Clinical trial NCT04718896: A Study to Assess the Pharmacokinetics, Safety, and Efficacy of Two Doses of Bimekizumab in Adolescent Study Participants With Moderate to Severe Plaque Psoriasis
Official title: A Multicenter, Open-Label, Randomized Study to Assess the Pharmacokinetics, Safety, and Efficacy of Two Doses of Bimekizumab in Adolescent Study Participants With Moderate to Severe Plaque Psoriasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Moderate to Severe Plaque Psoriasis
Keywords: bimekizumab
BKZ
adolescent study participants
psoriasis
PSO
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2021-01-22
Enrollment: 41
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to assess th pharmacokinetics (PK) of bimekizumab administered subcutaneously (sc) in adolescents with moderate to severe plaque psoriasis (PSO).


Eligibility criteria: Inclusion Criteria:

* Participant must be ≥12 to less than 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:

  1. Body surface area (BSA) affected by PSO ≥10%
  2. Investigator's Global Assessment (IGA) score ≥3 (on a scale from 0 to 4)
  3. Psoriasis Area and Severity Index (PASI) score ≥12 OR
  4. 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:

* 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

Primary outcomes:
measure: Plasma concentration of bimekizumab at Week 0
timeFrame: Baseline (Week 0)
measure: Plasma concentration of bimekizumab at Week 1
timeFrame: Week 1
measure: Plasma concentration of bimekizumab at Week 4
timeFrame: Week 4
measure: Plasma concentration of bimekizumab at Week 8
timeFrame: Week 8
measure: Plasma concentration of bimekizumab at Week 12
timeFrame: Week 12
measure: Plasma concentration of bimekizumab at Week 16
timeFrame: Week 16
measure: Plasma concentration of bimekizumab at Week 20
timeFrame: Week 20
measure: Plasma concentration of bimekizumab at Week 36
timeFrame: Week 36
measure: Plasma concentration of bimekizumab at Week 40
timeFrame: Week 40
measure: Plasma concentration of bimekizumab at Week 64
timeFrame: Week 64
measure: Plasma concentration of bimekizumab at Week 88
timeFrame: Week 88
measure: Plasma concentration of bimekizumab at Week 112
timeFrame: Week 112
measure: Plasma concentration of bimekizumab at Week 124
timeFrame: Week 124
measure: Plasma concentration of bimekizumab at safety follow up (SFU)
timeFrame: Week 140 (SFU)
Secondary outcomes:
measure: Percentage of participants with treatment-emergent adverse events (TEAEs)
timeFrame: From day of first dose (Week 0) through 20 weeks after final dose of IMP (up to Week 140)]
measure: Percentage of participants with serious TEAEs
timeFrame: From day of first dose (Week 0) through 20 weeks after final dose of IMP (up to Week 140)
measure: Percentage of participants with TEAEs leading to discontinuation of investigational medicinal product (IMP)
timeFrame: From day of first dose (Week 0) through 20 weeks after final dose of IMP (up to Week 140)
measure: Percentage of participants with selected safety topics of interest
timeFrame: From day of first dose (Week 0) through 20 weeks after final dose of IMP (up to Week 140)
measure: Change from Baseline in vital signs (systolic and diastolic blood pressure)
timeFrame: From day of first dose (Week 0) through 20 weeks after final dose of IMP (up to Week 140)
measure: Change from Baseline in vital signs (heart rate or pulse rate)
timeFrame: From day of first dose (Week 0) through 20 weeks after final dose of IMP (up to Week 140)
measure: Change from Baseline in vital signs (temperature)
timeFrame: From day of first dose (Week 0) through 20 weeks after final dose of IMP (up to Week 140)
measure: 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
timeFrame: From day of first dose (Week 0) through 20 weeks after final dose of IMP (up to Week 140)
measure: Change from Baseline in hematology parameters (platelet count)
