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Monoclonal Antibodies

Dupilumab for Bullous Pemphigoid (LIBERTY-BP Trial)

Q: Can you explain what dupilumab is typically prescribed for?

<p>When it comes to treating <a href="https://www.withpower.com/clinical-trials/atopic-dermatitis">atopic dermatitis</a>, dupilumab is the go-to medication. However, this <a href="https://www.withpower.com/clinical-trials/immunotherapy">immunotherapy</a> drug can also be used for other purposes such as reducing eosinophils or aiding patients that have unsuccessfully tried corticosteroids for their <a href="https://www.withpower.com/clinical-trials/asthma">asthma</a>.</p>

Phase 2 & 3

Waitlist Available

Research Sponsored by Regeneron Pharmaceuticals

Eligibility Criteria Checklist

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

Must have

Study participants are required to have a confirmed diagnosis of BP based on histopathology, immunopathology, and serology at the baseline visit, as defined in the protocol.

Patients must have characteristic clinical features of bullous pemphigoid (BP) (eg, urticarial or eczematous or erythematous plaques, bullae, pruritus) at the screening and baseline visits.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to week 64

Awards & highlights

LIBERTY-BP Trial Summary

This trial is testing whether dupilumab is better than a placebo at achieving remission in patients with bullous pemphigoid, a skin disease.

Who is the study for?

Adults with bullous pemphigoid (BP), a skin condition, can join this trial if they have symptoms like skin plaques or itching, confirmed BP diagnosis through specific tests, and significant disease activity. They must not have used certain medications recently and should be relatively stable in terms of overall health.Check my eligibility

What is being tested?

The study is testing whether dupilumab helps patients with BP stop using oral corticosteroids without the disease coming back. It compares dupilumab to a placebo while measuring itch relief, quality of life improvements, antibody levels in blood, drug safety and body's acceptance of the drug.See study design

What are the potential side effects?

Dupilumab may cause side effects such as inflammation at injection site, eye irritation or redness, headache and cold sores. There might also be an increased risk of allergic reactions among other potential side effects.

LIBERTY-BP Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My diagnosis of BP was confirmed through specific lab tests.

Select...

I have symptoms like itchy blisters or red, swollen patches on my skin.

Select...

My worst itch intensity is 4 or higher on a scale of 0-10.

Select...

I am able to care for myself but may not be able to do active work.

LIBERTY-BP Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to week 64

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to week 64

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to week 64 for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Proportion of patients achieving sustained remission

Secondary outcome measures

Percent change in Bullous Pemphigoid Disease Area Index Activity Score (BPDAI) activity score

Percent change in weekly average of daily peak pruritus numerical rating score (NRS)

Total cumulative dose of oral corticosteroids (OCS)

Other outcome measures

Change in ABQOL

Change in BP180 autoantibody (IgG) titers

Change in BP230 autoantibody (IgG) titers

+18 more

Side effects data

From 2022 Phase 3 trial • 133 Patients • NCT04417894

24%

Nasopharyngitis

16%

COVID-19

10%

Upper respiratory tract infection

Dermatitis atopic

Blood creatine phosphokinase increased

Metastases to lung

Post procedural infection

Adenocarcinoma of colon

Syncope

Dizziness

100%

80%

60%

40%

20%

Study treatment Arm

Matching Placebo

Dupilumab Q2W

LIBERTY-BP Trial Design

2Treatment groups

Experimental Treatment

Group I: dupilumabExperimental Treatment2 Interventions

Group II: Matching placeboExperimental Treatment2 Interventions

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Matching Placebo

2012

Completed Phase 4

~10710

dupilumab

2022

Completed Phase 4

~330

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Regeneron PharmaceuticalsLead Sponsor

615 Previous Clinical Trials

379,741 Total Patients Enrolled

SanofiIndustry Sponsor

2,163 Previous Clinical Trials

3,512,374 Total Patients Enrolled

Clinical Trial ManagementStudy DirectorRegeneron Pharmaceuticals

259 Previous Clinical Trials

250,938 Total Patients Enrolled

Media Library

Dupilumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04206553 — Phase 2 & 3

Bullous Pemphigoid Clinical Trial 2023: Dupilumab Highlights & Side Effects. Trial Name: NCT04206553 — Phase 2 & 3

Dupilumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04206553 — Phase 2 & 3

Bullous Pemphigoid Research Study Groups: dupilumab, Matching placebo

Frequently Asked Questions

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

Are people who are 50 years or older being recruited for this clinical trial?

"Eligibility for this trial includes being between 18-90 years old."

Answered by AI

Are there still places available in this research project for people who want to participate?

"That is correct, the public clinicaltrials.gov website specifies that this research project is looking for 98 individuals at 9 locations. The trial was first posted on October 28th 2020 and was most recently updated on November 2nd 2022."

Answered by AI

Is this a new or innovative approach to research?

"Dupilumab has been trialed in 52 different ongoing studies, located in 455 cities and 43 countries. The very first study was sponsored by Sanofi in 2015. That initial Phase 3 trial included 880 patients and completed drug approval stages. In the 5 years since then, 134 more dupilumab trials have been conducted."

Answered by AI

What are the most similar treatments to dupilumab that have been trialed in the past?

"Dupilumab is being investigated in 52 different clinical trials, 14 of which are currently in Phase 3. Most of these medical studies concerning dupilumab's efficacy are based out of Louisville, Kentucky; however, there are 2662 locations across the world testing this medication."

Answered by AI

Would I be able to partake in this clinical trial?

"This clinical trial is seeking 98 participants between the ages of 18 and 90 who have bullous pemphigoid. In addition to meeting this criteria, it is important that potential patients also have the following: Bullous Pemphigoid Disease Area Index (BPDAI) activity score ≥24 at baseline and screening visits., Karnofsky performance status score ≥50% at the screening visit., Patients must have characteristic clinical features of bullous pemphigoid (BP) (eg, urticarial or eczematous or erythematous plaques, bullae, pruritus)"

Answered by AI

How many study volunteers are participating in this trial?

"Yes, currently this study is looking for individuals to take part in their clinical trial. The original posting date was October 28th 2020 and the most recent update was November 2nd 2022. They are enrolling a total of 98 people at 9 sites."

Answered by AI

Can you explain what dupilumab is typically prescribed for?

"When it comes to treating atopic dermatitis, dupilumab is the go-to medication. However, this immunotherapy drug can also be used for other purposes such as reducing eosinophils or aiding patients that have unsuccessfully tried corticosteroids for their asthma."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study to Evaluate the Efficacy and Safety of Dupilumab in Adult Patients With Bullous Pemphigoid

2020. "A Study to Evaluate the Efficacy and Safety of Dupilumab in Adult Patients With Bullous Pemphigoid". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04206553.

All > Bullous Pemphigoid