Study Overview- This study aims to evaluate the efficacy, safety and tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of efgartigimod PH20 SC in participants with active, moderate-to-severe TED, compared with placebo PH20 SC.
After the screening period, eligible participants will be randomized in a 2:1 ratio to receive efgartigimod PH20 SC or placebo PH20 SC, respectively during the double-blinded treatment period (DBTP). At the end of the DBTP, participants may enter a follow-up observational period while off study drug. Some participants may also enter the open-label treatment period with efgartigimod PH20 SC. The study duration varies from approximately 60-110 weeks
A Phase 3, Randomized, Double-Masked, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Efgartigimod PH20 SC Administered by Prefilled Syringe in Adult Participants With Thyroid Eye Disease
Combination Product: Efgartigimod PH20 SC or Other: Placebo PH20 SC
Subcutaneous Injection
Total Number of treatments – 24-weeks Double-Blinded Treatment Period; Follow-up observational period while off drug or open-label treatment period with efgartigimod PH20 SC. Complete study duration varies from approximately 60-110 weeks.
1 week
Recruiting globally
216
NCT06307626
2023-509198-22-00
ARGX-113-2309 or ARGX-113-2301