timeFrame: From day of first dose (Week 0) through 20 weeks after final dose of IMP (up to Week 140)
measure: Change from Baseline in hematology parameters (mean corpuscular hemoglobin)
timeFrame: From day of first dose (Week 0) through 20 weeks after final dose of IMP (up to Week 140)
measure: Change from Baseline in hematology parameters (mean corpuscular volume)
timeFrame: From day of first dose (Week 0) through 20 weeks after final dose of IMP (up to Week 140)
measure: Change from Baseline in hematology parameters (erythrocytes)
timeFrame: From day of first dose (Week 0) through 20 weeks after final dose of IMP (up to Week 140)
measure: Change from Baseline in hematology parameters (hemoglobin)
timeFrame: From day of first dose (Week 0) through 20 weeks after final dose of IMP (up to Week 140)
measure: Change from Baseline in hematology parameters (hematocrit)
timeFrame: From day of first dose (Week 0) through 20 weeks after final dose of IMP (up to Week 140)
measure: Change from Baseline in clinical chemistry parameters (alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase)
timeFrame: From day of first dose (Week 0) through 20 weeks after final dose of IMP (up to Week 140)
measure: Change from Baseline in hematology parameters (basophils, eosinophils, lymphocytes, monocytes, neutrophils, leukocytes)
timeFrame: From day of first dose (Week 0) through 20 weeks after final dose of IMP (up to Week 140)
measure: Change from Baseline in clinical chemistry parameters (calcium, potassium, sodium, blood urea nitrogen, glucose (nonfasting))
timeFrame: From day of first dose (Week 0) through 20 weeks after final dose of IMP (up to Week 140)
measure: Change from Baseline in clinical chemistry parameters (creatinine, total and direct bilirubin)
timeFrame: From day of first dose (Week 0) through 20 weeks after final dose of IMP (up to Week 140)
measure: Change from Baseline in clinical chemistry parameters (total protein)
timeFrame: From day of first dose (Week 0) through 20 weeks after final dose of IMP (up to Week 140)
measure: Change from Baseline in height
timeFrame: From day of first dose (Week 0) through 20 weeks after final dose of IMP (up to Week 140)
measure: Change from Baseline in weight
timeFrame: From day of first dose (Week 0) through 20 weeks after final dose of IMP (up to Week 140)
measure: Percentage of participants with Psoriasis Area and Severity Index (PASI) 90 response at Week 16
timeFrame: Week 16
measure: 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
timeFrame: Week 16
measure: Percentage of participants with Psoriasis Area and Severity Index (PASI) 75 response at Week 4
timeFrame: Week 4
measure: Percentage of participants with anti-bimekizumab antibody (AbAb) detection prior to investigational medicinal product (IMP) administration
timeFrame: Baseline (Week 0)
measure: Percentage of participants with anti-bimekizumab antibody (AbAb) detection following investigational medicinal product (IMP) administration
timeFrame: From Week 1 through 20 weeks after final dose of IMP (up to Week 140)
measure: Change from Baseline in Children's Dermatology Life Quality Index (CDLQI) response at Week 16
timeFrame: Week 16, compared to Baseline
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Ps0020 50344
state: Indiana
city: Cypress
country: United States
facility: Ps0020 50359
state: Texas
city: Calgary
country: Canada
facility: Ps0020 50354
city: St. John's
country: Canada
facility: Ps0020 50357
city: Frankfurt
country: Germany
facility: Ps0020 40645
city: Bialystok
country: Poland
facility: Ps0020 40626
city: Lodz
country: Poland
facility: Ps0020 40625
city: Rzeszow
country: Poland
facility: Ps0020 40396
city: Warszawa
country: Poland
facility: Ps0020 40335
city: Wroclaw
country: Poland
facility: Ps0020 40333
city: Wroclaw
country: Poland
facility: Ps0020 40334
Study officials:
affiliation: 001 844 599 2273
name: UCB Cares
role: STUDY_DIRECTOR
References: