A Study to Evaluate the Pharmacokinetics, Safety, and Effectiveness of Certolizumab Pegol in Children With Moderate to Severe Chronic Plaque Psoriasis (CIMcare)

UCB

Status and phase: Enrolling; Phase 3

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

Treatments: Drug: Placebo; Drug: Certolizumab pegol

Study type: Interventional

Funder types: Industry

Identifiers

NCT04123795

PS0007

Details and patient eligibility

About

The purpose of the study is to evaluate the pharmacokinetic (PK) of certolizumab pegol (CZP) in study participants aged 6 to 17 years with moderate to severe chronic plaque psoriasis (PSO) in order to support extrapolation of efficacy.

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 of the Active Treatment period 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) under Amendment 4 and earlier. Study participants in this arm will receive weight-based subcutaneous doses of placebo from Week 1 to Week 16 of the Active Treatment period.

Treatment:

Drug: Certolizumab pegol

Drug: Placebo

Cohort B - certolizumab pegol - Open-label

Experimental group

Description:

Enrolling study participants aged 6 to 17 years (inclusive). Study participants in this arm will receive weight-based subcutaneous doses of certolizumab pegol from Week 1 to Week 52 of the Open-label Period and through the subsequent Open-Label Extension Period.

Treatment:

Drug: Certolizumab pegol