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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Chronic Plaque Psoriasis

Intervention / Treatment
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* Drug: Certolizumab Pegol
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Subcutaneous injections of Placebo every 2 weeks | Other: Placebo<br>* Matching Placebo to Certolizumab Pegol<br>|
| Experimental: Certolizumab Pegol 200 mg<br>Subcutaneous injections of 400 mg initial dose at week 0 with 200 mg every 2 weeks thereafter | Drug: Certolizumab Pegol<br>* Pharmaceutical Form: solution for injection in pre-filled syringe Route of Administration: subcutaneous use<br>* Other names: Cimzia;|
| Experimental: Certolizumab Pegol 400 mg<br>Subcutaneous injections of 400 mg every 2 weeks | Drug: Certolizumab Pegol<br>* Pharmaceutical Form: solution for injection in pre-filled syringe Route of Administration: subcutaneous use<br>* Other names: Cimzia;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Achievement of Psoriasis Activity and Severity Index (PASI75) Response at 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 %. | Week 12 | 
| Achievement of a Physician's Global Assessment (PGA) of Clear or Almost Clear at 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) | Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Psoriasis Activity and Severity Index 50 (PASI50) | 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). | During the 12-weeks Treatment Period | 
| Time to Psoriasis Activity and Severity Index 75 (PASI75) | 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). | During the 12-weeks Treatment Period | 
| Time to Relapse | 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). | During the 12-weeks Treatment Period | 
| Achievement of a Psoriasis Activity and Severity Index (PASI50) Response at 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 %. | Week 12 | 
| Achievement of a Psoriasis Activity and Severity Index (PASI90) Response at 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 %. | Week 12 | 
| Experience of a Rebound Effect Within 2 Months After 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. | Within 2 months of stopping therapy | 
| Percent of Body Surface Area (BSA) Affected by Psoriasis at 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 %) | Week 12 | 
| Absolute Change From Baseline in the Body Surface Area (BSA) Affected by Psoriasis at 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. | Baseline up to Week 12 | 
| Time to Discontinuation From the Treatment Period Due to Lack of Efficacy or Worsening of Psoriasis |  | During the 12-week Treatment Period | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chronic plaque psoriasis, anti TNFα, CDP870, Cimzia