A study to learn if bimekizumab is safe and how it moves throughout the body in children with certain types of juvenile idiopathic arthritis

Overview

Sponsor-declared trial summary

Key facts

Sponsor

UCB Biopharma

Participant type

Pediatric, Patients

Age range

0-17 years

Gender

Male and Female

Therapeutic area

Diseases [C] - Musculoskeletal Diseases [C05]

Trial duration

11 Mar 2025 → ongoing

Decision date (initial)

2024-10-14

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

External identifiers

EU CT number

2023-508845-41-00

WHO UTN

U1111-1305-2292

ClinicalTrials.gov

NCT06668181

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Others, Efficacy, Pharmacokinetic

To assess plasma bimekizumab concentrations following subcutaneous (sc) bimekizumab administration

Secondary objectives 3

1. To evaluate the safety of bimekizumab in study participants.
2. To evaluate the efficacy of bimekizumab in study participants.
3. To evaluate the immunogenicity of bimekizumab in study participants.

Conditions and MedDRA coding

Active juvenile idiopathic arthritis subtypes enthesitis-related arthritis (including juvenile-onset ankylosing spondylitis) and juvenile psoriatic arthritis

Regulatory references

EMA paediatric investigation plan (PIP)

EMEA-002189-PIP03-19

Plan to share IPD

Yes

IPD plan description

Data from this study may be requested by qualified researchers six months after product approval in the US and/or Europe, or global development is discontinued, and 18 months after trial completion. Investigators may request access to anonymized IPD and redacted study documents which may include: raw datasets, analysis-ready datasets, study protocol, blank case report form, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a pre-specified time, typically 12 months, on a password protected portal. This plan may change if a determination is made that the data cannot be adequately anonymized.

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 10

1. Study participant must be 2 to <18 years of age inclusive, at the Baseline Visit.
2. 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.
3. 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.
4. Study participants with inadequate response (at least 1 month) or intolerance to at least 1 nonsteroidal anti-inflammatory drug (NSAID).
5. 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.)
6. 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.
7. Body weight of ≥10kg.
8. Male and female.
9. 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: a)     Not a woman of childbearing potential (WOCBP) OR b)      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)
10. 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 12

1. 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).
2. Study participant has history of inflammatory bowel disease (IBD) or signs/symptoms suggestive of IBD.
3. Study participant has active uncontrolled uveitis.
4. Study participant has history of active tuberculosis (TB) unless successfully treated, latent TB unless prophylactically treated.
5. 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.
6. Study participant has laboratory abnormalities at Screening defined in the Protocol.
7. Study participant has an active infection or history of infections (such as serious infection, chronic infections, opportunistic infections, unusually severe infections).
8. Study participant has received drugs listed in the protocol outside the specified timeframes relative to the Baseline Visit or receives prohibited concomitant treatments.
9. Study participant had previous therapy with bimekizumab or prior treatment with other IL-17 biologic response modifier.
10. Study participant had prior treatment with more than one biologic response modifier (other than an IL-17).
11. Presence of active suicidal ideation, or positive suicide behavior.
12. Study participant has been diagnosed with severe depression in the past 6 months.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Plasma bimekizumab concentrations over the Initial Treatment Period

Secondary endpoints 16

1. Occurrence of Treatment-emergent adverse events (TEAEs)
2. Occurrence of Serious TEAEs
3. Occurrence of TEAEs leading to discontinuation of investigational medicinal product (IMP)
4. Occurrence of TEAEs leading to withdrawal from the study
5. Occurrence of selected safety events of interest (including infection [serious, opportunistic, fungal, and tuberculosis (TB)], inflammatory bowel disease [IBD], and injection site reactions)
6. Change from Baseline in vital signs (systolic blood pressure) at Week 16
7. Change from Baseline in vital signs (diastolic blood pressure) at Week 16
8. Change from Baseline in vital signs (heart rate) at Week 16
9. Change from Baseline in protocol planned laboratory analyses (chemistry) at Week 16
10. Change from Baseline in protocol planned laboratory analyses (hematology) at Week 16
11. Change from Baseline in growth assessments (height) at Week 16
12. Change from Baseline in growth assessments (weight) at Week 16
13. Acceptability assessments by injection site pain adverse events (AEs) during the Initial Treatment Period (Week 0 to Week 16)
14. American College of Rheumatology pediatric (ACR Pedi) 30/50/70/90/100 response at Week 16
15. Change from Baseline in Juvenile Arthritis Disease Activity Score (JADAS27) -high sensitivity C-reactive protein (hs-CRP) at Week 16
16. Anti-bimekizumab antibody and neutralizing antibody detection prior to and following IMP administration during the Initial Treatment Period

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

UCB Biopharma

Sponsor organisation

UCB Biopharma

Address

Researchdreef 60

City

Anderlecht

Postcode

1070

Country

Belgium

Scientific contact point

Organisation

UCB Biopharma

Contact name

UCB Cares

Public contact point

Organisation

UCB Biopharma

Contact name

UCB Cares

Third parties 8

Locations

4 EU/EEA countries · 16 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 77 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

7 submissions — initial application plus substantial / non-substantial modifications