BENITIONSClinical Trial Intelligence

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

Фаза 2/3 Прекращено NCT06241573

ЗаболеваниеHidradenitis Suppurativa
ФазаФаза 2/3
СпонсорBoehringer Ingelheim
СтатусПрекращено
Участники39 участн.
ВмешательствоSpesolimab
Дата начала8.05.2024
Дата завершения11.04.2025
Публикация результатов17.06.2026

Кратко

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.

Occurrence of Treatment Emergent Adverse Events (TEAE) up to the End of Maintenance Treatment Period

From first drug administration, up to 16 weeks after last administration, up to 39 weeks. · Participants

Spesolimab Low Dose3 Participants
Spesolimab High Dose6 Participants
Spesolimab High Dose With Prior Placebo5 Participants

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