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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT06241573
Registration number
NCT06241573
Ethics application status
Date submitted
29/01/2024
Date registered
5/02/2024
Date last updated
25/06/2024
Titles & IDs
Public title
A Study to Test Long-term Treatment With Spesolimab in People With a Skin Condition Disease Called Hidradenitis Suppurativa (HS) Who Took Part in a Previous Study With Spesolimab
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Scientific title
Lunsayil LTE: An Extension Trial Assessing Long-term Spesolimab Treatment in Patients With Hidradenitis Suppurativa (HS)
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Secondary ID [1]
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2023-508377-82-00
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Secondary ID [2]
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1368-0130
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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 (HS)
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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
Experimental: Patients treated in Part I of parent trial 1368-0098 (NCT05819398) -
Experimental: Patients treated in Part II of parent trial 1368-0098 (NCT05819398) -
Experimental: Patients treated in parent trial 1368-0100 -
Treatment: Drugs: Spesolimab
Spesolimab
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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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Occurrence of treatment emergent adverse events (TEAE)
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Assessment method [1]
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Timepoint [1]
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up to 92 weeks
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Eligibility
Key inclusion criteria
1. Signed and dated written informed consent in accordance with ICH Harmonized Guideline for Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial.
2. Participants must be within the defined Residual Effect Period corresponding to 16 weeks since last spesolimab administration.
3. Participants who have completed treatment in the parent hidradenitis suppurativa (HS) spesolimab trial (1368-0098 (NCT05819398) or 1368-0100) without premature discontinuation and are willing and able to continue treatment in this trial.
4. Woman of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly.
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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. Women who are pregnant, nursing, or who plan to become pregnant while in the trial.
2. Use of any drug considered by the investigator likely to interfere with the safe conduct of the trial since the last visit of the parent trials.
3. Use of immunomodulatory biologics or investigational agents since the last visit of the parent trials.
4. Participants who require / intend to use certain restricted medications such as immunomodulatory biologics or other investigational drugs/devices during the course of the trial.
5. Relevant chronic or acute infections including human immunodeficiency virus (HIV) and viral hepatitis. The corresponding laboratory tests will be performed at Visit 1. A participant can be re-screened if the participant was treated and is cured from the acute infection.
Further exclusion criteria apply.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised 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
16/04/2024
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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
17/04/2030
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Actual
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Sample size
Target
550
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
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Holdsworth House Medical Practice - Sydney
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Recruitment postcode(s) [1]
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2010 - Sydney
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Recruitment outside Australia
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Canada
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State/province [1]
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Ontario
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Country [2]
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Japan
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State/province [2]
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Tokyo, Bunkyo-ku
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Country [3]
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Singapore
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State/province [3]
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Singapore
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Boehringer Ingelheim
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
This study is open to people with hidradenitis suppurativa (HS) who have completed another study with spesolimab (study 1368-0098 (NCT05819398) or study 1368-0100).
The purpose of this study is to find out how well people tolerate spesolimab and whether it helps people with HS in the long-term. For about 1.5 years, participants get spesolimab injections under the skin every 2 weeks.
Participants are in the study for about 2 years. During this time, participants have 41 visits. 24 visits are done at the study site. 17 visits can be done by video call at the participant's home. At study visits, doctors check the severity of the participant's HS and collect information on any health problems of the participants.
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Trial website
https://clinicaltrials.gov/study/NCT06241573
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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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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Boehringer Ingelheim
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Address
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Country
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Phone
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18002430127
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/study/NCT06241573
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