Certolizumab Pegol for Plaque Psoriasis
(CIMcare Trial)
Recruiting in Palo Alto (17 mi)
+27 other locations
Age: < 18
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Recruiting
Sponsor: UCB Biopharma SRL
Disqualifiers: Generalized pustular psoriasis, Erythrodermic psoriasis, Severe major depression, others
Pivotal Trial (Near Approval)
Prior Safety Data
Approved in 4 Jurisdictions
Trial Summary
What is the purpose of this trial?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.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the drug Certolizumab Pegol for treating plaque psoriasis?
Certolizumab Pegol has shown significant improvements in patients with moderate to severe plaque psoriasis, with more patients achieving a 75% reduction in psoriasis symptoms compared to those receiving a placebo. It has also been effective in maintaining these improvements over time and is considered a good option for women of childbearing age due to its safety profile.
12345Is Certolizumab Pegol safe for humans?
Certolizumab Pegol (CZP) has been shown to have a safety profile similar to other TNF-α inhibitors, with no new safety concerns identified in studies for conditions like plaque psoriasis and psoriatic arthritis. It is considered safe for use in specific groups, including pregnant or breastfeeding women.
12367What makes the drug Certolizumab Pegol unique for treating plaque psoriasis?
Certolizumab Pegol is unique because it is an Fc-free, PEGylated TNF-ɑ inhibitor, which means it has a special structure that reduces its transfer across the placenta, making it a safer option for pregnant or breastfeeding women. It is also administered via subcutaneous injection, offering flexibility with self-injection devices, and has shown significant improvements in plaque psoriasis symptoms compared to other treatments.
12356Eligibility Criteria
This trial is for children and adolescents aged 6 to 17 with moderate to severe chronic plaque psoriasis. They must have a significant impact on certain body areas, be candidates for systemic therapy or phototherapy, and meet specific severity scores. Those with generalized pustular or erythrodermic psoriasis, primary failure to anti-TNF agents, previous CZP treatment, severe depression or recent suicidal ideation are excluded.Inclusion Criteria
I am 12 or older with moderate to severe mixed guttate/plaque psoriasis for 3+ months.
I have been diagnosed with moderate to severe plaque psoriasis for at least 3 months.
I am eligible for treatments that affect my whole body or use light for my psoriasis.
+4 more
Exclusion Criteria
I have a severe form of psoriasis.
You have a history of severe depression, attempted suicide, or have had thoughts of hurting yourself in the past 6 months.
I have been treated with more than two biologic therapies.
+3 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Active Treatment
Participants receive weight-based subcutaneous doses of certolizumab pegol or placebo
16 weeks
Regular visits for treatment and monitoring
Open-label Period
Participants receive weight-based subcutaneous doses of certolizumab pegol
52 weeks
Regular visits for treatment and monitoring
Open-label Extension
Participants may continue receiving certolizumab pegol long-term
Long-term
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Participant Groups
The study tests the effectiveness and safety of Certolizumab Pegol (CZP) in young patients with plaque psoriasis compared to a placebo. It aims to see if this medication can help reduce the symptoms of this skin condition safely in these age groups.
3Treatment groups
Experimental Treatment
Placebo Group
Group I: Cohort B - certolizumab pegol - Open-labelExperimental Treatment1 Intervention
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.
Group II: Cohort A - certolizumab pegolExperimental Treatment1 Intervention
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.
Group III: Cohort A - placeboPlacebo Group2 Interventions
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.
Certolizumab pegol is already approved in European Union, United States, Canada, Japan for the following indications:
🇪🇺 Approved in European Union as Cimzia for:
- Rheumatoid arthritis
- Psoriatic arthritis
- Ankylosing spondylitis
- Crohn's disease
- Plaque psoriasis
🇺🇸 Approved in United States as Cimzia for:
- Moderate to severe active Crohn’s disease
- Rheumatoid arthritis
- Psoriatic arthritis
- Ankylosing spondylitis
- Plaque psoriasis
- Non-radiographic axial spondyloarthritis
🇨🇦 Approved in Canada as Cimzia for:
- Rheumatoid arthritis
- Psoriatic arthritis
- Ankylosing spondylitis
- Crohn's disease
- Plaque psoriasis
🇯🇵 Approved in Japan as Cimzia for:
- Rheumatoid arthritis
- Psoriatic arthritis
- Ankylosing spondylitis
- Crohn's disease
- Plaque psoriasis
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Ps0007 50161Los Angeles, CA
Ps0007 50225Calgary, Canada
Ps0007 50158Brighton, MA
Ps0007 50150Philadelphia, PA
More Trial Locations
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Who Is Running the Clinical Trial?
UCB Biopharma SRLLead Sponsor
References
Efficacy and Safety of Certolizumab Pegol in Japanese Patients with Moderate to Severe Plaque Psoriasis: 52-Week Results. [2021]Certolizumab pegol (CZP), an Fc-free, PEGylated anti-tumour necrosis factor biologic, dosed at 400 mg every 2 weeks (Q2W) and 200 mg Q2W over 16 weeks, resulted in improvements in Japanese patients with moderate to severe plaque psoriasis (PSO); no new safety signals were identified. We present 52-week efficacy and safety results.
