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
Status: Recruiting
Location: See all (12) locations...
Intervention Type: Biological, Other
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Is at least 18 years of age and the local legal age of consent for clinical studies when 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) \<0.1 mIU/L at screening
• Has been treated with MMI (methimazole) or CBZ (carbimazole) for at least 3 months before screening
Locations
Other Locations
Canada
TLC Diabetes and Endocrinology Clinic
RECRUITING
Surrey
Georgia
High Technology Hospital Medcenter LLC
RECRUITING
Batumi
First Medical Clinic Ltd
RECRUITING
Tbilisi
LTD MediClub Georgia
RECRUITING
Tbilisi
Japan
Aso Iizuka Hospital
RECRUITING
Iizuka
Nippon Medical School Musashikosugi Hospital
RECRUITING
Kawasaki
Hospital of University of Occupational and Environmental Health
RECRUITING
Kitakyushu
National Hospital Organization Kyoto Medical Center
RECRUITING
Kyoto
Nagasaki University Hospital
RECRUITING
Nagasaki
Ito Hospital
RECRUITING
Shibuya City
SHOWA Medical University Northern Yokohama Hospital
RECRUITING
Yokohama
Tottori University Hospital
RECRUITING
Yonago
Contact Information
Primary
Sabine Coppieters, MD
clinicaltrials@argenx.com
857-350-4834
Time Frame
Start Date:2026-06-10
Estimated Completion Date:2030-05
Participants
Target number of participants:230
Treatments
Experimental: Part A - efgartigimod PH20 SC PFS
Participants will receive efgartigimod PH20 SC Via Prefilled Syringe (PFS) during the part A double-blinded treatment period.
Placebo_comparator: Part A - placebo PH20 SC PFS
Participants will receive placebo PH20 SC Via Prefilled Syringe (PFS) during the part A double-blinded treatment period.
Experimental: Part B - efgartigimod PH20 SC PFS
Participants will receive efgartigimod PH20 SC Via Prefilled Syringe (PFS) during the part B treatment period.
Experimental: Part B - placebo PH20 SC PFS
Participants will receive placebo PH20 SC Via Prefilled Syringe (PFS) during the part B treatment period.
Experimental: Part C - efgartigimod PH20 SC PFS
Participants, will receive efgartigimod PH20 SC PFS in the part C open-label treatment period