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)

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
argenx
Study ID
NCT04598477
Phase
PHASE3
Status
Terminated

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
  • prednisone — DRUG
    Oral prednisone tablets

Study Details

This was a prospective, multicenter, open label extension (OLE) trial on the efficacy, safety, patient outcome measures, tolerability, immunogenicity, PK and PD of efgartigimod PH20 SC in adult PV or PF participants, who participated in antecedent trial ARGX-113-1904. This trial provided extension of efgartigimod PH20 SC treatment and retreatment options for participants who had been randomized to efgartigimod PH20 SC treatment arm in the trial ARGX-113-1904, and first treatment of efgartigimod PH20 SC and retreatment options for participants who had been randomized to the placebo arm in trial ARGX-113-1904. The participants could also receive concomitant prednisone therapy. Investigators could increase or decrease the prednisone dose based on protocol-specified criteria. Trial ARGX-113-1905 evaluated the ability to (further) taper prednisone therapy and achieve Clinical Remission (CR) off therapy (CRoff), the ability to achieve CR and CR on minimal therapy (CRmin) for participants who had not yet achieved CR or CRmin, and the ability to treat flare; it also assessed patient outcome measures and the safety, PD, PK and immunogenicity of efgartigimod PH20 SC over the duration of trial. Study duration: Up to 60 weeks for participants who receive IMP administration up to 52 weeks and with a follow-up period of 8 weeks after the last IMP administration

Key Dates

Start date
Jul 15, 2021
Status verified
Mar 2025
Primary completion
Mar 25, 2024
Completion
Mar 25, 2024

Study Design

Enrollment
183 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

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

Primary Outcome Measure

Incidence of Treatment-Emergent Adverse Events (TEAE), Adverse Events of Special Interest (AESI), and Serious Adverse Events (SAE) [ Time Frame: Up to 60 weeks ]

Locations (17)

FacilityCityStateZIPSite coordinators
Investigator site 115 - US0010086BirminghamAlabama35233-
Investigator site 89 - US0010091ScottsdaleArizona85259-
Investigator site 124 - US0010092Redwood CityCalifornia94063-
Investigator site 1 - US0010087Boca RatonFlorida33428-
Investigator site 90 - US0010117MiamiFlorida33173-
Investigator site 91 - US0010109OrlandoFlorida32827-
Investigator site 126 - US0010090MinneapolisMinnesota55455-
Investigator site 111 - US0010098St LouisMissouri63110-
Investigator site 10 - US0010088BuffaloNew York14203-1070-
Investigator site 76 - US0010096DurhamNorth Carolina27710-
Investigator site 30 - US0010094ClevelandOhio44106-1716-
Investigator site 103 - US0010097PhiladelphiaPennsylvania19140-
Investigator site 84 - US0010089PhiladelphiaPennsylvania19104-
Investigator site 125 - US0010107DallasTexas75246-
Investigator site 87 - US0010084Dripping SpringsTexas78620-
Investigator site 88 - US0010114HoustonTexas77008-
Investigator site 44 - US0010106NorfolkVirginia23502-

Find similar trials in Birmingham, AL

By research site
Investigator site 115 - US0010086· Birmingham, ALInvestigator site 89 - US0010091· Scottsdale, AZInvestigator site 124 - US0010092· Redwood City, CAInvestigator site 1 - US0010087· Boca Raton, FLInvestigator site 90 - US0010117· Miami, FLInvestigator site 91 - US0010109· Orlando, FL

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