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A Study to Assess Efficacy and Safety of Efgartigimod PH20 SC PFS in Adult Participants With Graves' Disease.
Sponsor: argenx
Summary
The main purpose of this study is to look at how efgartigimod affects thyroid function in adults with Graves' Disease (GD). The study will also check whether efgartigimod is safe and well tolerated. It will look at how efgartigimod is distributed and eliminated in the body, how it changes antibody levels, and how the immune system responds to it. The study consists of a part A double-blinded treatment period, a part B treatment/observation period and a part C open-label treatment/observation period. During the part A and part B treatment periods, participants will receive efgartigimod PH20 SC via Prefilled Syringe (PFS) or placebo. During the part C open-label treatment period, participants will receive efgartigimod PH20 SC PFS. Participation in the different parts of the study will depend on the participant's response to treatment. The total study duration for participants ranges from 63 to 135 weeks, depending on the response to treatment. More information can be found here: https://clinicaltrials.argenx.com/vitalithy
Official title: A Phase 3, Randomized, Double-Masked, Placebo-Controlled, Multicenter Study Evaluating the Efficacy and Safety of Efgartigimod PH20 SC PFS in Adult Participants With Graves' Disease Inadequately Controlled With Antithyroid Drugs
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
230
Start Date
2026-06-10
Completion Date
2030-05
Last Updated
2026-09-24
Healthy Volunteers
No
Conditions
Interventions
efgartigimod PH20 SC
Subcutaneous injection of Efgartigimod PH20 Via Prefilled Syringe (PFS)
Placebo PH20 SC
Subcutaneous injection of placebo PH20 via Prefilled Syringe (PFS)
Locations (29)
Medical Center Tonus - 2013 OOD
Pazardzhik, Bulgaria
Multiprofile Hospital for Active Treatment Hadzhi Dimitar OOD
Sliven, Bulgaria
Diagnostic Consultative Center Ekvita OOD
Varna, Bulgaria
MC Klinika Nova
Varna, Bulgaria
Multi-Profile District Hospital for Active Treatment Dr. Stefan Cherkezov
Veliko Tarnovo, Bulgaria
Endocrinologie Oasis
Montreal, Quebec, Canada
TLC Diabetes and Endocrinology Clinic
Surrey, Canada
High Technology Hospital Medcenter LLC
Batumi, Georgia
First Medical Clinic Ltd
Tbilisi, Georgia
LTD MediClub Georgia
Tbilisi, Georgia
Juntendo University Hospital
Bunkyō-Ku, Tokyo, Japan
Toho University Omori Medical Center
Ōta-ku, Tokyo, Japan
Aso Iizuka Hospital
Iizuka, Japan
Nippon Medical School Musashikosugi Hospital
Kawasaki, Japan
Hospital of University of Occupational and Environmental Health
Kitakyushu, Japan
National Hospital Organization Kyoto Medical Center
Kyoto, Japan
Nagasaki University Hospital
Nagasaki, Japan
Ito Hospital
Shibuya City, Japan
SHOWA Medical University Northern Yokohama Hospital
Yokohama, Japan
Tottori University Hospital
Yonago, Japan
LTD M & M Centers
Adazi, Latvia
Hospital of Lithuanian University of Health Sciences Kaunas
Kaunas, Kauno, Lithuania
Klaipeda's University Hospital
Klaipėda, Lithuania
Osrodek Medyczny Osteomed
Krakow, Lesser Poland Voivodeship, Poland
NZOZ Holsamed- Oddzial Libero
Katowice, Silesian Voivodeship, Poland
Centrum Medyczne INTERCOR Sp. z o.o.
Bydgoszcz, Poland
ETC Zamosc
Zamość, Poland
Clinical Hospital of Emergency Sibiu Ambulatory if Endocrinology
Sibiu, Sibiu County, Romania
Instituto De Investigacion Marques De Valdecilla (IDIVAL
Santander, Spain