A Study to Assess the Pharmacokinetics and Safety of Bimekizumab in Children and Adolescents With Moderate to Severe Hidradenitis Suppurativa
Purpose
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)
Condition
- Hidradenitis Suppurativa
Eligibility
- Eligible Ages
- Between 9 Years and 17 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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.
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Bimekizumab |
Study participants will receive a bimekizumab dose which is weight-dependent. |
|
Recruiting Locations
Hs0006 50708
Roseville, California 95661
Roseville, California 95661
Hs0006 50712
Bowling Green, Kentucky 42104
Bowling Green, Kentucky 42104
Hs0006 50178
Clarkston, Michigan 48346
Clarkston, Michigan 48346
Hs0006 50710
Fort Gratiot, Michigan 48059
Fort Gratiot, Michigan 48059
Hs0006 50711
Troy, Michigan 48084
Troy, Michigan 48084
Hs0006 50201
Arlington, Texas 76011
Arlington, Texas 76011
More Details
- NCT ID
- NCT06921850
- Status
- Recruiting
- Sponsor
- UCB Biopharma SRL