Spesolimab for Pustular Psoriasis
Trial Summary
Do I need to stop my current medications for the trial?
The trial information does not specify if you need to stop taking your current medications. However, it mentions that treatment with any drug likely to interfere with the trial may be a reason for exclusion, so it's best to discuss your current medications with the trial doctors.
What data supports the effectiveness of the drug spesolimab for treating pustular psoriasis?
Is spesolimab safe for treating generalized pustular psoriasis?
How is the drug spesolimab unique in treating pustular psoriasis?
Spesolimab is unique because it is the first targeted treatment specifically studied for generalized pustular psoriasis (GPP) flares, working as an interleukin-36 receptor antagonist to rapidly clear pustules and improve skin condition. It has shown rapid and sustained improvements in patients compared to placebo, making it a novel option for this condition.12356
What is the purpose of this trial?
This study is open to adults with a serious skin disease called generalized pustular psoriasis (GPP) who have repeated flares of GPP. The purpose of this study is to find out whether a medicine called spesolimab helps people with repeated flares of GPP.Participants are given a single dose of spesolimab as an infusion into a vein on the first day of an outbreak of GPP. They may be given a second dose 1 week later if doctors think it is helpful. They are also treated for additional GPP flares.During the time of the study, doctors regularly examine participants' skin for signs of GPP to see how well the treatment works and take blood samples. The doctors also regularly check participants' health and take note of any unwanted effects.
Eligibility Criteria
Adults with a serious skin condition called generalized pustular psoriasis (GPP) who frequently experience flares can join this study. They must have a history of GPP documented by specific criteria and be willing to use effective birth control if applicable. People under 18 or those not able to consent are excluded.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a single dose of spesolimab as an infusion on the first day of a GPP flare, with a possible second dose 1 week later
Monitoring
Doctors regularly examine participants' skin for signs of GPP and take blood samples to assess treatment efficacy and safety
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Spesolimab
Spesolimab is already approved in United States, European Union for the following indications:
- Generalized pustular psoriasis (GPP) in adults and pediatric patients 12 years of age and older and weighing at least 40 kg
- Generalized pustular psoriasis (GPP) flares in adults
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Who Is Running the Clinical Trial?
Boehringer Ingelheim
Lead Sponsor