RecruitingPhase 3NCT07596849

A Study to Assess Efficacy and Safety of Efgartigimod PH20 SC PFS in Adult Participants With Graves' Disease.

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


Sponsor

argenx

Enrollment

230 participants

Start Date

Jun 10, 2026

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying Placebo PH20 SC and a biological treatment called efgartigimod PH20 SC for people with graves disease. The study is currently recruiting participants at 7 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALefgartigimod PH20 SC

Subcutaneous injection of Efgartigimod PH20 Via Prefilled Syringe (PFS)

OTHERPlacebo PH20 SC

Subcutaneous injection of placebo PH20 via Prefilled Syringe (PFS)


Locations(17)

Multiprofile Hospital for Active Treatment Hadzhi Dimitar OOD

Sliven, 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

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

Hospital of Lithuanian University of Health Sciences Kaunas

Kaunas, Kauno, Lithuania

Centrum Medyczne INTERCOR Sp. z o.o.

Bydgoszcz, Poland

ETC Zamosc

Zamość, Poland

View Full Details on ClinicalTrials.gov

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NCT07596849


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