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Saint Louis University | SLUCare Academic Pavilion - Endocrinology Division Research

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

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Status and phase

Invitation-only
Phase 3

Conditions

Bullous Pemphigoid

Treatments

Drug: Prednisone
Biological: efgartigimod PH20 SC

Study type

Interventional

Funder types

Industry

Identifiers

NCT05681481
ARGX-113-2010

Details and patient eligibility

About

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 receive efgartigimod PH20 SC. After the first 5 visits, the participants will visit the study centers 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 corticosterioids can be administered at the investigator's indiscretion

Enrollment

160 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Has completed the week 36 visit of ARGX-113-2009
  • Is capable of providing signed informed consent and complying with protocol requirements
  • Agrees to use contraceptive measures consistent with local regulations and the following: Women of childbearing potential must have a negative urine pregnancy test at baseline before receiving the study drug and must use one of the contraception methods described in the protocol from signing the ICF until the last dose of the study drug

Exclusion criteria

  • Clinically significant disease, recent major surgery (within 3 months of baseline), or intends to have surgery during the study; or any other medical condition that, in the investigator's opinion would confound the results of the study or put the participant at undue risk
  • Known hypersensitivity to the study drug or 1 of its excipients
  • Permanently discontinued IMP in ARGX-113-2009 due to an adverse event (AE) considered related to the study drug and for whom the benefit/risk balance is not considered positive

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

160 participants in 1 patient group

efgartigimod PH20 SC
Experimental group
Description:
participants receiving efgartigimod PH20 SC on top of Prednisone
Treatment:
Biological: efgartigimod PH20 SC
Drug: Prednisone

Trial contacts and locations

36

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Central trial contact

Sabine Coppieters, MD

Data sourced from clinicaltrials.gov

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