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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02326272
Other study ID # PS0002
Secondary ID 2014-003486-14
Status Completed
Phase Phase 3
First received
Last updated
Start date December 15, 2014
Est. completion date September 12, 2018

Study information

Verified date September 2019
Source UCB Pharma
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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


Recruitment information / eligibility

Status Completed
Enrollment 227
Est. completion date September 12, 2018
Est. primary completion date January 5, 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Austria Ps0002 253 Graz Steiermark
Canada Ps0002 221 Barrie Ontario
Canada Ps0002 223 London Ontario
Canada Ps0002 222 Peterborough Ontario
Canada Ps0002 220 Richmond Hill Ontario
Canada Ps0002 224 Waterloo Ontario
Poland Ps0002 230 Kielce Swietokrzyskie
Poland Ps0002 232 Krakow Malopolskie
Poland Ps0002 231 Wroclaw
United States Ps0002 214 Bakersfield California
United States Ps0002 205 Cleveland Ohio
United States Ps0002 202 East Windsor New Jersey
United States Ps0002 201 Greer South Carolina
United States Ps0002 210 New York New York
United States Ps0002 204 Ormond Beach Florida
United States Ps0002 203 Phoenix Arizona
United States Ps0002 200 Portland Oregon
United States Ps0002 207 Portsmouth New Hampshire
United States Ps0002 213 Richmond Virginia
United States Ps0002 206 Rochester New York
United States Ps0002 208 San Antonio Texas
United States Ps0002 212 Santa Monica California
United States Ps0002 209 Wilmington North Carolina

Sponsors (1)

Lead Sponsor Collaborator
UCB Biopharma S.P.R.L.

Countries where clinical trial is conducted

United States,  Austria,  Canada,  Poland, 

References & Publications (1)

Gottlieb AB, Blauvelt A, Thaçi D, Leonardi CL, Poulin Y, Drew J, Peterson L, Arendt C, Burge D, Reich K. Certolizumab pegol for the treatment of chronic plaque psoriasis: Results through 48 weeks from 2 phase 3, multicenter, randomized, double-blinded, pl — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Proportion of Participants Who Achieve a Psoriasis Activity and Severity Index (PASI75) Response at 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. Week 16
Primary Proportion of Participants Who Achieve a Physician's Global Assessment (PGA) Clear or Almost Clear (With at Least 2-category Improvement) Response at 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. Week 16
Secondary Proportion of Participants Who Achieve a Psoriasis Activity and Severity Index (PASI90) Response at 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. Week 16
Secondary Proportion of Participants Who Achieve a Physician's Global Assessment (PGA) Clear or Almost Clear (With at Least 2-category Improvement) Response at Week 48 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. Week 48
Secondary Proportion of Participants Who Achieve a Psoriasis Activity and Severity Index (PASI75) Response at 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. Week 48
Secondary Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 16 The DLQI is a subject-reported questionnaire designed for use in adult subjects with PSO. The DLQI is a skin disease-specific questionnaire aimed at the evaluation of how symptoms and treatment affect patients' health related quality of life (HRQoL). This instrument asks subjects about symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. It has been shown to be valid and reproducible in PSO patients. The DLQI score ranges from 0 to 30 with higher scores indicating lower HRQoL. A higher than or equal to (>=) 4-point change in the DLQI score (DLQI response) has been reported to be meaningful for the patient (within-patient minimal important difference Basra et al, 2015) a DLQI absolute score of lower than or equal to (=<) 1 indicates DLQI remission (i.e., no or small impact of the disease on HRQoL). Week 16
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