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Moderate to Severe PsoriasisPhase 2/3NCT03051217

A Study to Test the Efficacy and Safety of Certolizumab Pegol in Japanese Subjects With Moderate to Severe Chronic Psoriasis

A Phase 2/3 study testing Certolizumab Pegol in people with Moderate to Severe Psoriasis and Generalized Pustular Psoriasis and Erythrodermic Psoriasis, run by UCB Biopharma S.P.R.L. at 33 sites in Japan.

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 demonstrate the efficacy and safety of Certolizumab Pegol (CZP) in the treatment of moderate to severe chronic plaque Psoriasis (PSO) in Japanese subjects. Read more about this study

Who is it for?
Ages 20 years and older
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
127 participants
Where
33 sitesJapan
Study dates
21 Feb 2017to 16 Jan 2019
Phase
Phase 2/3
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 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subject is male or female, >= 20 years of age.
  • Institutional Review Board-approved written informed consent form is signed and dated by the subject.
  • Other protocol-defined inclusion criteria may apply.
  • For subjects with moderate to severe chronic plaque psoriasis (PSO)
  • Chronic plaque psoriasis for at least 6 months.
  • Baseline Psoriasis Activity and Severity Index (PASI) >=12 and Body Surface Area (BSA) affected by PSO >=10% and Physician's Global Assessment (PGA) score of 3 or higher.
Show all 11Show fewer
  • Candidates for systemic PSO therapy and/or phototherapy and/or chemophototherapy.
  • For subjects with generalized pustular PSO or erythrodermic PSO
  • Diagnosis of generalized pustular PSO or erythrodermic PSO at Screening.
  • History of plaque-type PSO if subjects have a diagnosis of erythrodermic PSO.
  • Baseline BSA affected by PSO >=80% if subjects have a diagnosis of erythrodermic PSO.

Who cannot join

  • Female subject who is breastfeeding, pregnant, or plans to become pregnant during the study or within 5 months following last dose of study drug. Male subject who is planning a partner pregnancy during the study or within 5 months following the last dose of study drug.
  • Subject has guttate psoriasis or drug-induced psoriasis. For subjects with moderate to severe plaque psoriasis, erythrodermic or pustular forms of psoriasis also are excluded.
  • History of current, chronic, or recurrent infections of viral, bacterial, or fungal origin as described in the protocol. Also, subjects with a high risk of infection in the Investigator's opinion.
  • History of a lymphoproliferative disorder including lymphoma or current signs and symptoms suggestive of lymphoproliferative disease.
  • History of other malignancy or concurrent malignancy as described in the protocol.
  • Class III or IV congestive heart failure
Show all 12Show fewer
  • History of, or suspected, demyelinating disease of the central nervous system (e.g., multiple sclerosis or optic neuritis).
  • Subject has any other condition which, in the Investigator's judgment, would make the subject unsuitable for inclusion in the study.
  • Concurrent medication restrictions as described in the protocol.
  • Subject with known tuberculosis (TB) infection, at high risk of acquiring TB infection, or with untreated latent tuberculosis infection (LTBI) or current or history of nontuberculous mycobacterial (NTMB) infection.
  • Subject has any protocol defined clinically significant laboratory abnormalities at the screening
  • Other protocol-defined exclusion criteria may apply.

Trial locations and contacts

33 sites in 1 country.

