Certolizumab Pegol for Plaque Psoriasis

(CIMcare Trial)

Recruiting at 27 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

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. ^{1 2 3 4 5}

Is 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. ^{1 2 4 6 7}

What 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. ^{1 2 4 5 6}

Research Team

UCB Cares

Principal Investigator

001 844 599 2273 (UCB)

Eligibility 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.

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

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

Treatment Details

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.

Participant Groups

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

Findings from Research

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]

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]

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 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) 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]

References

1. England pubmed.ncbi.nlm.nih.gov

Certolizumab pegol for the treatment of psoriatic arthritis and plaque psoriasis. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

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

3. Switzerland 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. [2022]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Certolizumab Pegol in Japanese Patients with Moderate to Severe Plaque Psoriasis: 52-Week Results. [2021]

5. New Zealand pubmed.ncbi.nlm.nih.gov

Certolizumab Pegol: A Review in Moderate to Severe Plaque Psoriasis. [2021]

6. Canada pubmed.ncbi.nlm.nih.gov

A Companion App to Support Rheumatology Patients Treated with Certolizumab Pegol: Results From a Usability Study. [2020]

7. England pubmed.ncbi.nlm.nih.gov

Certolizumab pegol for the treatment of psoriatic arthritis. [2018]