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-2

Phase 1

Conditions: Plaque Psoriasis
MedDRA version: 20.0Level: LLTClassification code 10071117Term: Plaque psoriasisSystem Organ Class: 100000004858
Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Registration Number: EUCTR2014-003486-14-AT

Lead Sponsor: CB Biopharma, SPR

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 225

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

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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective of the study is 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<br>Assess durability of the clinical response with continued treatment<br>Assess the safety and tolerability of CZP<br>Improvement of skin related quality of life (DLQI);Primary end point(s): PASI 75 at Week 16<br>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 Outcome Measures

Name	Time	Method
Secondary end point(s): PGA clear or almost clear (with at least 2 category improvement) at week 48<br>PASI 75 at Week 48<br>Change from baseline in DLQI at Week 16<br>PASI 90 at week 16;Timepoint(s) of evaluation of this end point: Week 48<br>Week 16