Phase
Condition
Thyroid Disease
Thyroid Disorders
Female Hormonal Deficiencies/abnormalities
Treatment
Placebo
TOUR006 - 20 MG
TOUR006 - 50 MG
Clinical Study ID
Ages 18-80 All Genders
Study Summary
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
Connect with a study center
Freire Pesquisa Clinica - Site 076-773
Belo Horizonte 3470127, 13334-290
BrazilActive - Recruiting
UFG - Hospital de Clinicas da Universidade Federal de Goias - Site 076-762
Goiânia 3462377, 74605-050
BrazilActive - Recruiting
NPCRS - Nucleo de Pesquisa Clinica do Rio Grande do Sul - Site 076-764
Porto Alegre 3452925, 90430-001
BrazilActive - Recruiting
Santa Casa de Misericordia de Porto Alegre - Site 076-767
Porto Alegre 3452925, 90020-090
BrazilActive - Recruiting
Universidade Federal do Rio Grande do Sul (UFRGS) - Site 076-775
Porto Alegre 3452925, 90410-000
BrazilActive - Recruiting
Centro Brasileiro de Pesquisa Clínica - Rio de Janeiro Ltd - Site 076-765
Rio de Janeiro 3451190, 22410-000
BrazilActive - Recruiting
IPEPO - Instituto Paulista de Estudos e Pesquisas em Oftalmologia - Site 076-761
São Paulo 3448439, 04038-032
BrazilActive - Recruiting
Irmandade da Santa Casa de Misericordia de Sao Paulo - Site 076-771
São Paulo 3448439, 01221-020
BrazilActive - Recruiting
Ottawa Hospital Research Institute - Site 124-202
Ottawa, Ontario
CanadaSite Not Available
Ottawa Hospital Research Institute Site - 0202
Ottawa, Ontario
CanadaSite Not Available
Site - 0202
Ottawa, Ontario
CanadaSite Not Available
Ottawa Hospital Research Institute - Site 124-202
Ottawa 6094817, Ontario 6093943
CanadaSite Not Available
McGill University Health Center - Site 124-201
Montréal, Quebec QC H4A 3S5
CanadaSite Not Available
McGill University Health Center Site - 0201
Montréal, Quebec QC H4A 3S5
CanadaActive - Recruiting
McGill University Health Center - Site 124-201
Montreal 6077243, Quebec 6115047 QC H4A 3S5
CanadaSite Not Available
CHU Angers - Site 250-252
Angers 3037656, 49933
FranceActive - Recruiting
CHU Angers - Site 250-252
Angers Cedex 09, 49933
FranceSite Not Available
CHU de Nantes - Hopital Nord Laennec - Site 250-251
NANTES cedex 1, 44800
FranceSite Not Available
CHU de Nantes - Hopital Nord Laennec - Site 250-251
Nantes 2990969, 44800
FranceActive - Recruiting
Azienda Ospedaliera Universitaria Federico II - Site 390-382
Napoli, 80131
ItalySite Not Available
Azienda Ospedaliera Universitaria Federico II - Site 380-382
Napoli 9031661, 80131
ItalyActive - Recruiting
Azienda Ospedaliera Universitaria Federico II - Site 390-382
Napoli 9031661, 80131
ItalyActive - Recruiting
Azienda Ospedaliero Universitaria Pisana - Site 380-381
Pisa, 56124
ItalySite Not Available
Azienda Ospedaliero Universitaria Pisana - Site 380-381
Pisa 3170647, 56124
ItalyActive - Recruiting
Al-Essra Hospital - Site 400-401
Amman,
JordanSite Not Available
Al-Essra Hospital Site - 0401
Amman,
JordanActive - Recruiting
Site - 0401
Amman,
JordanActive - Recruiting
Al-Essra Hospital - Site 400-401
Amman 250441,
JordanActive - Recruiting
Seoul National University Hospital - Site 410-002
Seoul, 03080
Korea, Republic ofSite Not Available
Riga East Clinical University Hospital, Clinic Bikernieki - Site 428-901
Riga, LV1006, Latvia
LatviaSite Not Available
Riga East Clinical University Hospital, Clinic Bikernieki - Site 428-901
Riga 456172, LV1006, Latvia
LatviaActive - Recruiting
Ziemelkurzemes Regional Hospital - Site 428-902
Ventspils,
LatviaSite Not Available
Ziemelkurzemes Regional Hospital - Site 428-902
Ventspils 454310,
LatviaActive - Recruiting
Southern Eye Specialists Ltd - Site 554-501
Christchurch, 8013
New ZealandSite Not Available
Southern Eye Specialists Ltd Site - 501
Christchurch, 8013
New ZealandActive - Recruiting
Southern Eye Specialists Ltd - Site 554-501
Christchurch 2192362, 8013
New ZealandActive - Recruiting
