A study to learn how the study drug bimekizumab works and how safe it is in treating moderate to severe hidradenitis suppurativa in children and adolescents who have reached puberty.

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] - Immune System Diseases [C20]

Trial duration

9 Oct 2025 → ongoing

Decision date (initial)

2025-07-24

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

External identifiers

EU CT number

2023-505323-31-00

WHO UTN

U1111-1316-5308

ClinicalTrials.gov

NCT06921850

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Pharmacodynamic, Efficacy, Pharmacokinetic, Therapy, Others

Assess the PK of bimekizumab following subcutaneous (sc) administration in study participants with moderate to severe Hidradenitis Suppurativa (HS)

Secondary objectives 1

1. • Evaluate the safety of bimekizumab in study participants with moderate to severe HS • Assess the immunogenicity of bimekizumab in study participants with moderate to severe HS

Conditions and MedDRA coding

Hidradenitis Suppurativa

Regulatory references

EMA paediatric investigation plan (PIP)

EMEA-002189-PIP04-20

Plan to share IPD

Yes

IPD plan description

Data from this trial 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 individual patient-level data and redacted trial documents which may include: analysis-ready datasets, study protocol, 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 prespecified time, typically 12 months, on a password protected portal. This plan may change if the risk of re-identifying trial participants is determined to be too high after the trial is completed; in this case and to protect participants, individual patient-level data would not be made available.

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 1

1. - Study participant must be 12 to <18 years of age at the time of informed consent/assent, at Tanner stage 2 or more, for the first 8 participants only, followed by also including participants ≥9 to <18 years of age at Tanner stage 2 or more. - Study participant must have a diagnosis of HS for at least 6 months prior to the Baseline Visit. - Study participant must have moderate to severe HS, defined as a total of ≥5 inflammatory lesions (ie, the sum of abscesses and inflammatory nodules), as assessed at both the Screening and Baseline Visits. - Study participant must have HS lesions present in at least 2 distinct anatomic areas, 1 of which must be at least Hurley Stage II or III, as assessed at both the Screening and Baseline Visits. - Study participant must have had a history of inadequate response to a course of a systemic antibiotic for treatment of HS - Study participant must weigh ≥30kg at the Screening Visit.

Exclusion criteria 1

1. - Study participant has a draining tunnel count of >20 at either the Screening or Baseline Visits. - Study participant has experienced primary failure (no response within 12 weeks) to 1 or more IL 17 biologic response modifiers (eg, brodalumab, ixekizumab, secukinumab) OR primary failure to more than 1 biologic response modifier other than an IL-17 biologic response modifier. - Study participant has previously participated in this study or has received previous therapy with bimekizumab. - Study participant has a history of IBD or symptoms suggestive of IBD. - History of active tuberculosis unless successfully treated, latent TB unless prophylactically treated - 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 outside the specified timeframes relative to the Baseline Visit or receives prohibited concomitant treatments - Study participant has the presence of active suicidal ideation, or positive suicide behavior, - Study participant diagnosed with severe depression in the past 6 months prior to the Screening Visit. - Study participant has a history of psychiatric inpatient hospitalization within the past year before enrolling into the study.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. • Geometric mean plasma bimekizumab concentration at Week 16

Secondary endpoints 8

1. 1. Exposure-adjusted incidence rate of Treatment- Emergent Adverse Events (TEAEs) over the Initial Treatment Period
2. 2. Exposure-adjusted incidence rate of Serious TEAEs over the Initial Treatment Period
3. 3. Exposure-adjusted incidence rate of TEAEs leading to withdrawal from study over the Initial Treatment Period
4. 4. Exposure-adjusted incidence rate of selected Safety Topics of Interest (including incidence of infections [serious, opportunistic, fungal, and TB], IBD, and injection site reactions) over the Initial Treatment Period
5. 5. Mean Change from Baseline in Systolic Blood Pressure, Diastolic Blood Pressure, and Pulse over the Initial Treatment Period
6. 6. Mean Change from Baseline in Biochemistry Laboratory Analyses over the Initial Treatment Period
7. 7. Mean Change from Baseline in Hematology Laboratory Analyses over the Initial Treatment Period
8. 8. Incidence rate for Positive, Negative, Missing Plasma Anti-Bimekizumab Antibodies 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

2 EU/EEA countries · 9 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 33 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