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Monoclonal Antibodies

Certolizumab Pegol for Plaque Psoriasis (CIMcare Trial)

Q: To what purpose is Certolizumab pegol most often applied?

<p>Though mainly used to treat severe <a href="https://www.withpower.com/clinical-trials/psoriatic-arthritis">psoriatic arthritis</a>, certolizumab pegol can also help patients with other inflammatory conditions like <a href="https://www.withpower.com/clinical-trials/crohn&#x27;s-disease">Crohn's disease</a> and psoriatic arthritis.</p>

Phase 3

Recruiting

Research Sponsored by UCB Biopharma SRL

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Study participant must have a diagnosis of moderate to severe plaque psoriasis (PSO) for ≥3 months

Body Surface Area (BSA) affected by psoriasis ≥10 %

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 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)

Awards & highlights

CIMcare Trial Summary

This trial is testing how well certolizumab pegol works in treating plaque psoriasis in children and adolescents aged 6 to 17 years old.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Certolizumab Pegol may cause side effects such as infections due to immune system suppression, injection site reactions like redness or swelling, allergic reactions that could be serious, headache, nausea and signs of autoimmune conditions like lupus-like syndrome.

CIMcare Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have been diagnosed with moderate to severe plaque psoriasis for at least 3 months.

Select...

Over 10% of my body is affected by psoriasis.

Select...

My PASI score is between 10 and 12, and I have significant psoriasis on my face, scalp, genitals, palms, soles, or underarms.

CIMcare Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 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)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~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)

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Percentage of participants achieving a 75% or higher improvement in Psoriasis Area and Severity Index (PASI) score at Week 16

Percentage of participants who achieve a Physician's Global Assessment (PGA) Clear or Almost Clear response (with at least a 2-category improvement) at Week 16

Secondary outcome measures

Incidence of serious treatment emergent adverse events

Incidence of treatment emergent adverse events leading to withdrawal

Percentage of participants achieving CDLQI score of 0 or 1 at Week 16

+7 more

Side effects data

From 2011 Phase 4 trial • 333 Patients • NCT00580840

13%

Upper respiratory tract infection

Urinary tract infection

Rheumatoid arthritis

Arthralgia

Nasopharyngitis

Cellulitis

Pneumonia

100%

80%

60%

40%

20%

Study treatment Arm

Run-in Overall

Certolizumab Pegol 400 mg and Placebo + Methotrexate

Certolizumab Pegol 200 mg and Placebo + Methotrexate

Placebo + Methotrexate

CIMcare Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: Cohort B - certolizumab pegolExperimental Treatment1 Intervention

Enrolling study participants aged 6 to 11 years (inclusive). Study participants in this arm will receive weight-based subcutaneous doses of certolizumab pegol from Week 1 to Week 52 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 and through the subsequent Open-Label Extension Period.

Group III: Cohort A - placeboPlacebo Group2 Interventions

Enrolling study participants aged 12 to 17 years (inclusive). Study participants in this arm will receive weight-based subcutaneous doses of placebo from Week 1 to 16 and certolizumab pegol to Week 52 and through the subsequent Open-Label Extension Period.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Certolizumab pegol

2008

Completed Phase 4

~3160

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

UCB Biopharma SRLLead Sponsor

101 Previous Clinical Trials

21,286 Total Patients Enrolled

UCB CaresStudy Director001 844 599 2273 (UCB)

205 Previous Clinical Trials

44,813 Total Patients Enrolled

Media Library

Certolizumab pegol (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04123795 — Phase 3

Plaque Psoriasis Research Study Groups: Cohort A - certolizumab pegol, Cohort A - placebo, Cohort B - certolizumab pegol

Plaque Psoriasis Clinical Trial 2023: Certolizumab pegol Highlights & Side Effects. Trial Name: NCT04123795 — Phase 3

Certolizumab pegol (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04123795 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any hospitals in Canada conducting this trial?

"Presently, this study is taking place at 42 different hospitals, clinics, and medical institutions. These are located in cities such as Brighton, Laredo, and Boca Raton, among others. If you enroll in this trial, it would be beneficial to choose the site closest to you to minimize travel."

Answered by AI

Does this experiment only include people over the age of 40?

"According to the inclusion criteria, the patients that can enroll in this clinical trial are aged 6 to 17. Out of the 202 clinical trials conducted, this is one of the 34 trials meant for patients under 18. The other 168 trials are for patients that are 65 years or older."

Answered by AI

Are there other examples of Certolizumab pegol's efficacy?

"The first study evaluating certolizumab pegol was completed in 2007 at the University of Nebraska Medical Center. As of right now, a total of 18289 studies have been completed. Out of these, 17 are still ongoing, with a large portion being conducted in Brighton, Massachusetts."

Answered by AI

To what purpose is Certolizumab pegol most often applied?

"Though mainly used to treat severe psoriatic arthritis, certolizumab pegol can also help patients with other inflammatory conditions like Crohn's disease and psoriatic arthritis."

Answered by AI

To whom does this clinical trial offer the opportunity to participate?

"Eligible participants for this psoriasis clinical trial must be aged 6 to 17. To date, the study has recruited 150 people in total."

Answered by AI

Has Certolizumab pegol been cleared by the FDA?

"Data collected thus far suggests that Certolizumab pegol is safe for use, as it has received a score of 3."

Answered by AI

How many people fit the criteria to enroll in this trial?

"That is correct. The clinicaltrials.gov website verifies that this trial is open and actively recruiting participants. This trial was first posted on 1/21/2020, and the most recent update was on 9/1/2022. There are 42 recruitment sites across the globe, and the study needs a total of 150 participants."

Answered by AI

Is it possible to enroll in this experiment at this time?

"That is correct. Information available on clinicaltrials.gov verifies that this study is looking for 150 individuals at 42 facilities. The trial was opened on 1/21/2020 and the most recent update was on 9/1/2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study to Evaluate the Efficacy, Safety, and Drug Concentration of Certolizumab Pegol (CZP) in Children and Adolescent Study Participants With Moderate to Severe Chronic Plaque Psoriasis (PSO)

2020. "A Study to Evaluate the Efficacy, Safety, and Drug Concentration of Certolizumab Pegol (CZP) in Children and Adolescent Study Participants With Moderate to Severe Chronic Plaque Psoriasis (PSO)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04123795.

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