Ongoing Clinical Trials for Pustular Psoriasis
There are currently 2 clinical trials underway investigating the treatment of pustular psoriasis, specifically focusing on generalized pustular psoriasis (GPP). These trials are testing spesolimab, a medication administered through infusion or injection, and are being conducted across several European countries including Belgium, France, Germany, Italy, and Spain.
Clinical trial locations
- Belgium
- France
- Germany
- Italy
- Spain
Study on Long-Term Spesolimab Treatment for Patients with Generalized Pustular Psoriasis from Previous Trials
This trial focuses on understanding how spesolimab works over an extended period for people with generalized pustular psoriasis, a rare and severe skin condition. GPP causes widespread pus-filled blisters on the skin, often accompanied by redness, pain, and fever.
Who can participate: This study is designed for patients who have already taken part in previous spesolimab trials and completed the treatment period without stopping early. Participants must be willing to continue receiving the medication and be either male or female, aged 18 or older. Women who can become pregnant must agree to use highly effective birth control methods during the study. All participants need to sign a consent form agreeing to take part in the trial.
Who cannot participate: Patients who did not finish previous spesolimab trials or who do not meet the eligibility requirements from those earlier studies cannot join this trial.
What the trial investigates: The main goal is to evaluate the long-term safety and effectiveness of spesolimab. Researchers want to see if the medication continues to work well over time and whether it remains safe for extended use, up to 252 weeks. The study monitors how the treatment affects GPP symptoms, such as pustules and overall skin condition, and tracks any side effects that may occur. Participants will receive regular assessments to measure their response to treatment and quality of life.
The investigational drug: Spesolimab is a biologic medication, meaning it is made from living organisms or their products. It is a type of monoclonal antibody that targets specific proteins in the immune system to reduce inflammation and prevent pustule formation. The medication can be given as an infusion directly into a vein or as an injection under the skin using a pre-filled syringe.
Study on Spesolimab for Treating Recurrent Flares in Patients with Generalized Pustular Psoriasis
This trial examines how well spesolimab works for treating repeated flare-ups of generalized pustular psoriasis. Flare-ups are sudden worsening episodes where symptoms like pustules, redness, and pain become more severe.
Who can participate: Patients aged 18 or older with a confirmed history of generalized pustular psoriasis can join this study. They must have experienced frequent flare-ups in the past—at least 2 flare-ups in the previous year if not currently on treatment, or a history of flares when their medication dose is reduced or stopped if they are on treatment. Participants should have a low severity score for pustules at the time of joining. Women who can become pregnant must use highly effective birth control during the trial. All participants must provide written consent after understanding the study details.
Who cannot participate: The study excludes patients with other skin conditions that could interfere with results, those with severe allergic reactions to similar medications, patients currently in another clinical trial, those with serious infections requiring antibiotics, people with weakened immune systems, pregnant or breastfeeding women, individuals with a history of drug or alcohol abuse, and anyone with medical conditions that might make participation unsafe.
What the trial investigates: The study aims to assess how effective spesolimab is in managing recurrent flare-ups after initial treatment. The primary focus is on achieving clear or nearly clear skin within one week of treatment, measured by the reduction or elimination of pustules. Researchers will also monitor how the body’s immune response to the medication affects its effectiveness and safety. Participants receive spesolimab through intravenous infusion and are closely monitored throughout the trial for symptom improvement and side effects.
The investigational drug: Spesolimab is administered through intravenous infusion, meaning it is delivered directly into a vein. It is a monoclonal antibody that targets specific pathways in the immune system to reduce inflammation and skin symptoms associated with generalized pustular psoriasis.
Summary
Both ongoing clinical trials for pustular psoriasis are focused exclusively on spesolimab, a biologic medication designed to treat generalized pustular psoriasis. The trials are being conducted in the same five European countries: Belgium, France, Germany, Italy, and Spain, indicating a coordinated international effort to study this rare condition.
One trial is designed for long-term follow-up of patients who have already participated in spesolimab studies, with the goal of understanding safety and effectiveness over up to 252 weeks. The other trial focuses on treating recurrent flare-ups, aiming to achieve rapid improvement in symptoms within one week of treatment. Together, these studies provide important information about both immediate and long-term management of generalized pustular psoriasis with spesolimab.
The consistent focus on spesolimab across both trials reflects ongoing research into this specific treatment approach for a challenging and rare skin condition. Patients interested in participating should discuss eligibility criteria with their healthcare providers, particularly if they have previously been involved in spesolimab research or experience frequent flare-ups of their condition.
