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Spesolimab for Hidradenitis Suppurativa
Study Summary
This trial is testing whether a medicine called spesolimab helps people with hidradenitis suppurativa (HS). Participants are divided into groups and some receive placebo injections, with doctors monitoring symptoms and unwanted effects.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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- I haven't used any experimental drugs or devices in the last 30 days or 5 half-lives of the drug.I am not pregnant, nursing, or planning to become pregnant during the trial.I have moderate to severe hidradenitis suppurativa.I have not used biologic treatments or have used TNF inhibitors for my condition.I haven't had cancer in the last 5 years, except for certain skin cancers or cervical cancer that was treated.I have signed and understand the consent form for this trial.I am legally old enough to make my own health decisions.You have moderate to severe hidradenitis suppurativa (HS).You have to have a certain level of dT count at the start of the study.I have previously been treated with IL-36R inhibitors like spesolimab.I have signed and understand the consent form for this trial.I am not allergic to the trial medication or its ingredients.You have a high level of a type of white blood cell called eosinophils.I have HS and antibiotics did not work for me.I have used biologic treatments for my condition, but not TNFi.I have had an organ transplant or received stem cell therapy.I need to keep taking certain medications that might affect the trial.You have to have at least 1 dT count at the start of the study.I have never used biologic therapy or have used TNF inhibitors for my condition.I am legally old enough to make my own medical decisions.I have HS and antibiotics haven't worked well for me in the past year.You have a high number of abnormal cells in your blood.I have skin lesions in at least two different body areas.I have HS lesions in two different body areas.
- Group 1: Part I: High dose group
- Group 2: Part II: Active (treatment) group
- Group 3: Part I: Medium dose group
- Group 4: Part II: Placebo group
- Group 5: Part I: Placebo group
- Group 6: Part I: Low dose group
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
How many volunteers have enrolled in this medical experiment?
"Affirmative. Clinicaltrials.gov corroborates that this research initiative, which was launched on April 10th 2023, is calling for participants. They require 200 volunteers to be recruited from 2 sites."
Is there any availability for individuals to participate in this research?
"Affirmative. Clinicaltrials.gov contains data that this research study is currently searching for participants, first posted on April 10th 2023 and edited as recently as April 19th 2023. The investigation seeks to recruit 200 subjects from 2 sites."
Who else is applying?
What state do they live in?
What site did they apply to?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
Why did patients apply to this trial?
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