Clinical trial NCT04123795: A Study to Evaluate the Pharmacokinetics, Safety, and Effectiveness of Certolizumab Pegol in Children With Moderate to Severe Chronic Plaque Psoriasis
Official title: Multicenter, Open Label or Double-Blind, Placebo-Controlled Study to Evaluate the Pharmacokinetics, Safety, and Effectiveness of Certolizumab Pegol in Pediatric Study Participants With Moderate to Severe Chronic Plaque Psoriasis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Moderate Chronic Plaque Psoriasis
Severe Chronic Plaque Psoriasis
Mixed Guttate/Plaque Psoriasis
Keywords: Chronic plaque psoriasis
Certolizumab pegol
Cimzia
Pediatric study
Phase 3
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2019-10-11
Enrollment: 150
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Plasma concentrations of Certolizumab pegol (CZP) at Week 16
timeFrame: Week 16
measure: Plasma anti-CZP antibody titers at Week 16
timeFrame: Week 16
measure: Plasma concentrations of CZP at Week 52
timeFrame: Week 52
measure: Plasma anti-CZP antibody titers at Week 52
timeFrame: Week 52
Secondary outcomes:
measure: Percentage of participants achieving a 75% or higher improvement in Psoriasis Area and Severity Index (PASI) score at Week 16
timeFrame: Week 16
measure: 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
timeFrame: Week 16
measure: Incidence of serious treatment emergent adverse events
timeFrame: 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)
measure: Incidence of treatment emergent adverse events leading to withdrawal
timeFrame: 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)
Other outcomes:
Locations:
city: Auburn
country: United States
facility: Ps0007 50214
state: Alabama
city: Phoenix
country: United States
facility: Ps0007 50175
state: Arizona
city: Anaheim
country: United States
facility: Ps0007 50213
state: California
city: Fountain Valley
country: United States
facility: Ps0007 50162
state: California
city: Los Angeles
country: United States
facility: Ps0007 50161
state: California
city: Thousand Oaks
country: United States
facility: Ps0007 50196
state: California
city: Aurora
country: United States
facility: Ps0007 50312
state: Colorado
city: Boca Raton
country: United States
facility: Ps0007 50217
state: Florida
city: Hialeah
country: United States
facility: Ps0007 50248
state: Florida
city: Jacksonville
country: United States
facility: Ps0007 50169
state: Florida
city: Jacksonville
country: United States
facility: Ps0007 50318
state: Florida
city: Miami
country: United States
facility: Ps0007 50268
state: Florida
city: Miami
country: United States
facility: Ps0007 50216
state: Florida
city: Pembroke Pines
country: United States
facility: Ps0007 50246
state: Florida
city: Pembroke Pines
country: United States
facility: Ps0007 50184
state: Florida
city: Wellington
country: United States
facility: Ps0007 50269
state: Florida
city: Rome
country: United States
facility: Ps0007 50230
state: Georgia
city: Savannah
country: United States
facility: Ps0007 50274
state: Georgia
city: Chicago
country: United States
facility: Ps0007 50168
state: Illinois
city: Overland Park
country: United States
facility: Ps0007 50222
state: Kansas
city: Topeka
country: United States
facility: Ps0007 50286
state: Kansas
city: Metairie
country: United States
facility: Ps0007 50188
state: Louisiana
city: Brighton
country: United States
facility: Ps0007 50158
state: Massachusetts
city: Clarkston
country: United States
facility: Ps0007 50178
state: Michigan
city: Detroit
country: United States
facility: Ps0007 50232
state: Michigan
city: Saint Joseph
country: United States
facility: Ps0007 50186
state: Michigan
city: Saint Louis
country: United States
facility: Ps0007 50105
state: Missouri
city: Lebanon
country: United States
facility: Ps0007 50185
state: New Hampshire
city: Portsmouth
country: United States
facility: Ps0007 50159
state: New Hampshire
city: Bronx
country: United States
facility: Ps0007 50247
state: New York
city: Forest Hills
country: United States
facility: Ps0007 50160
state: New York
city: Rocky Mount
country: United States
facility: Ps0007 50229
state: North Carolina
city: Marion
country: United States
facility: Ps0007 50326
state: Ohio
city: Tulsa
country: United States
facility: Ps0007 50212
state: Oklahoma
city: Philadelphia
country: United States
facility: Ps0007 50150
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Ps0007 50157
state: Pennsylvania
city: Arlington
country: United States
facility: Ps0007 50156
state: Texas
city: Houston
country: United States
facility: Ps0007 50226
state: Texas
city: Laredo
country: United States
facility: Ps0007 50281
state: Texas
city: San Antonio
country: United States
facility: Ps0007 50277
state: Texas
city: Seattle
country: United States
facility: Ps0007 50227
state: Washington
city: Calgary
country: Canada
facility: Ps0007 50163
city: Calgary
country: Canada
facility: Ps0007 50183
city: Calgary
country: Canada
facility: Ps0007 50225
city: Edmonton
country: Canada
facility: Ps0007 50187
city: Montreal
country: Canada
facility: Ps0007 50167
city: St- John's
country: Canada
facility: Ps0007 50215
city: Vancouver
country: Canada
facility: Ps0007 50279
city: Carolina
country: Puerto Rico
facility: Ps0007 50231
city: Ponce
country: Puerto Rico
facility: Ps0007 50278
city: San Juan
country: Puerto Rico
facility: Ps0007 50265
Study officials:
affiliation: 001 844 599 2273 (UCB)
name: UCB Cares
role: STUDY_DIRECTOR
References: