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Monoclonal Antibodies
efgartigimod PH20 SC for Pemphigus Vulgaris (ADDRESS Trial)
Phase 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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 41 weeks
Awards & highlights
Summary
This trial tests a new injection treatment for adults with specific autoimmune skin conditions. The treatment aims to reduce the immune system's attack on the skin and help the medication spread better. It targets people with Pemphigus Vulgaris or Pemphigus Foliaceus. Rituximab is increasingly used in the management of Pemphigus Vulgaris.
Eligible Conditions
- Pemphigus Vulgaris
- Pemphigus Foliaceus
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 41 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 41 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Proportion of Pemphigus Vulgaris (PV) participants who achieve complete clinical remission (CR) on minimal Prednisone therapy
Secondary study objectives
Anti desmoglein-1 and -3 autoantibodies serum levels
Autoimmune Bullous Disease Quality of Life (ABQOL) score
Composite Glucocorticoid Toxicity Index (C-GTI) comprising the Aggregate Improvement Score (AIS) and the Cumulative Worsening Score (CWS)
+26 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
Group I: placeboExperimental Treatment2 Interventions
patients receiving placebo on top of prednisone
Group II: efgartigimod PH20 SCExperimental Treatment2 Interventions
patients 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
1999
Completed Phase 3
~10920
Find a Location
Who is running the clinical trial?
argenxLead Sponsor
67 Previous Clinical Trials
10,152 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a type of skin cancer called basal cell or squamous cell skin cancer.You fit into one of the following categories:You have had problems with alcohol, drugs, or misusing medications within the past year.You have previously tried two different treatments for your condition, but they did not work.You have received a live viral vaccine within the past 28 days before the study.You are allergic to any of the ingredients in the treatments being used.You cannot take oral prednisone due to a known reason.
Research Study Groups:
This trial has the following groups:- Group 1: efgartigimod PH20 SC
- Group 2: placebo
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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.
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