A Study to Assess Efficacy and Safety of Efgartigimod PH20 SC PFS in Adult Participants With Graves' Disease. (NCT07596849)
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
🩺 Plain-English Summary (8th-Grade Level)
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
Who can join: Review the eligibility criteria below.
Location: TLC Diabetes and Endocrinology Clinic — Surrey
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (12 Sites)
- TLC Diabetes and Endocrinology Clinic — Surrey,
- High Technology Hospital Medcenter LLC — Batumi,
- First Medical Clinic Ltd — Tbilisi,
- LTD MediClub Georgia — Tbilisi,
- Aso Iizuka Hospital — Iizuka,
- Nippon Medical School Musashikosugi Hospital — Kawasaki,
- Hospital of University of Occupational and Environmental Health — Kitakyushu,
- National Hospital Organization Kyoto Medical Center — Kyoto,
- Nagasaki University Hospital — Nagasaki,
- Ito Hospital — Shibuya City,
- SHOWA Medical University Northern Yokohama Hospital — Yokohama,
- Tottori University Hospital — Yonago,
📞 Contact the Study Coordinator
Phone: (857) 350-4834
Email: clinicaltrials@argenx.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Graves Disease
- Evaluating an AI Tool for Detecting Thyrotoxic States — San Francisco, California
- Impact of Vitamin D Therapy on Thyroid Function and Antibody Levels in Pediatric Graves' Disease — New Hyde Park, New York
- Study to Determine if BHV-1300 is Effective and Safe in Adults With Graves' Disease — Burbank, California
- Preoperative Corticosteroids in Autoimmune Thyroid Disease — Indianapolis, Indiana
- Study of BHV-1300 in Graves' Disease — South Gate, California
- NEXUS Study: A Study to Test Single and Multiple Doses of MER511 Given to Adults With Graves' Disease — Torrance, California
Explore by condition: All Graves Disease clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.