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Spesolimab for Hidradenitis Suppurativa
Phase 2 & 3
Recruiting
Research Sponsored by Boehringer Ingelheim
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Moderate to severe HS.
Biologic naive or Tumor Necrosis Factor inhibitor (TNFi)-exposed for HS
Must not have
Women who are pregnant, nursing, or who plan to become pregnant while in the trial
Participants with any documented active or suspected malignancy or history of malignancy within 5 years prior to the screening visit, except appropriately treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ carcinoma of uterine cervix
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at baseline and at week 8
Summary
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.
Who is the study for?
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.
What is being tested?
The study tests if spesolimab helps people with HS. Participants are randomly assigned into groups receiving different doses of spesolimab or placebo via injections. After initial weekly treatments, they switch to every two weeks, and after four months, placebo groups start on spesolimab.
What are the potential side effects?
Potential side effects may include reactions at the injection site, allergic responses similar to other immune-modulating drugs like inflammation in various organs or increased infection risk; however specific side effects related to spesolimab will be monitored throughout the trial.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have moderate to severe hidradenitis suppurativa.
Select...
I have not used biologic treatments or have used TNF inhibitors for my condition.
Select...
I am legally old enough to make my own health decisions.
Select...
I have never used biologic therapy or have used TNF inhibitors for my condition.
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I have skin lesions in at least two different body areas.
Select...
I have HS lesions in two different body areas.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am not pregnant, nursing, or planning to become pregnant during the trial.
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I haven't had cancer in the last 5 years, except for certain skin cancers or cervical cancer that was treated.
Select...
I have previously been treated with IL-36R inhibitors like spesolimab.
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I am not allergic to the trial medication or its ingredients.
Select...
I have used biologic treatments for my condition, but not TNFi.
Select...
I need to keep taking certain medications that might affect the trial.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at baseline and at week 8
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at baseline and at week 8
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Secondary study objectives
Part 1: Absolute change from baseline in International hidradenitis suppurativa severity score system (IHS4) value at Week 8
Trial Design
6Treatment groups
Experimental Treatment
Placebo Group
Group I: Part II: Active (treatment) groupExperimental Treatment1 Intervention
Group II: Part I: Medium dose groupExperimental Treatment2 Interventions
Group III: Part I: Low dose groupExperimental Treatment2 Interventions
Group IV: Part I: High dose groupExperimental Treatment2 Interventions
Group V: Part II: Placebo groupPlacebo Group1 Intervention
Group VI: Part I: Placebo groupPlacebo Group2 Interventions
Find a Location
Who is running the clinical trial?
Boehringer IngelheimLead Sponsor
2,550 Previous Clinical Trials
15,769,093 Total Patients Enrolled
3 Trials studying Hidradenitis Suppurativa
647 Patients Enrolled for Hidradenitis Suppurativa
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.
Research Study Groups:
This trial has the following groups:- 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
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- 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.
Hidradenitis Suppurativa Patient Testimony for trial: Trial Name: NCT05819398 — Phase 2 & 3
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