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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT05819398
Registration number
NCT05819398
Ethics application status
Date submitted
6/04/2023
Date registered
19/04/2023
Titles & IDs
Public title
Lunsayil 1: A Study to Test Whether Spesolimab Helps People With a Skin Disease Called Hidradenitis Suppurativa
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Scientific title
Randomised, Double-blind, Placebo-controlled, Phase IIb/Phase III Study to Evaluate the Efficacy and Safety of Spesolimab in Patients With Moderate to Severe Hidradenitis Suppurativa. Lunsayil 1.
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Secondary ID [1]
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2022-501074-19-00
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Secondary ID [2]
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1368-0098
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Hidradenitis Suppurativa
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Spesolimab Formulation 1
Treatment: Drugs - Spesolimab Formulation 2
Treatment: Drugs - Placebo matching Spesolimab Formulation 1
Treatment: Drugs - Placebo matching Spesolimab Formulation 2
Experimental: Part I: Low dose group -
Experimental: Part I: Medium dose group -
Experimental: Part I: High dose group -
Placebo comparator: Part I: Placebo group -
Experimental: Part II: Active (treatment) group -
Placebo comparator: Part II: Placebo group -
Treatment: Drugs: Spesolimab Formulation 1
Spesolimab Formulation 1
Treatment: Drugs: Spesolimab Formulation 2
Spesolimab Formulation 2
Treatment: Drugs: Placebo matching Spesolimab Formulation 1
Placebo matching Spesolimab Formulation 1
Treatment: Drugs: Placebo matching Spesolimab Formulation 2
Placebo matching Spesolimab Formulation 2
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Part 1: Percent change from baseline in Draining fistula/tunnel (dT) count at Week 8
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Assessment method [1]
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Timepoint [1]
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At baseline and at week 8
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Secondary outcome [1]
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Part 1: Percent change from baseline in dT count at Week 16 (part 1)
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Assessment method [1]
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Timepoint [1]
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At baseline and at week 16
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Secondary outcome [2]
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Part 1: Absolute change from baseline in International hidradenitis suppurativa severity score system (IHS4) value at Week 8
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Assessment method [2]
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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.
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Timepoint [2]
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At baseline and at week 8
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Secondary outcome [3]
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Part 1: Absolute change from baseline in IHS4 value at Week 16
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Assessment method [3]
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Timepoint [3]
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At baseline and at week 16
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Secondary outcome [4]
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Part 1: Occurrence of treatment emergent adverse events (TEAEs)
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Assessment method [4]
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Timepoint [4]
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up to 64 weeks
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Eligibility
Key inclusion criteria
1. Of full age of consent at screening.
2. Signed and dated written informed consent in accordance with International Council on Harmonisation-Good clinical practice (ICH-GCP) and local legislation prior to admission to the trial.
3. Moderate to severe HS.
4. HS lesions in at least 2 distinct anatomic areas.
5. Biologic naive or Tumor Necrosis Factor inhibitor (TNFi)-exposed for HS.
6. For biologic naïve, inadequate response to an adequate course of appropriate oral antibiotics for treatment of HS in the last 1 year prior to the Baseline visit, as per investigator discretion. All participants must have previous exposure to antibiotics for HS.
7. Total AN count of greater than or equal to 5.
8. Total dT count of at least 1 at Baseline visit. Further inclusion criteria apply.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. Participants who must or wish to continue the intake of restricted medications or any drug considered likely to interfere with the safe conduct of the trial.
2. Prior exposure to any immunosuppressive/immunomodulatory biologic other than TNFi for HS.
3. Prior exposure to Interleukin 36 receptor (IL-36R) inhibitors including spesolimab.
4. Treated with any investigational device or investigational drug of chemical or biologic nature within a minimum of 30 days or 5 half-lives of the drug, whichever is longer.
5. Women who are pregnant, nursing, or who plan to become pregnant while in the trial.
6. Participants with history of allergy/hypersensitivity to the systemically administered trial medication agent or its excipients.
7. Participants with a transplanted organ (with exception of a corneal transplant >12 weeks prior to screening) or who has ever received stem cell therapy (e.g., Remestemcel-L).
8. 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.
Further exclusion criteria apply.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
10/04/2023
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
29/08/2028
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Actual
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Sample size
Target
200
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,VIC
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Recruitment hospital [1]
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Holdsworth House Medical Practice - Sydney
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Westmead Hospital - Westmead
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Alfred Hospital - Melbourne
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2010 - Sydney
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2145 - Westmead
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3004 - Melbourne
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Gloucester
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United Kingdom
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London
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Vietnam
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Ho Chi Minh
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Boehringer Ingelheim
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Ethics approval
Ethics application status
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Summary
Brief summary
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.
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Trial website
https://clinicaltrials.gov/study/NCT05819398
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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Contact person for public queries
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Boehringer Ingelheim
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1-800-243-0127
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[email protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
Once the criteria in section "Time Frame" are fulfilled, researchers can use the following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement".
Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms o
Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
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When will data be available (start and end dates)?
After structured results have been posted, all regulatory activities are completed in the US and EU for the product and indication, and after the primary manuscript has been accepted for publication.
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Available to whom?
For study documents - upon signing of a 'Document Sharing Agreement'. For study data - 1. after the submission and approval of the research proposal (checks will be performed by the sponsor and/or the independent review panel, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a legal agreement.
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Available for what types of analyses?
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How or where can data be obtained?
IPD available at link: https://www.mystudywindow.com/msw/datasharing
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT05819398