University of Puerto Rico, Medical Sciences Campus - Site 630-602
San Juan, 00921
Puerto RicoSite Not Available
University of Puerto Rico, Medical Sciences Campus - Site 630-602
San Juan 4568127, 00921
Puerto RicoActive - Recruiting
Univerzitna nemocnica Bratislava - Nemocnica sv. Cyrila a Metoda - Site 703-211
Bratislava 3060972, 851 07
SlovakiaActive - Recruiting
Seoul National University Hospital - Site 410-002
Seoul 1835848, 03080
South KoreaActive - Recruiting
Seoul St. Mary's Hospital Site 410-001
Seoul 1835848, 06591
South KoreaActive - Recruiting
Hospital La Arruzafa - Site 724-802
Córdoba, 14012
SpainSite Not Available
Hospital La Arruzafa - Site 724-802
Córdoba 2519240, 14012
SpainActive - Recruiting
Hospital Universitario Ramon y Cajal - Site 724-803
Madrid, 28034
SpainSite Not Available
Hospital Universitario Ramon y Cajal Site - 803
Madrid, 28034
SpainActive - Recruiting
Hospital Universitario Ramon y Cajal - Site 724-803
Madrid 3117735, 28034
SpainActive - Recruiting
Hospital Universitario Virgen Macarena - Site 724-801
Sevilla, 41009
SpainSite Not Available
Hospital Universitario Virgen Macarena Site - 801
Sevilla, 41009
SpainActive - Recruiting
Hospital Universitario Virgen Macarena - Site 724-801
Seville 2510911, 41009
SpainActive - Recruiting
Catalina Eye Care - Site 840-121
Tucson, Arizona 85712
United StatesSite Not Available
Catalina Eye Care Site - 0121
Tucson, Arizona 85712
United StatesActive - Recruiting
Site - 0121
Tucson, Arizona 85712
United StatesActive - Recruiting
Catalina Eye Care - Site 840-121
Tucson 5318313, Arizona 5551752 85712
United StatesActive - Recruiting
Headlands Research - AMCR - Site 840-131
Escondido, California 92025
United StatesSite Not Available
Headlands Research - AMCR Site - 0131
Escondido, California 92025
United StatesActive - Recruiting
Foothill Eye Institute - Site 840-116
Pasadena, California 91107
United StatesSite Not Available
Foothill Eye Institute Site - 0116
Pasadena, California 91107
United StatesTerminated
Site - 0116
Pasadena, California 91107
United StatesActive - Recruiting
University of California Davis Eye Center - Site 840-119
Sacramento, California 95817
United StatesSite Not Available
Cockerham Eye Consultants - Site 840-114
San Diego, California 92108
United StatesSite Not Available
Cockerham Eye Consultants Site - 0114
San Diego, California 92108
United StatesActive - Recruiting
Site - 0114
San Diego, California 92108
United StatesActive - Recruiting
The Pacific Center for Oculofacial and Aesthetic Plastic Surgery - Site 840-122
San Francisco, California 94115
United StatesSite Not Available
The Pacific Center for Oculofacial and Aesthetic Plastic Surgery Site - 0122
San Francisco, California 94115
United StatesActive - Recruiting
Headlands Research - AMCR - Site 840-131
Escondido 5346827, California 5332921 92025
United StatesActive - Recruiting
Foothill Eye Institute - Site 840-116
Pasadena 5381396, California 5332921 91107
United StatesTerminated
University of California Davis Eye Center - Site 840-119
Sacramento 5389489, California 5332921 95817
United StatesActive - Recruiting
Cockerham Eye Consultants - Site 840-114
San Diego 5391811, California 5332921 92108
United StatesSite Not Available
The Pacific Center for Oculofacial and Aesthetic Plastic Surgery - Site 840-122
San Francisco 5391959, California 5332921 94115
United StatesActive - Recruiting
Site - 0101
Aurora, Colorado 80045
United StatesActive - Recruiting
UC Hospital Sue Anschulz-Rodgers Eye Center - Site 840-101
Aurora, Colorado 80045
United StatesSite Not Available
UC Hospital Sue Anschulz-Rodgers Eye Center Site - 0101
Aurora, Colorado 80045
United StatesActive - Recruiting
UC Hospital Sue Anschulz-Rodgers Eye Center - Site 840-101
Aurora 5412347, Colorado 5417618 80045
United StatesSite Not Available
Bascom Palmer Eye Institute - Site 840-115
