Actively Recruiting

Phase 3
Age: 9Years - 17Years
All Genders
NCT06921850

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

Led by UCB Biopharma SRL · Updated on 2026-03-27

40

Participants Needed

18

Research Sites

204 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 9Years - 17Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Participant is between 12 and less than 18 years old at the time of consent and at Tanner stage 2 or higher for the first 8 participants, then includes participants aged 9 to less than 18 years at Tanner stage 2 or higher
  • Diagnosis of hidradenitis suppurativa for at least 6 months before the baseline visit
  • Moderate to severe hidradenitis suppurativa with at least 5 inflammatory lesions (abscesses and nodules) at screening and baseline visits
  • Hidradenitis suppurativa lesions in at least 2 different body areas, with at least one area at Hurley Stage II or III at screening and baseline visits
  • History of inadequate response to a course of systemic antibiotics for hidradenitis suppurativa
  • Weight of at least 30 kg at screening visit
Not Eligible

You will not qualify if you...

  • Draining tunnel count greater than 20 at screening or baseline visits
  • Primary failure (no response within 12 weeks) to one or more IL-17 biologic response modifiers or to more than one biologic response modifier other than IL-17 modifiers
  • Previous participation in this study or prior treatment with bimekizumab
  • History or symptoms suggestive of inflammatory bowel disease
  • Active tuberculosis unless successfully treated or latent tuberculosis unless prophylactically treated
  • Active infection or history of serious, chronic, opportunistic, or unusually severe infections
  • Receipt of prohibited drugs outside specified timeframes or prohibited concomitant treatments
  • Presence of active suicidal thoughts or positive suicide behavior
  • Diagnosis of severe depression within 6 months prior to screening
  • Psychiatric inpatient hospitalization within 1 year before enrollment

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 18 locations

1

Hs0006 50175

Phoenix, Arizona, United States, 85006

Actively Recruiting

2

Hs0006 50708

Roseville, California, United States, 95661

Actively Recruiting

3

Hs0006 50684

Sacramento, California, United States, 95815

Actively Recruiting

4

Hs0006 50707

Washington D.C., District of Columbia, United States, 20010

Actively Recruiting

5

Hs0006 50199

Miami, Florida, United States, 33136

Actively Recruiting

6

Hs0006 50178

Clarkston, Michigan, United States, 48346

Actively Recruiting

7

Hs0006 50710

Fort Gratiot, Michigan, United States, 48059

Actively Recruiting

8

Hs0006 50711

Troy, Michigan, United States, 48084

Actively Recruiting

9

Hs0006 50712

New York, New York, United States, 10023

Actively Recruiting

10

Hs0006 50706

Chapel Hill, North Carolina, United States, 27516

Actively Recruiting

11

Hs0006 50202

Fairborn, Ohio, United States, 45324

Actively Recruiting

12

Hs0006 50201

Arlington, Texas, United States, 76011

Actively Recruiting

13

Hs0006 40326

Berlin, Germany

Actively Recruiting

14

Hs0006 40747

Mainz, Germany

Actively Recruiting

15

Hs0006 40625

Warsaw, Poland

Actively Recruiting

16

Hs0006 40761

Warsaw, Poland

Actively Recruiting

17

Hs0006 40095

Wroclaw, Poland

Actively Recruiting

18

Hs0006 40845

Wroclaw, Poland

Actively Recruiting

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Research Team

U

UCB Cares

CONTACT

U

UCB Cares

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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