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Lunsayil 1: A Study to Test Whether Spesolimab Helps People With a Skin Disease Called Hidradenitis Suppurativa
This study is open to adults with moderate to severe hidradenitis suppurativa (HS). The purpose of this study is to find out whether a medicine called spesolimab helps people with HS. People who have previously taken specific medicines such as immunosuppressive biologics other than Tumor necrosis factor (TNF) inhibitors cannot take part.
This study has 2 parts. In Part 1, participants are divided into 4 groups of almost equal size. 3 groups get different doses of spesolimab, 1 group gets placebo.
All participants get injections into a vein or under the skin. Placebo injections look like spesolimab injections, but do not contain any medicine. Every participant has an equal chance of being in each group.
In the beginning, participants get the study medicine every week and later every 2 weeks. After 4 months, participants in the placebo group switch to spesolimab treatment. In Part 2, participants are divided into 2 groups.
One group gets a suitable dose of spesolimab that was found in Part 1 of the study. The other group gets placebo. After 4 months, participants in the placebo group switch to spesolimab treatment.
Participants join only one of the two parts. They are in the study for about 1 year. During this time, they visit the study site in the beginning every week and later every 2 weeks.
Some of the visits can be done at the participant's home instead of the study site. The doctors regularly check participants' HS symptoms. The results are compared between the groups to see whether spesolimab works.
The doctors also regularly check participants' general health and take note of any unwanted effects.
Study details:
Main endpoints for Part 2 will be supported by Part 1 results available at time of primary analysis.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
Eligibility
Age eligible for study : 18 and older
Healthy volunteers accepted : No
Gender eligible for study: All
Things to know
Study dates
Study start: 2023-04-10
Primary completion: 2024-08-01
Study completion finish: 2028-08-29
Study type
TREATMENT
Phase
PHASE2
PHASE3
Trial ID
NCT05819398
Intervention or treatment
DRUG: Spesolimab Formulation 1
DRUG: Spesolimab Formulation 2
DRUG: Placebo matching Spesolimab Formulation 1
DRUG: Placebo matching Spesolimab Formulation 2
Conditions
- • Hidradenitis Suppurativa
Find a site
Closest Location:
Holdsworth House Medical Practice
Research sites nearby
Select from list below to view details:
Holdsworth House Medical Practice
Sydney, New South Wales, Australia
Westmead Hospital
Westmead, New South Wales, Australia
Alfred Hospital
Melbourne, Victoria, Australia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Participant Group/Arm | Intervention/Treatment |
---|---|
EXPERIMENTAL: Part I: Low dose group
| DRUG: Spesolimab Formulation 1
|
EXPERIMENTAL: Part I: Medium dose group
| DRUG: Spesolimab Formulation 1
|
EXPERIMENTAL: Part I: High dose group
| DRUG: Spesolimab Formulation 1
|
PLACEBO_COMPARATOR: Part I: Placebo group
| DRUG: Placebo matching Spesolimab Formulation 1
|
EXPERIMENTAL: Part II: Active (treatment) group
| DRUG: Spesolimab Formulation 2
|
PLACEBO_COMPARATOR: Part II: Placebo group
| DRUG: Placebo matching Spesolimab Formulation 2
|
What is the study measuring?
Primary outcome
Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
---|---|---|
Part 1: Percent change from baseline in Draining fistula/tunnel (dT) count at Week 8 | Not Specified | At baseline and at week 8 |
Secondary outcome
Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome Time Frame |
---|---|---|
Part 1: Percent change from baseline in dT count at Week 16 (part 1) | Not Specified | At baseline and at week 16 |
Part 1: Absolute change from baseline in International hidradenitis suppurativa severity score system (IHS4) value at Week 8 | The IHS4 score is arrived at by the number of nodules (multiplied by 1) plus the number of abscesses (multiplied by 2) plus the number of draining tunnels (multiplied by 4). A total score of 3 or less signifies mild, 4-10 signifies moderate and 11 or higher signifies severe disease. | At baseline and at week 8 |
Part 1: Absolute change from baseline in IHS4 value at Week 16 | Not Specified | At baseline and at week 16 |
Part 1: Occurrence of treatment emergent adverse events (TEAEs) | Not Specified | up to 64 weeks |
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