Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Not recruitingRare disease

Study on Long-Term Spesolimab Treatment for Patients with Generalized Pustular Psoriasis from Previous Trials

Verified siteInvestigationalNo placebo
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

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 called spesolimab in people with a skin condition known as Generalized Pustular Psoriasis (GPP). GPP is a rare and severe form of psoriasis characterized by widespread pustules, which are small, pus-filled blisters on the skin. The treatment being tested, spesolimab, is a medication of biological origin, meaning it is made from living organisms or their products. It is administered either as a solution for infusion, which is delivered directly into the bloodstream through a vein, or as a solution for injection using a pre-filled syringe.

The purpose of this study is to evaluate the long-term safety and effectiveness of spesolimab in patients who have previously participated in spesolimab trials and are eligible to continue treatment. Participants in this study will receive spesolimab over an extended period, with the aim of understanding how well the treatment works and how safe it is for long-term use. The study will monitor for any side effects that may occur during the treatment period, which can last up to 252 weeks.

Throughout the study, researchers will also observe how the treatment affects the symptoms of GPP, such as the presence of pustules and overall skin condition. The study will help determine if spesolimab can maintain its effectiveness over time and improve the quality of life for those living with GPP. Participants will be closely monitored by healthcare professionals to ensure their safety and well-being during the trial.

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 spesolimab trial without early withdrawal.

    Eligibility requires signing a consent form and, for women of childbearing potential, using effective birth control methods.

  2. Step 2

    Initial treatment phase

    The treatment involves the administration of spesolimab, a medication used to manage generalized pustular psoriasis.

    Spesolimab is provided as a solution for infusion (intravenous) and as a solution for injection in a pre-filled syringe (subcutaneous).

  3. Step 3

    Maintenance treatment

    The long-term treatment aims to assess the safety and effectiveness of spesolimab over an extended period.

    The primary focus is on monitoring any adverse effects that may occur during the treatment, up to week 252.

  4. Step 4

    Monitoring and assessment

    Regular assessments are conducted to evaluate the recurrence of psoriasis symptoms and the effectiveness of the treatment.

    The study measures include the time to achieve a low score on the Generalized Pustular Psoriasis Physician Global Assessment (GPPGA) and changes in the Psoriasis Symptom Scale (PSS) score.

  5. Step 5

    Completion of the study

    The study is expected to conclude by January 20, 2028.

    Participants will have contributed to understanding the long-term effects of spesolimab in managing generalized pustular psoriasis.

Who can join the trial?

3 criteria

  • Patients must be male or female and have completed the treatment period in a previous trial with the medication spesolimab, without stopping early, and be willing and able to continue treatment in the current trial.
  • Women who can have children must be ready and able to use very effective birth control methods that have a low chance of failing (less than 1% per year) when used correctly. A list of these methods is provided in the information given to the patient or their legal guardian. A woman is considered able to have children from the time she starts menstruating until she becomes postmenopausal, unless she has had a permanent procedure to prevent pregnancy, such as a hysterectomy (removal of the uterus), bilateral salpingectomy (removal of both fallopian tubes), or bilateral oophorectomy (removal of both ovaries). Tubal ligation (tying the tubes) is not considered a permanent method. A woman is postmenopausal if she has not had a menstrual period for 12 months without another medical reason.
  • Patients must provide a signed and dated written informed consent and assent for the current trial, following international guidelines and local laws, before joining the trial.

Who cannot join the trial?

2 criteria

  • Patients who have not completed previous trials with the medication spesolimab.
  • Patients who do not qualify for entry based on the criteria of the previous spesolimab trials.
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

Spesolimab is a medication being studied for its long-term safety and effectiveness in treating patients with Generalized Pustular Psoriasis (GPP). This trial is for patients who have already participated in previous studies involving spesolimab and have been deemed eligible to continue receiving the treatment. The goal is to ensure that spesolimab remains safe and beneficial for these patients over an extended period.

What is already known about the treatment

Spesolimab – Spesolimab is administered as an injection, typically given under the skin. It is currently being studied in clinical trials for its safety and effectiveness in treating Generalized Pustular Psoriasis (GPP), a rare and severe skin condition. The medication works by targeting and blocking specific proteins in the immune system that contribute to inflammation and the formation of pustules in GPP. Spesolimab is classified as a monoclonal antibody, which is a type of medication designed to interact with specific molecules in the body 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 inflammation. The condition can cause intense itching and pain, and it may be accompanied by fever and chills. The skin may also become dry and peel off in large sheets. This disease can progress rapidly, requiring careful management to control symptoms.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-509216-28-00Protocol code1368-0025Estimated enrolment133 patientsSponsorLeo Pharma A/S

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.