A study to learn how bimekizumab works in children and teenagers with moderate to severe plaque psoriasis

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

12 Aug 2024 → ongoing

Decision date (initial)

2024-07-22

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

UCB Biopharma SRL

External identifiers

EU CT number

2023-503859-10-00

WHO UTN

U1111-1293-2383

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Pharmacokinetic, Others, Safety, Therapy, Efficacy

To evaluate the efficacy of bimekizumab administered subcutaneous (sc) compared to active control (ustekinumab) in children and adolescents aged 6 to <18 years of age with moderate to severe plaque psoriasis (PSO)

Secondary objectives 1

1. - To evaluate the efficacy of bimekizumab compared to active control (ustekinumab) in children and adolescents aged 6 to <18 years of age with moderate to severe plaque PSO - To evaluate the safety of bimekizumab compared to active control (ustekinumab) in children and adolescents aged 6 to <18 years of age with moderate to severe plaque PSO - To evaluate the effect of bimekizumab on health-related quality of life compared to active control (ustekinumab) in children and adolescents aged 6 to <18 years of age with moderate to severe plaque PSO - To assess the pharmacokinetics (PK) of bimekizumab administered sc in children and adolescents aged 6 to <18 years of age with moderate to severe plaque PSO - To assess the immunogenicity of bimekizumab administered sc in children and adolescents aged 6 to <18 years of age with moderate to severe plaque PSO

Conditions and MedDRA coding

Moderate to Severe Plaque Psoriasis

Regulatory references

EMA paediatric investigation plan (PIP)

EMEA-002189-PIP01-17

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 1

1. - Study participant must be 6 to <18 years of age, inclusive, at the time of signing the informed consent/assent according to local regulation - Study participant has had a diagnosis of moderate to severe plaque psoriasis (PSO) for at least 3 months prior to the Screening Visit - Study participant meets the following at both the Screening and Baseline Visits: •a) Body surface area (BSA) affected by PSO ≥10% •b). Investigator's Global Assessment (IGA) score ≥3 (on a scale from 0 to 4) •c). Psoriasis Area and Severity Index (PASI) score ≥12 OR PASI score ≥10 plus at least 1 of the following: i) Clinically relevant facial involvement ii) Clinically relevant genital involvement iii) Clinically relevant hand and foot involvement - Study participant is a candidate for systemic PSO therapy and/or photo/chemotherapy and for treatment with ustekinumab per labeling - Study participant has body weight ≥15 kg and body mass index for age percentile of ≥5 at Screening

Exclusion criteria 1

1. - Primary failure (no response within 12 weeks) to 1 or more interleukin-17 (IL-17) biologic response modifiers (eg, brodalumab, ixekizumab, secukinumab) OR more than 1 biologic response modifier other than an IL-17 - Study participant has a presence of guttate, inverse, pustular, or erythrodermic PSO or other dermatological condition that may impact the clinical assessment of PSO - Study participant has a history of inflammatory bowel disease (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 previously received bimekizumab - Study participant has previously received ustekinumab - 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 Screening) should be excluded - 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 2

1. Psoriasis Area Severity Index 90 (PASI90) response at Week 16
2. Investigator´s Global Assessment (IGA) 0/1 response at Week 16

Secondary endpoints 23

1. PASI75 response at Week 4
2. PASI100 response at Week 16
3. PASI90 response at Week 48
4. IGA 0/1 response at Week 48
5. PASI100 response at Week 48
6. IGA 0 response at Week 16
7. IGA 0 response at Week 48
8. Treatment-emergent adverse events (TEAE)s
9. Serious TEAEs
10. TEAEs leading to discontinuation of investigational medicinal product (IMP)
11. TEAEs leading to withdrawal from the study
12. Selected safety topics of interest (including infection [serious, opportunistic, fungal, and tuberculosis (TB)], inflammatory bowel disease (IBD), and injection site reactions) with onset occurring from day of first dose through 20 weeks after final dose of IMP adjusted by duration of study participant exposure to IMP
13. Change from Baseline in vital signs
14. Change from Baseline in physical examination findings
15. Change from Baseline in height (growth assessment)
16. Change from Baseline in weight (growth assessment)
17. Change from Baseline in laboratory analyses (chemistry and hematology)
18. Change from Baseline in Children’s Dermatology Life Quality Index (CDLQI) total score at Week 16
19. Change from Baseline in CDLQI total score at Week 48
20. Change from Baseline in Childhood Health Assessment Questionnaire (CHAQ) disability index at Week 16 for study participants with juvenile psoriatic arthritis (PsA) prior to Baseline
21. Change from Baseline in Peak Pruritus numerical rating scale (NRS) score at Week 16
22. Plasma bimekizumab concentrations prior to and following IMP administration over the Initial Treatment Period, over the Maintenance Period, and over the OLE Period
23. Plasma anti-bimekizumab antibodies prior to and following IMP administration over the Initial Treatment Period, over the Maintenance Period, and over the OLE Period

Investigational products

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

Test 1

Comparator 1

Placebo 2

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 18

Locations

8 EU/EEA countries · 36 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 101 files

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

Application history

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