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 sites3 target enrollmentTBD

Overview

Trial is onging in other countries

Registry

who.int

Start Date

TBD

End Date

November 19, 2018

Last Updated

2 years ago

Study Type

Interventional

Sponsor

CB Biopharma, SPR

•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