A Phase 3, Multicenter, Randomized, Double-blind, Parallel-group Study Followed by a Dose-blind Period and Open Label Follow-up to Evaluate the Efficacy and Safety of Certolizumab Pegol in Subjects with Moderate to Severe Chronic Plaque Psoriasis - CIMPASI-1

CB Biopharma, SPR0 个研究点目标入组 225 人开始时间: 2014年12月18日最近更新: 2018年11月26日

适应症

试验速览

暂无简介。

•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
•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
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•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 5 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

发起方

CB Biopharma, SPR