A Phase 2/3 Study 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
• placebo — OTHER
  Subcutaneous injection of placebo coformulated with rHuPH20, a permeation enhancer
• Prednisone — DRUG
  Oral Prednisone

Study Details

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).

Key Dates

Start date

Jun 9, 2022

Status verified

Sep 2025

Primary completion

Sep 13, 2024

Completion

Sep 13, 2024

Study Design

Enrollment

98 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

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

Primary Outcome Measure

Number of Participants With CRoff at Week 36 [ Time Frame: at week 36 ]

Locations (21)

Find similar trials in Phoenix, AZ

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