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

Conditions

• Bullous Pemphigoid

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• efgartigimod PH20 SC — BIOLOGICAL
  Subcutaneous injection of efgartigimod coformulated with rHuPH20, a permeation enhancer
• Prednisone — DRUG
  Oral Prednisone

Study Details

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.

Key Dates

Start date

Mar 22, 2023

Status verified

Feb 2026

Primary completion

Mar 20, 2025

Completion

Mar 20, 2025

Study Design

Enrollment

64 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: efgartigimod PH20 SC
  participants receiving efgartigimod PH20 SC on top of Prednisone

Primary Outcome Measure

Number of Participants With Treatment-emergent AEs, SAEs and AESIs [ Time Frame: Up to 56 weeks ]

Locations (6)

Find similar trials in Phoenix, AZ

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