Open-label follow-up trial of ARGX-113-1904

JRCT ID: jRCT2031210277

Registered date:27/08/2021

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Adult patients with moderate to severe pemphigus vulgaris (PV) or pemphigus foliaceus (PF)
• Date of first enrollment: 27/08/2021
• Target sample size: 12
• Countries of recruitment: Bulgaria,Japan,France,Japan,Germany,Japan,Greece,Japan,Hungary,Japan,Italy,Japan,Poland,Japan,Spain,Japan,Romania,Japan,USA,Japan,UK,Japan,Australia,Japan,Georgia,Japan,India,Japan,Israel,Japan,Russia,Japan,Serbia,Japan,Turkey,Japan,Ukraine,Japan,Netherlands,Japan
• Study type: Interventional
• Intervention(s): Efgartigimod PH20 SC will be administered either weekly 1000 mg or 2000 mg on day 1 and day 8, followed by weekly 1000 mg with treatment being stopped upon achieving complete remission on minimal therapy (CRmin).

Outcome(s)

Primary Outcome

- Incidence and severity of treatment-emergent adverse events (TEAEs), adverse events of special interest (AESIs), and serious adverse events (SAEs) by system organ class (SOC) and preferred term (PT)
- Vital sign measurements, physical examinations, electrocardiograms (ECGs), and clinical laboratory safety evaluations

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

Participants are eligible to be included in the trial only if all of the following criteria apply:
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:
a. Male participants:
- Male participants must agree to use acceptable method of contraception, and not donate sperm from signing the ICF until the end of the study.
b. Female participants:
- Women of childbearing potential must:
- have a negative serum pregnancy test at screening and negative urine pregnancy test at baseline
before the IMP can be administered.
- agree to use a highly effective or acceptable contraception methods, which should be maintained at
minimum until 90 days after the last dose of IMP.

Exclude 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 or within 90 days after the last administration of IMP.
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.

Related Information

• Primary Sponsor: Aoyama Yumi