A Phase 3, Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo- And Active-Controlled Study Followed By A Placebo-Controlled Maintenance Period And Open-Label Follow-Up To Evaluate The Efficacy And Safety Of Certolizumab Pegol In Subjects With Moderate To Severe Chronic Plaque Psoriasis - CIMPACT

CB Biopharma, SPR0 个研究点目标入组 3 人开始时间: 待定最近更新: 2024年4月23日

适应症

试验速览

Trial is onging in other countries

•Most important inclusion criteria (Protocol v1.0 25Jul2014, chapter 6.1, p.28):
•1.Provided informed consent;2.Adult men or women >=18 years;3.Chronic plaque psoriasis for at least 6 months;4.Baseline psoriasis activity and severity index >=12 and body surface area >=10% and Physician*s Global Assessments score >=3;5.Candidate for systemic psoriasis therapy and/or phototherapy and/or chemophototherapy;6.Other protocol-defined inclusion criteria may apply

•Most important exclusion criteria (Protocol v1.0 25Jul2014, chapter 6.2, p.28-30):
•1.Erythrodermic, guttate, generalized pustular form of psoriasis;2.History of current, chronic, or recurrent infections of viral, bacterial, or fungal origin as described in the protocol;3.Congestive heart failure ;4.History of a lymphoproliferative disorder including lymphoma or current signs and symptoms suggestive of lymphoproliferative disease;5.History of other malignancy concurrent malignancy as described in the protocol;6.History of, or suspected, demyelinating disease of the central nervous system (eg, multiple sclerosis or optic neuritis);7.Female subjects who are breastfeeding, pregnant, or plan to become pregnant during the study or within 3 months following last dose of study drug. Male subjects who are planning a partner pregnancy during the study or within 10 weeks following the last dose;8.Any other condition which, in the Investigator*s judgment, would make the subject unsuitable for participation in the study;9.Other protocol-defined exclusion criteria may apply ;10.Prior etanercept use

发起方

CB Biopharma, SPR