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PsoriasisPhase 3CIMPASI-1NCT02326298

An Efficacy and Safety Study of Two Dose Levels of Certolizumab Pegol (CZP) in Subjects With Plaque Psoriasis (PSO)

A Phase 3 study testing Certolizumab Pegol in people with Psoriasis and Plaque Psoriasis, run by UCB Biopharma S.P.R.L. at 30 sites in 5 countries.

Completed

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

Official record
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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 when administered every 2 weeks. 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
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
234 participants
Where
30 sitesin 5 countries
Study dates
16 Dec 2014to 24 Oct 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 Czech Republic and Germany) and within 3 months for all other countries. Male subjects who are planning a partner pregnancy during the study or within 10 weeks following the last dose of study drug
  • 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

30 sites in 5 countries.

30 sites in 5 countries

United States8 sites

  • Ps0005 507

    Albuquerque, New Mexico, 87106

  • Ps0005 500

    Baton Rouge, Louisiana, 70809

  • Ps0005 506

    Boston, Massachusetts, 02111

  • Ps0005 501

    Houston, Texas, 77004

  • Ps0005 508

    Nashville, Tennessee, 37215

  • Ps0005 504

    San Diego, California, 92123

  • Ps0005 505

    St Louis, Missouri, 63117

  • Ps0005 502

    West Des Moines, Iowa, 50265

Other trials in United States

Germany8 sites

  • Ps0005 560

    Berlin

  • Ps0005 561

    Dresden

  • Ps0005 563

    Hamburg

  • Ps0005 568

    Hamburg

  • Ps0005 566

    Kiel

  • Ps0005 569

    Lübeck, Schleswig-Holstein

  • Ps0005 562

    Mahlow, Brandenburg

  • Ps0005 565

    Witten, North Rhine-Westphalia

Other trials in Germany

Canada7 sites

  • Ps0005 596

    Ajax, Ontario

  • Ps0005 595

    Drummondville, Quebec

  • Ps0005 597

    Edmonton, Alberta

  • Ps0005 590

    Hamilton, Ontario

  • Ps0005 594

    Québec, Quebec

  • Ps0005 591

    Surrey, British Columbia

  • Ps0005 593

    Toronto, Ontario

Other trials in Canada

Czechia4 sites

  • Ps0005 553

    Náchod

  • Ps0005 550

    Olomouc

  • Ps0005 551

    Ostrava-Poruba

  • Ps0005 552

    Prague

Other trials in Czechia

Hungary3 sites

  • Ps0005 582

    Budapest

  • Ps0005 580

    Orosháza, Bekes County

  • Ps0005 581

    Pécs

Other trials in Hungary

About this study

Official title: A Phase 3, Multicenter, Randomized, Double-Blind, Parallel-Group, Study Followed by a Dose-Blind 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 in adults with moderate to severe chronic plaque psoriasis when administered every 2 weeks.

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 Treatment Period from Week 48 to Week 144
  • Safety Follow-Up Period from Week 144 to Week 152
Being tested
Certolizumab Pegol, 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

