Moderate Chronic Plaque PsoriasisPhase 3CIMcareNCT04123795
A Study to Evaluate the Pharmacokinetics, Safety, and Effectiveness of Certolizumab Pegol in Children With Moderate to Severe Chronic Plaque Psoriasis
A Phase 3 study testing Certolizumab pegol in people with Moderate Chronic Plaque Psoriasis and Severe Chronic Plaque Psoriasis, run by UCB Biopharma SRL at 19 sites in 3 countries.
Trial summary
The purpose of the study is to evaluate the pharmacokinetic (PK) of certolizumab pegol (CZP) in study participants aged 6 to 17 years with moderate to severe chronic plaque psoriasis (PSO) in order to support extrapolation of efficacy. Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Moderate Chronic Plaque Psoriasis, Severe Chronic Plaque Psoriasis, Mixed Guttate/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
- 49 participants
- Where
- 19 sitesin 3 countries
- Study dates
- 21 Jan 2020to 23 Jul 2026
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 6 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Study participant must have a diagnosis of moderate to severe plaque psoriasis (PSO) for ≥3 months and:
- Body Surface Area (BSA) affected by psoriasis ≥10 %
- Physician's Global Assessment (PGA) score ≥3 (on a scale from 0 to 4)
- Psoriasis Area and Severity Index (PASI) score is ≥12 or
- PASI score is ≥10 and <12 with at least one of the following:
- >Clinically relevant facial or scalp involvement
Show all 10Show fewer
- >Clinically relevant genital involvement
- >Clinically relevant palm and sole involvement
- >Clinically relevant axillary involvement Study participants aged ≥12 years may alternatively have a diagnosis of moderate to severe mixed guttate/plaque PSO with >50 % to <80 % guttate lesions for ≥3 months, and must meet the same criteria listed above
- Study participant must be a candidate for systemic psoriasis therapy and/or phototherapy and/or photochemotherapy
Who cannot join
- Study participant previously participated in this study or has previously been treated with certolizumab pegol (CZP)
- Study participant has generalized pustular or erythrodermic psoriasis (PSO)
- Study participant has guttate PSO without plaque PSO
- Study participant has had a primary failure to an anti-tumor necrosis factor agent
- Study participant has had prior exposure to >2 biologic therapies
- Study participant has a history of severe major depression or suicide attempt (including an actual attempt, interrupted attempt, or aborted attempt), or has had suicidal ideation in the past 6 months as indicated by a positive response ("Yes") to either Question 4 or Question 5 of the "Screening/Baseline" version of the Columbia Suicide Severity Rating Scale (CSSRS) at Screening
Trial locations and contacts
19 sites in 3 countries.
19 sites in 3 countries
United States15 sites
Ps0007 50156
Arlington, Texas, 76011
Ps0007 50217
Boca Raton, Florida, 33428
Ps0007 50168
Chicago, Illinois, 60611
Ps0007 50232
Detroit, Michigan, 48202
Ps0007 50162
Fountain Valley, California, 92708
Ps0007 50248
Hialeah, Florida, 33016
Ps0007 50169
Jacksonville, Florida, 32256
Ps0007 50161
Los Angeles, California, 90045
Ps0007 50268
Miami, Florida, 33155
Ps0007 50175
Phoenix, Arizona, 85006
Ps0007 50230
Rome, Georgia, 30161
Ps0007 50277
San Antonio, Texas, 78218
Ps0007 50196
Thousand Oaks, California, 91320
Ps0007 50286
Topeka, Kansas, 66614
Ps0007 50269
Wellington, Florida, 33449
About this study
Official title: Multicenter, Open Label or Double-Blind, Placebo-Controlled Study to Evaluate the Pharmacokinetics, Safety, and Effectiveness of Certolizumab Pegol in Pediatric Study Participants With Moderate to Severe Chronic Plaque Psoriasis
The purpose of the study is to evaluate the pharmacokinetic (PK) of certolizumab pegol (CZP) in study participants aged 6 to 17 years with moderate to severe chronic plaque psoriasis (PSO) in order to support extrapolation of efficacy.
