Plaque Psoriasis MedDRA version: 20.0 Level: LLT Classification code 10071117 Term: Plaque psoriasis System Organ Class: 100000004858
Conditions
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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate 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 in the treatment of moderate to severe chronic plaque PSO.;Secondary Objective: Assess the optimal initial treatment dose for the treatment of moderate to severe chronic plaque PSO Assess durability of the clinical response with continued treatment Assess the safety and tolerability of CZP Improvement of skin related quality of life (DLQI);Primary end point(s): PASI75 at Week 16 PGA clear or almost clear (with at least 2 category improvement) at Week 16;Timepoint(s) of evaluation of this end point: Week 16 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): PGA clear or almost clear (with at least 2 category improvement) at Week 48 PASI75 at Week 48 Change from baseline in DLQI at Week 16 PASI90 at week 16;Timepoint(s) of evaluation of this end point: Week 16 Week 48 | — |
Countries
Czech Republic, France, Germany, Hungary, United States
Contacts
Public ContactCT Registries & Results Disclosure
UCB Biopharm, SPRL
Outcome results
None listed