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Study on Long-Term Use of Spesolimab for Patients with Hidradenitis Suppurativa Who Completed a Previous Spesolimab Study

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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 a skin condition called Hidradenitis Suppurativa (HS). HS is a chronic skin disease that causes small, painful lumps to form under the skin, often in areas where skin rubs together. The trial involves a treatment called Spesolimab, which is a solution for injection. Spesolimab is a type of medication known as a humanized monoclonal antibody, which is designed to target specific proteins in the body that may be involved in causing inflammation.

The purpose of this study is to assess the long-term safety of Spesolimab in people with HS who have already participated in a previous study with this medication. Participants in this trial will receive Spesolimab or a placebo, which is a substance with no active medication, to compare the effects. The study will monitor participants over a period to observe any side effects or changes in their condition.

Throughout the study, participants will receive regular injections of Spesolimab and will be closely monitored by healthcare professionals. The trial aims to provide valuable information on how safe and effective Spesolimab is for long-term use in treating HS. This information could help improve treatment options for people living with this challenging skin condition.

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 trial

    Upon joining the trial, ensure that a signed and dated written informed consent is provided. This is in accordance with guidelines for good clinical practice and local legislation.

    Confirm that participation is within the defined residual effect period, which is 16 weeks since the last administration of spesolimab.

  2. Step 2

    Eligibility confirmation

    Verify completion of treatment in the previous spesolimab trial (1368-0098) without premature discontinuation.

    Confirm willingness and ability to continue treatment in this trial.

  3. Step 3

    Treatment administration

    Receive spesolimab as a solution for injection in a pre-filled syringe. The administration is subcutaneous, meaning it is injected under the skin.

    The trial aims to assess the long-term safety of spesolimab in participants with hidradenitis suppurativa (HS).

  4. Step 4

    Monitoring and assessment

    The primary focus is on monitoring the occurrence of treatment emergent adverse events (TEAE).

    Regular assessments will be conducted to ensure safety and effectiveness of the treatment.

  5. Step 5

    Trial duration

    The estimated end date for the trial is April 17, 2030.

    The recruitment for the trial is expected to start on May 6, 2024.

Who can join the trial?

4 criteria

  • You must have signed and dated a written informed consent form. This means you agree to participate in the study and understand what it involves.
  • You should be within the **Residual Effect Period**, which is 16 weeks since your last dose of the study medication called spesolimab.
  • You must have completed treatment in the previous study with spesolimab for **Hidradenitis Suppurativa (HS)**, without stopping early, and be willing to continue treatment in this new study.
  • If you are a woman who can have children, you must be ready and able to use very effective birth control methods. These methods should have a very low chance of failing, less than 1% per year, if used correctly and consistently.

Who cannot join the trial?

8 criteria

  • Participants who have not completed approximately 8 to 12 months of treatment with the study medication, spesolimab, in the earlier parts of the trial.
  • Participants who have any medical condition that the study doctors believe would make it unsafe for them to participate.
  • Participants who are currently taking other medications that might interfere with the study medication.
  • Participants who are pregnant or breastfeeding.
  • Participants who have a history of severe allergic reactions to medications similar to spesolimab.
  • Participants who have any other skin conditions that might interfere with the study results.
  • Participants who have a history of drug or alcohol abuse that might affect their ability to follow the study procedures.
  • Participants who have participated in another clinical trial within a certain period before this study.
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Investigated drugs

Spesolimab is a medication being studied for its long-term safety in patients with Hidradenitis Suppurativa (HS). This trial is for participants who have already received spesolimab treatment for about 8 to 12 months in a previous trial. The goal is to understand how safe spesolimab is when used over a longer period.

What is already known about the treatment

Spesolimab – Spesolimab is administered as an injection, typically under the skin. It is currently being studied in clinical trials for its long-term safety and effectiveness in treating Hidradenitis Suppurativa (HS), a chronic skin condition. The medication works by targeting and blocking specific proteins in the immune system that contribute to inflammation, helping to reduce symptoms of HS. Spesolimab is classified as a monoclonal antibody, which is a type of biological therapy designed to interfere with the immune system's inflammatory response.

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 tunnels under the skin 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 fully understood, but it is believed to involve hair follicles becoming blocked and inflamed. Factors such as genetics, hormones, and lifestyle may contribute to its development. The condition can significantly impact quality of life due to pain and discomfort.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IVTrial ID2023-508377-82-00Protocol code1368-0130Estimated enrolment465 patientsSponsorBoehringer Ingelheim Espana S.A.

sourced from the EU Clinical Trials Register and site verification

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