  • 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 NCT02326298
Study groupRoleWhat they receive
CZP 200 mgExperimentalCZP 400 mg at Weeks 0, 2, 4, followed by CZP 200 mg every two weeks (Q2W) from Week 6 to Week 14. Treatment received from Week 16-48 is based on initial treatment and response to treatment: * PASI50 responders at Week 16 continue to receive CZP 200 mg Q2W. * PASI50 non-responders at Week 16 will be removed from blinded study medication and escape to unblinded 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. * PASI50 non-responders at Week 32 or a later time point will be withdrawn from the study. Subjects who complete the Maintenance Period (with PASI50 response at Week 48) enter the Open-label Extension Period on CZP 200 mg Q2W. Week 48 completers in the escape arm continue to receive CZP 400 mg Q2W or may switch to CZP 200 mg Q2W. Depending on PASI50 or PASI75 responses at Week 60 or a later time point, subjects may switch to CZP 400 mg Q2W or withdraw from the study.
Receives: Biological: Certolizumab Pegol
CZP 400 mgExperimentalCZP 400 mg every two weeks (Q2W) through Week 14. Treatment received from Week 16 - 48 is based on initial treatment and response to treatment: * PASI50 responders at Week 16 continue to receive CZP 400 mg Q2W. * PASI50 non-responders 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. * PASI50 non-responders at Week 32 or a later time point will be withdrawn from the study. Subjects who complete the Maintenance Period (with PASI50 response at Week 48) enter the Open-label Extension (OLE) Period on CZP 200 mg Q2W. Week 48 completers in the escape arm continue to receive CZP 400 mg Q2W or may switch to CZP 200 mg Q2W. Subjects who achieve a PASI75 response during the OLE Phase may switch to CZP 200 mg Q2W.
Receives: Biological: Certolizumab Pegol
PlaceboPlacebo comparatorPlacebo subcutaneous (sc) injection every two weeks (Q2W). Treatment received from Week 16 - 48 is based on initial treatment and response to treatment: * PASI50 responders at Week 16, who do not achieve a PASI75 response at Week 16 receive CZP 400 mg at Weeks 16, 18 and 20 (loading doses) followed by CZP 200 mg Q2W starting at Week 22. * PASI75 responders at Week 16 continue to receive Placebo. * PASI50 non-responders 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. * PASI50 non-responders at Week 32 or a later time point will be withdrawn from the study. Subjects who complete the Maintenance Period (with PASI50 response at Week 48) enter the Open-label Extension Period on CZP 200 mg Q2W. Week 48 completers in the escape arm continue to receive CZP 400 mg Q2W or may switch to CZP 200 mg Q2W.
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 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: At Week 16

  2. Proportion of Subjects 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.

    Measured: At Week 16

Secondary outcomes (4)

  1. 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: At Week 16

  2. Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 16

    The DLQI is a subject-reported questionnaire designed for use in adult participants 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 participants 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 of 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).

    Measured: At Week 16

  3. Proportion of Subjects 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.

    Measured: At Week 48

  4. Proportion of Subjects 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.

    Measured: At 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 posted29 Dec 2014 (estimated)
  2. Study start16 Dec 2014
  3. Primary completion8 Mar 2016
  4. Study completion24 Oct 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
234 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02326298
Sponsor's protocol ID
PS0005
Other IDs
2014-003513-28, 2014
Acronym
CIMPASI-1
Status last verified
Oct 2019
First submitted
22 Dec 2014
Last updated
7 Nov 2019
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Expanded access
Available

Publications

  • Gottlieb AB, Blauvelt A, Thaci 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, placebo-controlled studies (CIMPASI-1 and CIMPASI-2). J Am Acad Dermatol. 2018 Aug;79(2):302-314.e6. doi: 10.1016/j.jaad.2018.04.012. Epub 2018 Apr 13.

    PubMed 29660421

  • Gisondi P, Gottlieb AB, Elewski B, Augustin M, McBride S, Tsai TF, de la Loge C, Fierens F, Lopez Pinto JM, Tilt N, Lebwohl M. Long-Term Health-Related Quality of Life in Patients with Plaque Psoriasis Treated with Certolizumab Pegol: Three-Year Results from Two Randomised Phase 3 Studies (CIMPASI-1 and CIMPASI-2). Dermatol Ther (Heidelb). 2023 Jan;13(1):315-328. doi: 10.1007/s13555-022-00861-4. Epub 2022 Dec 13.

    PubMed 36509889

  • Gordon KB, Warren RB, Gottlieb AB, Blauvelt A, Thaci D, Leonardi C, Poulin Y, Boehnlein M, Brock F, Ecoffet C, Reich K. Long-term efficacy of certolizumab pegol for the treatment of plaque psoriasis: 3-year results from two randomized phase III trials (CIMPASI-1 and CIMPASI-2). Br J Dermatol. 2021 Apr;184(4):652-662. doi: 10.1111/bjd.19393. Epub 2020 Sep 9.

    PubMed 32652544

  • 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 in people with Psoriasis and Plaque Psoriasis, run by UCB Biopharma S.P.R.L. at 30 sites in 5 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 7 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 30 sites in United States, Germany, Canada, Czechia, Hungary. 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 13 Aug 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 16 (time frame: At Week 16). The study lists 2 primary outcomes in all. 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 NCT02326298, which also lists 4 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 7 Nov 2019.

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