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Completed

NCT Number: NCT02346240

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

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.

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Key information

Conditions

Psoriasis Plaque Psoriasis Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Ps0003 345, Dupnitsa, Kyustendil, Bulgaria

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About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Certolizumab Pegol

Biological
  • 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

etanercept

Biological
  • 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

Placebo

Other
  • Active Substance: Placebo
  • Pharmaceutical Form: Solution for injection in pre-filled syringe
  • Concentration: 0.9 % saline
  • Route of Administration: Subcutaneous use

Other names: PBO

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

Sponsors and collaborators

Lead sponsor

UCB Biopharma S.P.R.L.

Industry

Registry information

Official study title

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

Acronym: CIMPACT

Important dates

Study start
2015
Primary completion
2016
Study completion
2018
First posted
Jan 26, 2015
Registry last updated
Jul 16, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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