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Immunomodulator
Efgartigimod for Bullous Pemphigoid
Phase 2 & 3
Waitlist Available
Research Sponsored by argenx
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Participants have clinical signs of BP
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 46 weeks
Awards & highlights
Study Summary
This trial is studying if 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.
Who is the study for?
Adults with moderate to severe Bullous Pemphigoid (BP) can join this trial. They must understand and follow the study's procedures, agree to use contraception according to local guidelines, and not be pregnant. People with other autoimmune diseases, unstable BP treatments in the last 4 weeks, or a history of certain cancers cannot participate.Check my eligibility
What is being tested?
The trial is testing efgartigimod PH20 SC against a placebo while also using Prednisone for BP treatment. It has two parts: Phase 2 tests if efgartigimod works (proof of concept), and Phase 3 confirms these results in more people. Participants are randomly chosen to receive either the drug or placebo.See study design
What are the potential side effects?
Possible side effects include reactions at the injection site, increased risk of infections due to immune system changes, potential allergic reactions to ingredients in efgartigimod or Prednisone, as well as typical steroid-related side effects like weight gain and mood swings.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I show symptoms of Bell's palsy.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 46 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 46 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Proportion of participants who are in complete remission (CR) while receiving efgartigimod PH20 SC or placebo and have been off oral corticosteroid (OCS) therapy for ≥8 weeks at week 36
Secondary outcome measures
Autoimmune Bullous Disease Quality of Life (ABQoL) scores over time
Changes from baseline in the 24-hour average itch score from the Itch Numerical Rating Scale (Itch NRS)
Changes from baseline in the 24-hour worst itch score from the Itch Numerical Rating Scale (Itch NRS)
+41 moreSide effects data
From 2021 Phase 3 trial • 110 Patients • NCT0473543215%
Injection site rash
13%
Headache
13%
Injection site erythema
11%
Myasthenia gravis
9%
Injection site pruritus
7%
Injection site bruising
5%
Injection site pain
4%
Fatigue
2%
Fall
2%
Cellulitis
2%
Humerus fracture
2%
Dyspnoea
2%
Optic neuritis
2%
Syncope
2%
Diarrhoea
2%
Urinary tract infection
100%
80%
60%
40%
20%
0%
Study treatment Arm
Efgartigimod PH20 SC
Efgartigimod IV
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: efgartigimod PH20 SCExperimental Treatment2 Interventions
participants receiving efgartigimod PH20 SC on top of Prednisone
Group II: placebo PH20 SCPlacebo Group2 Interventions
participants receiving placebo 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
Find a Location
Who is running the clinical trial?
argenxLead Sponsor
60 Previous Clinical Trials
9,172 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am of legal age and can consent to participate.I am not using BP treatments other than OCS, TCS, immunosuppressants, or dapsone.I am not pregnant, breastfeeding, nor planning to become pregnant during the study.You have tested positive for COVID-19.I cannot take oral corticosteroids due to health reasons.You have a positive blood test for active hepatitis B, hepatitis C, or HIV.I haven't changed my blood pressure medication dose in the last 4 weeks.I have a different type of pemphigoid or another autoimmune blistering skin condition.I have not received a live vaccine in the last 4 weeks.I currently have an ongoing infection.I show symptoms of Bell's palsy.I had cancer before but have been free of it for over 3 years.I don't have any serious health issues that could interfere with the study.You are allergic to any parts of the treatments being given.
Research Study Groups:
This trial has the following groups:- Group 1: efgartigimod PH20 SC
- Group 2: placebo PH20 SC
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this clinical trial happening at a great number of sites in North America?
"There are 13 trial sites for this study, which are situated in cities including Pittsburgh, Ann Arbor and Clearwater. To limit the amount of travelling required, patients are encouraged to choose a clinical site that is close to their location."
Answered by AI
How many people are allowed to be enrolled in this experiment at one time?
"The sponsor needs a total of 160 eligible patients to run the trial. The sites where argenx will be recruiting are Investigator site 25 - US0010158 in Pittsburgh, Pennsylvania and Investigator site 50 - US0010149 in Ann Arbor, Michigan."
Answered by AI
Are we still able to sign up for this clinical trial?
"Yes, the clinical trial is still looking for patients. According to the listing on clinicaltrials.gov, which was last updated on October 27th, 160 people are needed for the 13 different sites taking part in this study."
Answered by AI
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