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Monoclonal Antibodies

Efgartigimod for Bullous Pemphigoid (BALLAD+ Trial)

Phase 3

Recruiting

Research Sponsored by argenx

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up for participants continuing/starting efgartigimod ph20 sc treatment at rollover or relapse: at weeks 0, 2, 4 and 8 and then every 4 weeks to efgartigimod stop, every 8 weeks after efgartigimod stop and at weeks 48, 52 and 56.

Awards & highlights

BALLAD+ Trial Summary

This trial aims to provide evidence that efgartigimod PH20 SC is a safe and effective treatment for people with bullous pemphigoid, reducing symptoms and exposure to oral corticosteroids.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Potential side effects of efgartigimod PH20 SC may include reactions at the injection site, general discomfort, possible immune system changes leading to increased infection risk, and allergic reactions if sensitive to the drug.

BALLAD+ Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ for participants continuing/starting efgartigimod ph20 sc treatment at rollover or relapse: at weeks 0, 2, 4 and 8 and then every 4 weeks until efgartigimod stop, every 8 weeks after efgartigimod stop and at weeks 48, 52 and 56.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~for participants continuing/starting efgartigimod ph20 sc treatment at rollover or relapse: at weeks 0, 2, 4 and 8 and then every 4 weeks until efgartigimod stop, every 8 weeks after efgartigimod stop and at weeks 48, 52 and 56.

This trial's timeline: 3 weeks for screening, Varies for treatment, and for participants continuing/starting efgartigimod ph20 sc treatment at rollover or relapse: at weeks 0, 2, 4 and 8 and then every 4 weeks until efgartigimod stop, every 8 weeks after efgartigimod stop and at weeks 48, 52 and 56. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Incidence of adverse events of special interest

Incidence of serious adverse events

Incidence of treatment-emergent adverse events

+4 more

Secondary outcome measures

Autoimmune Bullous Disease Quality of Life (ABQoL) scores over time

Bullous Pemphigoid Disease Area Index (BPDAI) activity scores over time

Dermatology Life Quality Index (DLQI) scores over time

+20 more

BALLAD+ Trial Design

1Treatment groups

Experimental Treatment

Group I: efgartigimod PH20 SCExperimental Treatment2 Interventions

participants receiving efgartigimod PH20 SC on top of Prednisone

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

efgartigimod PH20 SC

2021

Completed Phase 3

~390

Prednisone

2014

Completed Phase 4

~2370

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

argenxLead Sponsor

60 Previous Clinical Trials

9,095 Total Patients Enrolled

Media Library

efgartigimod PH20 SC (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05681481 — Phase 3

Bullous Pemphigoid Research Study Groups: efgartigimod PH20 SC

Bullous Pemphigoid Clinical Trial 2023: efgartigimod PH20 SC Highlights & Side Effects. Trial Name: NCT05681481 — Phase 3

efgartigimod PH20 SC (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05681481 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has efgartigimod PH20 SC been given regulatory clearance by the FDA?

"Taking into account the Phase 3 status of efgartigimod PH20 SC, which is indicative of both efficacy and multiple safety studies, our team at Power ranked its safety as a 3."

Answered by AI

Are there any available vacancies for prospective participants in this clinical investigation?

"According to information posted on clinicaltrials.gov, this trial is actively searching for prospective participants. It was published on March 22nd 2023 and the most recent update occured September 21st of that same year."

Answered by AI

How many participants are actively taking part in the research?

"Affirmative. Clinicaltrials.gov reveals that this trial, first posted on March 22nd 2023, is actively looking for participants. The study requires 160 patients to be recruited from 4 different medical facilities."

Answered by AI

What is the ultimate purpose of this clinical experiment?

"This study, which has a maximum duration of 56 weeks, measures the Severity of treatment-emergent adverse events as its primary outcome. The secondary outcomes are Proportion of participants achieving complete remission while off oral corticosteroids for ≥ 8 weeks; Prevalence of antidrug antibody(ies) (ADA) against efgartigimod (serum levels); and Proportion of participants achieving complete remission or partial remission while off oral corticosteroids for ≥ 8 weeks."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2023. "A Phase 3 Study to Evaluate the Long-term Safety, Tolerability and Efficacy of Efgartigimod PH20 SC in Adult Participants With Bullous Pemphigoid". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05681481.

All > Bullous Pemphigoid