Miami, Florida 33136
United StatesActive - Recruiting
Bascom Palmer Eye Institute Site - 0115
Miami, Florida 33136
United StatesActive - Recruiting
Cordova Research Institute - Site 0103
Miami, Florida 33174
United StatesActive - Recruiting
Cordova Research Institute - Site 840-103
Miami, Florida 33174
United StatesSite Not Available
Site - 0103
Miami, Florida 33174
United StatesActive - Recruiting
Site - 0115
Miami, Florida 33136
United StatesActive - Recruiting
Bascom Palmer Eye Institute - Site 840-115
Miami 4164138, Florida 4155751 33136
United StatesActive - Recruiting
Cordova Research Institute - Site 840-103
Miami 4164138, Florida 4155751 33174
United StatesActive - Recruiting
Aran Eye Associate
Sweetwater 4174600, Florida 4155751 33182
United StatesSite Not Available
Site - 0108
Louisville, Kentucky 40202
United StatesActive - Recruiting
University of Louisville Health Eye Institute - Site 840-108
Louisville, Kentucky 40202
United StatesSite Not Available
University of Louisville Health Eye Institute Site - 0108
Louisville, Kentucky 40202
United StatesActive - Recruiting
University of Louisville Health Eye Institute - Site 840-108
Louisville 4299276, Kentucky 6254925 40202
United StatesActive - Recruiting
Ophthalmic Consultants of Boston - Site 840-128
Boston, Massachusetts 02114
United StatesSite Not Available
Ophthalmic Consultants of Boston Site - 0128
Boston, Massachusetts 02114
United StatesActive - Recruiting
Ophthalmic Consultants of Boston - Site 840-128
Boston 4930956, Massachusetts 6254926 02114
United StatesActive - Recruiting
W.K. Kellogg Eye Center - Site 840-126
Ann Arbor, Michigan 48105
United StatesSite Not Available
Michigan State University - Site 840-127
East Lansing, Michigan 48824
United StatesSite Not Available
Kahana Oculoplastic and Orbital Surgery - Site 840-112
Livonia, Michigan 48152
United StatesSite Not Available
Kahana Oculoplastic and Orbital Surgery Site - 0112
Livonia, Michigan 48152
United StatesActive - Recruiting
Site - 0112
Livonia, Michigan 48152
United StatesActive - Recruiting
W.K. Kellogg Eye Center - Site 840-126
Ann Arbor 4984247, Michigan 5001836 48105
United StatesActive - Recruiting
Michigan State University - Site 840-127
East Lansing 4991640, Michigan 5001836 48824
United StatesActive - Recruiting
Kahana Oculoplastic and Orbital Surgery - Site 840-112
Livonia 4999837, Michigan 5001836 48152
United StatesActive - Recruiting
Mayo Clinic - 0102
Rochester, Minnesota 55905
United StatesActive - Recruiting
Mayo Clinic - Site 840-102
Rochester, Minnesota 55905
United StatesSite Not Available
Mayo Clinic Site - 0102
Rochester, Minnesota 55905
United StatesSite Not Available
Mayo Clinic - Site 840-102
Rochester 5043473, Minnesota 5037779 55905
United StatesSite Not Available
University of Missouri-Kansas City School of Medicine
Kansas City, Missouri 64108
United StatesActive - Recruiting
University of Missouri-Kansas City School of Medicine - Site 840-130
Kansas City, Missouri 64108
United StatesSite Not Available
University of Missouri-Kansas City School of Medicine - Site 840-130
Kansas City 4393217, Missouri 4398678 64108
United StatesActive - Recruiting
Ophthalmic Plastic, Reconstructive, Orbital & Cosmetic Surgery - Site 840-123
Las Vegas, Nevada 89144
United StatesSite Not Available
Ophthalmic Plastic, Reconstructive, Orbital & Cosmetic Surgery - Site 840-123
Las Vegas 5506956, Nevada 5509151 89144
United StatesActive - Recruiting
Hackensack University Medical Center - Site 840-105
Hackensack, New Jersey 07601
United StatesSite Not Available
Hackensack University Medical Center Site - 0105
Hackensack, New Jersey 07601
United StatesActive - Recruiting
Hackensack University Medical Center - Site 840-105
Hackensack 5098706, New Jersey 5101760 07601
United StatesActive - Recruiting
