BIMEKIZUMAB for Hidradenitis Suppurativa

Inclusion criteria

• {"criterion_text":"-\tStudy 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."}
• {"criterion_text":"-\tStudy participant must have a diagnosis of HS for at least 6 months prior to the Baseline Visit."}
• {"criterion_text":"-\tStudy 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."}
• {"criterion_text":"-\tStudy 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."}
• {"criterion_text":"-\tStudy participant must have had a history of inadequate response to a course of a systemic antibiotic for treatment of HS"}
• {"criterion_text":"-\tStudy participant must weigh ≥30kg at the Screening Visit."}

Exclusion criteria

• {"criterion_text":"-\tStudy participant has a draining tunnel count of >20 at either the Screening or Baseline Visits."}
• {"criterion_text":"-\tStudy 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."}
• {"criterion_text":"-\tStudy participant has previously participated in this study or has received previous therapy with bimekizumab."}
• {"criterion_text":"-\tStudy participant has a history of IBD or symptoms suggestive of IBD."}
• {"criterion_text":"-\t History of active tuberculosis unless successfully treated, latent TB unless prophylactically treated"}
• {"criterion_text":"-\tStudy participant has an active infection or history of infections (such as serious infection, chronic infections, opportunistic infections, unusually severe infections)"}
• {"criterion_text":"-\tStudy participant has received drugs outside the specified timeframes relative to the Baseline Visit or receives prohibited concomitant treatments "}
• {"criterion_text":"-\tStudy participant has the presence of active suicidal ideation, or positive suicide behavior, "}
• {"criterion_text":"-\tStudy participant diagnosed with severe depression in the past 6 months prior to the Screening Visit."}
• {"criterion_text":"-\tStudy participant has a history of psychiatric inpatient hospitalization within the past year before enrolling into the study."}

Primary endpoints

• {"endpoint_text":"-\t•\tGeometric mean plasma bimekizumab concentration at Week 16","definition_or_measurement_approach":"Plasma bimekizumab concentration measured at Week 16; summary reported as geometric mean."}

Secondary endpoints

• {"endpoint_text":"-1. Exposure-adjusted incidence rate of Treatment- Emergent Adverse Events (TEAEs) over the Initial Treatment Period","definition_or_measurement_approach":"Exposure-adjusted incidence rates of TEAEs during the Initial Treatment Period."}
• {"endpoint_text":"-2. Exposure-adjusted incidence rate of Serious TEAEs over the Initial Treatment Period","definition_or_measurement_approach":"Exposure-adjusted incidence rates of serious TEAEs during the Initial Treatment Period."}
• {"endpoint_text":"-3.\tExposure-adjusted incidence rate of TEAEs leading to withdrawal from study over the Initial Treatment Period","definition_or_measurement_approach":"Exposure-adjusted incidence rates of TEAEs leading to withdrawal during the Initial Treatment Period."}
• {"endpoint_text":"-4.\tExposure-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","definition_or_measurement_approach":"Exposure-adjusted incidence rates for predefined safety topics (infections, IBD, injection site reactions) over the Initial Treatment Period."}
• {"endpoint_text":"-5.\tMean Change from Baseline in Systolic Blood Pressure, Diastolic Blood Pressure, and Pulse over the Initial Treatment Period","definition_or_measurement_approach":"Mean change from baseline in vital signs (systolic BP, diastolic BP, pulse) during the Initial Treatment Period."}
• {"endpoint_text":"-6.\tMean Change from Baseline in Biochemistry Laboratory Analyses over the Initial Treatment Period","definition_or_measurement_approach":"Mean change from baseline in biochemistry laboratory parameters during the Initial Treatment Period."}
• {"endpoint_text":"-7.\tMean Change from Baseline in Hematology Laboratory Analyses over the Initial Treatment Period","definition_or_measurement_approach":"Mean change from baseline in hematology laboratory parameters during the Initial Treatment Period."}
• {"endpoint_text":"-8.\tIncidence rate for Positive, Negative, Missing Plasma Anti-Bimekizumab Antibodies during the Initial Treatment Period","definition_or_measurement_approach":"Incidence (rates) of positive/negative/missing anti-bimekizumab antibody results in plasma during the Initial Treatment Period."}

Germany

Earliest CTIS Part Ii Submission Date

25-06-2025

Latest Decision Or Authorization Date

24-10-2025

Processing Time Days

121

Number Of Sites

4

Number Of Participants

8

Poland

Earliest CTIS Part Ii Submission Date

24-06-2025

Latest Decision Or Authorization Date

06-05-2026

Processing Time Days

316

Number Of Sites

5

Number Of Participants

10

Primary sponsor

Full Name

UCB Biopharma

Organisation Type

Pharmaceutical company

Country Of Registered Address

Belgium

Contract research organisations

Name

Icon Clinical Research Limited

Responsibilities

code:4

Name

PPD Development LP

Responsibilities

code:4

Name

4G Clinical B.V.

Responsibilities

code:3

Name

Drug Development Solutions Limited

Responsibilities

code:4

Third parties

• {"country":"United States","full_name":"Center For Information And Study On Clinical Research Participation Inc.","duties_or_roles":"code:11","organisation_type":"Patient organisation/association"}
• {"country":"United States","full_name":"RWS Life Sciences Inc.","duties_or_roles":"Scales & Linguistic validation services (code:15)","organisation_type":"Pharmaceutical company"}
• {"country":"Netherlands","full_name":"4G Clinical B.V.","duties_or_roles":"code:3","organisation_type":"Non-Pharmaceutical company"}
• {"country":"Germany","full_name":"BioAgilytix Europe GmbH","duties_or_roles":"code:4","organisation_type":"Pharmaceutical company"}
• {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"code:4","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Veeva Systems Inc.","duties_or_roles":"code:7","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United States","full_name":"PPD Development LP","duties_or_roles":"code:4","organisation_type":"Pharmaceutical company"}
• {"country":"United Kingdom","full_name":"Drug Development Solutions Limited","duties_or_roles":"code:4","organisation_type":"Pharmaceutical company"}