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

Who is this study for? Children with moderate to severe chronic plaque psoriasis
What treatments are being studied? Certolizumab pegol
Status: Recruiting
Location: See all (51) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 6
Maximum Age: 17
Healthy Volunteers: f
View:

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

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

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

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

⁃ 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

Locations
United States
Alabama
Ps0007 50214
WITHDRAWN
Auburn
Arizona
Ps0007 50175
COMPLETED
Phoenix
California
Ps0007 50213
WITHDRAWN
Anaheim
Ps0007 50162
RECRUITING
Fountain Valley
Ps0007 50161
RECRUITING
Los Angeles
Ps0007 50196
RECRUITING
Thousand Oaks
Colorado
Ps0007 50312
WITHDRAWN
Aurora
Florida
Ps0007 50217
RECRUITING
Boca Raton
Ps0007 50248
RECRUITING
Hialeah
Ps0007 50169
RECRUITING
Jacksonville
Ps0007 50318
WITHDRAWN
Jacksonville
Ps0007 50216
WITHDRAWN
Miami
Ps0007 50268
RECRUITING
Miami
Ps0007 50184
WITHDRAWN
Pembroke Pines
Ps0007 50246
RECRUITING
Pembroke Pines
Ps0007 50269
COMPLETED
Wellington
Georgia
Ps0007 50230
COMPLETED
Rome
Ps0007 50274
WITHDRAWN
Savannah
Illinois
Ps0007 50168
RECRUITING
Chicago
Kansas
Ps0007 50222
WITHDRAWN
Overland Park
Ps0007 50286
COMPLETED
Topeka
Louisiana
Ps0007 50188
WITHDRAWN
Metairie
Massachusetts
Ps0007 50158
RECRUITING
Brighton
Michigan
Ps0007 50178
RECRUITING
Clarkston
Ps0007 50232
RECRUITING
Detroit
Ps0007 50186
RECRUITING
Saint Joseph
Missouri
Ps0007 50105
WITHDRAWN
St Louis
North Carolina
Ps0007 50229
WITHDRAWN
Rocky Mount
New Hampshire
Ps0007 50185
WITHDRAWN
Lebanon
Ps0007 50159
WITHDRAWN
Portsmouth
New York
Ps0007 50160
WITHDRAWN
Forest Hills
Ps0007 50247
WITHDRAWN
The Bronx
Ohio
Ps0007 50326
WITHDRAWN
Marion
Oklahoma
Ps0007 50212
WITHDRAWN
Tulsa
Pennsylvania
Ps0007 50150
RECRUITING
Philadelphia
Ps0007 50157
WITHDRAWN
Pittsburgh
Texas
Ps0007 50156
COMPLETED
Arlington
Ps0007 50226
WITHDRAWN
Houston
Ps0007 50281
WITHDRAWN
Laredo
Ps0007 50277
RECRUITING
San Antonio
Washington
Ps0007 50227
WITHDRAWN
Seattle
Other Locations
Canada
Ps0007 50163
WITHDRAWN
Calgary
Ps0007 50183
RECRUITING
Calgary
Ps0007 50225
RECRUITING
Calgary
Ps0007 50187
RECRUITING
Edmonton
Ps0007 50167
WITHDRAWN
Montreal
Ps0007 50215
RECRUITING
St. John's
Ps0007 50279
WITHDRAWN
Vancouver
Puerto Rico
Ps0007 50231
RECRUITING
Carolina
Ps0007 50278
WITHDRAWN
Ponce
Ps0007 50265
RECRUITING
San Juan
Contact Information
Primary
UCB Cares
UCBCares@ucb.com
0018445992273
Time Frame
Start Date: 2020-01-21
Estimated Completion Date: 2034-08-15
Participants
Target number of participants: 150
Treatments
Experimental: Cohort A - certolizumab pegol
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.
Placebo_comparator: Cohort A - placebo
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.
Experimental: Cohort B - certolizumab pegol - Open-label
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.
Related Therapeutic Areas
Sponsors
Leads: UCB Biopharma SRL

This content was sourced from clinicaltrials.gov