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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 30 weeks
Awards & highlights
Pivotal Trial

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
  • Pemphigus Vulgaris

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 30 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 30 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of Pemphigus Vulgaris (PV) Participants Who Achieve Complete Clinical Remission (CR) on Minimal Prednisone Therapy
Secondary study objectives
Normalized Cumulative Prednisone Dose During the Treatment Period in Pemphigus Vulgaris Participants
Normalized Cumulative Prednisone Dose During the Treatment Period in Pemphigus Vulgaris and Pemphigus Foliaceus Participants
Number of Pemphigus Vulgaris (PV) and Pemphigus Foliaceus (PF) Participants Who Achieve Complete Clinical Remission (CR) on Minimal Prednisone Therapy Within 30 Weeks
+4 more

Side effects data

From 2023 Phase 3 trial • 222 Patients • NCT04598451
14%
HYPERTENSION
12%
INSOMNIA
12%
COVID-19
7%
BLOOD LACTATE DEHYDROGENASE INCREASED
7%
HYPERTRIGLYCERIDAEMIA
6%
MYOPATHY
6%
HEADACHE
6%
DEPRESSION
5%
DERMATITIS ACNEIFORM
5%
INJECTION SITE ERYTHEMA
4%
ORAL CANDIDIASIS
3%
NASOPHARYNGITIS
3%
URINARY TRACT INFECTION
3%
LEUKOCYTURIA
3%
INCREASED TENDENCY TO BRUISE
1%
SPINAL COMPRESSION FRACTURE
1%
GLOMERULONEPHRITIS
1%
DRUG ERUPTION
1%
SKIN INFECTION
1%
HYPOPROTEINAEMIA
1%
RESPIRATORY FAILURE
1%
TACHYCARDIA
1%
VISION BLURRED
1%
WEIGHT INCREASED
1%
PEMPHIGUS
1%
ERYSIPELAS
1%
VOMITING
1%
COVID-19 PNEUMONIA
1%
GASTROENTERITIS
1%
PNEUMONIA
1%
DIABETES MELLITUS
100%
80%
60%
40%
20%
0%
Study treatment Arm
Efgartigimod PH20 SC
Placebo PH20 SC

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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
~490
prednisone
1999
Completed Phase 3
~10920

Find a Location

Who is running the clinical trial?

argenxLead Sponsor
71 Previous Clinical Trials
10,858 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
~45 spots leftby Nov 2025
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