AzTrials
AzTrials

PsoriasisPhase 3CIMPACTNCT02346240

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

A Phase 3 study testing Certolizumab Pegol and Etanercept in people with Psoriasis and Plaque Psoriasis, run by UCB Biopharma S.P.R.L. at 70 sites in 9 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Psoriasis, Plaque Psoriasis
What is being tested?
Certolizumab Pegol and Etanercept
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
559 participants
Where
70 sitesin 9 countries
Study dates
11 Feb 2015to 17 Dec 2018
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)
Show all 9Show fewer
  • 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

Trial locations and contacts

70 sites in 9 countries.

70 sites in 9 countries

United States19 sites

  • Ps0003 301

    Beverly Hills, California, 90212

  • Ps0003 404

    Buffalo, New York, 14203

  • Ps0003 401

    Dallas, Texas, 75246

  • Ps0003 400

    Henderson, Nevada, 89052

  • Ps0003 403

    Houston, Texas, 77065

  • Ps0003 310

    Indianapolis, Indiana, 46256

  • Ps0003 309

    Johnston, Rhode Island, 02919

  • Ps0003 306

    Little Rock, Arkansas, 72204

  • Ps0003 307

    Los Angeles, California, 90045

  • Ps0003 317

    Mobile, Alabama, 36608

  • Ps0003 407

    Portland, Oregon, 97223

  • Ps0003 406

    San Antonio, Texas, 78213

  • Ps0003 405

    San Diego, California, 92123

  • Ps0003 302

    Springfield, Illinois, 62703

  • Ps0003 319

    Verona, New Jersey, 07044-29

  • Ps0003 316

    Washington D.C., District of Columbia, 20037

  • Ps0003 311

    Webster, Texas, 77598

  • Ps0003 313

    West Dundee, Illinois, 60118

  • Ps0003 304

    West Palm Beach, Florida, 33409

Other trials in United States

Germany15 sites

  • Ps0003 367

    Berlin

  • Ps0003 372

    Berlin

  • Ps0003 375

    Berlin

  • Ps0003 378

    Bochum, North Rhine-Westphalia

  • Ps0003 369

    Dresden

  • Ps0003 363

    Erfurt, Thuringia

  • Ps0003 368

    Frankfurt am Main, Hesse

  • Ps0003 374

    Friedrichshafen, Baden-Wurttemberg

  • Ps0003 361

    Giessen

  • Ps0003 362

    Hamburg

  • Ps0003 366

    Hanover

  • Ps0003 365

    Kiel, Schleswig-Holstein

  • Ps0003 370

    Mainz, Rhineland-Palatinate

  • Ps0003 373

    Munich, Bavaria

  • Ps0003 371

    Wuppertal, North Rhine-Westphalia

Other trials in Germany

Poland14 sites

  • Ps0003 333

    Bialystok, Podlaskie Voivodeship

  • Ps0003 425

    Bialystok

  • Ps0003 427

    Gdansk

  • Ps0003 423

    Gdynia

  • Ps0003 334

    Katowice, Silesian Voivodeship

  • Ps0003 335

    Lublin, Lublin Voivodeship

  • Ps0003 424

    Poznan, Greater Poland Voivodeship

  • Ps0003 332

    Szczecin

  • Ps0003 330

    Torun, Kuyavian-Pomeranian Voivodeship

  • Ps0003 338

    Warsaw, Masovian Voivodeship

  • Ps0003 421

    Warsaw, Masovian Voivodeship

  • Ps0003 336

    Warsaw

  • Ps0003 422

    Wroclaw, Lower Silesian Voivodeship

  • Ps0003 339

    Wroclaw

Other trials in Poland

United Kingdom6 sites

  • Ps0003 395

    Cardiff, Wales

  • Ps0003 390

    Dundee, Angus

  • Ps0003 393

    Edgbaston

  • Ps0003 391

    Hexham, Northumberland

  • Ps0003 394

    Liverpool

  • Ps0003 392

    Manchester

Other trials in United Kingdom

Hungary5 sites

  • Ps0003 382

    Budapest

  • Ps0003 383

    Budapest

  • Ps0003 384

    Budapest

  • Ps0003 380

    Debrecen, Hajdú-Bihar

  • Ps0003 381

    Orosháza, Bekes County

Other trials in Hungary

Bulgaria4 sites

  • Ps0003 345

    Dupnitsa, Kyustendil

  • Ps0003 344

    Plovdiv

  • Ps0003 343

    Sofia, Sofia-Grad

  • Ps0003 342

    Varna

Other trials in Bulgaria

Czechia4 sites

  • Ps0003 353

    Pardubice, District of Columbia

  • Ps0003 351

    Pardubice

  • Ps0003 352

    Prague

  • Ps0003 350

    Ústí nad Labem

Other trials in Czechia

France2 sites

  • Ps0003 320

    Nice

  • Ps0003 325

    Toulouse

Other trials in France

Netherlands1 site

  • Ps0003 340

    Breda

Other trials in Netherlands

About this study

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

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.

