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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
2026-11-03
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 (35)
Profound Research LLC at Tri-City Primary Care
Carlsbad, California, United States
Diabetes Associates Medical Group
Orange, California, United States
Pasadena Clinical Trials
Pasadena, California, United States
Havana Research Institute LLC.
Pasadena, California, United States
San Jose Clinical Trials
San Jose, California, United States
Northeast Florida Endocrine & Diabetes Associates (NEFEDA) - Orange Park Location
Fleming Island, Florida, United States
The Center for Diabetes and Endocrine Care
Fort Lauderdale, Florida, United States
University of Florida Jacksonville College of Medicine
Jacksonville, Florida, United States
Ilumina Medical Research LLC
Kissimmee, Florida, United States
Oceane 7 Medical & Research Center, Inc
Miami, Florida, United States
Johnson County Clin-Trials, Inc.
Lenexa, Kansas, United States
Alliance for Multispecialty Research, LLC
Wichita, Kansas, United States
University of Michigan
Ann Arbor, Michigan, United States
Metro Detroit Endocrinology Center
Dearborn, Michigan, United States
Profound Research
Farmington Hills, Michigan, United States
Truman Medical Center
Kansas City, Missouri, United States
Albany Medical College Community Endocrinology
Albany, New York, United States
Endocrine Associates of West Village PC
New York, New York, United States
Asheville Clinical Research
Asheville, North Carolina, United States
Wake Internal Medicine Consultants
Raleigh, North Carolina, United States
Research Institute of Dallas
Dallas, Texas, United States
Frontier Medical Center - Academy of Diabetes Thyroid and Endocrine
El Paso, Texas, United States
Juno Research
Houston, Texas, United States
Clinic of Endocrinology
Houston, Texas, United States
Tekton Research Irving
Irving, Texas, United States
Biopharma Informatic, LLC
McAllen, Texas, United States
Tekton Research - McKinney
McKinney, Texas, United States
Southern Endocrinology Associates PA
Mesquite, Texas, United States
Consano Clinical Research
Shavano Park, Texas, United States
LLC American Hospital Network
Tbilisi, Georgia
LTD Israeli-Georgian Medical Research Clinic Healthycore
Tbilisi, Georgia
New Hospitals
Tbilisi, Georgia
LLC Todua Clinic
Tbilisi, Georgia
In Vitro Fertilization Center LLC
Tbilisi, Georgia
Queen Elizabeth Hospital (Gateshead Health NHS Foundation Trust)
Gateshead, Tyne and Wear, United Kingdom