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Study to Evaluate the Effectiveness of Spesolimab for Patients with Moderate to Severe Hidradenitis Suppurativa

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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, which is characterized by painful lumps under the skin, often in areas like the armpits or groin. The study is testing a treatment called spesolimab, which is a type of medication known as a humanized monoclonal antibody. This medication is being tested in two forms: a solution for infusion and a solution for injection in a pre-filled syringe. The purpose of the study is to evaluate how effective and safe spesolimab is for people with moderate to severe hidradenitis suppurativa.

The study is divided into two parts. The first part aims to find the best dose of spesolimab for treating moderate to severe hidradenitis suppurativa. The second part will confirm how well the treatment works and how safe it is for patients. Participants in the study may receive either spesolimab or a placebo, which is a substance with no active medication. The study will monitor changes in the condition of the skin over time to assess the treatment's effectiveness.

Participants will receive the treatment over a period of time, with regular check-ups to monitor their progress and any side effects. The study is designed to ensure that the treatment is both effective and safe for those with hidradenitis suppurativa. The results of this study could provide valuable information about a new potential treatment option for this challenging skin condition.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, you will be required to provide a signed and dated written informed consent. This is to ensure that you understand the study and agree to participate.

    You must be of full age of consent and have moderate to severe hidradenitis suppurativa, with lesions in at least two distinct anatomic areas.

  2. Step 2

    Initial assessment

    An initial assessment will be conducted to confirm your eligibility. This includes checking your medical history and current health status.

    You must have a total AN count of greater than or equal to 5 and a total dT count of at least 1 at the baseline visit.

  3. Step 3

    Treatment phase

    The treatment phase consists of two parts: Phase IIb and Phase III. The purpose is to find the optimal dose and assess the efficacy and safety of spesolimab.

    You may receive spesolimab or a placebo. The medication is administered as a solution for infusion or injection in a pre-filled syringe.

  4. Step 4

    Medication administration

    During the trial, you will receive the medication at specified intervals. The exact dosage and frequency will be determined by the study protocol.

    The duration of administration will be communicated to you by the study team.

  5. Step 5

    Monitoring and follow-up

    Regular monitoring will be conducted to assess your response to the treatment and any side effects.

    You will be required to attend follow-up visits as scheduled by the study team.

  6. Step 6

    Completion of the study

    Upon completion of the study, a final assessment will be conducted to evaluate the overall outcomes.

    You will be informed about the results and any further steps, if necessary.

Who can join the trial?

9 criteria

  • You must be of full age of consent at the time of screening.
  • You need to provide a signed and dated written informed consent, which means you agree to participate in the study after understanding all the details.
  • You must have moderate to severe Hidradenitis suppurativa (HS).
  • You should have HS lesions in at least two different areas of your body.
  • You can participate if you have never used biologic treatments for HS or if you have used TNFi (a type of biologic treatment) before.
  • If you have never used biologic treatments, you must have tried an adequate course of oral antibiotics for HS and found them not effective enough. All participants must have used antibiotics for HS before.
  • You need to have a total AN count (a way to measure the severity of HS) of 5 or more.
  • You must have a total dT count (another measure related to HS) of at least 1 at the start of the study.
  • Additional criteria may apply.

Who cannot join the trial?

10 criteria

  • Patients with other serious health conditions that might interfere with the study.
  • Patients who are pregnant or breastfeeding.
  • Patients who have participated in another clinical trial recently.
  • Patients who have a history of allergic reactions to the study medication.
  • Patients who are unable to follow the study procedures.
  • Patients with certain infections that are not well controlled.
  • Patients who have had a major surgery recently.
  • Patients with a history of drug or alcohol abuse.
  • Patients who are taking medications that might interfere with the study.
  • Patients with certain immune system disorders.
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Investigated drugs

Spesolimab is a medication being studied for its potential to help people with a skin condition called hidradenitis suppurativa, which causes painful lumps under the skin. This medication works by targeting specific parts of the immune system that are thought to play a role in causing the inflammation and symptoms of this condition. The goal of using spesolimab in this trial is to see if it can reduce the severity of the symptoms and improve the quality of life for patients with moderate to severe forms of this condition.

What is already known about the treatment

Spesolimab – Spesolimab is administered as an injection, typically under the skin, and is currently being studied in clinical trials for its effectiveness and safety in treating moderate to severe hidradenitis suppurativa, a chronic skin condition. It is in the advanced stages of clinical research, specifically in Phase IIb and Phase III trials, which aim to determine the best dose and confirm its benefits and safety. The medication works by targeting specific proteins in the immune system that contribute to inflammation, helping to reduce the symptoms of the condition. Spesolimab is classified as a monoclonal antibody, a type of drug designed to interact with the immune system to treat various diseases.

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 tunnels under the skin. Over time, the condition can cause scarring and the development of sinus tracts, which are channels that connect the lumps under the skin. The disease often starts after puberty and can persist for many years, with periods of flare-ups and remission. The exact cause of hidradenitis suppurativa is not fully understood, but it is believed to involve a combination of genetic, hormonal, and environmental factors.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IVTrial ID2022-501074-19-00Protocol code1368-0098Estimated enrolment193 patientsSponsorBoehringer Ingelheim Espana S.A.

sourced from the EU Clinical Trials Register and site verification

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