- Conditions
- Moderate Chronic Plaque Psoriasis, Severe Chronic Plaque Psoriasis, Mixed Guttate/Plaque Psoriasis
- Being tested
- Certolizumab pegol, Placebo
- Keywords
- Chronic plaque psoriasis, Certolizumab pegol, Cimzia, Pediatric study, Phase 3
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Certolizumab pegolDrug
Also called -Cimzia, -CDP870, -CZP
Certolizumab Pegol
- Pharmaceutical Form: Solution for injection in pre-filled syringe
- Route of Administration: Subcutaneous use
PlaceboDrug
Placebo
- Pharmaceutical Form: Solution for injection in pre-filled syringe
- Route of Administration: Subcutaneous use
| Study group | Role | What they receive |
|---|---|---|
| Cohort A - certolizumab pegol | Experimental | Enrolling study participants aged 12 to 17 years (inclusive). Study participants in this arm will receive weight-based subcutaneous doses of certolizumab pegol from Week 1 to Week 52 of the Active Treatment period and through the subsequent Open-Label Extension Period. Receives: Drug: Certolizumab pegol |
| Cohort A - placebo | Placebo comparator | Enrolling study participants aged 12 to 17 years (inclusive) under Amendment 4 and earlier. Study participants in this arm will receive weight-based subcutaneous doses of placebo from Week 1 to Week 16 of the Active Treatment period. Receives: Drug: Certolizumab pegol; Drug: Placebo |
| Cohort B - certolizumab pegol - Open-label | Experimental | Enrolling study participants aged 6 to 17 years (inclusive). Study participants in this arm will receive weight-based subcutaneous doses of certolizumab pegol from Week 1 to Week 52 of the Open-label Period and through the subsequent Open-Label Extension Period. Receives: Drug: Certolizumab pegol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma concentrations of Certolizumab pegol (CZP) at Week 16
Blood samples will be collected for measurement of plasma concentrations of CZP at Week 16.
Measured: Week 16
Plasma anti-CZP antibody titers at Week 16
Blood samples will be collected for measurement of anti-CZP antibody titers at Week 16.
Measured: Week 16
Plasma concentrations of CZP at Week 52
Blood samples will be collected for measurement of plasma concentrations of CZP at Week 52.
Measured: Week 52
Plasma anti-CZP antibody titers at Week 52
Blood samples will be collected for measurement of anti-CZP antibody titers at Week 52.
Measured: Week 52
Secondary outcomes (2)
Incidence of serious treatment emergent adverse events
A serious treatment emergent adverse event (serious TEAE) is any untoward medical occurrence that at any dose:
- Results in death
- Is life-threatening
- Requires in patient hospitalization or prolongation of existing hospitalization
- Is a congenital anomaly or birth defect
- Is an infection that requires treatment parenteral antibiotics
- Other important medical events which based on medical or scientific judgement may jeopardize the patients, or may require medical or surgical intervention to prevent any of the above
Measured: From Baseline until participant reaches 18 years of age or Cimzia becomes commercially available for pediatric PSO in participant's region (up to 12 years)
Incidence of treatment emergent adverse events leading to withdrawal
An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation participants administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. Treatment emergent adverse events (TEAEs) are events that emerge during treatment, having been absent pre-treatment, or worsens relative to the pre-treatment state.
Measured: From Baseline until participant reaches 18 years of age or Cimzia becomes commercially available for pediatric PSO in participant's region (up to 12 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2019
- Study start21 Jan 2020
- Primary completion9 Apr 2026
- Study completion23 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Moderate Chronic Plaque PsoriasisStudies of the same condition, open and under way.
- More trials run by UCB Biopharma SRLThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- UCB Biopharma SRL
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- UCB Cares, Study director, 001 844 599 2273 (UCB)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04123795
- Sponsor's protocol ID
- PS0007
- Acronym
- CIMcare
- Status last verified
- Aug 2026
- First submitted
- 9 Oct 2019
- Last updated
- 4 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe, or global development is discontinued, and 18 months after trial completion. Investigators may request access to anonymized individual patient-level data and redacted trial documents which may include: analysis-ready datasets, study protocol, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a prespecified time, typically 12 months, on a password protected portal. This plan may change if the risk of re-identifying trial participants is determined to be too high after the trial is completed; in this case and to protect participants, individual patient-level data would not be made available.
