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A Study to Evaluate the Efficacy and Safety of Two Dose Levels of Certolizumab Pegol (CZP) in Subjects With Plaque Psoriasis (PSO) (CIMPASI-2)

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02326272
First Posted: December 29, 2014
Last Update Posted: October 4, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Dermira, Inc.
Information provided by (Responsible Party):
UCB Pharma ( UCB Biopharma S.P.R.L. )
  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.

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: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


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: Week 16 ]
  • Proportion of subjects who achieve a Physician's Global Assessment (PGA) Clear or Almost Clear (with at least 2-category improvement) response at Week 16 [ Time Frame: Week 16 ]

Secondary Outcome Measures:
  • Proportion of subjects who achieve a Psoriasis Activity and Severity Index (PASI90) response at Week 16 [ Time Frame: Week 16 ]
  • Proportion of subjects who achieve a Physician's Global Assessment (PGA) Clear or Almost Clear (with at least 2-category improvement) response at Week 48 [ Time Frame: Week 48 ]
  • Proportion of subjects who achieve a Psoriasis Activity and Severity Index (PASI75) response at Week 48 [ Time Frame: Week 48 ]
  • Change from Baseline in Dermatology Life Quality Index (DLQI) at Week 16 [ Time Frame: Week 16 ]

Enrollment: 227
Actual Study Start Date: December 15, 2014
Estimated Study Completion Date: August 31, 2018
Primary Completion Date: January 5, 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CZP 200 mg

CZP 400 mg at Weeks 0, 2, 4, followed by CZP 200 mg every two weeks (Q2W) from Week 6 to Week 14.

Treatment received from Week 16-48 is based on initial treatment and response to treatment:

  • PASI50 responders at Week 16 continue to receive CZP 200 mg Q2W.
  • PASI50 non-responders at Week 16 will be removed from blinded study medication and escape to unblinded CZP 400 mg Q2W. Subjects who receive unblinded CZP 400 mg Q2W for 16 weeks and do not achieve a PASI50 response will be withdrawn from the study.
  • PASI50 non-responders at Week 32 or a later time point will be withdrawn from the study.

Subjects who complete the Maintenance Period (with PASI50 response at Week 48) enter the Open-label Extension Period on CZP 200 mg Q2W.

Week 48 completers in the escape arm continue to receive CZP 400 mg Q2W or may switch to CZP 200 mg Q2W.

Depending on PASI50 or PASI75 responses at Week 60 or a later time point, subjects may switch to CZP 400 mg Q2W or withdraw from the study.

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

CZP 400 mg every two weeks (Q2W) through Week 14.

Treatment received from Week 16 - 48 is based on initial treatment and response to treatment:

  • PASI50 responders at Week 16 continue to receive CZP 400 mg Q2W.
  • PASI50 non-responders at Week 16 will be removed from blinded study medication and escape to CZP 400 mg Q2W. Subjects who receive unblinded CZP 400 mg Q2W for 16 weeks and do not achieve a PASI50 response will be withdrawn from the study.
  • PASI50 non-responders at Week 32 or a later time point will be withdrawn from the study.

Subjects who complete the Maintenance Period (with PASI50 response at Week 48) enter the Open-label Extension (OLE) Period on CZP 200 mg Q2W. Week 48 completers in the escape arm continue to receive CZP 400 mg Q2W or may switch to CZP 200 mg Q2W.

Subjects who achieve a PASI75 response during the OLE Phase may switch to CZP 200 mg 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).

Treatment received from Week 16 - 48 is based on initial treatment and response to treatment:

  • PASI50 responders at Week 16, who do not achieve a PASI75 response at Week 16 receive CZP 400 mg at Weeks 16, 18 and 20 (loading doses) followed by CZP 200 mg Q2W starting at Week 22.
  • PASI75 responders at Week 16 continue to receive Placebo.
  • PASI50 non-responders at Week 16 will be removed from blinded study medication and escape to CZP 400 mg Q2W. Subjects who receive unblinded CZP 400 mg Q2W for 16 weeks and do not achieve a PASI50 response will be withdrawn from the study.
  • PASI50 non-responders at Week 32 or a later time point will be withdrawn from the study.

Subjects who complete the Maintenance Period (with PASI50 response at Week 48) enter the Open-label Extension Period on CZP 200 mg Q2W. Week 48 completers in the escape arm continue to receive CZP 400 mg Q2W or may switch to CZP 200 mg 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

Detailed Description:

This study consists of the following Periods:

  • Initial Treatment Period from Week 0 to Week 16
  • Maintenance Treatment Period from Week 16 to Week 48
  • Open-label Treatment Period from Week 48 to Week 144
  • Safety Follow-Up Period from Week 144 to Week 152
  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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
  • Concurrent malignancy or a history of 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02326272


  Show 23 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: NCT02326272     History of Changes
Other Study ID Numbers: PS0002
2014-003486-14 ( EudraCT Number )
First Submitted: December 22, 2014
First Posted: December 29, 2014
Last Update Posted: October 4, 2017
Last Verified: September 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

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