Phase II long-term extension study to assess the safety, tolerability, and efficacy of BI 730357 in patients with moderate-to-severe plaque psoriasis - BI 730357 - Psoriasis Long-Term Extension

Boehringer Ingelheim Pharma GmbH & Co. KG0 个研究点目标入组 180 人开始时间: 2019年5月2日最近更新: 2021年8月17日

研究概览

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•1. WOCBP must be ready and able to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly from date of screening until 4 weeks after last treatment in this trial. A list of contraception methods meeting these criteria is provided in the patient information.
•2. Patients with moderate-to-severe plaque PsO who have completed the randomized treatment period without early treatment discontinuation in the preceding trial, achieved a PASI50 at Week 24 of the preceding trial, and are willing and able to continue treatment in this study.
•3. Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial.
•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 140
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 40

•1. Nonplaque forms of PsO (including guttate, erythrodermic, or pustular), current druginduced PsO (including a new onset or exacerbation of PsO from, e.g., beta blockers, calcium channel blockers, lithium), active ongoing inflammatory diseases (including but not limited to inflammatory bowel disease (IBD)) other than PsO that might confound trial evaluations.
•2. Previous enrolment in this trial.
•3. Currently enrolled in another investigational device or drug trial or is receiving other investigational treatment(s) (with the exception of 1407-0030).
•4. Intake of any restricted medication or any drug considered likely to interfere with the safe conduct of the trial.
•5. Any plan to receive a live vaccination during the conduct of the trial.
•6. Patients not expected to comply with the protocol requirements or not expected to complete the trial as scheduled.
•7. Further criteria apply

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