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Open Label or Double-Blind, Placebo-Controlled Study to Evaluate the Pharmacokinetics, Safety, and Effectiveness of Certolizumab Pegol in Pediatric Study Participants With Moderate to Severe Chronic Plaque Psoriasis
- ClinicalTrials.gov ID
- NCT04123795
- Acronym / sponsor ID
- CIMcare / PS0007
- Conditions
- Moderate Chronic Plaque Psoriasis, Severe Chronic Plaque Psoriasis, Mixed Guttate/Plaque Psoriasis
- Keywords
- Chronic plaque psoriasis, Certolizumab pegol, Cimzia, Pediatric study, Phase 3
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- UCB Biopharma SRLIndustry (pharma, biotech, devices)
- Study start
- 21 Jan 2020 (actual)
- Primary completion
- 9 Apr 2026 (actual)
- Study completion
- 23 Jul 2026 (actual)
- First posted
- 11 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to evaluate the pharmacokinetic (PK) of certolizumab pegol (CZP) in study participants aged 6 to 17 years with moderate to severe chronic plaque psoriasis (PSO) in order to support extrapolation of efficacy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort A - certolizumab pegol | Experimental | Drug: Certolizumab pegolEnrolling study participants aged 12 to 17 years (inclusive). Study participants in this arm will receive weight-based subcutaneous doses of certolizumab pegol from Week 1 to Week 52 of the Active Treatment period and through the subsequent Open-Label Extension Period. |
| Cohort A - placebo | Placebo comparator | Drug: Certolizumab pegol, Drug: PlaceboEnrolling study participants aged 12 to 17 years (inclusive) under Amendment 4 and earlier. Study participants in this arm will receive weight-based subcutaneous doses of placebo from Week 1 to Week 16 of the Active Treatment period. |
| Cohort B - certolizumab pegol - Open-label | Experimental | Drug: Certolizumab pegolEnrolling study participants aged 6 to 17 years (inclusive). Study participants in this arm will receive weight-based subcutaneous doses of certolizumab pegol from Week 1 to Week 52 of the Open-label Period and through the subsequent Open-Label Extension Period. |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- Study participant must have a diagnosis of moderate to severe plaque psoriasis (PSO) for ≥3 months and:
- >Clinically relevant facial or scalp involvement
- >Clinically relevant genital involvement
- >Clinically relevant palm and sole involvement
- >Clinically relevant axillary involvement Study participants aged ≥12 years may alternatively have a diagnosis of moderate to severe mixed guttate/plaque PSO with >50 % to <80 % guttate lesions for ≥3 months, and must meet the same criteria listed above
Key exclusion criteria (6 listed)
- Study participant previously participated in this study or has previously been treated with certolizumab pegol (CZP)
- Study participant has generalized pustular or erythrodermic psoriasis (PSO)
- Study participant has guttate PSO without plaque PSO
- Study participant has had a primary failure to an anti-tumor necrosis factor agent
- Study participant has had prior exposure to >2 biologic therapies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Certolizumab pegolAlso: -Cimzia, -CDP870, -CZPCertolizumab Pegol * Pharmaceutical Form: Solution for injection in pre-filled syringe * Route of Administration: Subcutaneous use | Drug | Cohort A - certolizumab pegol, Cohort A - placebo, Cohort B - certolizumab pegol - Open-label |
| PlaceboPlacebo * Pharmaceutical Form: Solution for injection in pre-filled syringe * Route of Administration: Subcutaneous use | Drug | Cohort A - placebo |
Primary outcome
Plasma concentrations of Certolizumab pegol (CZP) at Week 16
Time frame: Week 16
Blood samples will be collected for measurement of plasma concentrations of CZP at Week 16.
Plasma anti-CZP antibody titers at Week 16
Time frame: Week 16
Blood samples will be collected for measurement of anti-CZP antibody titers at Week 16.
Plasma concentrations of CZP at Week 52
Time frame: Week 52
Blood samples will be collected for measurement of plasma concentrations of CZP at Week 52.
Plasma anti-CZP antibody titers at Week 52
Time frame: Week 52
Blood samples will be collected for measurement of anti-CZP antibody titers at Week 52.
2 secondary outcomes
Incidence of serious treatment emergent adverse events
Time frame: From Baseline until participant reaches 18 years of age or Cimzia becomes commercially available for pediatric PSO in participant's region (up to 12 years)
Incidence of treatment emergent adverse events leading to withdrawal
Time frame: From Baseline until participant reaches 18 years of age or Cimzia becomes commercially available for pediatric PSO in participant's region (up to 12 years)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2026.
- Individual participant dataSharing planned: Yes. Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe, or global development is discontinued, and 18 months after trial completion. Investigators may request access to anonymized individual patient-level data and redacted trial documents which may include: analysis-ready datasets, study protocol, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a prespecified time, typically 12 months, on a password protected portal. This plan may change if the risk of re-identifying trial participants is determined to be too high after the trial is completed; in this case and to protect participants, individual patient-level data would not be made available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
UCB Cares study director
001 844 599 2273 (UCB)
19 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Certolizumab pegol in people with Moderate Chronic Plaque Psoriasis and Severe Chronic Plaque Psoriasis, run by UCB Biopharma SRL at 19 sites in 3 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 10 inclusion and 6 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 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in United States, Canada, Puerto Rico. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Plasma concentrations of Certolizumab pegol (CZP) at Week 16 (time frame: Week 16). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Aug 2026.