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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
39
Administered every 2 weeks with a subcutaneous injection.
Administered every 2 weeks with a subcutaneous injection.
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
Occurrence of Treatment Emergent Adverse Events (TEAE) up to the End of Maintenance Treatment Period
The occurrence of treatment emergent adverse events (TEAEs) is reported as the number of patients with TEAEs. TEAEs were defined as all adverse events occurring between start of treatment in the extension trial and the end of its residual effect period. Adverse events that start before first drug intake in the extension trial and deteriorate under treatment during the extension trial were also considered as 'treatment-emergent'.
Time frame: From first drug administration, up to 16 weeks after last administration, up to 39 weeks.
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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
...and 26 more locations