetwater 4174600, Florida 4155751 33182
    United States

    Site Not Available

  • Site - 0108

    Louisville, Kentucky 40202
    United States

    Active - Recruiting

  • University of Louisville Health Eye Institute - Site 840-108

    Louisville, Kentucky 40202
    United States

    Site Not Available

  • University of Louisville Health Eye Institute Site - 0108

    Louisville, Kentucky 40202
    United States

    Active - Recruiting

  • University of Louisville Health Eye Institute - Site 840-108

    Louisville 4299276, Kentucky 6254925 40202
    United States

    Active - Recruiting

  • Ophthalmic Consultants of Boston - Site 840-128

    Boston, Massachusetts 02114
    United States

    Site Not Available

  • Ophthalmic Consultants of Boston Site - 0128

    Boston, Massachusetts 02114
    United States

    Active - Recruiting

  • Ophthalmic Consultants of Boston - Site 840-128

    Boston 4930956, Massachusetts 6254926 02114
    United States

    Active - Recruiting

  • W.K. Kellogg Eye Center - Site 840-126

    Ann Arbor, Michigan 48105
    United States

    Site Not Available

  • Michigan State University - Site 840-127

    East Lansing, Michigan 48824
    United States

    Site Not Available

  • Kahana Oculoplastic and Orbital Surgery - Site 840-112

    Livonia, Michigan 48152
    United States

    Site Not Available

  • Kahana Oculoplastic and Orbital Surgery Site - 0112

    Livonia, Michigan 48152
    United States

    Active - Recruiting

  • Site - 0112

    Livonia, Michigan 48152
    United States

    Active - Recruiting

  • W.K. Kellogg Eye Center - Site 840-126

    Ann Arbor 4984247, Michigan 5001836 48105
    United States

    Active - Recruiting

  • Michigan State University - Site 840-127

    East Lansing 4991640, Michigan 5001836 48824
    United States

    Active - Recruiting

  • Kahana Oculoplastic and Orbital Surgery - Site 840-112

    Livonia 4999837, Michigan 5001836 48152
    United States

    Active - Recruiting

  • Mayo Clinic - 0102

    Rochester, Minnesota 55905
    United States

    Active - Recruiting

  • Mayo Clinic - Site 840-102

    Rochester, Minnesota 55905
    United States

    Site Not Available

  • Mayo Clinic Site - 0102

    Rochester, Minnesota 55905
    United States

    Site Not Available

  • Mayo Clinic - Site 840-102

    Rochester 5043473, Minnesota 5037779 55905
    United States

    Site Not Available

  • University of Missouri-Kansas City School of Medicine

    Kansas City, Missouri 64108
    United States

    Active - Recruiting

  • University of Missouri-Kansas City School of Medicine - Site 840-130

    Kansas City, Missouri 64108
    United States

    Site Not Available

  • University of Missouri-Kansas City School of Medicine - Site 840-130

    Kansas City 4393217, Missouri 4398678 64108
    United States

    Active - Recruiting

  • Ophthalmic Plastic, Reconstructive, Orbital & Cosmetic Surgery - Site 840-123

    Las Vegas, Nevada 89144
    United States

    Site Not Available

  • Ophthalmic Plastic, Reconstructive, Orbital & Cosmetic Surgery - Site 840-123

    Las Vegas 5506956, Nevada 5509151 89144
    United States

    Active - Recruiting

  • Hackensack University Medical Center - Site 840-105

    Hackensack, New Jersey 07601
    United States

    Site Not Available

  • Hackensack University Medical Center Site - 0105

    Hackensack, New Jersey 07601
    United States

    Active - Recruiting

  • Hackensack University Medical Center - Site 840-105

    Hackensack 5098706, New Jersey 5101760 07601
    United States

    Active - Recruiting

  • Columbia University - Site 840-125

    New York, New York 10032
    United States

    Site Not Available

  • Columbia University - Site 840-125

    New York 5128581, New York 5128638 10032
    United States

    Active - Recruiting

  • Site - 0104

    Chapel Hill, North Carolina 27517
    United States

    Active - Recruiting

  • University of North Carolina at Chapel Hill - Site 840-104

    Chapel Hill, North Carolina 27517
    United States

    Site Not Available

