Long-term Spesolimab Treatment for Hidradenitis Suppurativa
Trial Summary
Do I have to stop taking my current medications for the trial?
The trial protocol does not specify if you need to stop taking your current medications. However, you cannot use any restricted medication or drugs that might interfere with the study, as determined by the investigator.
How is the drug Spesolimab different from other treatments for hidradenitis suppurativa?
Spesolimab is unique because it targets a different part of the immune system compared to other treatments like adalimumab, which is a TNF-α inhibitor. Spesolimab works by blocking interleukin-36, a protein involved in inflammation, offering a novel approach for patients who may not respond well to existing therapies.12345
What is the purpose of this trial?
This trial involves adults with hidradenitis suppurativa who previously took part in a spesolimab study. Participants receive spesolimab injections regularly over a long period. The study aims to see if the drug is safe and effective over time by reducing inflammation and symptoms.
Eligibility Criteria
Adults with hidradenitis suppurativa who were in a prior spesolimab study can join. They must have finished the previous trial without early stoppage, agree to birth control if applicable, and not be planning pregnancy or major surgery. Those with severe health issues or allergies to the drug are excluded.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive spesolimab injections every 2 weeks for 2 years
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