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

Psoriasis Clinical Trial

— CIMPACT  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02346240
• Other study ID #: PS0003
• Secondary ID: 2014-003492-36
• Status: Completed
• Phase: Phase 3
• Start date: February 11, 2015
• Est. completion date: December 17, 2018

Study information

• Verified date: July 2021
• Source: UCB Pharma
• Contact: n/a
• Is FDA regulated: No
• 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 compared to active comparator and placebo 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 Extension Treatment Period (96 weeks)

• Safety Follow-Up (10 weeks)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 559
• Est. completion date: December 17, 2018
• Est. primary completion date: March 22, 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 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

Related Conditions & MeSH terms

• Plaque Psoriasis
• Psoriasis

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
• Etanercept
Active Substance: Etanercept Pharmaceutical Form: Solution for injection in pre-filled syringe Concentration: 50 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
Bulgaria	Ps0003 345	Dupnitsa	Kyustendil
Bulgaria	Ps0003 344	Plovdiv
Bulgaria	Ps0003 343	Sofia	Sofia-Grad
Bulgaria	Ps0003 342	Varna
Czechia	Ps0003 351	Pardubice
Czechia	Ps0003 353	Pardubice	District Of Columbia
Czechia	Ps0003 352	Praha
Czechia	Ps0003 350	Ústí nad Labem
France	Ps0003 320	Nice cedex 3
France	Ps0003 325	Toulouse Cedex 9
Germany	Ps0003 367	Berlin
Germany	Ps0003 372	Berlin
Germany	Ps0003 375	Berlin
Germany	Ps0003 378	Bochum	Nordrhein-Westfalen
Germany	Ps0003 369	Dresden
Germany	Ps0003 363	Erfurt	Thueringen
Germany	Ps0003 368	Frankfurt am Main	Hessen
Germany	Ps0003 374	Friedrichshafen	Baden-Wuerttemberg
Germany	Ps0003 361	Giessen
Germany	Ps0003 362	Hamburg
Germany	Ps0003 366	Hannover
Germany	Ps0003 365	Kiel	Schleswig-Holstein
Germany	Ps0003 370	Mainz	Rheinland-Pfalz
Germany	Ps0003 373	Muenchen	Bayern
Germany	Ps0003 371	Wuppertal	Nordrhein-Westfalen
Hungary	Ps0003 382	Budapest
Hungary	Ps0003 383	Budapest
Hungary	Ps0003 384	Budapest
Hungary	Ps0003 380	Debrecen	Hajdú-Bihar
Hungary	Ps0003 381	Orosháza	Bekes
Netherlands	Ps0003 340	Breda
Poland	Ps0003 333	Bialystok	Podlaskie
Poland	Ps0003 425	Bialystok
Poland	Ps0003 427	Gdansk
Poland	Ps0003 423	Gdynia
Poland	Ps0003 334	Katowice	Slaskie
Poland	Ps0003 335	Lublin	Lubelskie
Poland	Ps0003 424	Poznan	Wielkopolskie
Poland	Ps0003 332	Szczecin
Poland	Ps0003 330	Torun	Kujawsko-pomorskie
Poland	Ps0003 336	Warszawa
Poland	Ps0003 338	Warszawa	Mazowieckie
Poland	Ps0003 421	Warszawa	Mazowieckie
Poland	Ps0003 339	Wroclaw
Poland	Ps0003 422	Wroclaw	Dolnoslaskie
United Kingdom	Ps0003 395	Cardiff	Wales
United Kingdom	Ps0003 390	Dundee	Angus
United Kingdom	Ps0003 393	Edgbaston
United Kingdom	Ps0003 391	Hexham	Northumberland
United Kingdom	Ps0003 394	Liverpool
United Kingdom	Ps0003 392	Manchester
United States	Ps0003 301	Beverly Hills	California
United States	Ps0003 404	Buffalo	New York
United States	Ps0003 401	Dallas	Texas
United States	Ps0003 400	Henderson	Nevada
United States	Ps0003 403	Houston	Texas
United States	Ps0003 310	Indianapolis	Indiana
United States	Ps0003 309	Johnston	Rhode Island
United States	Ps0003 306	Little Rock	Arkansas
United States	Ps0003 307	Los Angeles	California
United States	Ps0003 317	Mobile	Alabama
United States	Ps0003 407	Portland	Oregon
United States	Ps0003 406	San Antonio	Texas
United States	Ps0003 405	San Diego	California
United States	Ps0003 302	Springfield	Illinois
United States	Ps0003 319	Verona	New Jersey
United States	Ps0003 316	Washington	District of Columbia
United States	Ps0003 311	Webster	Texas
United States	Ps0003 313	West Dundee	Illinois
United States	Ps0003 304	West Palm Beach	Florida

Sponsors (1)

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

Countries where clinical trial is conducted

United States,  Bulgaria,  Czechia,  France,  Germany,  Hungary,  Netherlands,  Poland,  United Kingdom, 

References & Publications (2)

Lebwohl M, Blauvelt A, Paul C, Sofen H, Weglowska J, Piguet V, Burge D, Rolleri R, Drew J, Peterson L, Augustin M. Certolizumab pegol for the treatment of chronic plaque psoriasis: Results through 48 weeks of a phase 3, multicenter, randomized, double-bli — View Citation

Warren RB, Lebwohl M, Sofen H, Piguet V, Augustin M, Brock F, Arendt C, Fierens F, Blauvelt A. Three-year efficacy and safety of certolizumab pegol for the treatment of plaque psoriasis: Results from the randomized phase 3 CIMPACT trial. J Eur Acad Dermat — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of Subjects Who Achieve a Psoriasis Activity and Severity Index (PASI75) Response at 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.	Week 12
Secondary	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	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 12
Secondary	Proportion of Subjects Who Achieve a Psoriasis Activity and Severity Index (PASI90) Response at 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.	Week 12
Secondary	Proportion of Subjects 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
Secondary	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	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 Subjects 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 Subjects Who Achieve a Psoriasis Activity and Severity Index (PASI75) Response at Week 48 for Those Achieving PASI75 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 48

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