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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
21/11/2024

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
Scientific title
Lunsayil LTE: An Extension Trial Assessing Long-term Spesolimab Treatment in Patients With Hidradenitis Suppurativa (HS)
Secondary ID [1] 0 0
2023-508377-82-00
Secondary ID [2] 0 0
1368-0130
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hidradenitis Suppurativa (HS) 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Occurrence of treatment emergent adverse events (TEAE)
Timepoint [1] 0 0
up to 92 weeks

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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
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
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
8/05/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
17/04/2030
Actual
Sample size
Target
Accrual to date
Final
39
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Holdsworth House Medical Practice - Sydney
Recruitment hospital [2] 0 0
Westmead Hospital - Westmead
Recruitment hospital [3] 0 0
Alfred Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
2010 - Sydney
Recruitment postcode(s) [2] 0 0
2145 - Westmead
Recruitment postcode(s) [3] 0 0
3004 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
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United States of America
State/province [2] 0 0
Indiana
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United States of America
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Oklahoma
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United States of America
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South Carolina
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Argentina
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Caba
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Argentina
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Rosario
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Austria
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Vienna
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Austria
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Wien
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Belgium
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Bruxelles
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Belgium
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Liège
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Bulgaria
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Pleven
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Bulgaria
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Sofia
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Bulgaria
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Stara Zagora
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Canada
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Ontario
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Chile
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Comuna De Recoleta
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Chile
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Vitacura
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China
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Beijing
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China
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Changchun
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China
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Changsha
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China
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Chengdu
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China
State/province [21] 0 0
Guangzhou
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China
State/province [22] 0 0
Hangzhou
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China
State/province [23] 0 0
Urumqi
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China
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Wuhan
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Czechia
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Ostrava
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Czechia
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Plzen-Bory
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Czechia
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Prague
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Czechia
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Praha
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Denmark
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Aarhus
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Denmark
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København NV
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Denmark
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Roskilde
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Finland
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Tampere
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France
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Antony
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France
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Lyon
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France
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Marseille
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France
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Nice
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France
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Paris
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France
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Poitiers
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France
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Rennes
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Germany
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Bad Bentheim
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Germany
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Bochum
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Germany
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Merzig
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Germany
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Oldenburg
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Greece
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Athens
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Greece
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Thessaloniki
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Israel
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Afula
Country [47] 0 0
Israel
State/province [47] 0 0
Haifa
Country [48] 0 0
Israel
State/province [48] 0 0
Petach Tikva
Country [49] 0 0
Israel
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Ramat Gan
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Israel
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Tel Aviv
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Italy
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Ancona
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Italy
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Catania
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Italy
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Milano
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Italy
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Modena
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Italy
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Napoli
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Italy
State/province [56] 0 0
Pisa
Country [57] 0 0
Italy
State/province [57] 0 0
Roma
Country [58] 0 0
Italy
State/province [58] 0 0
Rozzano (MI)
Country [59] 0 0
Italy
State/province [59] 0 0
Terracina (LT)
Country [60] 0 0
Italy
State/province [60] 0 0
Torino
Country [61] 0 0
Japan
State/province [61] 0 0
Aichi, Nagoya
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Japan
State/province [62] 0 0
Aichi, Toyoake
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Japan
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Gifu, Ogaki
Country [64] 0 0
Japan
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Okayama, Okayama
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Japan
State/province [65] 0 0
Tochigi, Shimotsuga-gun
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Japan
State/province [66] 0 0
Tokyo, Bunkyo-ku
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Japan
State/province [67] 0 0
Tokyo, Itabashi
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Japan
State/province [68] 0 0
Tokyo, Shinjuku-ku
Country [69] 0 0
Korea, Republic of
State/province [69] 0 0
Seoul
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Lithuania
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Kaunas
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Malaysia
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Georgetown Pulau Pinang
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Malaysia
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Johor Bahru
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Malaysia
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Kota Bahru
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Malaysia
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Kuala Lumpur
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Malaysia
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Kuala Terengganu
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Malaysia
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Kuching
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Mexico
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Aguascalientes
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Mexico
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Guadalajara
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Mexico
State/province [79] 0 0
Monterrey
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Mexico
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Nuevo León
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Mexico
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Veracruz
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Philippines
State/province [82] 0 0
Davao City
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Philippines
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Makati City
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Philippines
State/province [84] 0 0
Manila, Philippines
Country [85] 0 0
Philippines
State/province [85] 0 0
Quezon
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Poland
State/province [86] 0 0
Ossy
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Poland
State/province [87] 0 0
Poznan
Country [88] 0 0
Poland
State/province [88] 0 0
Rzeszow
Country [89] 0 0
Poland
State/province [89] 0 0
Warsaw
Country [90] 0 0
Poland
State/province [90] 0 0
Wroclaw
Country [91] 0 0
Slovakia
State/province [91] 0 0
Svidnik
Country [92] 0 0
Slovakia
State/province [92] 0 0
Trnava
Country [93] 0 0
Spain
State/province [93] 0 0
Barcelona
Country [94] 0 0
Spain
State/province [94] 0 0
Córdoba
Country [95] 0 0
Spain
State/province [95] 0 0
Granada
Country [96] 0 0
Spain
State/province [96] 0 0
Madrid
Country [97] 0 0
Spain
State/province [97] 0 0
Manises
Country [98] 0 0
Spain
State/province [98] 0 0
Salamanca
Country [99] 0 0
Spain
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Santiago de Compostela
Country [100] 0 0
Spain
State/province [100] 0 0
Zaragoza
Country [101] 0 0
Switzerland
State/province [101] 0 0
Basel
Country [102] 0 0
Switzerland
State/province [102] 0 0
Geneve
Country [103] 0 0
United Kingdom
State/province [103] 0 0
Gloucester
Country [104] 0 0
United Kingdom
State/province [104] 0 0
London
Country [105] 0 0
Vietnam
State/province [105] 0 0
Ho Chi Minh

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Boehringer Ingelheim
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/study/NCT06241573
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Boehringer Ingelheim
Address 0 0
Country 0 0
Phone 0 0
18002430127
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06241573