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Completed

NCT Number: NCT00245765

Efficacy Study of CDP870 in Subjects With Chronic Plaque Psoriasis Who Are Candidate for Systemic Therapy and/or Phototherapy/Photochemotherapy

A study to assess the safety and efficacy of 2 different doses of CDP870 versus placebo, administered during 12 weeks, to patients suffering from moderate to severe chronic plaque psoriasis, extended by a 12 to 24 week follow-up.

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Key information

Conditions

Chronic Plaque Psoriasis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Besançon, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adult men and women > 18 years
  • Subjects with chronic plaque psoriasis stable for at least 3 months and moderate to severe for at least 6 months
  • Subjects with Psoriasis Area and Severity Index (PASI) ≥ 12 and Body Surface Area (BSA) ≥ 10 %
  • Subjects were candidates for systemic psoriasis therapy and/or phototherapy and/or photochemotherapy

Exclusion criteria

  • Subjects with an erythrodermic, guttate, palmar or plantar, generalized pustular form of psoriasis
  • A history of chronic infection, recent serious or life-threatening infection (within six months, including herpes zoster), or any current sign or symptom that may indicate an infection (e.g. fever, cough);
  • White blood cell counts less than 4000/mm^3 or more than 20000/mm^3
  • Suspected or diagnosed demyelinating disease of the central nervous system (e.g. multiple sclerosis or optic neuritis)
  • Systemic Lupus
  • Non respect of adequate wash out periods for treatments that might have an impact on the disease
  • Any associated disease that could be impacted by the study treatment intake
  • Any other condition, which in the Investigator's judgment would make the subject unsuitable for inclusion in the study

Treatment and study plan

Certolizumab pegol

Drug
  • Pharmaceutical Form: solution for injection in pre-filled syringe
  • Route of Administration: subcutaneous use

Other names: Cimzia

Placebo

Other

Matching Placebo to Certolizumab Pegol

Primary outcomes

  1. Achievement of Psoriasis Activity and Severity Index (PASI75) Response at Week 12

    Time frame: Week 12

    Determining the PASI score involves the evaluation of erythema, infiltration, and desquamation and body surface area involvement over 4 body regions. These regions are the head, trunk, upper and lower extremities.

    PASI75 response at Week 12 is defined as a decrease in PASI score at Week 12 from Baseline of at least 75 %.

  2. Achievement of a Physician's Global Assessment (PGA) of Clear or Almost Clear at Week 12

    Time frame: Week 12

    The overall severity of the disease was evaluated using the following 6-point scale:

    5 = Severe: Very marked plaque elevation, scaling, and/or erythema. 4 = Moderate to severe: Marked plaque elevation, scaling, and/or erythema. 3 = Moderate: Moderate plaque elevation, scaling, and/or erythema. 2 = Mild: Slight plaque elevation, scaling, and/or erythema

    1 = Almost clear: Intermediate between mild and clear 0 = Clear: No signs of psoriasis (post-inflammatory hyperpigmentation may be present)

Secondary outcomes

  1. Time to Psoriasis Activity and Severity Index 50 (PASI50)

    Time frame: During the 12-weeks Treatment Period

    Time to PASI50 is defined as the time elapsed between the start of the Treatment Period (Week 0) and the first occurrence of PASI50 during the Treatment Period.

    This variable is defined only for those patients who have achieved PASI75 at the end of the Treatment Period (Week 12).

  2. Time to Psoriasis Activity and Severity Index 75 (PASI75)

    Time frame: During the 12-weeks Treatment Period

    Time to PASI75 is defined as the time elapsed between the start of the Treatment Period (Week 0) and the first occurrence of PASI75 during the Treatment Period.

    This variable is defined only for those patients who have achieved PASI75 at the end of the Treatment Period (Week 12).

  3. Time to Relapse

    Time frame: During the 12-weeks Treatment Period

    Time to relapse is defined as the time elapsed between the last dose and when maximal improvement in PASI from Baseline was reduced by > 50 %. This variable is defined only for those patients who have achieved PASI75 at the end of the Treatment Period (Week 12).

  4. Achievement of a Psoriasis Activity and Severity Index (PASI50) Response at Week 12

    Time frame: Week 12

    Determining the PASI score involves the evaluation of erythema, infiltration, and desquamation and body surface area involvement over 4 body regions. These regions are the head, trunk, upper and lower extremities.

    PASI50 response at Week 12 is defined as a decrease in PASI score at Week 12 from Baseline of at least 50 %.

  5. Achievement of a Psoriasis Activity and Severity Index (PASI90) Response at Week 12

    Time frame: Week 12

    Determining the PASI score involves the evaluation of erythema, infiltration, and desquamation and body surface area involvement over 4 body regions. These regions are the head, trunk, upper and lower extremities.

    PASI90 response at Week 12 is defined as a decrease in PASI score at Week 12 from Baseline of at least 90 %.

  6. Experience of a Rebound Effect Within 2 Months After Stopping Therapy

    Time frame: Within 2 months of stopping therapy

    Rebound is defined as worsening of psoriasis over baseline value with more than 125 % or new pustular, erythrodermic or more inflammatory psoriasis within 2 months of stopping therapy.

  7. Percent of Body Surface Area (BSA) Affected by Psoriasis at Week 12

    Time frame: Week 12

    Two methods were used for the evaluation of BSA:

    • The area of one side of a subject's flat closed hand was used to represent 1 % to the total body surface area (BSA) to estimate the extent of skin involvement in subjects with psoriasis
    • The rule of nines method assumed that the total BSA comprises head (9 %), anterior trunk (upper, 9 %; lower, 9 %), posterior trunk (upper, 9 %; lower, 9 %), each leg (anterior, 9 %; posterior, 9 %), each arm (9 %) and genitalia (1 %)

  8. Absolute Change From Baseline in the Body Surface Area (BSA) Affected by Psoriasis at Week 12

    Time frame: Baseline up to Week 12

    Two methods were used for the evaluation of BSA:

    • The area of one side of a subject's flat closed hand was used to represent 1 % to the total body surface area (BSA) to estimate the extent of skin involvement in subjects with psoriasis
    • The rule of nines method assumed that the total BSA comprises head (9 %), anterior trunk (upper, 9 %; lower, 9 %), posterior trunk (upper, 9 %; lower, 9 %), each leg (anterior, 9 %; posterior, 9 %), each arm (9 %) and genitalia (1 %) A positive value in Change from Baseline indicates an improvement from Baseline. The higher the positive value, the higher the change.

  9. Time to Discontinuation From the Treatment Period Due to Lack of Efficacy or Worsening of Psoriasis

    Time frame: During the 12-week Treatment Period

Sponsors and collaborators

Lead sponsor

UCB Pharma

Industry

Registry information

Official study title

Multicenter, Dose Response, Randomized, Double Blind, Parallel, Placebo Controlled Clinical Trial to Evaluate the Efficacy and the Safety of Subcutaneous CDP870 in Subjects Suffering From Moderate-to-severe Chronic Plaque Psoriasis Who Are Candidates for Systemic Therapy and/or Phototherapy and/or Photochemotherapy

Important dates

Study start
2005
Primary completion
2006
Study completion
2006
First posted
Oct 28, 2005
Registry last updated
May 3, 2019

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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