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.

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.

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.