A study to assess the safety and efficacy of a subcutaneous formulation of efgartigimod PH20 SC in adults with Pemphigus (Vulgaris or Foliaceus)

Phase 1

• Conditions: Pemphigus Vulgaris or Pemphigus Foliaceus; MedDRA version: 20.0Level: LLTClassification code 10052802Term: Pemphigus vulgarisSystem Organ Class: 10040785 - Skin and subcutaneous tissue disorders; MedDRA version: 20.0Level: LLTClassification code 10057069Term: Pemphigus foliaceusSystem Organ Class: 10040785 - Skin and subcutaneous tissue disorders; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2020-002917-16-GR
• Lead Sponsor: argenx BV

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-10-15
• Last Update Posted: 26 February 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

Participants must meet all of the following inclusion criteria:
1. 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).
2. The participant participated in trial ARGX-113-1904 and completed the study or has the defined criteria for rollover.
3. Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those
participating clinical trials and:
Women of childbearing potential:
a. Male participants:
- Male participants must agree to use an acceptable method of contraception from signing the ICF until the last dose the study drug.
b. Female participants:
- Women of childbearing potential have a negative urine pregnancy test
at baseline before the IMP can be administered.
- agree to use a highly effective or acceptable contraception method,
which should be maintained at minimum until after the last dose
of IMP.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 153
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 27

Exclusion Criteria

Participants are excluded from the trial if any of the following criteria apply:
1. Pregnant and lactating women and those intending to become pregnant during the trial.
2. 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.
3. Known hypersensitivity to any of the components of the administered treatments.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified