Effisayil® REP: An open-label, multicenter, single-arm, post-marketing trial (in select countries) to evaluate efficacy and safety and the impact of immunogenicity on efficacy, safety, and pharmacokinetics of spesolimab i.v. in treatment of patients with Generalized Pustular Psoriasis (GPP) presenting with a recurrent flare following their initial GPP flare treatment with spesolimab i.v.
Generalised pustular psoriasis (GPP) is a rare skin condition that causes painful, pus-filled blisters across the body. This clinical study tests a medicine called spesolimab, given through a drip into a vein (intravenously). Researchers want to see how well spesolimab works for adults experiencing a repeat flare-up of GPP after having received this treatment in the past. The main goal is to see if the medicine can completely clear the skin blisters within one week of treatment. Doctors will also check the medicine's safety, how the body handles repeat doses, and whether the immune system reacts to the drug over time. Everyone taking part in this study receives the active medicine, with no dummy drug (placebo) used.
At a glance
What is this study about?
Generalised pustular psoriasis, often called GPP, is a serious, long-term skin condition. Unlike typical psoriasis, GPP causes sudden flare-ups where wide areas of red, painful skin break out into tiny, non-infectious blisters filled with pus. These flares can make people feel very unwell, often bringing fevers, extreme tiredness, and severe discomfort. Finding quick, dependable ways to calm these flares is crucial.
Spesolimab is a targeted medicine designed to block specific signals in the immune system that cause this sudden swelling and blister formation. This study focuses on how well the medicine works when a person experiences a new flare-up after already having had spesolimab for an earlier one. Researchers want to know if giving the medicine again is just as safe and effective as the first time.
During the trial, doctors will closely monitor how quickly the skin improves. The key hope is that the pus-filled blisters will be completely cleared by the end of the first week. By understanding how the body responds to repeat doses, this study aims to give doctors clearer guidance on managing repeated GPP flare-ups in everyday clinical care.
Key takeaways
- The study tests spesolimab for treating repeat flare-ups of generalised pustular psoriasis (GPP).
- It is open to adults who have already received this medicine for a previous flare-up.
- The main aim is to see if skin blisters clear within one week of treatment.
- All participants receive the study medicine; there is no placebo.
- Participation is voluntary and you are monitored closely by specialist doctors.
Who may be eligible?
This study is open to adults aged 18 and over who have been diagnosed with generalised pustular psoriasis (GPP). To take part, you must be experiencing a new flare-up of the condition with visible, pus-filled blisters on your skin.
Crucially, you must have already received spesolimab in the past for an earlier GPP flare-up. The study is specifically designed to understand how safe and effective it is to treat recurrent flares with the same medicine.
People who have never had spesolimab before, or those whose current skin flare-up is caused by an active infection or another skin condition, will not be able to join. The study team will review your full medical history to ensure it is safe for you to take part.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- I am 18 years of age or older.
- I have a confirmed diagnosis of generalised pustular psoriasis (GPP).
- I am currently having a flare-up with visible pus-filled blisters on my skin.
- I have been treated with spesolimab for a previous GPP flare-up.
- I am willing and able to attend hospital visits for an IV drip and regular check-ups.
What does participation involve?
If you join the study, you will receive spesolimab as an intravenous (IV) infusion, which means the liquid medicine is delivered slowly into your bloodstream through a small tube in your arm. Because this is an 'open-label' study without a placebo, everyone who joins receives the actual medicine.
You will need to attend hospital or clinic appointments for your infusion and follow-up checks. At these visits, doctors will examine your skin to count and score any blisters, carry out routine blood tests, and check your general health. A major assessment happens at Week 1 to see how quickly the blisters have cleared. You will also have follow-up visits over several weeks or months so the team can monitor your recovery, watch for any side effects, and see how long the improvements last.
Potential risks and benefits
Locations (5)
- —UnverifiedFrance
- —UnverifiedGermany
- —UnverifiedItaly
- —UnverifiedSpain
- —UnverifiedBelgium
Common questions
Will I receive a placebo (dummy medicine)?
No. This is a single-arm study, which means every person who qualifies and takes part receives the active medicine, spesolimab.
How is the medicine given?
It is given as an intravenous infusion, meaning it goes directly into a vein through a soft plastic tube over a set period.
How quickly might I see results?
The study team will check your skin closely within the first week of treatment to see if the blisters have cleared or significantly reduced.
Can I leave the study if I change my mind?
Yes. You have the right to withdraw from the trial at any point, and your usual healthcare team will continue to look after you.
Does taking part cost anything?
No. The study medicine and trial-related health checks are provided free of charge, and help with travel expenses is often available.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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