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

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What is this study about?

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.

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 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 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 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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
Azienda USL Toscana Centro Florence Italy
Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania Catania Italy
Universita Degli Studi Di Brescia Brescia Italy
Aawhjxtdui Pvxrnwll Hecadrpn Dc Pxpti Paris France
Cqkxeavfh Udlepewrvcczdr Svacrpbam Woluwe-Saint-Lambert Belgium
Lrokal Mrwjlhmqce Uoxppnxesh Ot Mmaffj Munich Germany
Gfakoi Upzlcmmdtg Frggsvkrm Frankfurt Germany
Hfywkjag Vmji dmvcvxki Barcelona Spain

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Belgium Belgium
Not recruiting
22.11.2023
France France
Not recruiting
22.11.2023
Germany Germany
Not recruiting
22.11.2023
Italy Italy
Not recruiting
22.11.2023
Spain Spain
Not recruiting
22.11.2023

Trial locations

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.

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 ID:
2022-502128-38-00
Protocol code:
1368-0120
Trial Phase:
Human Pharmacology (Phase I) – Other

Other Trials to Consider

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

    Not recruiting

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    Investigated drugs:
    Belgium France Germany Italy Spain