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Hidradenitis SuppurativaPhase 3NCT06921850

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

A Phase 3 study testing Bimekizumab in people with Hidradenitis Suppurativa, run by UCB Biopharma SRL at 16 sites in 3 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

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) Read more about this study

Who is it for?
Ages 9 to 17 years
Conditions the study is for
Hidradenitis Suppurativa
What is being tested?
Bimekizumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
43 participants
Where
16 sitesin 3 countries
Study dates
7 Apr 2025to 6 Mar 2029
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 9 to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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.

Who cannot join

  • 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)
Show all 10Show fewer
  • 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.

Trial locations and contacts

16 sites in 3 countries.

16 sites in 3 countries

United States11 sites

  • Hs0006 50201

    Arlington, Texas, 76011

  • Hs0006 50712

    Bowling Green, Kentucky, 42104

  • Hs0006 50706

    Chapel Hill, North Carolina, 27516

  • Hs0006 50178

    Clarkston, Michigan, 48346

  • Hs0006 50202

    Fairborn, Ohio, 45324

  • Hs0006 50710

    Fort Gratiot, Michigan, 48059

  • Hs0006 50199

    Miami, Florida, 33136

  • Hs0006 50708

    Roseville, California, 95661

  • Hs0006 50684

    Sacramento, California, 95815

  • Hs0006 50711

    Troy, Michigan, 48084

  • Hs0006 50707

    Washington D.C., District of Columbia, 20010

Other trials in United States

Poland4 sites

  • Hs0006 40625

    Lodz

  • Hs0006 40761

    Warsaw

  • Hs0006 40095

    Wroclaw

  • Hs0006 40845

    Wroclaw

Other trials in Poland

Germany1 site

  • Hs0006 40326

    Berlin

Other trials in Germany

About this study

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

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)

Being tested
Bimekizumab
Keywords
Bimekizumab, HS, Hidradenitis Suppurativa
Medical subject headings
Hidradenitis Suppurativa

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BimekizumabDrug

    Bimekizumab will be administered at pre-specified timepoints.

Study groups in NCT06921850
Study groupRoleWhat they receive
BimekizumabExperimentalStudy participants will receive a bimekizumab dose which is weight-dependent.
Receives: Drug: Bimekizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Geometric Mean Plasma bimekizumab concentrations at Week 16

    Plasma samples will be collected prior to dosing for measurement of plasma concentrations of bimekizumab at the specified timepoint.

    Measured: At Week 16

Secondary outcomes (14)

  1. Exposure-adjusted incidence rate of Treatment- Emergent Adverse Events (TEAEs) during the Initial Treatment Period

    The TEAEs adjusted by duration of exposure to study treatment are scaled such that it provides an incidence rate per 100 patient-years. If a participant has multiple events, the time of exposure will be calculated to first occurrence of the AE being considered. If a participant has no events, the total time at risk will be used. An Adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of investigational medicinal product (IMP), whether or not considered related to IMP.

    Measured: From Baseline until end of the Initial Treatment Period (up to 16 weeks)

  2. Exposure-adjusted incidence rate of Serious TEAEs during the Initial Treatment Period

    The TEAEs adjusted by duration of exposure to study treatment are scaled such that it provides an incidence rate per 100 patient-years. If a participant has multiple events, the time of exposure will be calculated to first occurrence of the AE being considered. If a participant has no events, the total time at risk will be used. A SAE is defined as any untoward medical occurrence that, at any dose:

    • Results in death
    • Is life-threatening
    • Requires inpatient hospitalization or prolongation of existing hospitalization
    • Results in persistent disability/incapacity
    • Is a congenital anomaly/birth defect
    • Important medical events

    Measured: From Baseline until end of the Initial Treatment Period (up to 16 weeks)

  3. Exposure-adjusted incidence rate of TEAEs leading to withdrawal during the Initial Treatment Period

    The TEAEs adjusted by duration of exposure to study treatment are scaled such that it provides an incidence rate per 100 patient-years. If a participant has multiple events, the time of exposure will be calculated to first occurrence of the AE being considered. If a participant has no events, the total time at risk will be used. An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of IMP, whether or not considered related to IMP.

