A Study to Evaluate the Efficacy and Safety of Bimekizumab Compared to Ustekinumab in Children and Adolescents From 6 Years to Less Than 18 Years of Age With Moderate to Severe Plaque Psoriasis

Part of paid clinical trials in Fountain Valley, California.

Sponsor
UCB Biopharma SRL
Study ID
NCT06425549
Phase
PHASE3
Status
Recruiting
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Conditions

  • Moderate to Severe Plaque Psoriasis

Eligibility Criteria

Sex
ALL
Age
6 Years - 17 Years
Healthy Volunteers
Not accepted

Interventions

  • bimekizumab — DRUG
    Study participants receive bimekizumab (BKZ) administered as subcutaneous injection at pre-specified timepoints and dosage regimen during the study.
  • ustekinumab — DRUG
    Study participants receive ustekinumab (USTE) administered as subcutaneous injection at pre-specified timepoints during the study.
  • placebo — DRUG
    Study participants receive placebo at pre-specified timepoints during the study to maintain the blinding.

Study Details

The primary purpose of this study is to evaluate the efficacy of bimekizumab administered subcutaneously (sc) compared to active control (ustekinumab) in children and adolescents aged 6 to \<18 years of age with moderate to severe plaque psoriasis (PSO).

Key Dates

Start date
Jun 25, 2024
Status verified
May 2026
Primary completion
Aug 21, 2028
Completion
Nov 8, 2030

Study Design

Enrollment
168 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: bimekizumab
    Study participants randomized to this arm receive bimekizumab dosage regimen 1 at pre-specified timepoints during the Initial Treatment Period (16 weeks). They continue to receive bimekizumab dosage regimen 2 in the Maintenance Period (32 weeks). Under certain conditions study participants may be offered to continue on bimekizumab dosage regimen 2 in the Open-label Extension (OLE) Period (104 weeks).
  • Active Comparator: ustekinumab
    Study participants randomized to this arm receive ustekinumab at pre-specified timepoints during the Initial Treatment Period (16 weeks) and during the Maintenance Period. Under certain conditions participants may switch to bimekizumab dosage regimen 1 (16 weeks) and continue with bimekizumab dosage regimen 2 in the last 16 weeks of the Maintenance Period. Under certain conditions study participants may be offered to participate in the OLE Period also receiving bimekizumab dosage regimen 2.

Primary Outcome Measure

Psoriasis Area Severity Index 90 (PASI90) response at Week 16 [ Time Frame: Week 16 ]

Central Contacts

Locations (9)

FacilityCityStateZIPSite coordinators
Ps0021 50162Fountain ValleyCalifornia92708-
Ps0021 50161Los AngelesCalifornia90045-
Ps0021 50196NorthridgeCalifornia91325-
Ps0021 50581MiamiFlorida33165-
Ps0021 50344IndianapolisIndiana46250-
Ps0021 50599Kew GardensNew York11415-
Ps0021 50084CharlestonSouth Carolina29425-
Ps0021 50201ArlingtonTexas76011-
Ps0021 50355DallasTexas75235-

Find similar trials in Fountain Valley, CA

By research site
Ps0021 50162· Fountain Valley, CAPs0021 50161· Los Angeles, CAPs0021 50196· Northridge, CAPs0021 50581· Miami, FLPs0021 50344· Indianapolis, INPs0021 50599· Kew Gardens, NY

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