Assessing the effects of bimekizumab in children and adolescents with moderate to severe hidradenitis suppurativa
A Multicenter, Open-Label Study to Assess The Pharmacokinetics And Safety of Bimekizumab in Pubertal Children And Adolescents With Moderate to Severe Hidradenitis Suppurativa
This study is testing a new medication called bimekizumab to see if it can help children and teens with moderate to severe hidradenitis suppurativa feel better and improve their quality of life.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 9 Years to 17 Years |
| Sex | All |
| Sponsor | UCB Pharma Industry-sponsored |
| Drugs / interventions | brodalumab, ixekizumab, secukinumab, bimekizumab |
| Locations | 18 sites (Phoenix, Arizona and 17 other locations) |
| Trial ID | NCT06921850 on ClinicalTrials.gov |
What this trial studies
This study evaluates the pharmacokinetics and safety of bimekizumab, a medication administered subcutaneously, in children and adolescents diagnosed with moderate to severe hidradenitis suppurativa (HS). Participants aged 9 to 18 years with a history of HS will be monitored for their response to the treatment, focusing on the drug's absorption and safety profile. The study aims to determine the effectiveness of bimekizumab in managing HS symptoms and improving the quality of life for affected individuals.
Who should consider this trial
Good fit: Ideal candidates are children and adolescents aged 9 to 18 years with moderate to severe hidradenitis suppurativa who have not responded adequately to previous treatments.
Not a fit: Patients with mild hidradenitis suppurativa or those who have not previously tried systemic antibiotics may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve the management of hidradenitis suppurativa in young patients.
How similar studies have performed: Previous studies on bimekizumab have shown promise in treating hidradenitis suppurativa, indicating potential for success in this age group.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Phoenix, Arizona and 17 other locations
- Hs0006 50175 — Phoenix, Arizona, United States (Recruiting)
- Hs0006 50708 — Roseville, California, United States (Recruiting)
- Hs0006 50684 — Sacramento, California, United States (Recruiting)
- Hs0006 50707 — Washington D.C., District of Columbia, United States (Recruiting)
- Hs0006 50199 — Miami, Florida, United States (Recruiting)
- Hs0006 50178 — Clarkston, Michigan, United States (Recruiting)
- Hs0006 50710 — Fort Gratiot, Michigan, United States (Recruiting)
- Hs0006 50711 — Troy, Michigan, United States (Recruiting)
- Hs0006 50712 — New York, New York, United States (Recruiting)
- Hs0006 50706 — Chapel Hill, North Carolina, United States (Recruiting)
- Hs0006 50202 — Fairborn, Ohio, United States (Recruiting)
- Hs0006 50201 — Arlington, Texas, United States (Recruiting)
- Hs0006 40326 — Berlin, Germany (Recruiting)
- Hs0006 40747 — Mainz, Germany (Recruiting)
- Hs0006 40625 — Warsaw, Poland (Recruiting)
- Hs0006 40761 — Warsaw, Poland (Recruiting)
- Hs0006 40095 — Wroclaw, Poland (Recruiting)
- Hs0006 40845 — Wroclaw, Poland (Recruiting)
Study contacts
- Study coordinator: UCB Cares
- Email: ucbcares@ucb.com
- Phone: +18445992273
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.