33 sites in 1 country

Japan33 sites

  • Ps0017 024

    Asahikawa

  • Ps0017 012

    Bunkyō City

  • Ps0017 010

    Chiyoda-Ku

  • Ps0017 007

    Chūōku

  • Ps0017 004

    Fukuoka

  • Ps0017 039

    Fukushima

  • Ps0017 028

    Gifu

  • Ps0017 040

    Hamamatsu

  • Ps0017 022

    Kobe

  • Ps0017 032

    Kumamoto

  • Ps0017 031

    Kurume

  • Ps0017 021

    Kyoto

  • Ps0017 041

    Matsumoto

  • Ps0017 009

    Minatoku

  • Ps0017 033

    Miyazaki

  • Ps0017 016

    Nagoya

  • Ps0017 029

    Nankoku

  • Ps0017 005

    Obihiro

  • Ps0017 017

    Osaka

  • Ps0017 042

    Osaka

  • Ps0017 037

    Ōsaka-sayama

  • Ps0017 001

    Sapporo

  • Ps0017 027

    Sendai

  • Ps0017 015

    Shimotsuke

  • Ps0017 008

    Shinagawa-Ku

  • Ps0017 002

    Shinjuku

  • Ps0017 003

    Shinjuku

  • Ps0017 011

    Shinjuku

  • Ps0017 014

    Shinjuku

  • Ps0017 034

    Sumida City

  • Ps0017 013

    tabashi City

  • Ps0017 038

    Takaoka

  • Ps0017 025

    Tsu

Other trials in Japan

About this study

Official title: Phase 2/3, Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study To Evaluate the Efficacy and Safety of Certolizumab Pegol in Japanese Subjects With Moderate to Severe Chronic Psoriasis

The purpose of this study is to demonstrate the efficacy and safety of Certolizumab Pegol (CZP) in the treatment of moderate to severe chronic plaque Psoriasis (PSO) in Japanese subjects.

Being tested
Placebo, Certolizumab Pegol
Keywords
Psoriasis, PSO, Chronic plaque psoriasis, Certolizumb Pegol, Cimzia, Generalized pustular psoriasis and erythrodermic psoriasis
Medical subject headings
Psoriasis

What participants receive

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

  • PlaceboOther

    Also called PBO

    • Pharmaceutical Form: Solution for injection in pre-filled syringe
    • Concentration: 0.9 % saline
    • Route of Administration: Subcutaneous use Q2W

  • Certolizumab PegolDrug

    Also called Cimzia, CDP870, CZP

    • Pharmaceutical Form: Solution for injection in pre-filled syringe
    • Concentration: 200 mg/mL
    • Route of Administration: Subcutaneous use
Study groups in NCT03051217
Study groupRoleWhat they receive
PlaceboPlacebo comparatorPlacebo subcutaneous (sc) injection every two weeks (Q2W)
Receives: Other: Placebo
CZP 200 mgExperimentalCertolizumab Pegol subcutaneous (sc) injection 400 mg at Weeks 0, 2, 4, followed by Certolizumab Pegol subcutaneous (sc) injection 200 mg every two weeks (Q2W) with PBO administered to maintain the blind, starting at Week 6
Receives: Other: Placebo; Drug: Certolizumab Pegol
CZP 400 mgExperimentalCertolizumab Pegol subcutaneous (sc) injection 400 mg every two weeks (Q2W).
Receives: Drug: Certolizumab Pegol

What is being measured

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

  1. Percentage of Subjects Achieving a 75 % or Higher Improvement in Psoriasis Area and Severity Index (PASI) Score at Week 16

    The PASI75 response assessments were 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

Secondary outcomes (6)

  1. Percentage of Subjects Who Achieve a Physician's Global Assessment (PGA) Clear or Almost Clear Response (With at Least 2-category Improvement) at Week 16

    This Outcome Measure applied to participants with moderate to severe chronic plaque Psoriasis (PSO).

    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

  2. Percentage of Subjects Achieving a 90 % or Higher Improvement in Psoriasis Area and Severity Index (PASI) Score at Week 16

    The PASI90 response assessments were 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

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

    This Outcome Measure applied to participants with moderate to severe chronic plaque Psoriasis (PSO).

    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 asked 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 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).

    Measured: Baseline and Week 16

  4. Change From Baseline in Itch Numeric Rating Scale at Week 16

    This Outcome Measure applied to participants with moderate to severe chronic plaque Psoriasis (PSO).

    The Itch Numeric Rating Scale (NRS) has been developed as a simple, single item instrument to assess the patient-reported severity of itch at its most intense during the past 24h period. Participants indicate itch severity by circling the integer that best describes the worst level of itching due to PSO in the past 24h period on an 11-point scale anchored at 0, representing "no itching" and 10, representing "worst itch imaginable" (Kimball et al, 2016).

