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 Sex
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

ArmDescriptionAssigned Intervention
Experimental
Bimekizumab 		Study participants will receive a bimekizumab dose which is weight-dependent.
  • Drug: Bimekizumab
    Bimekizumab will be administered at pre-specified timepoints.

Recruiting Locations

Hs0006 50175
Phoenix 5308655, Arizona 5551752 85006

Hs0006 50708
Roseville 5388881, California 5332921 95661

Hs0006 50199
Miami 4164138, Florida 4155751 33125

Hs0006 50178
Clarkston 4988997, Michigan 5001836 48346

Hs0006 50710
Fort Gratiot, Michigan 5001836 48059

Hs0006 50711
Troy 5012639, Michigan 5001836 48084

Hs0006 50712
Brooklyn 5110302, New York 5128638 10455

Hs0006 50706
Chapel Hill 4460162, North Carolina 4482348 27516

Hs0006 50202
Fairborn 4511263, Ohio 5165418 45324

Hs0006 50201
Arlington 4671240, Texas 4736286 76011

More Details

Status
Recruiting
Sponsor
UCB Biopharma SRL

Study Contact

UCB Cares
+18445992273
ucbcares@ucb.com