A Randomized, Double-Blinded, Placebo-Controlled Trial to Investigate the Efficacy, Safety, and Tolerability of Efgartigimod PH20 SC in Adult Patients With Pemphigus (Vulgaris or Foliaceus) (ADDRESS) - ADDRESS

argenx BV0 个研究点目标入组 213 人2020年10月15日

概览

暂无简介。

注册库

who.int

开始日期

2020年10月15日

结束日期

待定

最后更新

2年前

研究类型

Interventional clinical trial of medicinal product

性别

All

发起方

•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 is male or female, and aged from 18 years at the time of signing the informed consent form (ICF).
•3\. The participant has a clinical diagnosis of PV (mucosal, cutaneous, mucocutaneous) or PF that has been confirmed by cutaneous histology,
•positive direct immunofluorescence (IF), and positive indirect IF and/or ELISA.
•4\. The participant meets 1 of the following profiles:
•a. Newly diagnosed disease with PDAI \=15 at baseline and naïve to
•b. Newly diagnosed disease with PDAI \=15 while receiving a first course of oral prednisone (or equivalent). According to clinical
•judgment, the participant has shown no significant improvement of PV or PF signs for at least 2 weeks before baseline and is considered fit to
•start prednisone treatment at 0\.5 mg/kg qd at baseline.
•c. Experiencing flare with PDAI \=15, a maximum of 4 years since disease onset, and off prednisone therapy ± a conventional

•.1\. Participant has a confirmed diagnosis of paraneoplastic pemphigus, drug\-induced pemphigus, pemphigus vegetans, pemphigus
•erythematosus, or any other non\-PV/non\-PF autoimmune blistering disease.
•2\. Participants with mild disease severity as defined by PDAI \<15 at baseline.
•3\. Participants who show a significant improvement of PV or PF in the period from screening to baseline according to clinical judgment (eg, the
•Participant has achieved DC or a substantial reduction in PDAI activity score during screening period).
•4\. The Participant has been administered therapy other than oral prednisone, conventional immunosuppressants (eg, azathioprine,
•cyclophosphamide, methotrexate, mycophenolate mofetil) or dapsone within 2 months before the baseline visit and that can affect clinical
•disease activity. For example, excluded medications are intravenous methylprednisolone, dapsone, sulfasalazine, tetracyclines, nicotinamide
•at doses above the recommended daily allowance (RDA)/dietaryreference intake (DRI), plasmapheresis/ plasma exchange,
•immunoadsorption, and IVIg. Note: conventional immunosuppressants and dapsone must be discontinued before baseline. Nicotinamide doses