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 - VitaliThy

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2071260011

Enrollment

Registered

2026-04-22

Start date

2026-04-22

Completion date

Unknown

Last updated

2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Graves Disease

Interventions

- efgartigimod PH20 SC: subcutaneous injection of efgartigimod PH20 Via Prefilled Syringe - placebo PH20 SC: subcutaneous injection of placebo PH20 via Prefilled Syringe (PFS)

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Main inclusion criteria: - 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

Exclusion criteria

Exclusion criteria: Main exclusion criteria: - History of hyperthyroidism not caused by GD (eg, toxic adenoma or toxic multinodular goiter) - History of RAI (radioactive iodine) therapy or received a total thyroidectomy - T3- or T4-containing medication or supplement (eg, levothyroxine, liothyronine, desiccated thyroid preparations, or thyroid-support supplements) received <6 weeks before screening - Any complication of hyperthyroidism or underlying medical condition that would put the participant at undue risk. This includes arrhythmia or tachyarrhythmia related to GD, such as atrial fibrillation or atrial flutter not sufficiently controlled with medications. - Graves or bitopathy/Thyroid Eye Disease (GO/TED) requiring systemic therapy (eg, corticosteroids), orbital injections, orbital surgery, or orbital radiation, or expected immediate surgical intervention and/or planned corrective surgery/irradiation or medical therapy during the study

Design outcomes

Primary

Measure	Time frame
Percentage of participants who are euthyroid (fT3, fT4, and TSH within normal ranges) off ATDs at week 24 in part A	—

Countries

Belgium, Bulgaria, Canada, China, Czechia, Denmark, France, Georgia, Germany, Greece, Italy, Japan, Latvia, Lithuania, Poland, Romania, Spain, Sweden

Contacts

Public ContactClinical trial contact

ICON Clinical Research GK

Japan-Chiken@iconplc.com+81-6-4560-2001

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Sep 19, 2026