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Study on Spesolimab for Treating Recurrent Flares in Patients with Generalized Pustular Psoriasis

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 (GPP), a rare and severe skin condition characterized by widespread pustules, which are small, pus-filled blisters. The trial aims to evaluate the effectiveness and safety of a treatment called , which is administered through an intravenous infusion, meaning it is given directly into a vein. Spesolimab is being tested to see if it can help people who experience repeated flare-ups of GPP after their initial treatment with the same medication.

The purpose of the study is to assess how well spesolimab works in managing these recurrent flare-ups. Participants in the study will receive spesolimab infusions and will be monitored to see if their skin condition improves, specifically looking for a reduction in pustules. The study will also observe any side effects and how the body responds to the medication over time.

Throughout the study, participants will have regular check-ups to track their progress and ensure their safety. The trial is designed to provide valuable information on the use of spesolimab for treating GPP, potentially offering a new option for managing this challenging condition. The study does not involve a placebo, meaning all participants will receive the active treatment.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial treatment

    Upon joining the study, the patient receives an initial treatment with spesolimab administered intravenously. This is a solution given through a vein.

    The purpose of this treatment is to address a flare of Generalized Pustular Psoriasis (GPP), a skin condition characterized by widespread pustules.

  2. Step 2

    Monitoring and assessment

    After the initial treatment, the patient's condition is monitored to evaluate the response to the medication.

    The primary goal is to achieve a pustulation subscore of 0, indicating no visible pustules, by Week 1.

  3. Step 3

    Follow-up treatment

    If necessary, additional doses of spesolimab may be administered to manage recurrent flares of GPP.

    The treatment aims to achieve a pustulation subscore of 0 or 1, with at least a 2-point reduction from the baseline score by Week 1.

  4. Step 4

    Ongoing evaluation

    Throughout the trial, the patient's response to the treatment is continuously evaluated to ensure safety and effectiveness.

    The impact of the body's immune response to the medication is also assessed to understand its effects on treatment outcomes.

Who can join the trial?

8 criteria

  • Patients must have a history of **Generalized Pustular Psoriasis (GPP)**, which is a skin condition that causes red, scaly patches and pus-filled blisters.
  • Patients should have a **GPPGA pustulation subscore** of 0 or 1, which is a way to measure the severity of the skin condition.
  • Patients must have experienced **frequent GPP flares** in the past. A flare is a sudden worsening of symptoms.
  • If patients are not currently on treatment for GPP, they must have had at least 2 flare-ups in the past year.
  • If patients are on treatment for GPP, they must stop this treatment on the day they start the trial medication. They should have a history of flares when their medication dose is reduced or stopped.
  • Patients must be **18 years or older** at the time of screening. If local laws have a different age of consent, those laws will be followed.
  • Patients must provide **written informed consent** before joining the trial, which means they agree to participate after understanding the details of the study.
  • Women who can have children must agree to use **highly effective birth control methods** to prevent pregnancy during the study. These methods should have a failure rate of less than 1% per year when used correctly.

Who cannot join the trial?

8 criteria

  • Patients who have any other skin conditions that might interfere with the study results.
  • Patients who have a history of severe allergic reactions to medications similar to the one being tested.
  • Patients who are currently participating in another clinical trial.
  • Patients who have a serious infection that requires treatment with antibiotics.
  • 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 condition that the study doctors think might make it unsafe for them to participate.
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Investigated drugs

Spesolimab is a medication used in this trial to treat patients with Generalized Pustular Psoriasis (GPP). It is administered through an intravenous (i.v.) infusion. The trial aims to assess how effective and safe spesolimab is when used to manage recurrent flares of GPP after the initial treatment with the same medication. The study also looks at how the body's immune response to spesolimab might affect its effectiveness and safety.

What is already known about the treatment

Spesolimab – This medication is administered intravenously and is currently being studied in clinical trials for its effectiveness and safety in treating Generalized Pustular Psoriasis (GPP). It is in the post-marketing phase, where its impact on the immune system and its pharmacokinetics are being evaluated. Spesolimab is primarily indicated for patients experiencing recurrent flares of GPP after initial treatment. At the molecular level, it works by targeting specific pathways in the immune system to reduce inflammation and skin symptoms. It is classified as a monoclonal antibody, which is a type of biologic therapy used to modulate immune responses.

Investigated diseases

Generalized Pustular Psoriasis – This is a rare and severe form of psoriasis characterized by widespread pustules on the skin. It often begins with red, tender skin that quickly develops into pus-filled blisters. These pustules can merge, forming larger areas of pus and redness. The condition can cause intense itching and pain, and it may be accompanied by fever and chills. Flare-ups can occur suddenly and may recur over time. The disease can significantly impact the skin's appearance and the individual's quality of life.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase ITrial ID2022-502128-38-00Protocol code1368-0120Estimated enrolment40 patientsSponsorLeo Pharma A/S

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