ARGX-113-1904 (Pemphigus) - Clinical Trial

What is the Purpose of this Study?

We are doing this study to see how an investigational drug called "efgartigimod PH20 SC" works in people with pemphigus.

What is the Condition Being Studied?

Pemphigus, a skin disorder that causes blistering of the skin

Who Can Participate in the Study?

Adults who have been diagnosed with pemphigus vulgaris or foliaceus (also called superficial pemphigus).

For more information about who can join this study, please contact the study team at connor.whatley@duke.edu

Age Group
Adults

What is Involved?

The study drug will be given by an injection under the skin for up to 30 weeks. During the study, you will be asked to come to the study site on a weekly basis.

In addition to receiving the drug, this study involves having physical exams done, monitoring your lesions, ECGs, blood draws, and urine sample collections.

When you become free of symptoms and upon agreement of your study doctor, after the first 6 visits on site, a study nurse can visit your home to give you the study drug injections instead of having on-site visits.

Study Details

Full Title
A Randomized, Double-Blinded, Placebo-Controlled Trial to Investigate the Efficacy, Safety, and Tolerability of Efgartigimod PH20 SC in Adult Patients With Pemphigus (Vulgaris or Foliaceus) (ADDRESS)
Principal Investigator
Russell Hall
Protocol Number
IRB: PRO00106917
NCT: NCT04598451
Phase
Phase III
ClinicalTrials.gov
Enrollment Status
Open for Enrollment
Participate
Contact the Duke Recruitment Innovation Center
MyResearchPartners@duke.edu
or
919-681-5698