A study to learn how safe bimekizumab, how well it works and how it moves through the bloodstream in adolescents 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

30 Aug 2021 → 13 Mar 2025

Decision date (initial)

2024-04-25

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

External identifiers

EU CT number

2023-509832-24-00

EudraCT number

2020-001724-34

WHO UTN

U1111-1303-1875

ClinicalTrials.gov

NCT04718896

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Others, Safety, Efficacy, Pharmacokinetic, Dose response, Therapy

Assess the pharmacokinetics (PK) of bimekizumab administered subcutaneously (sc) in adolescents with moderate to severe plaque psoriasis (PSO)

Secondary objectives 1

1. -Evaluate the safety of bimekizumab in adolescents with moderate to severe plaque PSO -Evaluate the efficacy of bimekizumab in adolescents with moderate to severe plaque PSO -Evaluate the immunogenicity of bimekizumab in adolescents with moderate to severe plaque PSO -Evaluate the change in quality of life in adolescents 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

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 1

1. -Participant must be ≥12 to <18 years of age at the time of signing the informed consent/assent according to local regulation -Participant has had a diagnosis of moderate to severe plaque psoriasis (PSO) for at least 3 months prior to the Screening Visit and: 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 d) 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 -Participant must be candidate for systemic PSO therapy and/or photo/chemotherapy -Body weight ≥30 kg and body mass index for age percentile of ≥5 at Baseline -Male or female A female participant will be eligible to participate if she is not pregnant, not breastfeeding, and a woman of childbearing potential (WOCBP) agrees to follow the contraceptive guidance -Capable of giving/having parent(s) or legal representative provide signed informed consent/assent (where appropriate)

Exclusion criteria 1

1. -Participant has a presence of guttate, inverse, pustular, or erythrodermic PSO or other dermatological condition that may impact the clinical assessment of PSO -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 -Participant has an active infection or history of infections (such as serious infection, chronic infections, opportunistic infections, unusually severe infections) -Participant has laboratory abnormalities at Screening -Participant has experienced primary failure to one or more interleukin-17 (IL-17) biologic response modifier OR primary failure to more than 1 biologic response modifier other than an IL-17 biologic response modifier -Presence of active suicidal ideation, or positive suicide behavior -Participant has been diagnosed with severe depression in the past 6 months

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 14

1. Plasma concentration of bimekizumab at Week 0
2. Plasma concentration of bimekizumab at Week 1
3. Plasma concentration of bimekizumab at Week 4
4. Plasma concentration of bimekizumab at Week 8
5. Plasma concentration of bimekizumab at Week 12
6. Plasma concentration of bimekizumab at Week 16
7. Plasma concentration of bimekizumab at Week 20
8. Plasma concentration of bimekizumab at Week 36
9. Plasma concentration of bimekizumab at Week 40
10. Plasma concentration of bimekizumab at Week 64
11. Plasma concentration of bimekizumab at Week 88
12. Plasma concentration of bimekizumab at Week 112
13. Plasma concentration of bimekizumab at Week 124
14. Plasma concentration of bimekizumab at safety follow up (SFU)

Secondary endpoints 27

1. Percentage of participants with treatment-emergent adverse events (TEAEs)
2. Percentage of participants with serious TEAEs
3. Percentage of participants with TEAEs leading to discontinuation of investigational medicinal product (IMP)
4. Percentage of participants with selected safety topics of interest
5. Change from Baseline in vital signs (systolic and diastolic blood pressure)
6. Change from Baseline in vital signs (heart rate or pulse rate)
7. Change from Baseline in vital signs (temperature)
8. Change from Baseline in physical examination findings reported as TEAEs with onset occurring from day of first dose through 20 weeks after final dose of IMP
9. Change from Baseline in hematology parameters (platelet count)
10. Change from Baseline in hematology parameters (mean corpuscular hemoglobin)
11. Change from Baseline in hematology parameters (mean corpuscular volume)
12. Change from Baseline in hematology parameters (erythrocytes)
13. Change from Baseline in hematology parameters (hemoglobin)
14. Change from Baseline in hematology parameters (hematocrit)
15. Change from Baseline in hematology parameters (basophils, eosinophils, lymphocytes, monocytes, neutrophils, leukocytes)
16. Change from Baseline in clinical chemistry parameters (calcium, potassium, sodium, blood urea nitrogen, glucose (nonfasting))
17. Change from Baseline in clinical chemistry parameters (alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase)
18. Change from Baseline in clinical chemistry parameters (creatinine, total and direct bilirubin)
19. Change from Baseline in clinical chemistry parameters (total protein)
20. Change from Baseline in height
21. Change from Baseline in weight
22. Percentage of participants with Psoriasis Area and Severity Index (PASI) 90 response at Week 16
23. Percentage of participants with Investigator's Global Assessment (IGA) 0/1 (Clear [0]/Almost Clear [1] with at least 2-category improvement from Baseline) response at Week 16
24. Percentage of participants with Psoriasis Area and Severity Index (PASI) 75 response at Week 4
25. Percentage of participants with anti-bimekizumab antibody (AbAb) detection prior to investigational medicinal product (IMP) administration
26. Percentage of participants with anti-bimekizumab antibody (AbAb) detection following investigational medicinal product (IMP) administration
27. Change from Baseline in Children's Dermatology Life Quality Index (CDLQI) response at Week 16

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 · 7 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

Summary of results Art. 37(4) CTR

Layperson summary Annex V

Documents 6 files

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

Application history

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