    Measured: Baseline and Week 16

  5. Plasma Concentration of Certolizumab Pegol (CZP)

    Plasma concentration was expressed in micrograms per milliliter (μg/mL).

    Values below Lower Limit of Quantification (LLOQ) were set to half the LLOQ to present summaries.

    The geometric mean and geometric coefficient of variation were only displayed if at least 2/3 of the data were above the LLOQ.

    Measured: Blood samples were collected at Baseline (Week 0) and at Weeks 2, 4, 6, 8, 12, 16, 24, 32, 40, 52, 60

  6. Percentage of Participants With Positive Anti-Certolizumab Pegol-antibody Levels in Plasma

    A pre-anti-drug (CZP) antibody (ADA) positive subject was defined as having a confirmed positive sample at Baseline. A pre-ADA negative subject was defined as having a Screening below the cut point (BCP) sample, or a screening above the cut point (ACP) sample, but not confirmed positive at Baseline.

    A treatment-emergent ADA positive subject was defined as either 1) pre-ADA negative subjects having at least 1 ADA confirmed positive sample or 2) pre-ADA positive subjects with at least 1 sample with greater then or equal to (>=) 1.67-fold increase from Baseline on CZP treatment.

    Measured: Blood samples will be collected at Baseline (Week 0) and at Weeks 2, 4, 6, 8, 12, 16, 24, 32, 40, 52, 60

Timeline

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

  1. First posted13 Feb 2017
  2. Study start21 Feb 2017
  3. Primary completion19 Nov 2018
  4. Study completion16 Jan 2019

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 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
127 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03051217
Sponsor's protocol ID
PS0017
Status last verified
Nov 2020
First submitted
9 Feb 2017
Last updated
4 Jan 2022
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Imafuku S, Tada Y, Umezawa Y, Sakurai S, Hoshii N, Nakagawa H. Certolizumab Pegol in Japanese Patients with Moderate to Severe Plaque Psoriasis: Effect of Demographics and Baseline Disease Characteristics on Efficacy. Dermatol Ther (Heidelb). 2022 Jan;12(1):121-135. doi: 10.1007/s13555-021-00645-2. Epub 2021 Nov 26.

    PubMed 34826124

  • Okubo Y, Umezawa Y, Sakurai S, Hoshii N, Nakagawa H. Efficacy and Safety of Certolizumab Pegol in Japanese Patients with Generalized Pustular Psoriasis and Erythrodermic Psoriasis: 52-Week Results. Dermatol Ther (Heidelb). 2022 Jun;12(6):1397-1415. doi: 10.1007/s13555-022-00741-x. Epub 2022 May 27.

    PubMed 35622315

  • Umezawa Y, Asahina A, Imafuku S, Tada Y, Sano S, Morita A, Sakurai S, Hoshii N, Tilt N, Nakagawa H. Efficacy and Safety of Certolizumab Pegol in Japanese Patients with Moderate to Severe Plaque Psoriasis: 52-Week Results. Dermatol Ther (Heidelb). 2021 Jun;11(3):943-960. doi: 10.1007/s13555-021-00520-0. Epub 2021 Apr 22.

    PubMed 33886085

  • Umezawa Y, Sakurai S, Hoshii N, Nakagawa H; PS0017 Study Group. Certolizumab Pegol for the Treatment of Moderate to Severe Plaque Psoriasis: 16-Week Results from a Phase 2/3 Japanese Study. Dermatol Ther (Heidelb). 2021 Apr;11(2):513-528. doi: 10.1007/s13555-021-00494-z. Epub 2021 Feb 19.

    PubMed 33606269

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Certolizumab Pegol in people with Moderate to Severe Psoriasis and Generalized Pustular Psoriasis and Erythrodermic Psoriasis, run by UCB Biopharma S.P.R.L. at 33 sites in Japan.

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 11 inclusion and 12 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 4 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 33 sites in Japan. 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 combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 11 Dec 2019). 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?

Percentage of Subjects Achieving a 75 % or Higher Improvement in Psoriasis Area and Severity Index (PASI) Score at Week 16 (time frame: Week 16). 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 NCT03051217, 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 4 Jan 2022.

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