Read the detailed 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)
Being tested
Certolizumab Pegol, Etanercept, Placebo
Keywords
Certolizumab Pegol, Cimzia, Psoriasis
Medical subject headings
Psoriasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Certolizumab PegolBiological

    Also called Cimzia, CDP870, CZP

    • Active Substance: Certolizumab Pegol
    • Pharmaceutical Form: Solution for injection in pre-filled syringe
    • Concentration: 200 mg/ mL
    • Route of Administration: Subcutaneous use

  • EtanerceptBiological

    Also called Enbrel, ETN

    • Active Substance: Etanercept
    • Pharmaceutical Form: Solution for injection in pre-filled syringe
    • Concentration: 50 mg / mL
    • Route of Administration: Subcutaneous use

  • PlaceboOther

    Also called PBO

    • Active Substance: Placebo
    • Pharmaceutical Form: Solution for injection in pre-filled syringe
    • Concentration: 0.9 % saline
    • Route of Administration: Subcutaneous use
Study groups in NCT02346240
Study groupRoleWhat they receive
CZP 200 mgExperimentalCertolizumab 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 with a PASI75 response at Week 16 will be re-randomized to receive either CZP 200 mg Q2W or CZP 400 mg every 4 weeks (Q4W; with Placebo administered on alternate dosing weeks to maintain the blind) or Placebo Q2W. * Subjects who do not achieve a PASI75 response at Week 16 will be removed from blinded study medication and escape to CZP 400 mg Q2W. Subjects who receive unblinded CZP 400 mg Q2W for 16 weeks and do not achieve a PASI50 response will be withdrawn from the study. Subjects can enter a 96-week open-label extension period after completing the Maintenance Period and receive CZP under certain conditions.
Receives: Biological: Certolizumab Pegol
CZP 400 mgExperimentalCertolizumab 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 with a PASI75 response at Week 16 will be re-randomized to CZP 200 mg Q2W or CZP 400 mg Q2W or Placebo Q2W. * Subjects who do not achieve a PASI75 response at Week 16 will be removed from blinded study medication and escape to CZP 400 mg Q2W. Subjects who receive unblinded CZP 400 mg Q2W for 16 weeks and do not achieve a PASI50 response will be withdrawn from the study. Subjects can enter a 96-week open-label extension period after completing the Maintenance Period and receive CZP under certain conditions.
Receives: Biological: Certolizumab Pegol
EtanerceptActive comparatorEtanercept (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 with a PASI75 response at Week 16 will be re-randomized to either Certolizumab Pegol (loading dose of 400 mg at Weeks 16, 18, and 20 followed by 200 mg Q2W) or Placebo Q2W. * Subjects who do not achieve a PASI75 response at Week 16 will be removed from blinded study medication and escape to CZP 400 mg Q2W. Subjects who receive unblinded CZP 400 mg Q2W for 16 weeks and do not achieve a PASI50 response will be withdrawn from the study. Subjects can enter a 96-week open-label extension period after completing the Maintenance Period and receive CZP under certain conditions.
Receives: Biological: Etanercept
PlaceboPlacebo comparatorPlacebo 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 with a PASI75 response at Week 16 continue to receive blinded Placebo. * Subjects who do not achieve a PASI75 response at Week 16 will be removed from blinded study medication and escape to CZP 400 mg Q2W. Subjects who receive unblinded CZP 400 mg Q2W for 16 weeks and do not achieve a PASI50 response will be withdrawn from the study. Subjects can enter a 96-week open-label extension period after completing the Maintenance Period and receive CZP under certain conditions.
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Week 12

Secondary outcomes (6)

  1. 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.

    Measured: Week 12

  2. 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.

    Measured: Week 12

  3. 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.

    Measured: Week 16

  4. 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.

    Measured: Week 16

  5. 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.

    Measured: Week 16

  6. 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.

    Measured: Week 48

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jan 2015 (estimated)
  2. Study start11 Feb 2015
  3. Primary completion22 Mar 2016
  4. Study completion17 Dec 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
559 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02346240
Sponsor's protocol ID
PS0003
Other IDs
2014-003492-36, 2014
Acronym
CIMPACT
Status last verified
Jul 2021
First submitted
20 Jan 2015
Last updated
16 Jul 2021
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Expanded access
Available

Publications

  • 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-blind, etanercept- and placebo-controlled study (CIMPACT). J Am Acad Dermatol. 2018 Aug;79(2):266-276.e5. doi: 10.1016/j.jaad.2018.04.013. Epub 2018 Apr 14.

    PubMed 29660425

  • Warren RB, Lebwohl M, Sofen H, Piguet V, Augustin M, Brock F, C Arendt, 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 Dermatol Venereol. 2021 Dec;35(12):2398-2408. doi: 10.1111/jdv.17486. Epub 2021 Aug 17.

    PubMed 34192387

  • Blauvelt A, Paul C, van de Kerkhof P, Warren RB, Gottlieb AB, Langley RG, Brock F, Arendt C, Boehnlein M, Lebwohl M, Reich K. Long-term safety of certolizumab pegol in plaque psoriasis: pooled analysis over 3 years from three phase III, randomized, placebo-controlled studies. Br J Dermatol. 2021 Apr;184(4):640-651. doi: 10.1111/bjd.19314. Epub 2020 Sep 6.

    PubMed 32531798

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Certolizumab Pegol and Etanercept in people with Psoriasis and Plaque Psoriasis, run by UCB Biopharma S.P.R.L. at 70 sites in 9 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 70 sites in United States, Germany, Poland, United Kingdom, Hungary and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Jul 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of Subjects Who Achieve a Psoriasis Activity and Severity Index (PASI75) Response at Week 12 (time frame: Week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02346240, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2021.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in