Clinical Trial 45676

Pembroke Pines, FL 33024


Summary:

This Phase 3, multicenter study, PS0007, will include 2 cohorts: Cohort A, enrolling study participants aged 12 to 17 years (inclusive), and Cohort B, enrolling study participants aged 6 to 11 years (inclusive). For Cohort A, this study will be randomized, parallel-group, double-blind, and placebo-controlled through Week 16 with one certolizumab pegol (CZP) arm; all eligible study participants will receive CZP from Week 16 to Week 52 and through the subsequent 104- week Open-Label Extension (OLE) Period. For Cohort B, there will be a single open-label CZParm throughout the 3-year study. Dosing of CZP in both cohorts will be based on the study participant’s weight. In both cohorts, the study will evaluate the efficacy, safety, and pharmacokinetics (PK) of CZP in pediatric study participants with moderate to severe chronic plaque psoriasis (PSO). Certolizumab pegol is a humanized antibody antigen binding (Fab′) fragment with specificity forhuman tumor necrosis factor alpha (TNFα), conjugated to polyethylene glycol (PEG). The drug product intended for use in this study is the liquid formulation in a prefilled syringe (PFS). Investigational medicinal product (IMP) will be administered by subcutaneous (sc) injection.


Qualified Participants Must:

• Study participant is male or female, 6 to 17 years of age
• Have had moderate to severe plaque psoriasis for at least 6 months
• Have a parent, caregiver or legal guardian to help them throughout the study


Qualified Participants May Receive:

Participants will recieve compensation for their time and travel.


Available At:

Intervent Clinical Research Center
9050 Pines Blvd., Suite 351
Pembroke Pines, FL 33024
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Clinical trials are medical research studies designed to test the safety and/or effectiveness of new investigational drugs, devices, or treatments in humans. These studies are conducted worldwide for a range of conditions and illnesses. Learn more about clinical research and participating in a study at About Clinical Trials.