Spesolimab for Hidradenitis Suppurativa
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests spesolimab, a drug that may help adults with moderate to severe hidradenitis suppurativa (HS). It works by calming the immune system to reduce inflammation and heal the skin. The study aims to see if spesolimab is effective and safe for these patients.
Will I have to stop taking my current medications?
The trial protocol does not specify if you must stop taking your current medications, but you cannot continue any restricted medications or drugs that might interfere with the trial. It's best to discuss your current medications with the trial doctors to see if they are allowed.
Is spesolimab safe for humans?
What makes the drug Spesolimab unique for treating hidradenitis suppurativa?
Are You a Good Fit for This Trial?
Adults with moderate to severe hidradenitis suppurativa (HS) can join this trial. They must have had an inadequate response to antibiotics, be biologic naive or only exposed to TNF inhibitors for HS treatment, and not have used other immunosuppressive biologics. Pregnant women and those with certain allergies or a history of cancer within the last 5 years are excluded.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment Part 1
Participants are divided into 4 groups receiving different doses of spesolimab or placebo. Injections are administered weekly and later every 2 weeks.
Treatment Part 2
Participants are divided into 2 groups receiving a suitable dose of spesolimab or placebo. Placebo group switches to spesolimab after 4 months.
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Placebo matching Spesolimab Formulation 1
- Placebo matching Spesolimab Formulation 2
- Spesolimab
Find a Clinic Near You
Who Is Running the Clinical Trial?
Boehringer Ingelheim
Lead Sponsor