A study to test whether spesolimab helps people with a skin disease called hidradenitis suppurativa (Lunsayil 1)
D
David Rosmarin
Primary Investigator
Recruiting
18-75 years
All
Phase
2/3
5 participants needed
2 Locations
Brief description of study
What is this study about?
Hidradenitis suppurativa (HS) is a painful skin condition
with recurring lumps, abscesses, and tunnels that drain unpleasant fluids,
significantly affecting quality of life. Spesolimab is a new treatment being
studied for its potential to reduce these symptoms by blocking certain immune
responses. This study aims to find the best dose of spesolimab and confirm its
effectiveness and safety for people with moderate to severe HS. Participants
will receive either spesolimab or a placebo (a harmless pill) for part of the
study to compare results, and then everyone will have a chance to try spesolimab.
Researchers hope this treatment will improve life for those with HS.
Detailed description of study
What happens during the study?
Screening: Before joining the study, you'll have a check-up
to ensure you meet the requirements. This includes a physical exam, medical
history review, and possibly some lab tests.
Part 1 - Dose Finding Phase:
You'll be assigned to receive either spesolimab or a placebo
(a harmless pill) without knowing which one you're getting.
Over 8 weeks, doctors will monitor how your symptoms change,
focusing on the number of draining tunnels you have.
The goal is to find the best dose of spesolimab that works
well and is safe.
Part 2 - Confirmatory Phase:
After finding the optimal dose, you'll either continue with
the same or switch to the best dose of spesolimab found in Part 1.
This phase lasts 16 weeks, comparing the results of
spesolimab with the placebo to confirm its benefits.
Everyone who started with the placebo will switch to
spesolimab after 16 weeks to ensure all participants receive the potential
treatment.
Monitoring and Follow-Up:
Throughout the study, regular visits to the clinic will be
needed for check-ups, lab tests, and to monitor any side effects.
The total study duration may extend up to 50 weeks to
observe long-term effects and safety.
By participating, you help researchers determine if
spesolimab can effectively treat HS and improve quality of life for many
others.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: hidradenitis suppurativa
-
Age: Between 18 Years - 75 Years
-
Gender: All
Diagnosis:
You need to have moderate to severe Hidradenitis Suppurativa
(HS) to join the study.
Part 1 (Phase IIb)
Who Can Join:
- You must have had HS for at least 6 months.
- Your HS must affect at least two different parts of your body.
- You can join whether you've tried certain biologic treatments (TNF inhibitors) for HS before or not.
- If you haven't tried biologics, you need to have tried antibiotics for HS in the past year, but they didn't work well for you.
- You need to have at least 5 active lumps and at least 1 draining tunnel.
Who Cannot Join:
- You can't use certain medications that might interfere with the study.
- You can't have used other immune-suppressing biologic treatments for HS (except TNF inhibitors).
- You can't have used IL-36R inhibitors, including spesolimab.
Part 2 (Phase III)
The criteria for Part 2 will be mostly the same as Part 1.
Some additional criteria might be added based on the results
from Part 1.
These criteria help ensure the right people join the study
to get the best results.
Updated on
11 Sep 2024.
Study ID: DERM-BIP-1368-0098, 20590
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