Recruiting
Phase 3

Bimekizumab

Sponsor:

UCB Biopharma SRL

Code:

NCT06668181

Conditions

Enthesitis-related Arthritis

Juvenile Psoriatic Arthritis

Eligibility Criteria

Sex: All

Age: 2 - 18

Healthy Volunteers: Not accepted

Interventions

Bimekizumab

Study Details

Brief summary:

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

Conditions

Enthesitis-related Arthritis

Juvenile Psoriatic Arthritis

Study ID

NCT06668181

Start date

Mar 11, 2025

Status verified date

Oct, 2026

Completion date

Jul 31, 2030

Anticipated

Primary completion date

Apr 12, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 2 - 18

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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, each of which needs to be included in the joints assessed in the JADAS27, 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:

1. Not a woman of childbearing potential (WOCBP) OR
2. 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.

Exclusion Criteria:

  • Study participants fulfilling any International League of Associations for Rheumatology (ILAR) diagnostic juvenile idiopathic arthritis (JIA) category other than enthesitis-related arthritis (ERA; including juvenile-onset ankylosing spondylitis (JAS)) and/or juvenile psoriatic arthritis (JPsA).
  • Study participant has history of inflammatory bowel disease (IBD) or signs/symptoms suggestive of IBD.
  • Study participant has active uncontrolled uveitis.
  • Study participant has history of active tuberculosis (TB) unless successfully treated, latent TB unless prophylactically treated.
  • Study participant has had major surgery (including joint surgery) within the 3 months prior to the Baseline Visit or has planned major surgery within 6 months after entering the study.
  • Study participant has laboratory abnormalities at Screening defined in the Protocol.
  • Study participant has an active infection or history of infections (such as serious infection, chronic infections, opportunistic infections, unusually severe infections).
  • Study participant has received drugs listed in the protocol outside the specified timeframes relative to the Baseline Visit or receives prohibited concomitant treatments.
  • Study participant had previous therapy with bimekizumab or prior treatment with other IL-17 biologic response modifier.
  • Study participant had prior treatment with more than one biologic response modifier (other than an IL-17).
  • Presence of active suicidal ideation, or positive suicide behavior.
  • Study participant has been diagnosed with severe depression in the past 6 months.

Study Design

Enrollment

40 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Bimekizumab

Study participants will receive a bimekizumab dose which is dependent on their weight.

Interventions

Bimekizumab

Bimekizumab will be administered at pre-specified timepoints.

Primary outcome measure

  • Plasma bimekizumab concentrations over the Initial Treatment Period [ Time Frame: Up to Week 16 ]

Central Contacts and Locations

Central contacts

Locations

Ja0005 50646

Recruiting

Calgary, Canada

Ja0005 50644

Recruiting

Montreal, Canada

Ja0005 50645

Recruiting

Saskatoon, Canada

More Information

Sponsor

UCB Biopharma SRL

Last update posted

Oct 9, 2026

Last verified

Oct, 2026

Keywords

  • Arthritis
  • Bimekizumab

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-11. This information was provided to ClinicalTrials.gov by UCB Biopharma SRL on 2026-10-09. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.