A Study to Assess the Efficacy and Safety of a Subcutaneous Formulation of Efgartigimod PH20 SC in Adults With Pemphigus (Vulgaris or Foliaceus)

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
argenx
Study ID
NCT04598451
Phase
PHASE3
Status
Completed

Conditions

  • Pemphigus Foliaceus
  • Pemphigus Vulgaris

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • efgartigimod PH20 SC — BIOLOGICAL
    Subcutaneous injection of efgartigimod using rHuPH20 (PH20) as a permeation enhancer
  • Placebo — OTHER
    Subcutaneous injection of placebo
  • prednisone — DRUG
    Oral prednisone tablets

Study Details

This is a prospective, multicenter, randomized, double-blinded, placebo-controlled trial to investigate the efficacy, safety, patient outcome measures, tolerability, immunogenicity, PK, and PD of efgartigimod PH20 SC in adult participants aged from 18 years with PV or PF. The trial comprises a screening period of up to 3 weeks, a treatment period of up to 30 weeks, and an 8-week follow-up period for participants who do not enroll into the open-label extension (OLE) trial ARGX-113-1905. The primary objective of the ARGX-113-1904 trial is to demonstrate the efficacy of subcutaneous administration of efgartigimod co-formulated with recombinant human hyaluronidase PH20 (Efgartigimod PH20 SC) compared to placebo in the treatment of participants with Pemphigus Vulgaris (PV). Secondary objectives are to also demonstrate the efficacy of efgartigimod PH20 SC in the treatment of participants with Pemphigus Foliaceus (PF), and to demonstrate early onset of action and a prednisone-sparing effect. After confirmation of eligibility, participants will be randomized in a 2: 1 ratio to receive efgartigimod PH20 SC or placebo

Key Dates

Start date
Dec 1, 2020
Status verified
Sep 2024
Primary completion
Aug 22, 2023
Completion
Aug 22, 2023

Study Design

Enrollment
222 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: efgartigimod PH20 SC
    patients receiving efgartigimod PH20 SC on top of prednisone
  • Experimental: placebo
    patients receiving placebo on top of prednisone

Primary Outcome Measure

Number of Pemphigus Vulgaris (PV) Participants Who Achieve Complete Clinical Remission (CR) on Minimal Prednisone Therapy [ Time Frame: up to 30 weeks treatment period ]

Locations (21)

FacilityCityStateZIPSite coordinators
Investigator site 77 - US0010086BirminghamAlabama35233-
Investigator site 97 - US0010091ScottsdaleArizona85259-
Investigator site 121 - US0010092Redwood CityCalifornia94063-
Investigator site 125 - US0010153Castle RockColorado80109-
Investigator site 2 - US0010087Boca RatonFlorida33428-
Investigator site 99 - US0010117MiamiFlorida33173-
Investigator site 78 - US0010109OrlandoFlorida32827-
Investigator site 127 - US0010155West LafayetteIndiana47906-
Investigator site 61 - US0010090MinneapolisMinnesota55455-
Investigator site 102 - US0010098St LouisMissouri63110-
Investigator site 19 - US0010088BuffaloNew York14203-1070-
Investigator site 136 - US0010196New YorkNew York10128-
Investigator site 60 - US0010096DurhamNorth Carolina27710-
Investigator site 20 - US0010094ClevelandOhio44106-1716-
Investigator site 101 - US0010097PhiladelphiaPennsylvania19140-
Investigator site 73 - US00100PhiladelphiaPennsylvania19104-
Investigator site 98 - US0010107DallasTexas75246-
Investigator site 1 - US0010084Dripping SpringsTexas78620-
Investigator site 126 - US0010182HoustonTexas77004-
Investigator site 88 - US0010114HoustonTexas77008-
Investigator site 59 - US0010106NorfolkVirginia23502-

Find similar trials in Birmingham, AL

By research site
Investigator site 77 - US0010086· Birmingham, ALInvestigator site 97 - US0010091· Scottsdale, AZInvestigator site 121 - US0010092· Redwood City, CAInvestigator site 125 - US0010153· Castle Rock, COInvestigator site 2 - US0010087· Boca Raton, FLInvestigator site 99 - US0010117· Miami, FL

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