NCT05267600

A Phase 2/3 Study of Efgartigimod PH20 SC in Adult Participants With Bullous Pemphigoid

A Phase 2/3, Randomized, Double-Blinded, Placebo-Controlled, Parallel-Group Study to Investigate the Efficacy and Safety of Efgartigimod PH20 SC in Adult Participants With Bullous Pemphigoid

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 98 (actual)
• Sponsor: argenx · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

ARGX-113-2009 is an operationally seamless 2-part, phase 2/3, prospective, global, multicenter, randomized, double-blinded, placebo-controlled study to investigate the efficacy, safety, tolerability, immunogenicity, participant-reported outcome measures (including those assessing participant QoL), PK, and PD of efgartigimod PH20 SC administered via subcutaneous (SC) injection in adult participants with moderate to severe BP. This study intends to demonstrate that efgartigimod is an effective and safe treatment for BP, providing participants with control of disease activity (CDA) and eventually remission while reducing their cumulative exposure to OCS. study will consist of 2 parts: * Part A of the study is a phase 2 evaluation that intends to provide proof of concept for the therapeutic activity of efgartigimod PH20 SC in participants with BP. * Part B of the study is a phase 3 evaluation that intends to confirm the results obtained from part A in a separate, larger group of participants with BP. An interim analysis will be performed during part A (on data obtained through week 26 for all Part A participants) to assess the primary endpoint and several secondary endpoints, confirm the appropriate sample size for part B of the study, and determine whether the efficacy results observed through week 26 of part A warrant continued study of efgartigimod PH20 SC for the treatment of participants with BP (futility analysis).

Conditions

• Bullous Pemphigoid

Interventions

Type	Name	Description
BIOLOGICAL	efgartigimod PH20 SC	Subcutaneous injection of efgartigimod coformulated with rHuPH20, a permeation enhancer
OTHER	placebo	Subcutaneous injection of placebo coformulated with rHuPH20, a permeation enhancer
DRUG	Prednisone	Oral Prednisone

Timeline

• Start date: 2022-06-09
• Primary completion: 2024-09-13
• Completion: 2024-09-13
• First posted: 2022-03-04
• Last updated: 2025-10-23
• Results posted: 2025-10-23

Locations

129 sites across 21 countries: United States, Australia, Bulgaria, China, Croatia, Czechia, France, Germany, Greece, Hungary, Israel, Italy, Japan, Latvia, Netherlands, Poland, Romania, Serbia, Slovakia, Spain, United Kingdom

Regulatory

• FDA-regulated drug study