Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT02346240
Previous Study | Return to List | Next Study

Efficacy and Safety Study of Certolizumab Pegol (CZP) Versus Active Comparator and Placebo in Subjects With Plaque Psoriasis (PSO) (CIMPACT)

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.
 
ClinicalTrials.gov Identifier: NCT02346240
Recruitment Status : Completed
First Posted : January 26, 2015
Results First Posted : July 18, 2018
Last Update Posted : April 13, 2020
Sponsor:
Information provided by (Responsible Party):
UCB Pharma ( UCB Biopharma S.P.R.L. )

Tracking Information
First Submitted Date  ICMJE January 20, 2015
First Posted Date  ICMJE January 26, 2015
Results First Submitted Date  ICMJE June 22, 2018
Results First Posted Date  ICMJE July 18, 2018
Last Update Posted Date April 13, 2020
Study Start Date  ICMJE February 11, 2015
Actual Primary Completion Date March 22, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 22, 2018)
Proportion of Subjects Who Achieve a Psoriasis Activity and Severity Index (PASI75) Response at Week 12 [ Time Frame: Week 12 ]
The PASI75 response assessments are based on at least 75% improvement in the PASI score from Baseline. This is a scoring system that averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale), and weights the resulting score by the area of skin involved. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease.
Original Primary Outcome Measures  ICMJE
 (submitted: January 20, 2015)
Proportion of Subjects Who Achieve a Psoriasis Activity and Severity Index (PASI75) Response at Week 12 [ Time Frame: From Baseline to Week 12 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 22, 2018)
  • Proportion of Subjects Who Achieve a Physician's Global Assessment (PGA) Clear or Almost Clear Response (With at Least 2 Category Improvement) at Week 12 [ Time Frame: Week 12 ]
    The Investigator assessed the overall severity of Psoriasis (PSO) using the following 5-point scale: 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe.
  • Proportion of Subjects Who Achieve a Psoriasis Activity and Severity Index (PASI90) Response at Week 12 [ Time Frame: Week 12 ]
    The PASI90 response assessments are based on at least 90% improvement in the PASI score from Baseline. This is a scoring system that averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale), and weights the resulting score by the area of skin involved. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease.
  • Proportion of Subjects Who Achieve a Psoriasis Activity and Severity Index (PASI75) Response at Week 16 [ Time Frame: Week 16 ]
    The PASI75 response assessments are based on at least 75% improvement in the PASI score from Baseline. This is a scoring system that averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale), and weights the resulting score by the area of skin involved. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease.
  • Proportion of Subjects Who Achieve a Physician's Global Assessment (PGA) Clear or Almost Clear Response (With at Least 2 Category Improvement) at Week 16 [ Time Frame: Week 16 ]
    The Investigator assessed the overall severity of Psoriasis (PSO) using the following 5-point scale: 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe.
  • Proportion of Subjects Who Achieve a Psoriasis Activity and Severity Index (PASI90) Response at Week 16 [ Time Frame: Week 16 ]
    The PASI90 response assessments are based on at least 90% improvement in the PASI score from Baseline. This is a scoring system that averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale), and weights the resulting score by the area of skin involved. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease.
  • Proportion of Subjects Who Achieve a Psoriasis Activity and Severity Index (PASI75) Response at Week 48 for Those Achieving PASI75 at Week 16 [ Time Frame: Week 48 ]
    The PASI75 response assessments are based on at least 75% improvement in the PASI score from Baseline. This is a scoring system that averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale), and weights the resulting score by the area of skin involved. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease.
Original Secondary Outcome Measures  ICMJE
 (submitted: January 20, 2015)
  • Proportion of subjects who achieve a Physician's Global Assessment (PGA) Clear or Almost Clear response at Week 12 [ Time Frame: From Baseline to Week 12 ]
  • 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 ]
  • Proportion of subjects who achieve a Psoriasis Activity and Severity Index (PASI75) response at Week 48 [ Time Frame: From Baseline to Week 48 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety Study of Certolizumab Pegol (CZP) Versus Active Comparator and Placebo in Subjects With Plaque Psoriasis (PSO)
Official Title  ICMJE A Phase 3, Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo- and Active-Controlled Study Followed by a Placebo-Controlled Maintenance Period and Open-Label Follow-Up to Evaluate the Efficacy and Safety of Certolizumab Pegol in Subjects With Moderate to Severe Chronic Plaque Psoriasis
Brief Summary The purpose of this study is to investigate the efficacy and safety of two dose levels of certolizumab pegol compared to active comparator and placebo in adults with moderate to severe chronic plaque psoriasis.
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 Extension Treatment Period (96 weeks)
  • Safety Follow-Up (10 weeks)
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Psoriasis
  • Plaque Psoriasis
Intervention  ICMJE
  • 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
  • Biological: Etanercept
    • Active Substance: Etanercept
    • Pharmaceutical Form: Solution for injection in pre-filled syringe
    • Concentration: 50 mg / mL
    • Route of Administration: Subcutaneous use
    Other Names:
    • Enbrel
    • ETN
  • 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
Study Arms  ICMJE
  • Experimental: CZP 200 mg

