Certolizumab Pegol for Plaque Psoriasis

(CIMcare Trial)

Recruiting at 24 trial locations

Overseen By UCB Cares

Age: < 18

Sex: Any

Trial Phase: Phase 3

Sponsor: UCB Biopharma SRL

Disqualifiers: Generalized pustular psoriasis, Erythrodermic psoriasis, Severe major depression, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

150 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore how certolizumab pegol, an anti-inflammatory medication, works in treating moderate to severe plaque psoriasis, a skin condition causing red, scaly patches. It involves two groups: one receiving the drug and another receiving a placebo, a substance with no therapeutic effect, to compare outcomes. Participants should be between 6 and 17 years old and have had plaque psoriasis affecting at least 10% of their body for three months or more. This trial may suit those needing systemic therapy or light-based treatments. As a Phase 3 trial, it represents the final step before FDA approval, offering participants a chance to contribute to the potential availability of a new treatment.

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.

Is there any evidence suggesting that certolizumab pegol is likely to be safe for humans?

Research has shown that certolizumab pegol, a treatment for plaque psoriasis, is generally well-tolerated. Studies found a similar number of side effects over 16 weeks of treatment. Long-term safety data indicate no new safety concerns, even with extended or increased use of the treatment, meaning the risks did not increase over time.

However, it is important to note a higher risk of serious infections, which could lead to hospitalization or worse. This risk mirrors that seen when using certolizumab pegol for other conditions like psoriatic arthritis. While most patients do well on this treatment, awareness of these potential risks is crucial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for plaque psoriasis, which often include topical therapies, phototherapy, or systemic agents like methotrexate and cyclosporine, certolizumab pegol stands out due to its unique mechanism as a PEGylated anti-TNF (tumor necrosis factor) biologic. This treatment works differently by targeting and neutralizing TNF-alpha, a substance in the body that causes inflammation and is overproduced in psoriasis. Researchers are excited because certolizumab pegol is administered through subcutaneous injections, which can offer a more convenient and potentially faster-acting solution compared to traditional oral or topical treatments. Additionally, its weight-based dosing allows for personalized treatment, particularly beneficial for younger patients aged 6 to 17.

What evidence suggests that certolizumab pegol might be an effective treatment for plaque psoriasis?

Studies have shown that certolizumab pegol effectively treats plaque psoriasis. Research indicates that after 12 months of treatment, many patients experienced significant skin improvement, with 75% or more of their psoriasis symptoms clearing up. Some patients even achieved a 90% improvement from their initial condition. Long-term studies over three years also support these findings, demonstrating that the treatment remains effective and safe. Overall, certolizumab pegol shows strong potential in managing moderate to severe plaque psoriasis. Participants in this trial will receive certolizumab pegol in different cohorts, with some receiving it in an open-label format. ^{6 7 8 9 10}

Who Is on the Research Team?

UCB Cares

Principal Investigator

001 844 599 2273 (UCB)

Are You a Good Fit for This Trial?

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.

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Certolizumab pegol

Trial Overview 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.

How Is the Trial Designed?

Group I: Cohort B - certolizumab pegol - Open-label Experimental Treatment 1 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 pegol Experimental Treatment 1 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 - placebo Placebo Group 2 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

Who Is Running the Clinical Trial?

UCB Biopharma SRL

Lead Sponsor

Trials

118

Recruited

23,200+

Jean-Christophe Tellier

UCB Biopharma SRL

Chief Executive Officer since 2015

MD from University of Reims Champagne-Ardenne, Rheumatology specialization from University of Paris V, Executive business programs at Harvard and INSEAD

Dr. Iris Loew-Friedrich

UCB Biopharma SRL

Chief Medical Officer since 2014

MD from University of Leuven, PhD in Medical Sciences from University of Leuven

Published Research Related to This Trial

In a usability study with 15 patients using the CimplyMe companion app for certolizumab pegol (CZP) self-injection, 86% of critical tasks were successfully completed on the first attempt, indicating the app's effectiveness in supporting self-management of treatment.

All noncritical tasks were completed without errors, suggesting that the app is user-friendly and can help patients manage their treatment without the need for formal training.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Companion App to Support Rheumatology Patients Treated with Certolizumab Pegol: Results From a Usability Study. Domańska, B., Vansant, S., Mountian, I.[2020]

Certolizumab pegol (CZP) has shown significant and sustained improvements in treating moderate-to-severe plaque psoriasis and psoriatic arthritis, as demonstrated in three phase III trials involving various patient populations.

CZP's unique structure and favorable safety profile make it a preferred treatment option for specific groups, including patients with comorbidities and those who are pregnant or breastfeeding.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Certolizumab pegol for the treatment of psoriatic arthritis and plaque psoriasis. Esposito, M., Carubbi, F., Giunta, A., et al.[2021]

In a study of 59 patients with moderate-to-severe plaque psoriasis, certolizumab pegol (CZP) demonstrated significant clinical efficacy, with mean PASI scores decreasing from 13.0 to 2.3 after 12 months of treatment.

