A Multicenter, Open-Label Study to Assess The Pharmacokinetics And Safety of Bimekizumab in Pubertal Children And Adolescents With Moderate to Severe Hidradenitis Suppurativa

Status: Recruiting
Location: See all (16) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 9
Maximum Age: 17
Healthy Volunteers: f
View:

• 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.

Locations
United States
Arizona
Hs0006 50175
RECRUITING
Phoenix
California
Hs0006 50708
RECRUITING
Roseville
Florida
Hs0006 50199
RECRUITING
Miami
Michigan
Hs0006 50178
RECRUITING
Clarkston
Hs0006 50710
RECRUITING
Fort Gratiot
Hs0006 50711
RECRUITING
Troy
North Carolina
Hs0006 50706
RECRUITING
Chapel Hill
New York
Hs0006 50712
RECRUITING
Brooklyn
Ohio
Hs0006 50202
RECRUITING
Fairborn
Texas
Hs0006 50201
RECRUITING
Arlington
Other Locations
Germany
Hs0006 40326
RECRUITING
Berlin
Hs0006 40747
RECRUITING
Mainz
Poland
Hs0006 40625
RECRUITING
Lodz
Hs0006 40761
RECRUITING
Warsaw
Hs0006 40095
RECRUITING
Wroclaw
Hs0006 40845
RECRUITING
Wroclaw
Contact Information
Primary
UCB Cares
ucbcares@ucb.com
+18445992273
Backup
UCB Cares
001 844 599 2273
Time Frame
Start Date: 2025-04-07
Estimated Completion Date: 2029-05-30
Participants
Target number of participants: 40
Treatments
Experimental: Bimekizumab
Study participants will receive a bimekizumab dose which is weight-dependent.
Related Therapeutic Areas
Sponsors
Leads: UCB Biopharma SRL

This content was sourced from clinicaltrials.gov