    Measured: From Baseline until end of the Initial Treatment Period (up to 16 weeks)

  4. Exposure-adjusted incidence rate of Selected Safety Topics of Interest (including incidence of infections [serious, opportunistic, fungal, and TB], IBD, and injection site reactions) over the Initial Treatment Period

    Safety topics of interest for this study include events for which special monitoring will be for infections (serious, opportunistic, fungal, and tuberculosis [TB]), inflammatory bowel disease (IBD), and injection site reactions.

    Measured: Up to Week 16

  5. Mean Change from Baseline in vital signs (Systolic Blood Pressure and Diastolic Blood Pressure) at Week 16

    Blood pressure (Systolic Blood Pressure and Diastolic Blood Pressure) will be measured in millimeters of mercury (mmHg).

    Measured: Baseline and Week 16

  6. Mean Change from Baseline in vital sign (Pulse rate) at Week 16

    Pulse Rate will be measured in beats per minute (beats/min).

    Measured: Baseline and Week 16

  7. Mean Change from Baseline in Biochemistry Laboratory Analyses (glucose, potassium, sodium, calcium) at Weeks 4,12, and 16

    Glucose, potassium, sodium and calcium will be measured in millimoles per liter (mmol/L).

    Measured: Baseline, Weeks 4, 12, and 16

  8. Mean Change from Baseline in Biochemistry Laboratory Analyses (total bilirubin and direct bilirubin, total protein, blood urea nitrogen, and creatinine) at Weeks 4,12, and 16

    Biochemistry parameters (total bilirubin and direct bilirubin, total protein, blood urea nitrogen [BUN], and creatinine) will be measured in micromols per liter (μmol/L).

    Measured: Baseline, Weeks 4, 12, and 16

  9. Mean Change from Baseline in Biochemistry Laboratory Analyses (alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, gamma-glutamyltransferase) at Weeks 4,12, and 16

    Biochemistry parameters (alkaline phosphatase (ALP), alanine aminotransferase (ALT), aspartate aminotransferase (AST), gamma-glutamyltransferase (GGT) will be measured in units per liter (U/L).

    Measured: Baseline, Weeks 4, 12, and 16

  10. Mean Change from Baseline in Hematology Laboratory Analyses (hemoglobin) at Weeks 4,12, and 16

    Hemoglobin will be measured in grams per liter (g/L).

    Measured: Baseline, Weeks 4, 12, and 16

  11. Mean Change from Baseline in Hematology Laboratory Analyses (hematocrit) at Weeks 4,12, and 16

    Hematocrit will be measured in volume percentage (%) of red blood cells in blood.

    Measured: Baseline, Weeks 4, 12, and 16

  12. Mean Change from Baseline in Hematology Laboratory Analyses (platelets, leukocytes, neutrophils, lymphocytes, eosinophils, basophils, and monocytes) at Weeks 4, 12, and 16

    Platelets, leukocytes, neutrophils, lymphocytes, eosinophils, basophils, and monocytes will be measured in number of blood cells per liter (10^9/L)

    Measured: Baseline, Weeks 4, 12, and 16

  13. Mean Change from Baseline in Hematology Laboratory Analyses (erythrocytes)

    Erythrocytes will be measured in number of red blood cells per liter (10^12/L).

    Measured: Baseline, Week 4, 12, and 16

  14. Incidence rate for Positive, Negative, Missing Plasma Anti-Bimekizumab Antibodies at Baseline and Week 16

    Positive, negative, and missing plasma anti-bimekizumab antibodies detection prior to and following IMP administration during the Initial Treatment Period.

    Measured: Baseline and Week 16

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Apr 2025
  2. Study start7 Apr 2025
  3. Primary completion21 Dec 2026 (estimated)
  4. Study completion6 Mar 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
43 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06921850
Sponsor's protocol ID
HS0006
Other IDs
2023-505323-31, U1111-1316-5308, 2023
Status last verified
Sep 2026
First submitted
3 Apr 2025
Last updated
25 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe, or global development is discontinued, and 18 months after trial completion. Investigators may request access to anonymized individual patient-level data and redacted trial documents which may include: analysis-ready datasets, study protocol, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a prespecified time, typically 12 months, on a password protected portal. This plan may change if the risk of re-identifying trial participants is determined to be too high after the trial is completed; in this case and to protect participants, individual patient-level data would not be made available.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Bimekizumab in people with Hidradenitis Suppurativa, run by UCB Biopharma SRL at 16 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in United States, Poland, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Geometric Mean Plasma bimekizumab concentrations at Week 16 (time frame: At Week 16). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06921850.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.

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