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

Study acronym: VitaliThy
StatusRecruiting
PhasePhase 3
Sponsorargenx
Started2026-06-10
View on ClinicalTrials.gov ↗

Amendment history

2026-09-23
Trial sites expanded: 17 → 29 locations
2026-08-20
Study Status, Outcome Measures, Contacts/Locations v2
Trial sites expanded: 12 → 17 locations
Trial sites expanded: 7 → 12 locations
Secondary endpoints21 to 23 entries
Percentage of participants who remain euthyroid off ATDs Percentage of participants who are euthyroid and receiving MMI ≤5 mg/day or CBZ ≤7.5 mg/day
2026-07-07
Study Status, Study Description, Contacts/Locations, References v1
Recruitment opened
Trial sites expanded: 0 → 7 locations
Start dateestimated 2026-06→confirmed 2026-06-10
2026-05-13
Original filing
Argenx
56 trials monitored
See 2 trials at risk
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
Trial Details
NCT Number NCT07596849
Lead Sponsor argenx
Conditions Graves Disease
Enrollment 230 participants
Start Date 2026-06-10
Primary Completion 2028-06 (estimated)
Study Completion 2030-05 (estimated)
Updated on ClinicalTrials.gov 2026-09-24