Clinical Trial – A Study of Efgartigimod PH20 SC Given by Prefilled Syringe in Adults With Thyroid Eye Disease

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

Condition
Thyroid Eye Disease – TED

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

Intervention

Combination Product: Efgartigimod PH20 SC or Other: Placebo PH20 SC

Delivery

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.

Time between treatments

1 week

EU Trial (CTIS) Recruiting

Recruiting globally

Recruiting

216

NCT Number

NCT06307626

EU Trial (CTIS) Number

2023-509198-22-00

Study Name

ARGX-113-2309 or ARGX-113-2301

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