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Monoclonal Antibodies

Certolizumab Pegol for Plaque Psoriasis (CIMcare Trial)

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 %

Must not have

Study participant has generalized pustular or erythrodermic psoriasis (PSO)

Study participant has had prior exposure to >2 biologic therapies

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

Pivotal 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.

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.

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.

Eligibility Criteria

Inclusion Criteria

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

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

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Over 10% of my body is affected by psoriasis.

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a severe form of psoriasis.

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I have been treated with more than two biologic therapies.

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I did not respond to my initial treatment targeting tumor inflammation.

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I have been in this study before or have taken certolizumab pegol.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

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

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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 / 7Eligibility criteria met