Open-Label, Single-Arm Trial to Evaluate the Pharmacokinetics and Safety of Bimekizumab in Pediatric Study Participants From 2 to Less Than 18 Years of Age With Active Juvenile Idiopathic Arthritis Subtypes Enthesitis-Related Arthritis (Including Juvenile-Onset Ankylosing Spondylitis) and Juvenile Psoriatic Arthritis

Status: Recruiting
Location: See all (23) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

The purpose of this study is to assess plasma bimekizumab concentrations following subcutaneous (sc) bimekizumab administration.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 2
Maximum Age: 18
Healthy Volunteers: f
View:

• Study participant must be 2 to \<18 years of age inclusive, at the Baseline Visit.

• Study participants who have confirmed diagnosis of enthesitis-related arthritis (ERA; including juvenile-onset ankylosing spondylitis (JAS)) and/or juvenile psoriatic arthritis (JPsA) according to the juvenile-International League of Associations for Rheumatology (JIA-ILAR) classification criteria of at least 3 months duration prior to the Screening Visit.

• Study participants who have active disease (ERA \[including JAS\] and/or JPsA) defined as having at least 3 active joints and for ERA at least 1 site of enthesitis at Baseline or documented by history.

• Study participants with inadequate response (at least 1 month) or intolerance to at least 1 nonsteroidal anti-inflammatory drug (NSAID).

• Study participants taking concomitant methotrexate or sulfasalazine are allowed to continue the medication if it has been used for the past 12 weeks with a stable dose for the 4 weeks prior to Baseline, with no change in dose for the first 16 weeks of treatment foreseen. (Note: prior or concomitant use of methotrexate or sulfasalazine is NOT required for study participation.)

• Study participants with no concomitant use of second line agents such as disease-modifying and/or immunosuppressive drugs with the exception of methotrexate or sulfasalazine.

• Body weight of ≥10kg.

• Male and female.

• A female study participant will be eligible to participate if she is not pregnant, not breastfeeding, and at least 1 of the following conditions applies:

‣ Not a woman of childbearing potential (WOCBP) OR

⁃ A WOCBP who agrees to follow the contraceptive guidance during the Initial Treatment Period, the Open-label Extension (OLE) Period, and for at least 20 weeks after the final dose of investigational medicinal product (IMP; ie, the Safety Follow-up (SFU) Period)

• Capable of giving/having parent(s) or legal representative provide signed informed consent/assent (where appropriate), which includes compliance with the requirements and restrictions listed in the Informed Consent Form (ICF) and assent and in this protocol.

Locations
Other Locations
Canada
Ja0005 50646
RECRUITING
Calgary
Ja0005 50644
RECRUITING
Montreal
Ja0005 50645
RECRUITING
Saskatoon
France
Ja0005 40777
RECRUITING
Indre-et-loire
Ja0005 40510
RECRUITING
Le Kremlin-bicêtre
Ja0005 40778
RECRUITING
Paris
Ja0005 40776
RECRUITING
Poitiers
Germany
Ja0005 40369
RECRUITING
Berlin
Ja0005 40356
RECRUITING
Dresden
Ja0005 40072
ACTIVE_NOT_RECRUITING
Freiburg Im Breisgau
Ja0005 40852
RECRUITING
Hamburg
Ja0005 40787
RECRUITING
Sankt Augustin
Ja0005 40779
ACTIVE_NOT_RECRUITING
Sendenhorst
Ja0005 40427
RECRUITING
Tübingen
Poland
Ja0005 40720
RECRUITING
Krakow
Ja0005 40780
ACTIVE_NOT_RECRUITING
Sosnowiec
Spain
Ja0005 40781
RECRUITING
Esplugues De Llobregat
Ja0005 40100
RECRUITING
Madrid
Ja0005 40782
RECRUITING
Valencia
United Kingdom
Ja0005 40786
ACTIVE_NOT_RECRUITING
Bristol
Ja0005 40783
RECRUITING
Manchester
Ja0005 40785
RECRUITING
Nottingham
Ja0005 40784
ACTIVE_NOT_RECRUITING
Stroke-on-trent
Contact Information
Primary
UCB Cares
ucbcares@ucb.com
+18445992273
Backup
UCB Cares
001 844 599 2273
Time Frame
Start Date: 2025-03-11
Estimated Completion Date: 2030-07-31
Participants
Target number of participants: 40
Treatments
Experimental: Bimekizumab
Study participants will receive a bimekizumab dose which is dependent on their weight.
Sponsors
Leads: UCB Biopharma SRL

This content was sourced from clinicaltrials.gov