A study to evaluate the efficacy and safety of bimekizumab compared to ustekinumab in children and adolescents from 6 years to less than 18 years of age with moderate to severe plaque psoriasis.

JRCT ID: jRCT2041240092

Registered date:30/09/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Plaque Psoriasis
• Date of first enrollment: 31/10/2024
• Target sample size: 6
• Countries of recruitment: Europe and North America,Japan
• Study type: Interventional

Intervention(s)

[Experimental: bimekizumab]
Study participants randomized to this arm receive bimekizumab dosage regimen 1 at pre-specified timepoints during the Initial Treatment Period (16 weeks). They continue to receive bimekizumab dosage regimen 2 in the Maintenance Period (32
weeks). Under certain conditions study participants may be offered to continue on bimekizumab dosage regimen 2 in the Open-label Extension (OLE) Period (104 weeks).
[Active Comparator: ustekinumab]
Study participants randomized to this arm receive ustekinumab at pre-specified timepoints during the Initial Treatment Period (16 weeks) and during the Maintenance Period. Under certain conditions participants may switch to bimekizumab dosage regimen 1 (16 weeks) and continue with bimekizumab dosage regimen 2 in the last 16 weeks of the Maintenance Period. Under certain conditions study participants may be offered to participate in the OLE Period also receiving bimekizumab dosage regimen 2.

Outcome(s)

Primary Outcome

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

Secondary Outcome

3. PASI75 response at Week 4
4. PASI100 response at Week 16
5. PASI90 response at Week 48
6. IGA 0/1 response at Week 48
7. PASI100 response at Week 48
8. IGA 0 response at Week 16
9. IGA 0 response at Week 48
10. Incidence of treatment-emergent adverse events (TEAE)s
11. Incidence of serious TEAEs
12. Incidence of TEAEs leading to discontinuation of Investigational Medicinal Product (IMP)
13. Incidence of TEAEs leading to withdrawal from the study
14. Incidence of TEAEs predefined as safety topics of interest
15. Change from Baseline in vital signs (systolic blood pressure)
16. Change from Baseline in vital signs (diastolic blood pressure)
17. Change from Baseline in vital signs (pulse rate)
18. Incidence of clinically significant physical examination findings reported as TEAEs
19. Change from Baseline in height (growth assessment)
20. Change from Baseline in weight (growth assessment)
21. Change from Baseline in hematology parameters (platelet count)
22. Change from Baseline in hematology parameters (erythrocytes)
23. Change from Baseline in hematology parameters (hemoglobin)
24. Change from Baseline in hematology parameters (hematocrit)
25.Change from Baseline in biochemistry parameters (alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, gamma-glutamyltransferase)
26. Change from Baseline in hematology parameters (basophils, eosinophils, lymphocytes, monocytes, neutrophils, leukocytes)
27. Change from Baseline in biochemistry parameters (glucose, potassium, sodium, calcium)
28. Change from Baseline in biochemistry parameters (total bilirubin and direct bilirubin, total protein, blood urea nitrogen, and creatinine)
29. Change from Baseline in Children's Dermatology Life Quality Index (CDLQI) total score at Week 16
30. Change from Baseline in Children's Dermatology Life Quality Index (CDLQI) total score at Week 48
31. Change from Baseline in Childhood Health Assessment Questionnaire (CHAQ) disability index at Week 16 for study participants with juvenile PsA prior to Baseline
32. Change from Baseline in Peak Pruritus numerical rating scale (NRS) score at Week 16
33. Plasma bimekizumab concentrations prior to and following IMP administration over the Initial Treatment Period, over the Maintenance Period, and over the OLE Period
34. Plasma anti-bimekizumab antibodies prior to and following IMP administration over the Initial Treatment Period, over the Maintenance Period, and over the OLE Period

Key inclusion & exclusion criteria

• Age minimum: >= 6age old
• Age maximum: < 18age old
• Gender: Both

Include criteria

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

Exclude criteria

-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

Related Information

• Primary Sponsor: Matano Mizuho
• Secondary ID(s): ID: NCT06425549