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New hope for teens with severe skin disease: drug trial launches

NCT ID NCT06921850

Disease control Sponsor: UCB Biopharma SRL Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 11, 2026 · Updated 3 times

Summary

This study tests a drug called bimekizumab in teenagers (ages 9 to 17) with moderate to severe hidradenitis suppurativa, a painful skin condition that causes boils. The goal is to see how the drug moves through the body and if it is safe. About 40 participants will receive the drug and be monitored for side effects and drug levels.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

43 people

The number who actually took part.

Started

Apr 2025

Expected to finish

Mar 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

9 to 17 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

hidradenitis suppurativa

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hidradenitis suppurativa

Contacts and locations

Locations

  • Hs0006 40095

    Wroclaw, Poland

  • Hs0006 40326

    Berlin, Germany

  • Hs0006 40625

    Lodz, Poland

  • Hs0006 40747

    Mainz, Germany

  • Hs0006 40761

    Warsaw, Poland

  • Hs0006 40845

    Wroclaw, Poland

  • Hs0006 50175

    Phoenix, Arizona, 85006, United States

  • Hs0006 50178

    Clarkston, Michigan, 48346, United States

  • Hs0006 50199

    Miami, Florida, 33136, United States

  • Hs0006 50201

    Arlington, Texas, 76011, United States

  • Hs0006 50202

    Fairborn, Ohio, 45324, United States

  • Hs0006 50684

    Sacramento, California, 95815, United States

  • Hs0006 50706

    Chapel Hill, North Carolina, 27516, United States

  • Hs0006 50707

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

  • Hs0006 50708

    Roseville, California, 95661, United States

  • Hs0006 50710

    Fort Gratiot, Michigan, 48059, United States

  • Hs0006 50711

    Troy, Michigan, 48084, United States

  • Hs0006 50712

    Bowling Green, Kentucky, 42104, United States

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