Columbia University - Site 840-125
New York, New York 10032
United StatesSite Not Available
Columbia University - Site 840-125
New York 5128581, New York 5128638 10032
United StatesActive - Recruiting
Site - 0104
Chapel Hill, North Carolina 27517
United StatesActive - Recruiting
University of North Carolina at Chapel Hill - Site 840-104
Chapel Hill, North Carolina 27517
United StatesSite Not Available
University of North Carolina at Chapel Hill Site - 0104
Chapel Hill, North Carolina 27517
United StatesActive - Recruiting
University of North Carolina at Chapel Hill - Site 840-104
Chapel Hill 4460162, North Carolina 4482348 27517
United StatesActive - Recruiting
Bergstrom Eye Research - Site 840-134
Fargo, North Dakota 58103
United StatesSite Not Available
Bergstrom Eye Research Site - 0134
Fargo, North Dakota 58103
United StatesActive - Recruiting
Bergstrom Eye Research - Site 840-134
Fargo 5059163, North Dakota 5690763 58103
United StatesActive - Recruiting
Eye Physicians, LLC - Site 840-118
Columbus, Ohio 43215
United StatesSite Not Available
Eye Physicians, LLC Site - 0118
Columbus, Ohio 43215
United StatesActive - Recruiting
Site - 0118
Columbus, Ohio 43215
United StatesActive - Recruiting
Eye Physicians, LLC - Site 840-118
Columbus 4509177, Ohio 5165418 43215
United StatesSite Not Available
Headlands Research - TMA - Site 840-132
Myrtle Beach, South Carolina 29572
United StatesSite Not Available
Headlands Research - TMA Site - 0132
Myrtle Beach, South Carolina 29572
United StatesActive - Recruiting
Headlands Research - TMA Site - 132
Myrtle Beach, South Carolina 29572
United StatesActive - Recruiting
Headlands Research - TMA - Site 840-132
Myrtle Beach 4588718, South Carolina 4597040 29572
United StatesActive - Recruiting
Academy of Diabetes, Thyroid, and Endocrine - Site 840-129
El Paso, Texas 79935
United StatesSite Not Available
Academy of Diabetes, Thyroid, and Endocrine Site - 0129
El Paso, Texas 79935
United StatesActive - Recruiting
DCT Fort Worth Research Center - Site 840-133
Fort Worth, Texas 76132
United StatesSite Not Available
DCT Fort Worth Research Center Site - 0133
Fort Worth, Texas 76132
United StatesActive - Recruiting
Houston Methodist Hospital - Site 840-124
Houston, Texas 77030
United StatesActive - Recruiting
Neuro-Eye Clinical Trials, Inc - Site 840-106
Houston, Texas 77004
United StatesSite Not Available
Neuro-Eye Clinical Trials, Inc Site - 0106
Houston, Texas 77004
United StatesActive - Recruiting
Site - 0106
Houston, Texas 77004
United StatesActive - Recruiting
Site - 0120
San Antonio, Texas 78215
United StatesActive - Recruiting
Sun Research Institute - Site 840-120
San Antonio, Texas 78215
United StatesSite Not Available
Sun Research Institute Site - 0120
San Antonio, Texas 78215
United StatesActive - Recruiting
Academy of Diabetes, Thyroid, and Endocrine - Site 840-129
El Paso 5520993, Texas 4736286 79935
United StatesActive - Recruiting
DCT Fort Worth Research Center - Site 840-133
Fort Worth 4691930, Texas 4736286 76132
United StatesActive - Recruiting
Houston Methodist Hospital - Site 840-124
Houston 4699066, Texas 4736286 77030
United StatesActive - Recruiting
Neuro-Eye Clinical Trials, Inc - Site 840-106
Houston 4699066, Texas 4736286 77004
United StatesSite Not Available
Sun Research Institute - Site 840-120
San Antonio 4726206, Texas 4736286 78215
United StatesActive - Recruiting
Site - 0113
Morgantown, West Virginia 26506
United StatesActive - Recruiting
University of West Virginia - Site 840-113
Morgantown, West Virginia 26506
United StatesSite Not Available
University of West Virginia Site - 0113
Morgantown, West Virginia 26506
United StatesActive - Recruiting
University of West Virginia - Site 840-113
Morgantown 4815352, West Virginia 4826850 26506
United StatesActive - Recruiting

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