Certolizumab Pegol Use in the Treatment of Moderate-to-Severe Psoriasis: Real-World Data From Two Canadian Centers. [2022]Certolizumab pegol (CZP) is a TNF-ɑ inhibitor used to treat moderate-to-severe plaque psoriasis (PsO) in adult patients, including women of childbearing potential (WOCBP) and patients with psoriatic arthritis (PsA). There are currently limited real-world data on CZP for treatment of PsO.
Certolizumab pegol for the treatment of psoriatic arthritis and plaque psoriasis. [2021]Introduction: Certolizumab pegol (CZP) is an Fc-free PEGylated TNF-α inhibitor approved for the treatment of psoriatic arthritis (PsA) and plaque psoriasis in many countries. It demonstrated favorable results in PsA in terms of improvement in peripheral arthritis, dactylitis, and enthesitis in a phase III trial (RAPID-PSA) and in real-life experiences. Recently, three phase III randomized clinical trials (CIMPASI-1, CIMPASI-2, CIMPACT) showed significant and sustained improvements in signs and symptoms of moderate-to-severe plaque psoriasis as well as in quality of life parameters as compared to placebo and etanercept.Areas covered: We reviewed the structure and the mechanism of action of CZP, and critically analyzed data from clinical trials and real-life, concerning its efficacy and safety in all aspects of the psoriatic disease. We designed a comprehensive literature search on this topic, by a review of published articles in indexed international journals up until 31 July 2019.Expertopinion: CZP demonstrated positive results in several domains of psoriatic disease, also in patients previously exposed to other TNF-α inhibitors and in patients receiving re-treatment after treatment interruption. The peculiar chemical structure, along with its well-established efficacy and safety, support CZP as the drug of choice in specific subgroups of patients with psoriatic disease, in particular patients with comorbidities and pregnant or breastfeeding female patients.
Certolizumab Pegol for the Treatment of Moderate to Severe Plaque Psoriasis: 16-Week Results from a Phase 2/3 Japanese Study. [2022]Certolizumab pegol (CZP), the Fc-free, PEGylated anti-tumor necrosis factor, is approved for the treatment of moderate to severe plaque psoriasis (PSO) in Western countries and in Japan, among other indications.
Certolizumab Pegol: A Review in Moderate to Severe Plaque Psoriasis. [2021]Certolizumab pegol (Cimzia®) is a PEGylated, Fab'-only, recombinant humanized antibody against TNF-α. Subcutaneous certolizumab pegol is indicated for the treatment of various immune-mediated inflammatory diseases (IMIDs), including moderate to severe plaque psoriasis. In pivotal phase III trials in adults with moderate to severe plaque psoriasis, significantly more patients receiving certolizumab pegol 200 mg or 400 mg once every 2 weeks than placebo recipients achieved a ≥ 75% reduction in PASI score (PASI75 responder) and a PGA score of clear/mostly clear with a ≥ 2 point improvement from baseline (PGA0/1 responder) at week 12 (CIMPACT) or 16 (CIMPASI-1 and -2). In CIMPACT, certolizumab pegol 400 mg once every 2 weeks was superior to etanercept (highest recommended dosage) at 12 weeks, with certolizumab pegol 200 mg once every 2 weeks demonstrating non-inferiority, but not superiority, to etanercept. The clinical benefits of certolizumab pegol were maintained during the maintenance phase (to week 48) and the open-label extension phase of these trials. Certolizumab pegol is unique among the biologics, with the absence of an Fc fragment conferring pharmacokinetic advantages; most notably, its minimal transfer across the placenta, and low relative infant dose during breastfeeding in conjunction with its low oral bioavailability. Certolizumab pegol was generally well tolerated and no new safety signals were identified in these phase III trials, which complements its established safety profile in other IMIDs. Certolizumab pegol is a useful option for the treatment of moderate to severe plaque psoriasis and provides an important treatment option for women of childbearing age, for whom there are limited options available.
A Companion App to Support Rheumatology Patients Treated with Certolizumab Pegol: Results From a Usability Study. [2020]Certolizumab pegol (CZP) is an anti-tumor necrosis factor drug approved for the treatment of multiple moderate to severe chronic inflammatory diseases. In the European Union, CZP is approved for administration by subcutaneous self-injection using a prefilled syringe, prefilled pen, or reusable electromechanical auto-injector (electronic device). CimplyMe is a companion app for use alongside CZP self-injection devices, designed to support CZP-treated patients self-managing their treatment and disease.
Certolizumab pegol for the treatment of psoriatic arthritis. [2018]Certolizumab pegol (CZP) is a TNF-α inhibitor approved for the treatment of psoriatic arthritis in 38 countries, including many European countries and the USA. It is a pegylated humanized anti-TNF-α antigen-binding fragment, administered subcutaneously. As other TNF-α antibodies, CZP binds to and neutralizes both soluble and membrane TNF-α. In contrast to whole antibodies and etanercept, CZP does not activate antibody-dependent cell-mediated cytotoxicity or complement-dependent cytotoxicity, as it does not have an Fc piece. CZP showed efficacy in improving skin scores and patient reported outcomes in a Phase II study of 176 adults with moderate-to-severe plaque psoriasis. In a Phase III study of CZP in 409 psoriatic arthritis patients, CZP treatment resulted in improvements in peripheral arthritis, as well as dactylitis, enthesitis, nail disease and quality of life. The safety profile of CZP appears to be similar to that of other TNF-α inhibitor.