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Study on Long-Term Safety and Effectiveness of Bimekizumab for Adults with Moderate to Severe Hidradenitis Suppurativa

Verified siteInvestigationalNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the long-term effects of a treatment for Hidradenitis Suppurativa, a skin condition that causes painful lumps under the skin, often in areas like the armpits and groin. The treatment being tested is called bimekizumab, which is given as a solution for injection. Bimekizumab is also known by its code name, UCB4940. The purpose of the study is to evaluate the safety of using bimekizumab over an extended period in adults with moderate to severe cases of this condition.

Participants in the study will receive bimekizumab through injections under the skin. The study will monitor participants for any side effects and assess how well the treatment works in managing the symptoms of Hidradenitis Suppurativa. Some participants may receive a placebo, which is a substance with no active medication, to compare the effects of bimekizumab. The study will also look at how the treatment affects the quality of life and skin pain experienced by participants.

The study is designed to last for several months, allowing researchers to gather information on the long-term use of bimekizumab. Participants will be regularly checked to ensure their safety and to track any changes in their condition. The results will help determine if bimekizumab is a safe and effective long-term treatment option for people with moderate to severe Hidradenitis Suppurativa.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Participation begins after completing a previous study related to hidradenitis suppurativa.

    Eligibility requires completion of the previous study's treatment period and meeting specific criteria.

  2. Step 2

    Initial assessment

    An initial assessment is conducted to confirm eligibility and ensure understanding of the study requirements.

    This includes reviewing the ability to adhere to the study protocol and medication schedule.

  3. Step 3

    Treatment phase

    The treatment involves the administration of bimekizumab, a solution for injection.

    The medication is given through subcutaneous injection, which means it is injected under the skin.

    The treatment period may extend up to 48 weeks, with possible additional extensions depending on specific criteria.

  4. Step 4

    Monitoring and follow-up

    Regular monitoring is conducted to evaluate the safety and effectiveness of the treatment.

    This includes tracking any adverse events and assessing clinical responses using specific measures like HiSCR50 and HiSCR75.

    Participants are also asked to complete questionnaires about symptoms and quality of life.

  5. Step 5

    Completion of study

    The study is estimated to conclude by December 5, 2025.

    Upon completion, final assessments are conducted to gather data on long-term treatment effects.

Who can join the trial?

4 criteria

  • The study participant must have completed the Maintenance Treatment Period through Week 48 in either HS0003 or HS0004 studies, was eligible to receive **bimekizumab** at the end of the previous study, and did not meet any withdrawal criteria from that study.
  • The study participant must be considered reliable and capable of following the study plan, which includes understanding and completing questionnaires, attending scheduled visits, and taking medication as instructed by the study doctor.
  • If the study participant is a female, she must not be pregnant or breastfeeding. Additionally, she must either not be a **woman of childbearing potential** (meaning she cannot become pregnant) or, if she can become pregnant, she must agree to use birth control during the study and for at least 20 weeks after the last dose of the study medication.
  • In France and Germany, participants who meet the criteria and provide informed consent can continue in the study for an additional 48-week treatment period. In France, this period can be extended for up to 40 more weeks if the criteria are met.

Who cannot join the trial?

10 criteria

  • Patients who have any other serious skin conditions that might interfere with the study.
  • Patients who have a history of severe allergic reactions to medications.
  • Patients who are currently participating in another clinical trial.
  • Patients who have a weakened immune system, which means their body has a harder time fighting infections.
  • Patients who are pregnant or breastfeeding.
  • Patients who have a history of drug or alcohol abuse.
  • Patients who have any other medical conditions that the study doctors think might make it unsafe for them to participate.
  • Patients who have had certain types of cancer in the past.
  • Patients who have active infections that need treatment.
  • Patients who have received certain treatments for Hidradenitis Suppurativa recently.
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Investigated drugs

Bimekizumab is a medication being studied for its long-term safety in treating moderate to severe Hidradenitis Suppurativa, a chronic skin condition. It works by targeting specific proteins in the body that are involved in inflammation, helping to reduce the symptoms and flare-ups associated with the condition.

What is already known about the treatment

Bimekizumab – Bimekizumab is administered via subcutaneous injection and is currently being studied in clinical trials for its long-term safety in treating moderate to severe Hidradenitis Suppurativa. It is not yet fully established in medical practice but shows promise in ongoing research. The main therapeutic indication for Bimekizumab is Hidradenitis Suppurativa, a chronic skin condition. At the molecular level, Bimekizumab works by inhibiting specific proteins involved in inflammation, helping to reduce symptoms. It is classified as a monoclonal antibody, targeting inflammatory pathways to provide relief from the condition.

Investigated diseases

Hidradenitis Suppurativa – Hidradenitis Suppurativa is a chronic skin condition characterized by the formation of painful lumps under the skin, typically in areas where skin rubs together, such as the armpits, groin, and under the breasts. These lumps can become inflamed and may rupture, leading to the formation of abscesses and scarring. The disease often starts after puberty and can persist for many years, with periods of flare-ups and remission. The exact cause is not well understood, but it is believed to involve hair follicles becoming blocked and inflamed. Over time, the condition can lead to tunnels under the skin and significant scarring, affecting the quality of life.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-511035-10-00Protocol codeHS0005Estimated enrolment628 patientsSponsorUCB Biopharma

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