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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
Sponsor: Boehringer Ingelheim
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.
Official title: Lunsayil LTE: An Extension Trial Assessing Long-term Spesolimab Treatment in Patients With Hidradenitis Suppurativa (HS)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
39
Start Date
2024-05-08
Completion Date
2025-04-11
Last Updated
2026-06-17
Healthy Volunteers
No
Conditions
Interventions
Spesolimab
Administered every 2 weeks with a subcutaneous injection.
Placebo
Administered every 2 weeks with a subcutaneous injection.
Locations (36)
First OC Dermatology
Fountain Valley, California, United States
Dermatology Research Associates
Los Angeles, California, United States
Integrative Skin Science and Research-Sacramento-69402
Sacramento, California, United States
Clinical Trials Research Institute
Thousand Oaks, California, United States
STAT Research
CABA, Argentina
Hospital Italiano de Buenos Aires
CABA, Argentina
Hospital Alemán
Capital Federal, Argentina
Holdsworth House Medical Practice
Sydney, New South Wales, Australia
Alfred Hospital
Melbourne, Victoria, Australia
Medical Center "Kordis"
Pleven, Bulgaria
ASMC-IPSMC-skin and Veneral Diseases
Sofia, Bulgaria
SimcoDerm Medical and Surgical Dermatology Centre
Barrie, Ontario, Canada
Guelph Dermatology Research
Guelph, Ontario, Canada
Dr. S. K. Siddha Medicine Professional Corporation
Newmarket, Ontario, Canada
HOP Privé Antony
Antony, France
Hôpital Edouard Herriot
Lyon, France
Fachklinik Bad Bentheim
Bad Bentheim, Germany
Hautmedizin Saar
Merzig, Germany
Kurume University Hospital
Fukuoka, Kurume, Japan
Ogaki Municipal Hospital
Gifu, Ogaki, Japan
The University of Tokyo Hospital
Tokyo, Bunkyo-ku, Japan
Nihon University Itabashi Hospital
Tokyo, Itabashi-ku, Japan
Tokyo Medical University Hospital
Tokyo, Shinjuku-ku, Japan
Hospital of Lithuanian University of Health Sciences Kauno Klinikos
Kaunas, Lithuania
Vilnius University Hospital, Santariskiu
Vilnius, Lithuania
Hospital Pulau Pinang-Pulau Pinang-21953
Georgetown Pulau Pinang, Malaysia
Hospital Sultan Ismail
Johor Bahru, Malaysia
Hospital Kuala Lumpur
Kuala Lumpur, Malaysia
Sarawak General Hospital
Kuching, Malaysia
Sunway Medical Centre
Selangor Darul Ehsan, Malaysia
Non-Public Health Care Facility LABDERM
Ossy, Poland
Provita Clinic
Warsaw, Poland
Royalderm
Warsaw, Poland
National University Hospital-Singapore-42005
Singapore, Singapore
Seoul National University Hospital
Seoul, South Korea
Hospital Universitario Miguel Servet
Zaragoza, Spain