NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCT2031210277

Registered date:27/08/2021

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

Basic Information

Recruitment status Pending
Health condition(s) or Problem(s) studiedAdult patients with moderate to severe pemphigus vulgaris (PV) or pemphigus foliaceus (PF)
Date of first enrollment27/08/2021
Target sample size12
Countries of recruitmentBulgaria,France,Germany,Greece,Hungary,Italy,Poland,Spain,Romania,USA,UK,Australia,Georgia,India,Israel,Russia,Serbia,Turkey,Ukraine,Japan
Study typeInterventional
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
Secondary Outcome

Key inclusion & exclusion criteria

Age minimum>= 20age old
Age maximumNot applicable
GenderBoth
Include criteriaParticipants 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 criteriaParticipants 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

Contact

Public contact
Name Munekiyo Kaneko
Address Nakanoshima Daibiru 16F, 3-3-23 Nakanoshima, Kita-ku, Osaka-shi, Osaka Osaka Japan 530-6116
Telephone +81-6-4560-6911
E-mail Munekiyo.kaneko@ppd.com
Affiliation PPD-SNBL K.K.
Scientific contact
Name Yumi Aoyama
Address 577 Matsushima, Kurashiki, Okayama Okayama Japan 701-0192
Telephone +81-86-462-1111
E-mail Munekiyo.kaneko@ppd.com
Affiliation Kawasaki Medical School Hospital