Active — Not RecruitingPhase 3

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

United States49 participantsStarted 2020-01-21

Plain-language 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.

Who can participate

Age range6 Years – 17 Years

SexALL

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Inclusion criteria

✓. 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:

What they're measuring

Plasma concentrations of Certolizumab pegol (CZP) at Week 16

Timeframe: Week 16

Plasma anti-CZP antibody titers at Week 16

Timeframe: Week 16

Plasma concentrations of CZP at Week 52

Timeframe: Week 52

Plasma anti-CZP antibody titers at Week 52

Timeframe: Week 52

Trial details

NCT IDNCT04123795

SponsorUCB Biopharma SRL

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-04-09

View on ClinicalTrials.gov More Moderate Chronic Plaque Psoriasis trials