An Open-label Study to Evaluate the Pharmacokinetics and Safety of Bimekizumab in Pediatric Study Participants With Active Juvenile Idiopathic Arthritis Subtypes Enthesitis-related Arthritis (Including Juvenile-onset Ankylosing Spondylitis) and Juvenile Psoriatic Arthritis
- Sponsor
- UCB Biopharma SRL
- Study ID
- NCT06668181
- Phase
- PHASE3
- Status
- Recruiting
Conditions
- Enthesitis-related Arthritis
- Juvenile Psoriatic Arthritis
Eligibility Criteria
- Sex
- ALL
- Age
- 2 Years - 18 Years
- Healthy Volunteers
- Not accepted
Interventions
- Bimekizumab — DRUGBimekizumab will be administered at pre-specified timepoints.
Study Details
The purpose of this study is to assess plasma bimekizumab concentrations following subcutaneous (sc) bimekizumab administration.
Key Dates
- Start date
- Mar 11, 2025
- Status verified
- Jun 2026
- Primary completion
- Apr 12, 2028
- Completion
- Jul 31, 2030
Study Design
- Enrollment
- 40 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: BimekizumabStudy participants will receive a bimekizumab dose which is dependent on their weight.
Primary Outcome Measure
Plasma bimekizumab concentrations over the Initial Treatment Period [ Time Frame: Up to Week 16 ]
Central Contacts
- UCB Cares+18445992273
- UCB Cares001 844 599 2273
Related Studies
- A Study to Assess Adverse Events, Change in Disease Activity, and How the Drug Moves Through the Body in Children With Juvenile Psoriatic Arthritis (jPsA) Receiving Subcutaneously Injected Risankizumab or AdalimumabPHASE3 · Recruiting · AbbVie · Little Rock, Arkansas
- Study to Evaluate the Pharmacokinetics (PK), Safety and Tolerability up to 6 Years of Intravenous (i.v.) Secukinumab in Pediatric Participants With Juvenile Psoriatic Arthritis (JPsA).PHASE1 · Recruiting · Novartis Pharmaceuticals · Gainesville, Florida
- A Study to Evaluate the Drug Levels, Efficacy, and Safety of Deucravacitinib (BMS-986165) in Pediatric Participants With Juvenile Psoriatic ArthritisPHASE3 · Recruiting · Bristol-Myers Squibb · Lancaster, California