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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

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.
Select...
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:
Select...
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 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
8%
Urinary tract infection
3%
Rheumatoid arthritis
3%
Arthralgia
2%
Nasopharyngitis
1%
Cellulitis
1%
Pneumonia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Run-in Overall
Certolizumab Pegol 400 mg and Placebo + Methotrexate
Certolizumab Pegol 200 mg and Placebo + Methotrexate
Placebo + Methotrexate

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

Find a Location

Who is running the clinical trial?

UCB Biopharma SRLLead Sponsor
110 Previous Clinical Trials
21,905 Total Patients Enrolled
UCB CaresStudy Director001 844 599 2273 (UCB)
212 Previous Clinical Trials
45,247 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
~77 spots leftby Sep 2029
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