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

    The treatment received from Week 16 to Week 48 is based on initial treatment and response to treatment at Week 16:

    • Subjects with a PASI75 response at Week 16 will be re-randomized to receive either CZP 200 mg Q2W or CZP 400 mg every 4 weeks (Q4W; with Placebo administered on alternate dosing weeks to maintain the blind) or Placebo Q2W.
    • Subjects who do not achieve a PASI75 response 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.

    Subjects can enter a 96-week open-label extension period after completing the Maintenance Period and receive CZP under certain conditions.

    Intervention: Biological: Certolizumab Pegol
  • Experimental: CZP 400 mg

    Certolizumab Pegol subcutaneous (sc) injection 400 mg every two weeks (Q2W) through Week 14.

    The treatment received from Week 16 to Week 48 is based on initial treatment and response to treatment at Week 16:

    • Subjects with a PASI75 response at Week 16 will be re-randomized to CZP 200 mg Q2W or CZP 400 mg Q2W or Placebo Q2W.
    • Subjects who do not achieve a PASI75 response 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.

    Subjects can enter a 96-week open-label extension period after completing the Maintenance Period and receive CZP under certain conditions.

    Intervention: Biological: Certolizumab Pegol
  • Active Comparator: Etanercept

    Etanercept (ETN) subcutaneous (sc) injection 50 mg twice weekly through Week 12.

    The treatment received from Week 16 to Week 48 is based on initial treatment and response to treatment at Week 16:

    • Subjects with a PASI75 response at Week 16 will be re-randomized to either Certolizumab Pegol (loading dose of 400 mg at Weeks 16, 18, and 20 followed by 200 mg Q2W) or Placebo Q2W.
    • Subjects who do not achieve a PASI75 response 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.

    Subjects can enter a 96-week open-label extension period after completing the Maintenance Period and receive CZP under certain conditions.

    Intervention: Biological: Etanercept
  • Placebo Comparator: Placebo

    Placebo subcutaneous (sc) injection every two weeks (Q2W).

    The treatment received from Week 16 to Week 48 is based on initial treatment and response to treatment at Week 16:

    • Subjects with a PASI75 response at Week 16 continue to receive blinded Placebo.
    • Subjects who do not achieve a PASI75 response 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.

    Subjects can enter a 96-week open-label extension period after completing the Maintenance Period and receive CZP under certain conditions.

    Intervention: Other: Placebo
Publications * Lebwohl M, Blauvelt A, Paul C, Sofen H, Węgłowska J, Piguet V, Burge D, Rolleri R, Drew J, Peterson L, Augustin M. Certolizumab pegol for the treatment of chronic plaque psoriasis: Results through 48 weeks of a phase 3, multicenter, randomized, double-blind, etanercept- and placebo-controlled study (CIMPACT). J Am Acad Dermatol. 2018 Aug;79(2):266-276.e5. doi: 10.1016/j.jaad.2018.04.013. Epub 2018 Apr 14.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 14, 2016)
559
Original Estimated Enrollment  ICMJE
 (submitted: January 20, 2015)
540
Actual Study Completion Date  ICMJE December 17, 2018
Actual Primary Completion Date March 22, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 5 months following last dose of study drug in the UK, Czech Republic, Germany, and France, and within 3 months for all other countries. Male subjects who are planning a partner pregnancy during the study or within 5 months following the last dose in France and within 10 weeks in all other countries
  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Bulgaria,   Czechia,   France,   Germany,   Hungary,   Netherlands,   Poland,   United Kingdom,   United States
Removed Location Countries Czech Republic
 
Administrative Information
NCT Number  ICMJE NCT02346240
Other Study ID Numbers  ICMJE PS0003
2014-003492-36 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE Not Provided
Responsible Party UCB Pharma ( UCB Biopharma S.P.R.L. )
Study Sponsor  ICMJE UCB Biopharma S.P.R.L.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: UCB Cares +1 844 599 2273 (UCB)
PRS Account UCB Pharma
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP