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) (CIMcare)

UCB

Status and phase: Enrolling; Phase 3

Conditions: Moderate Chronic Plaque Psoriasis; Severe Chronic Plaque Psoriasis; Mixed Guttate/Plaque Psoriasis

Treatments: Drug: Certolizumab pegol; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04123795

PS0007

Details and patient eligibility

About

The purpose of the study is to demonstrate the efficacy and safety of certolizumab pegol in the treatment of moderate to severe chronic plaque psoriasis in study participants aged 6 to 11 and 12 to 17 years.

Enrollment: 150 estimated patients

Sex: All

Ages: 6 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

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

  2. Physician's Global Assessment (PGA) score ≥3 (on a scale from 0 to 4)

  3. Psoriasis Area and Severity Index (PASI) score is ≥12 or

  4. PASI score is ≥10 and <12 with at least one of the following:

     • Clinically relevant facial or scalp involvement
     • Clinically relevant genital involvement
     • Clinically relevant palm and sole involvement
     • Clinically relevant axillary involvement Study participants aged ≥12 years may alternatively have a diagnosis of moderate to severe mixed guttate/plaque PSO with >50 % to <80 % guttate lesions for ≥3 months, and must meet the same criteria listed above

• Study participant must be a candidate for systemic psoriasis therapy and/or phototherapy and/or photochemotherapy

Exclusion criteria

• Study participant previously participated in this study or has previously been treated with certolizumab pegol (CZP)
• Study participant has generalized pustular or erythrodermic psoriasis (PSO)
• Study participant has guttate PSO without plaque PSO
• Study participant has had a primary failure to an anti-tumor necrosis factor agent
• Study participant has had prior exposure to >2 biologic therapies
• Study participant has a history of severe major depression or suicide attempt (including an actual attempt, interrupted attempt, or aborted attempt), or has had suicidal ideation in the past 6 months as indicated by a positive response ("Yes") to either Question 4 or Question 5 of the "Screening/Baseline" version of the Columbia Suicide Severity Rating Scale (CSSRS) at Screening

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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150 participants in 3 patient groups, including a placebo group

Cohort A - certolizumab pegol

Experimental group

Description:

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.

Treatment:

Drug: Certolizumab pegol

Cohort A - placebo

Placebo Comparator group

Description:

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:

Drug: Placebo

Drug: Certolizumab pegol

Cohort B - certolizumab pegol

Experimental group

Description:

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.

Treatment:

Drug: Certolizumab pegol