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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 belowSelect...
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.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a severe form of psoriasis.
Select...
I have been treated with more than two biologic therapies.
Select...
I did not respond to my initial treatment targeting tumor inflammation.
Select...
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)
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 moreSide effects data
From 2011 Phase 4 trial • 333 Patients • NCT0058084013%
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
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
Find a Location
Who is running the clinical trial?
UCB Biopharma SRLLead Sponsor
115 Previous Clinical Trials
22,756 Total Patients Enrolled
16 Trials studying Psoriasis
4,970 Patients Enrolled for Psoriasis
UCB CaresStudy Director001 844 599 2273 (UCB)
219 Previous Clinical Trials
46,130 Total Patients Enrolled
22 Trials studying Psoriasis
6,438 Patients Enrolled for Psoriasis
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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 have a severe form of psoriasis.I am eligible for treatments that affect my whole body or use light for my psoriasis.Over 10% of my body is affected by psoriasis.You have a history of severe depression, attempted suicide, or have had thoughts of hurting yourself in the past 6 months.My PASI score is between 10 and 12, and I have significant psoriasis on my face, scalp, genitals, palms, soles, or underarms.I have been treated with more than two biologic therapies.Your psoriasis is severe, with a Psoriasis Area and Severity Index (PASI) score of 12 or higher.A doctor rates your health as 3 or more out of 4.I did not respond to my initial treatment targeting tumor inflammation.I have been in this study before or have taken certolizumab pegol.I have guttate psoriasis without plaque psoriasis.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort A - certolizumab pegol
- Group 2: Cohort A - placebo
- Group 3: Cohort B - certolizumab pegol
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.