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)

Stopped early · Phase 3

Conditions studied: Pemphigus Vulgaris, Pemphigus Foliaceus

In brief

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 facts

Study ID

NCT04598477

Run by

argenx

People needed

183

Starts

2021-07-15

Expected to finish

2024-03-25

Last updated by the study team

2025-03-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Ability to understand the requirements of the trial, to provide written informed consent (including consent for the use and disclosure of research-related health information), willingness and ability to comply with the trial protocol procedures (including required trial visits).
• The participant participated in trial ARGX-113-1904 and completed the study or has the defined criteria for rollover.
• Contraceptive use by men and women should be consistent with local regulations regarding the methods for contraception for those participating in clinical trials and:
• Male participants:
• Male participants must agree to use an acceptable method of contraception as described in the protocol, from signing the ICF until the last dose of the study drug.
• Female participants
• Women of childbearing potential (WOCBP) must:
• have a negative urine pregnancy test at baseline before the IMP can be administered,
• agree to use a highly effective or acceptable contraception method (as described in the protocol), which should be maintained at minimum until after the last dose of IMP

You may not qualify if…

• Pregnant and lactating women and those intending to become pregnant during the trial.
• Participants with clinical evidence of other significant serious disease or participants who recently underwent or have planned a major surgery during the period of the trial, or any other condition in the opinion of the investigator, that could confound the results of the trial or put the participant at undue risk.
• Known hypersensitivity to any of the components of the administered treatments.

Where it is running

• Investigator site 89 - US0010091 — Scottsdale, Arizona, United States
• Investigator site 124 - US0010092 — Redwood City, California, United States
• Investigator site 1 - US0010087 — Boca Raton, Florida, United States
• Investigator site 90 - US0010117 — Miami, Florida, United States
• Investigator site 91 - US0010109 — Orlando, Florida, United States
• Investigator site 126 - US0010090 — Minneapolis, Minnesota, United States
• Investigator site 111 - US0010098 — St Louis, Missouri, United States
• Investigator site 10 - US0010088 — Buffalo, New York, United States
• Investigator site 76 - US0010096 — Durham, North Carolina, United States
• Investigator site 30 - US0010094 — Cleveland, Ohio, United States
• Investigator site 84 - US0010089 — Philadelphia, Pennsylvania, United States
• Investigator site 103 - US0010097 — Philadelphia, Pennsylvania, United States
• Investigator site 125 - US0010107 — Dallas, Texas, United States
• Investigator site 87 - US0010084 — Dripping Springs, Texas, United States
• Investigator site 88 - US0010114 — Houston, Texas, United States
• Investigator site 44 - US0010106 — Norfolk, Virginia, United States
• Investigator site 15 - AU0610006 — Sydney, New South Wales, Australia
• Investigator site 11 - AU0610007 — Parkville, Victoria, Australia
• Investigator site 92 - AU0610013 — Melbourne, Australia
• Investigator site 17 - BG3590012 — Pleven, Bulgaria
• Investigator site 18 - BG3590013 — Plovdiv, Bulgaria
• Investigator site 2 - BG3590010 — Sofia, Bulgaria
• Investigator site 16 - BG3590009 — Sofia, Bulgaria
• Investigator site 3 - BG3590011 — Sofia, Bulgaria
• Investigator site 115 - US0010086 — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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