NCT06503731

A Study to Evaluate the Safety and Tolerability of Efgartigimod PH20 SC Given by Prefilled Syringe in Kidney Transplant Recipients With Antibody-Mediated Rejection (AMR)

A Global, Multicenter, Randomized, Double-Blinded, Placebo-Controlled, Phase 2 Study to Evaluate the Safety, Tolerability, and Efficacy of Efgartigimod PH20 SC Administered by a Prefilled Syringe in Kidney Transplant Recipients With Antibody-Mediated Rejection

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: argenx · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the safety, tolerability, and efficacy of efgartigimod PH20 SC given by a prefilled syringe in participants with Antibody-Mediated Rejection (AMR) after kidney transplantation. After a screening period of up to 6 weeks, eligible participants will be randomized in a 1:1:1 ratio. The study drug will be administered subcutaneously while patients remain on their standard background immunosuppression therapy (tacrolimus, mycophenolate mofetil, steroids) during the treatment period (48 weeks). At the end of the treatment period, the participants will enter an observational/follow-up period (approximately 24 weeks). The participants will be in the study for up to 78 weeks.

Conditions

• Antibody-mediated Rejection

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Efgartigimod PH20 SC - prefilled syringe	Subcutaneous efgartigimod PH20 SC given by prefilled syringe
OTHER	Placebo PH20 SC - prefilled syringe	Subcutaneous placebo PH20 SC given by prefilled syringe

Timeline

• Start date: 2024-08-30
• Primary completion: 2027-09-01
• Completion: 2027-09-01
• First posted: 2024-07-16
• Last updated: 2026-03-18

Locations

23 sites across 8 countries: United States, Austria, Belgium, Canada, Czechia, France, Germany, Spain

Regulatory

• FDA-regulated drug study