A Study to Assess Efficacy and Safety of Efgartigimod PH20 SC PFS in Adult Participants With Graves' Disease
Start Date
6/10/2026
Completion Date
5/1/2030
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
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
Efgartigimod PH20 SC
Placebo PH20 SC
Conditions
Locations
Diabetes Associates Medical Group
Orange, California 92868
United States
Havana Research Institute LLC.
Pasadena, California 91105
United States
Northeast Florida Endocrine & Diabetes Associates (NEFEDA) - Orange Park Location
Fleming Island, Florida 32003
United States
The Center for Diabetes and Endocrine Care
Fort Lauderdale, Florida 33312
United States
Ilumina Medical Research LLC
Kissimmee, Florida 34744
United States
Johnson County Clin-Trials, Inc.
Lenexa, Kansas 66219
United States
Metro Detroit Endocrinology Center
Dearborn, Michigan 48126
United States
Profound Research
Farmington Hills, Michigan 48334
United States
Endocrine Associates of West Village PC
New York, New York 10016
United States
Research Institute of Dallas
Dallas, Texas 75231
United States
Juno Research
Houston, Texas 77040
United States
Tekton Research Irving
Irving, Texas 75039
United States
Biopharma Informatic, LLC
McAllen, Texas 78503
United States
Tekton Research - McKinney
McKinney, Texas 75069
United States
Southern Endocrinology Associates PA
Mesquite, Texas 75149
United States
Consano Clinical Research
Shavano Park, Texas 78231
United States
New Hospitals
Tbilisi, 0114
Georgia
LLC Todua Clinic
Tbilisi, 0119
Georgia