An Efficacy and Safety Study of Two Dose Levels of Certolizumab Pegol (CZP) in Subjects With Plaque Psoriasis (PSO) (CIMPASI-1)

This study is ongoing, but not recruiting participants.

Sponsor:

Collaborator:

Dermira, Inc.

Information provided by (Responsible Party):

UCB Pharma ( UCB Biopharma S.P.R.L. )

ClinicalTrials.gov Identifier:

NCT02326298

First received: December 22, 2014

Last updated: May 3, 2017

Last verified: May 2017

History of Changes

Purpose

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.

Condition	Intervention	Phase
Psoriasis Plaque Psoriasis	Biological: Certolizumab Pegol Other: Placebo	Phase 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Participant, Investigator Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Psoriasis

Drug Information available for: Certolizumab pegol

U.S. FDA Resources

Further study details as provided by UCB Pharma ( UCB Biopharma S.P.R.L. ):

Primary Outcome Measures:

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 Outcome Measures:

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 ]


Enrollment:	234
Study Start Date:	December 2014
Estimated Study Completion Date:	October 2018
Primary Completion Date:	March 2016 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: CZP 200 mg 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.	Biological: Certolizumab Pegol Active Substance: Certolizumab Pegol Pharmaceutical Form: Solution for injection in pre-filled syringe Concentration: 200 mg/mL Route of Administration: Subcutaneous use Other Names: Cimzia CDP870 CZP
Experimental: CZP 400 mg Certolizumab Pegol subcutaneous (sc) injection 400 mg every two weeks (Q2W).	Biological: Certolizumab Pegol Active Substance: Certolizumab Pegol Pharmaceutical Form: Solution for injection in pre-filled syringe Concentration: 200 mg/mL Route of Administration: Subcutaneous use Other Names: Cimzia CDP870 CZP
Placebo Comparator: Placebo Placebo subcutaneous (sc) injection every two weeks (Q2W).	Other: Placebo Active Substance: Placebo Pharmaceutical Form: Solution for injection in pre-filled syringe Concentration: 0.9 % saline Route of Administration: Subcutaneous use Other Name: PBO

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02326298

Show 30 Study Locations

Sponsors and Collaborators

UCB Biopharma S.P.R.L.

Dermira, Inc.

Investigators


Study Director:	UCB Cares	+1 844 599 2273 (UCB)

More Information


Responsible Party:	UCB Biopharma S.P.R.L.
ClinicalTrials.gov Identifier:	NCT02326298 History of Changes
Other Study ID Numbers:	PS0005 2014-003513-28 ( EudraCT Number )
Study First Received:	December 22, 2014
Last Updated:	May 3, 2017

Keywords provided by UCB Pharma ( UCB Biopharma S.P.R.L. ):


Certolizumab Pegol Cimzia Psoriasis

Additional relevant MeSH terms:


Psoriasis Skin Diseases, Papulosquamous Skin Diseases Certolizumab Pegol	Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antirheumatic Agents

ClinicalTrials.gov processed this record on July 17, 2017

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