A Study to Assess the Pharmacokinetics and Safety of Bimekizumab in Children and Adolescents With Moderate to Severe Hidradenitis Suppurativa

Description

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)

Conditions

Hidradenitis Suppurativa

Study Overview

Study Details

Study overview

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)

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

A Study to Assess the Pharmacokinetics and Safety of Bimekizumab in Children and Adolescents With Moderate to Severe Hidradenitis Suppurativa

Condition
Hidradenitis Suppurativa
Intervention / Treatment

-

Contacts and Locations

Roseville

Hs0006 50708, Roseville, California, United States, 95661

Clarkston

Hs0006 50178, Clarkston, Michigan, United States, 48346

Fort Gratiot

Hs0006 50710, Fort Gratiot, Michigan, United States, 48059

Troy

Hs0006 50711, Troy, Michigan, United States, 48084

Arlington

Hs0006 50201, Arlington, Texas, United States, 76011

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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.

Ages Eligible for Study

9 Years to 17 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

UCB Biopharma SRL,

UCB Cares, STUDY_DIRECTOR, 001 844 599 2273

Study Record Dates

2030-11-11