Plaque Psoriasis MedDRA version: 19.0 Level: LLT Classification code 10071117 Term: Plaque psoriasis System Organ Class: 100000004858
Conditions
Interventions
Trade Name: Cimzia 200 mg solution for injection
Product Name: Cimzia
Pharmaceutical Form: Solution for injection in pre-filled syringe
Pharmaceutical form of the placebo: Solution for injection in pr
Sponsors
UCB Biopharma, SPRL
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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 300 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 240
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the study is to compare the efficacy of CZP administered sc at the doses of CZP 400mg Q2W and CZP 200mg Q2W after a loading dose of CZP 400mg Q2W at Weeks 0, 2, and 4 to PBO in the treatment of moderate to severe chronic plaque PSO.;Secondary Objective: Secondary objective •Compare the efficacy of CZP administered sc at the doses of CZP 400mg Q2W and CZP 200mg Q2W after a loading dose of CZP 400mg at Weeks 0, 2, and 4 to ETN administered sc twice weekly at a cumulative weekly dose of 100mg in the treatment of moderate to severe chronic plaque PSO. •Assess the optimal initial treatment dose for the treatment of moderate to severe chronic plaque PSO •Assess the optimal maintenance dose for the treatment of moderate to severe chronic plaque PSO •Assess the safety and tolerability of CZP ;Primary end point(s): The primary efficacy variable is the PASI75 responder rate at Week 12. A subject will be classified as a PASI75 responder if the PASI score at the visit has improved at least 75% from Baseline. ;Timepoint(s) of evaluation of this end point: From Baseline to Week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary efficacy variables include PGA response of Clear or Almost clear (with at least a 2 category improvement) at Week 12 and Week 16, PASI 90 response at Weeks 12 and 16, PASI 75 response at Week 16, and PASI 75 response at Week 48 for subject achieving PASI 75 response at Week 16;Timepoint(s) of evaluation of this end point: From Baseline to Week 12, Week 16, Week 48 | — |
Countries
Bulgaria, Czech Republic, France, Germany, Hungary, Netherlands, Poland, United Kingdom, United States
Contacts
Public ContactClinical Trials Information
Dermira, Inc.
Outcome results
None listed