Clinical trial NCT06921850: A Study to Assess the Pharmacokinetics and Safety of Bimekizumab in Children and Adolescents With Moderate to Severe Hidradenitis Suppurativa
Official title: A Multicenter, Open-Label Study to Assess The Pharmacokinetics And Safety of Bimekizumab in Pubertal Children And Adolescents With Moderate to Severe Hidradenitis Suppurativa
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Hidradenitis Suppurativa
Keywords: Bimekizumab
HS
Hidradenitis Suppurativa
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2025-04-10
Enrollment: 40
Sex: ALL
Minimum age (years): 9
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to assess the PK of bimekizumab following subcutaneous (sc) administration in study participants with moderate to severe hidradenitis suppurativa (HS)


Eligibility criteria: Inclusion Criteria:

* 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:

* 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.

Primary outcomes:
measure: Geometric Mean Plasma bimekizumab concentrations at Week 16
timeFrame: At Week 16
Secondary outcomes:
measure: Exposure-adjusted incidence rate of Treatment- Emergent Adverse Events (TEAEs) during the Initial Treatment Period
timeFrame: From Baseline until end of the Initial Treatment Period (up to 16 weeks)
measure: Exposure-adjusted incidence rate of Serious TEAEs during the Initial Treatment Period
timeFrame: From Baseline until end of the Initial Treatment Period (up to 16 weeks)
measure: Exposure-adjusted incidence rate of TEAEs leading to withdrawal during the Initial Treatment Period
timeFrame: From Baseline until end of the Initial Treatment Period (up to 16 weeks)
measure: 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
timeFrame: Up to Week 16
measure: Mean Change from Baseline in vital signs (Systolic Blood Pressure and Diastolic Blood Pressure) at Week 16
timeFrame: Baseline and Week 16
measure: Mean Change from Baseline in vital sign (Pulse rate) at Week 16
timeFrame: Baseline and Week 16
measure: Mean Change from Baseline in Biochemistry Laboratory Analyses (glucose, potassium, sodium, calcium) at Weeks 4,12, and 16
timeFrame: Baseline, Weeks 4, 12, and 16
measure: Mean Change from Baseline in Biochemistry Laboratory Analyses (total bilirubin and direct bilirubin, total protein, blood urea nitrogen, and creatinine) at Weeks 4,12, and 16
timeFrame: Baseline, Weeks 4, 12, and 16
measure: Mean Change from Baseline in Biochemistry Laboratory Analyses (alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, gamma-glutamyltransferase) at Weeks 4,12, and 16
timeFrame: Baseline, Weeks 4, 12, and 16
measure: Mean Change from Baseline in Hematology Laboratory Analyses (hemoglobin) at Weeks 4,12, and 16
timeFrame: Baseline, Weeks 4, 12, and 16
measure: Mean Change from Baseline in Hematology Laboratory Analyses (hematocrit) at Weeks 4,12, and 16
timeFrame: Baseline, Weeks 4, 12, and 16
measure: Mean Change from Baseline in Hematology Laboratory Analyses (platelets, leukocytes, neutrophils, lymphocytes, eosinophils, basophils, and monocytes) at Weeks 4, 12, and 16
timeFrame: Baseline, Weeks 4, 12, and 16
measure: Mean Change from Baseline in Hematology Laboratory Analyses (erythrocytes)
timeFrame: Baseline, Week 4, 12, and 16
measure: Incidence rate for Positive, Negative, Missing Plasma Anti-Bimekizumab Antibodies at Baseline and Week 16
timeFrame: Baseline and Week 16
Other outcomes:
Locations:
city: Roseville
country: United States
facility: Hs0006 50708
state: California
city: Franklin
country: United States
facility: Hs0006 50712
state: Kentucky
city: Clarkston
country: United States
facility: Hs0006 50178
state: Michigan
city: Fort Gratiot
country: United States
facility: Hs0006 50710
state: Michigan
city: Troy
country: United States
facility: Hs0006 50711
state: Michigan
city: Arlington
country: United States
facility: Hs0006 50201
state: Texas
Study officials:
affiliation: 001 844 599 2273
name: UCB Cares
role: STUDY_DIRECTOR
References: