Overview

This trial is active, not recruiting.

Conditions psoriasis, plaque psoriasis
Treatments certolizumab pegol, placebo
Phase phase 3
Sponsor UCB Biopharma S.P.R.L.
Collaborator Dermira, Inc.
Start date December 2014
End date March 2016
Trial size 234 participants
Trial identifier NCT02326298, 2014-003513-28, PS0005

Summary

The purpose of this study is to investigate the efficacy and safety of two dose levels of certolizumab pegol in adults with moderate to severe chronic plaque psoriasis when administered every 2 weeks.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose treatment
Arm
(Experimental)
Certolizumab Pegol subcutaneous (sc) injection 400 mg at Weeks 0, 2, 4, followed by Certolizumab Pegol subcutaneous (sc) injection 200 mg every two weeks (Q2W) starting at Week 6.
certolizumab pegol Cimzia
Active Substance: Certolizumab Pegol Pharmaceutical Form: Solution for injection in pre-filled syringe Concentration: 200 mg/mL Route of Administration: Subcutaneous use
(Experimental)
Certolizumab Pegol subcutaneous (sc) injection 400 mg every two weeks (Q2W).
certolizumab pegol Cimzia
Active Substance: Certolizumab Pegol Pharmaceutical Form: Solution for injection in pre-filled syringe Concentration: 200 mg/mL Route of Administration: Subcutaneous use
(Placebo Comparator)
Placebo subcutaneous (sc) injection every two weeks (Q2W).
placebo PBO
Active Substance: Placebo Pharmaceutical Form: Solution for injection in pre-filled syringe Concentration: 0.9 % saline Route of Administration: Subcutaneous use

Primary Outcomes

Measure
Proportion of subjects who achieve a Psoriasis Activity and Severity Index (PASI75) response at Week 16
time frame: From Baseline to Week 16
Proportion of subjects who achieve a Physician's Global Assessment (PGA) Clear or Almost Clear response at Week 16
time frame: From Baseline to Week 16

Secondary Outcomes

Measure
Proportion of subjects who achieve a Physician's Global Assessment (PGA) Clear or Almost Clear Response at Week 48
time frame: From Baseline to Week 48
Proportion of subjects who achieve a Psoriasis Activity and Severity Index (PASI75) response at Week 48
time frame: From Baseline to Week 48
Change from Baseline in Dermatology Life Quality Index (DLQI) at Week 16
time frame: From Baseline to Week 16

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Provided informed consent - Adult men or women ≥ 18 years - Chronic plaque psoriasis for at least 6 months - Baseline psoriasis activity and severity index ≥ 12 and body surface area ≥ 10 % and Physician's Global Assessments score ≥ 3 - Candidate for systemic psoriasis therapy and/or phototherapy and/or chemophototherapy - Other protocol-defined inclusion criteria may apply Exclusion Criteria: - Erythrodermic, guttate, generalized pustular form of psoriasis - History of current, chronic, or recurrent infections of viral, bacterial, or fungal origin as described in the protocol - Congestive heart failure - History of a lymphoproliferative disorder including lymphoma or current signs and symptoms suggestive of lymphoproliferative disease - History of other malignancy concurrent malignancy as described in the protocol - History of, or suspected, demyelinating disease of the central nervous system (e.g., multiple sclerosis or optic neuritis) - 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 - Any other condition which, in the Investigator's judgment, would make the subject unsuitable for participation in the study - Other protocol-defined exclusion criteria may apply

Additional Information

Official title A Phase 3 Multicenter, Randomized, Double Blind, Parallel Group Study Followed by Dose Blind Period and Open Label Follow Up to Evaluate Efficacy and Safety of Certolizumab Pegol in Subjects With Moderate to Severe Chronic Plaque Psoriasis
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by UCB Pharma.