Efgartigimod for Bullous Pemphigoid

(BALLAD+ Trial)

Recruiting at 60 trial locations

Overseen By Sabine s Coppieters, MD

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: argenx

Disqualifiers: Significant disease, Recent surgery, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 13

Duration: 48 weeks

64 Participants Needed

Trial Summary

What is the purpose of this trial?

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

Eligibility Criteria

Adults with Bullous Pemphigoid who completed a previous study (ARGX-113-2009) can join. They must agree to use contraception, be able to consent, and not have any health issues or recent surgeries that could risk their safety or skew the study's results.

Inclusion Criteria

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 IMP and must use one of the contraception methods described in the protocol from signing the ICF until the last dose of IMP

Is capable of providing signed informed consent and complying with protocol requirements

You have finished the week 36 check-up for the ARGX-113-2009 study.

Exclusion Criteria

I have no major surgeries planned and no health issues that would risk my safety in the study.

I stopped taking a trial drug due to side effects and it was not beneficial for me.

You are allergic to the study medication or any of its ingredients.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive efgartigimod PH20 SC for up to 48 weeks

48 weeks

5 initial visits, then every 4 weeks

Observation

Participants not receiving efgartigimod PH20 SC are monitored with visits every 8 weeks

Variable, depending on participant status

Every 8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

8 weeks

Treatment Details

Interventions

• efgartigimod PH20 SC
• Prednisone

Trial Overview The trial is testing efgartigimod PH20 SC as a long-term treatment for Bullous Pemphigoid. It aims to control symptoms and achieve remission while reducing reliance on oral steroids like Prednisone.

Participant Groups

Group I: efgartigimod PH20 SC Experimental Treatment 2 Interventions

participants receiving efgartigimod PH20 SC on top of Prednisone

Who Is Running the Clinical Trial?

argenx

Lead Sponsor

Trials

76

Recruited

11,500+

Tim Van Hauwermeiren

argenx

Chief Executive Officer since 2008

B.Sc. and M.Sc. in Bioengineering from Ghent University, Executive MBA from The Vlerick School of Management

Dr. Peter Ulrichts

argenx

Chief Medical Officer since 2023

MD from Maastricht University, PhD in Molecular Immunology from Maastricht University