CZP was well tolerated, with a drug survival rate of 76.3% at 12 months, indicating its effectiveness in real-world clinical practice, especially for women of childbearing potential due to minimal placental transfer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Certolizumab Pegol Use in the Treatment of Moderate-to-Severe Psoriasis: Real-World Data From Two Canadian Centers. Vender, RB., Lynde, CW.[2022]

Certolizumab pegol (CZP) is an effective TNF-α inhibitor for treating psoriatic arthritis, showing significant improvements in symptoms and quality of life in a Phase III study involving 409 patients.

CZP has a unique mechanism of action that does not activate certain immune responses (like antibody-dependent cell-mediated cytotoxicity), which may contribute to its safety profile being similar to other TNF-α inhibitors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Certolizumab pegol for the treatment of psoriatic arthritis. Hansen, RB., Kavanaugh, A.[2018]

Certolizumab pegol (CZP) demonstrated sustained efficacy in treating moderate to severe plaque psoriasis over 52 weeks, with PASI 75/90 response rates of 83.0% and 81.1% for the 400 mg Q2W dose, indicating significant improvement in skin condition.

The treatment was well-tolerated with no new safety concerns identified, suggesting that CZP is a safe and effective long-term option for patients with psoriasis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Certolizumab Pegol in Japanese Patients with Moderate to Severe Plaque Psoriasis: 52-Week Results. Umezawa, Y., Asahina, A., Imafuku, S., et al.[2021]

Certolizumab pegol (Cimzia®) has been shown to significantly improve psoriasis symptoms in adults, with more patients achieving a 75% reduction in PASI score compared to placebo in phase III trials involving moderate to severe plaque psoriasis.

This medication is particularly beneficial for women of childbearing age due to its unique properties, such as minimal placental transfer and low infant exposure during breastfeeding, while maintaining a good safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Certolizumab Pegol: A Review in Moderate to Severe Plaque Psoriasis. Lee, A., Scott, LJ.[2021]

In a 16-week phase 2/3 trial involving 127 Japanese patients with moderate to severe plaque psoriasis, certolizumab pegol (CZP) at doses of 400 mg and 200 mg every 2 weeks showed significant improvements in psoriasis severity, with 87.1% and 73.0% of patients achieving PASI 75 response, respectively, compared to only 7.9% in the placebo group.

CZP treatment also led to significant enhancements in quality of life measures, such as the Dermatology Life Quality Index (DLQI) and Itch Numeric Rating Scale (INRS), with no new safety concerns identified, indicating that CZP is both effective and safe for treating psoriasis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Certolizumab Pegol for the Treatment of Moderate to Severe Plaque Psoriasis: 16-Week Results from a Phase 2/3 Japanese Study. Umezawa, Y., Sakurai, S., Hoshii, N., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8247431/

Long‐term efficacy of certolizumab pegol for the treatment of ... Efficacy data from the first 48 weeks of phase III trials have shown significant improvements in the signs and symptoms of psoriasis with certolizumab pegol ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT00245765

NCT00245765 | Efficacy Study of CDP870 in Subjects With ... Successful treatment of moderate to severe plaque psoriasis with the PEGylated Fab' certolizumab pegol: results of a phase II randomized, placebo-controlled ...

3. cimziahcp.com cimziahcp.com/dermatology/plaque-psoriasis

PSO Efficacy Long-term efficacy of certolizumab pegol for the treatment of plaque psoriasis: three-year results from two randomised phase 3 trials (CIMPASI-1 and CIMPASI-2).

4. link.springer.com link.springer.com/article/10.1007/s13555-024-01210-3

Certolizumab Pegol for the Treatment of Plaque Psoriasis ... At 12 months, CZP showed substantial effectiveness, achieving PASI 75 and PASI 90 response rates (≥ 75% and ≥ 90% improvement from baseline, ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9290019/

Three‐year efficacy and safety of certolizumab pegol for ... Reported outcomes include the proportions of patients achieving PASI 75, 90% improvement from baseline in PASI (PASI 90), or Physician's Global Assessment score ...

6. cimzia.com cimzia.com/plaque-psoriasis/safety

Side Effects & Clinical Trials Learn about CIMZIA® (certolizumab pegol) potential side effects. See full Prescribing Information including boxed warning on serious infections.

7. cimziahcp.com cimziahcp.com/rheumatology/psoriatic-arthritis/safety-and-adverse-events

Safety Information for Patients with PSA Patients treated with CIMZIA are at increased risk for developing serious infections that may lead to hospitalization or death. Most patients who developed ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8246928/

Long‐term safety of certolizumab pegol in plaque psoriasis Safety data from phase III trials in plaque psoriasis have found the incidence of adverse events to be generally similar over 16 weeks of treatment between the ...

9. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2024/125160s275lbl.pdf

Reference ID: 5445958 - accessdata.fda.gov The safety profile for patients with nr-axSpA treated with CIMZIA was similar to the safety profile seen in patients with RA and previous experience with CIMZIA ...

10. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/32531798/

Long-term safety of certolizumab pegol in plaque psoriasis No new safety signals were identified compared with previously reported data. Risk did not increase with longer or higher CZP exposure.