  • University of North Carolina at Chapel Hill Site - 0104

    Chapel Hill, North Carolina 27517
    United States

    Active - Recruiting

  • University of North Carolina at Chapel Hill - Site 840-104

    Chapel Hill 4460162, North Carolina 4482348 27517
    United States

    Active - Recruiting

  • Bergstrom Eye Research - Site 840-134

    Fargo, North Dakota 58103
    United States

    Site Not Available

  • Bergstrom Eye Research Site - 0134

    Fargo, North Dakota 58103
    United States

    Active - Recruiting

  • Bergstrom Eye Research - Site 840-134

    Fargo 5059163, North Dakota 5690763 58103
    United States

    Active - Recruiting

  • Eye Physicians, LLC - Site 840-118

    Columbus, Ohio 43215
    United States

    Site Not Available

  • Eye Physicians, LLC Site - 0118

    Columbus, Ohio 43215
    United States

    Active - Recruiting

  • Site - 0118

    Columbus, Ohio 43215
    United States

    Active - Recruiting

  • Eye Physicians, LLC - Site 840-118

    Columbus 4509177, Ohio 5165418 43215
    United States

    Site Not Available

  • Headlands Research - TMA - Site 840-132

    Myrtle Beach, South Carolina 29572
    United States

    Site Not Available

  • Headlands Research - TMA Site - 0132

    Myrtle Beach, South Carolina 29572
    United States

    Active - Recruiting

  • Headlands Research - TMA Site - 132

    Myrtle Beach, South Carolina 29572
    United States

    Active - Recruiting

  • Headlands Research - TMA - Site 840-132

    Myrtle Beach 4588718, South Carolina 4597040 29572
    United States

    Active - Recruiting

  • Academy of Diabetes, Thyroid, and Endocrine - Site 840-129

    El Paso, Texas 79935
    United States

    Site Not Available

  • Academy of Diabetes, Thyroid, and Endocrine Site - 0129

    El Paso, Texas 79935
    United States

    Active - Recruiting

  • DCT Fort Worth Research Center - Site 840-133

    Fort Worth, Texas 76132
    United States

    Site Not Available

  • DCT Fort Worth Research Center Site - 0133

    Fort Worth, Texas 76132
    United States

    Active - Recruiting

  • Houston Methodist Hospital - Site 840-124

    Houston, Texas 77030
    United States

    Active - Recruiting

  • Neuro-Eye Clinical Trials, Inc - Site 840-106

    Houston, Texas 77004
    United States

    Site Not Available

  • Neuro-Eye Clinical Trials, Inc Site - 0106

    Houston, Texas 77004
    United States

    Active - Recruiting

  • Site - 0106

    Houston, Texas 77004
    United States

    Active - Recruiting

  • Site - 0120

    San Antonio, Texas 78215
    United States

    Active - Recruiting

  • Sun Research Institute - Site 840-120

    San Antonio, Texas 78215
    United States

    Site Not Available

  • Sun Research Institute Site - 0120

    San Antonio, Texas 78215
    United States

    Active - Recruiting

  • Academy of Diabetes, Thyroid, and Endocrine - Site 840-129

    El Paso 5520993, Texas 4736286 79935
    United States

    Active - Recruiting

  • DCT Fort Worth Research Center - Site 840-133

    Fort Worth 4691930, Texas 4736286 76132
    United States

    Active - Recruiting

  • Houston Methodist Hospital - Site 840-124

    Houston 4699066, Texas 4736286 77030
    United States

    Active - Recruiting

  • Neuro-Eye Clinical Trials, Inc - Site 840-106

    Houston 4699066, Texas 4736286 77004
    United States

    Site Not Available

  • Sun Research Institute - Site 840-120

    San Antonio 4726206, Texas 4736286 78215
    United States

    Active - Recruiting

  • Site - 0113

    Morgantown, West Virginia 26506
    United States

    Active - Recruiting

  • University of West Virginia - Site 840-113

    Morgantown, West Virginia 26506
    United States

    Site Not Available

  • University of West Virginia Site - 0113

    Morgantown, West Virginia 26506
    United States

    Active - Recruiting

  • University of West Virginia - Site 840-113

    Morgantown 4815352, West Virginia 4826850 26506
    United States

    Active - Recruiting

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