Trial record 1 of 1 for:
NCT02346240
Efficacy and Safety Study of Certolizumab Pegol (CZP) Versus Active Comparator and Placebo in Subjects With Plaque Psoriasis (PSO) (CIMPACT)
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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 |
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Recruitment Status :
Completed
First Posted : January 26, 2015
Results First Posted : July 18, 2018
Last Update Posted : July 16, 2021
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Sponsor:
UCB Biopharma S.P.R.L.
Information provided by (Responsible Party):
UCB Pharma ( UCB Biopharma S.P.R.L. )
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Psoriasis Plaque Psoriasis | Biological: Certolizumab Pegol Biological: Etanercept Other: Placebo | Phase 3 |
Expanded Access : An investigational treatment associated with this study is available outside the clinical trial. More info ...
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 559 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official 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 |
| Study Start Date : | February 11, 2015 |
| Actual Primary Completion Date : | March 22, 2016 |
| Actual Study Completion Date : | December 17, 2018 |
| Arm | Intervention/treatment |
|---|---|
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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 can enter a 96-week open-label extension period after completing the Maintenance Period and receive CZP under certain conditions. |
Biological: Certolizumab Pegol
Other Names:
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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 can enter a 96-week open-label extension period after completing the Maintenance Period and receive CZP under certain conditions. |
Biological: Certolizumab Pegol
Other Names:
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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 can enter a 96-week open-label extension period after completing the Maintenance Period and receive CZP under certain conditions. |
Biological: Etanercept
Other Names:
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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 can enter a 96-week open-label extension period after completing the Maintenance Period and receive CZP under certain conditions. |
Other: Placebo
Other Name: PBO |
Primary Outcome Measures :
- 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 Outcome Measures :
- 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.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02346240
Locations
Show 70 study locations
Sponsors and Collaborators
UCB Biopharma S.P.R.L.
Investigators
| Study Director: | UCB Cares | +1 844 599 2273 (UCB) |
Additional Information:
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | UCB Biopharma S.P.R.L. |
| ClinicalTrials.gov Identifier: | NCT02346240 |
| Other Study ID Numbers: |
PS0003 2014-003492-36 ( EudraCT Number ) |
| First Posted: | January 26, 2015 Key Record Dates |
| Results First Posted: | July 18, 2018 |
| Last Update Posted: | July 16, 2021 |
| Last Verified: | July 2021 |
| 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 |
Keywords provided by UCB Pharma ( UCB Biopharma S.P.R.L. ):
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Certolizumab Pegol Cimzia Psoriasis |
Additional relevant MeSH terms:
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Psoriasis Skin Diseases, Papulosquamous Skin Diseases Etanercept Certolizumab Pegol Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents |
Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Inflammatory Agents Antirheumatic Agents Gastrointestinal Agents Immunosuppressive Agents Immunologic Factors Tumor Necrosis Factor Inhibitors |