NCT05681481

A Phase 3 Study to Evaluate the Long-term Safety, Tolerability and Efficacy of Efgartigimod PH20 SC in Adult Participants With Bullous Pemphigoid

An Open-label Extension Study of ARGX-113-2009 to Evaluate the Long Term Safety, Tolerability, and Efficacy of Efgartigimod PH20 SC in Adult Participants With Bullous Pemphigoid

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: argenx · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety of efgartigimod PH20 SC over a longer period of time in adult participants with moderate-to-severe bullous pemphigoid (BP) who have completed ARGX-113-2009 study. The study will also evaluate the efficacy of efgartigimod PH20 SC. Eligible participants can roll over from the main study (ARGX-113-2009) to this open-label extension study (ARGX-113-2010). The study consists of a treatment period of up to 48 weeks in which participants could receive efgartigimod PH20 SC according to their clinical status. After the first 5 visits, the participants will visit the study centres at least once every 4 weeks. The participants who are not receiving efgartigimod PH20 SC (after the main study or currently on the study), will enter an observation period with study visits at least once every 8 weeks. If the participant relapses, they can re-enter the treatment period where they will receive efgartigimod PH20 SC. The treatment and observation period is followed by a follow-up period of 8 weeks. Oral or topical corticosteroids can be administered at the investigator's discretion.

Conditions

• Bullous Pemphigoid

Interventions

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

Timeline

• Start date: 2023-03-22
• Primary completion: 2025-03-20
• Completion: 2025-03-20
• First posted: 2023-01-12
• Last updated: 2026-02-25
• Results posted: 2026-02-25

Locations

40 sites across 17 countries: United States, Australia, Bulgaria, China, Croatia, Czechia, Germany, Greece, Hungary, Israel, Italy, Japan, Netherlands, Serbia, Slovakia, Spain, United Kingdom

Regulatory

• FDA-regulated drug study