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

Sponsor
argenx
Study ID
NCT07596849
Phase
PHASE3
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • efgartigimod PH20 SC — BIOLOGICAL
    Subcutaneous injection of Efgartigimod PH20 Via Prefilled Syringe (PFS)
  • Placebo PH20 SC — OTHER
    Subcutaneous injection of placebo PH20 via Prefilled Syringe (PFS)

Study Details

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

Key Dates

First listed
May 19, 2026
Start date
Jun 10, 2026
Status verified
Jul 2026
Primary completion
Jun 30, 2028
Completion
May 31, 2030

Study Design

Enrollment
230 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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

Primary Outcome Measure

Percentage of participants who are euthyroid (fT3, fT4, and TSH within normal ranges) off ATDs at week 24 in part A [ Time Frame: up to 24 weeks (part A) ]

Central Contacts

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