An Open-Label, Multicenter, Follow-up Trial of ARGX-113-1904 to Evaluate the Safety, Tolerability, and Efficacy of Efgartigimod PH20 SC in Patients with Pemphigus (ADDRESS+) - ADDRESS+

argenx BV0 个研究点目标入组 180 人开始时间: 2020年8月31日最近更新: 2024年5月6日

试验速览

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•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.
•3A. 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:
•i. Male participants:
•- Male participants must agree to use an acceptable method of contraception from signing the ICF (informed consent form) until the last dose the study drug.
•b. Female participants:
•- Women of childbearing potential 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, 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

•Participants are excluded from the trial if any of the following criteria apply:
•1A. 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.

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