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

Last updated: January 23, 2025
Sponsor: UCB Biopharma SRL
Overall Status: Active - Recruiting

Phase

3

Condition

Scalp Disorders

Skin Wounds

Rosacea

Treatment

Placebo

Certolizumab pegol

Clinical Study ID

NCT04123795
PS0007
  • Ages 6-17
  • All Genders

Study 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

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 yearsmay alternatively have a diagnosis of moderate to severe mixedguttate/plaque PSO with >50 % to <80 % guttate lesions for ≥3 months, andmust meet the same criteria listed above

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

Exclusion

Exclusion Criteria:

  • Study participant previously participated in this study or has previously beentreated 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 hadsuicidal 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 theColumbia Suicide Severity Rating Scale (CSSRS) at Screening

Study Design

Total Participants: 150
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 3
Study Start date:
January 21, 2020
Estimated Completion Date:
August 15, 2034

Connect with a study center

  • Ps0007 50163

    Calgary,
    Canada

    Site Not Available

  • Ps0007 50183

    Calgary,
    Canada

    Active - Recruiting

  • Ps0007 50225

    Calgary,
    Canada

    Active - Recruiting

  • Ps0007 50187

    Edmonton,
    Canada

    Active - Recruiting

  • Ps0007 50167

    Montreal,
    Canada

    Site Not Available

  • Ps0007 50167

    Montréal,
    Canada

    Site Not Available

  • Ps0007 50225

    Red Deer,
    Canada

    Site Not Available

  • Ps0007 50215

    Saint John's,
    Canada

    Site Not Available

  • Ps0007 50215

    St- John's,
    Canada

    Active - Recruiting

  • Ps0007 50279

    Vancouver,
    Canada

    Site Not Available

  • Ps0007 50231

    Carolina,
    Puerto Rico

    Active - Recruiting

  • Ps0007 50278

    Ponce,
    Puerto Rico

    Site Not Available

  • Ps0007 50265

    San Juan, 00917
    Puerto Rico

    Active - Recruiting

  • Ps0007 50214

    Auburn, Alabama 36832
    United States

    Site Not Available

  • Ps0007 50175

    Phoenix, Arizona 85006
    United States

    Completed

  • Ps0007 50213

    Anaheim, California 92804
    United States

    Site Not Available

  • Ps0007 50162

    Fountain Valley, California 92708
    United States

    Active - Recruiting

  • Ps0007 50161

    Los Angeles, California 90045
    United States

    Active - Recruiting

  • Ps0007 50196

    Thousand Oaks, California 91320
    United States

    Active - Recruiting

  • Ps0007 50312

    Aurora, Colorado 80012
    United States

    Active - Recruiting

  • Ps0007 50217

    Boca Raton, Florida 33428
    United States

    Active - Recruiting

  • Ps0007 50248

    Hialeah, Florida 33016
    United States

    Active - Recruiting

  • Ps0007 50169

    Jacksonville, Florida 32256
    United States

    Active - Recruiting

  • Ps0007 50318

    Jacksonville, Florida 32277
    United States

    Site Not Available

  • Ps0007 50216

    Miami, Florida 33186
    United States

    Site Not Available

  • Ps0007 50268

    Miami, Florida 33155
    United States

    Active - Recruiting

  • Ps0007 50184

    Pembroke Pines, Florida 33028
    United States

    Site Not Available

  • Ps0007 50246

    Pembroke Pines, Florida 33024
    United States

    Active - Recruiting

  • Ps0007 50269

    Wellington, Florida 33449
    United States

    Completed

  • Ps0007 50230

    Rome, Georgia 30161
    United States

    Completed

  • Ps0007 50274

    Savannah, Georgia 31419
    United States

    Site Not Available

  • Ps0007 50168

    Chicago, Illinois 60611
    United States

    Active - Recruiting

  • Ps0007 50222

    Overland Park, Kansas 66210
    United States

    Site Not Available

  • Ps0007 50286

    Topeka, Kansas 66614
    United States

    Completed

  • Ps0007 50188

    Metairie, Louisiana 70005
    United States

    Site Not Available

  • Ps0007 50158

    Brighton, Massachusetts 02135
    United States

    Active - Recruiting

  • Ps0007 50178

    Clarkston, Michigan 48346
    United States

    Active - Recruiting

  • Ps0007 50232

    Detroit, Michigan 48202
    United States

    Active - Recruiting

  • Ps0007 50186

    Saint Joseph, Michigan 49085
    United States

    Active - Recruiting

  • Ps0007 50105

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • Ps0007 50185

    Lebanon, New Hampshire 03756
    United States

    Site Not Available

  • Ps0007 50159

    Portsmouth, New Hampshire 03801
    United States

    Site Not Available

  • Ps0007 50247

    Bronx, New York 10468
    United States

    Active - Recruiting

  • Ps0007 50160

    Forest Hills, New York 11375
    United States

    Active - Recruiting

  • Ps0007 50229

    Rocky Mount, North Carolina 27804
    United States

    Site Not Available

  • Ps0007 50326

    Marion, Ohio 43302
    United States

    Site Not Available

  • Ps0007 50212

    Tulsa, Oklahoma 74135
    United States

    Active - Recruiting

  • Ps0007 50150

    Philadelphia, Pennsylvania 19103
    United States

    Active - Recruiting

  • Ps0007 50157

    Pittsburgh, Pennsylvania 15213
    United States

    Site Not Available

  • Ps0007 50156

    Arlington, Texas 76011
    United States

    Completed

  • Ps0007 50226

    Houston, Texas 77030
    United States

    Site Not Available

  • Ps0007 50281

    Laredo, Texas 78041
    United States

    Site Not Available

  • Ps0007 50277

    San Antonio, Texas 78218
    United States

    Active - Recruiting

  • Ps0007 50227

    Seattle, Washington 98105
    United States

    Site Not Available

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