Phase
Condition
N/ATreatment
Placebo PH20 SC
efgartigimod PH20 SC
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Is at least 18 years of age and the local legal age of consent for clinical studieswhen signing the ICF.
Has a documented diagnosis of GD with TRAb (anti-thyrotropin receptor antibody)levels >=ULN (upper limit of normal) at screening
Has active hyperthyroidism due to GD with TSH (thyroid-stimulating hormone) <0.1mIU/L at screening
Has been treated with MMI (methimazole) or CBZ (carbimazole) for at least 3 monthsbefore screening
Exclusion
Exclusion Criteria:
History of hyperthyroidism not caused by GD (eg, toxic adenoma or toxic multinodulargoiter)
History of RAI (radioactive iodine) therapy or received a total thyroidectomy
T3- or T4-containing medication or supplement (eg, levothyroxine, liothyronine,desiccated thyroid preparations, or thyroid-support supplements) received <6 weeksbefore screening
Any complication of hyperthyroidism or underlying medical condition that would putthe participant at undue risk. This includes arrhythmia or tachyarrhythmia relatedto GD, such as atrial fibrillation or atrial flutter not sufficiently controlledwith medications.
Graves' orbitopathy/Thyroid Eye Disease (GO/TED) requiring systemic therapy (eg,corticosteroids), orbital injections, orbital surgery, or orbital radiation, orexpected immediate surgical intervention and/or planned correctivesurgery/irradiation or medical therapy during the study
Study Design
Connect with a study center
Medical Center Tonus - 2013 OOD
Pazardzhik, 4400
BulgariaActive - Recruiting
Multiprofile Hospital for Active Treatment Hadzhi Dimitar OOD
Sliven, 8800
BulgariaActive - Recruiting
Diagnostic Consultative Center Ekvita OOD
Varna, 9000
BulgariaActive - Recruiting
MC Klinika Nova
Varna, 9000
BulgariaActive - Recruiting
Multi-Profile District Hospital for Active Treatment Dr. Stefan Cherkezov
Veliko Tarnovo, 5000
BulgariaActive - Recruiting
Endocrinologie Oasis
Montreal, Quebec H4J1E3
CanadaActive - Recruiting
TLC Diabetes and Endocrinology Clinic
Surrey, V3T 2V6
CanadaActive - Recruiting
High Technology Hospital Medcenter LLC
Batumi, 6000
GeorgiaActive - Recruiting
First Medical Clinic Ltd
Tbilisi, 0102
GeorgiaActive - Recruiting
LTD MediClub Georgia
Tbilisi, 0160
GeorgiaActive - Recruiting
Juntendo University Hospital
Bunkyō-Ku, Tokyo 113-8431
JapanActive - Recruiting
Toho University Omori Medical Center
Ōta-ku, Tokyo 143-8541
JapanActive - Recruiting
Aso Iizuka Hospital
Iizuka, 820-8505
JapanActive - Recruiting
Nippon Medical School Musashikosugi Hospital
Kawasaki, 211-8533
JapanActive - Recruiting
Hospital of University of Occupational and Environmental Health
Kitakyushu, 807-8556
JapanActive - Recruiting
National Hospital Organization Kyoto Medical Center
Kyoto, 612-0861
JapanActive - Recruiting
Nagasaki University Hospital
Nagasaki, 852-8501
JapanActive - Recruiting
Ito Hospital
Shibuya City, 150-8308
JapanActive - Recruiting
SHOWA Medical University Northern Yokohama Hospital
Yokohama, 224-8503
JapanActive - Recruiting
Tottori University Hospital
Yonago, 683-8504
JapanActive - Recruiting
LTD M & M Centers
Adazi, LV2164
LatviaActive - Recruiting
Hospital of Lithuanian University of Health Sciences Kaunas
Kaunas, Kauno 50161
LithuaniaActive - Recruiting
Klaipeda's University Hospital
Klaipėda, LT-92288
LithuaniaActive - Recruiting
Osrodek Medyczny Osteomed
Krakow, Lesser Poland Voivodeship 30-074
PolandActive - Recruiting
NZOZ Holsamed- Oddzial Libero
Katowice, Silesian Voivodeship 40-600
PolandActive - Recruiting
Centrum Medyczne INTERCOR Sp. z o.o.
Bydgoszcz, 85-605
PolandActive - Recruiting
ETC Zamosc
Zamość, 22400
PolandActive - Recruiting
Clinical Hospital of Emergency Sibiu Ambulatory if Endocrinology
Sibiu, Sibiu County 550245
RomaniaActive - Recruiting
Instituto De Investigacion Marques De Valdecilla (IDIVAL
Santander, 39011
SpainActive - Recruiting

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