← Back to Search

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

ADDRESS Trial Summary

This trial is testing a new medication, efgartigimod PH20 SC, to see if it is effective in treating Pemphigus Vulgaris (PV) and Pemphigus Foliaceus (PF), autoimmune diseases that cause blistering of the skin and mucous membranes. The trial will compare efgartigimod PH20 SC to a placebo, and will measure efficacy by looking at patient outcomes.

Eligible Conditions
  • Pemphigus Vulgaris
  • Pemphigus Foliaceus

ADDRESS Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 41 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 41 weeks 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 Pemphigus Vulgaris (PV) participants who achieve complete clinical remission (CR) on minimal Prednisone therapy
Secondary outcome measures
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 more

Side effects data

From 2021 Phase 3 trial • 110 Patients • NCT04735432
15%
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

ADDRESS 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
61 Previous Clinical Trials
9,045 Total Patients Enrolled

Media Library

efgartigimod PH20 SC (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04598451 — Phase 3
Pemphigus Vulgaris Research Study Groups: efgartigimod PH20 SC, placebo
Pemphigus Vulgaris Clinical Trial 2023: efgartigimod PH20 SC Highlights & Side Effects. Trial Name: NCT04598451 — Phase 3
efgartigimod PH20 SC (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04598451 — Phase 3

Frequently Asked Questions

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

How many different healthcare facilities are conducting this research in the city?

"There are presently 20 sites running this clinical trial, which are located in major cities such as Houston, West Lafayette and Philadelphia. To minimize travel requirements, patients are encouraged to select the clinical trial site that is closest to their location."

Answered by AI

What is the maximum number of patients that can enroll in this research project?

"To complete this clinical trial, 213 patients who meet the pre-determined criteria must be enrolled. There are multiple locations patients can choose from, such as Investigator site 126 - US0010182 in Houston, Texas and Investigator site 127 - US0010155 in West Lafayette, Indiana."

Answered by AI

What is the efgartigimod PH20 SC FDA approval status?

"Efgartigimod PH20 SC is considered safe. This is due to the fact that it is a Phase 3 trial, which means that there is not only some evidence of its efficacy, but also that it has undergone multiple rounds of safety testing."

Answered by AI

What are some of the conditions efgartigimod PH20 SC has been known to improve?

"Efgartigimod PH20 SC can help alleviate symptoms for patients suffering from thyroiditis, ulcerative colitis, and malignant neoplasms."

Answered by AI

Are there other ongoing research projects with efgartigimod PH20 SC?

"efgartigimod PH20 SC was first studied in 2001 and, as of now, there have been a total of 18784 completed trials. There are 338 active trials at the moment, a majority of which are based in Houston, Texas."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Study to Assess the Efficacy and Safety of a Subcutaneous Formulation of Efgartigimod PH20 SC in Adults With Pemphigus (Vulgaris or Foliaceus)
2020. "A Study to Assess the Efficacy and Safety of a Subcutaneous Formulation of Efgartigimod PH20 SC in Adults With Pemphigus (Vulgaris or Foliaceus)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04598451.
~50 spots leftby May 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top