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
2/3期
提前终止
NCT06241573
| 适应症 | Hidradenitis Suppurativa |
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| 分期 | 2/3期 |
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| 申办方 | Boehringer Ingelheim |
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| 状态 | 提前终止 |
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| 受试者人数 | 39 人 |
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| 干预(药物) | Spesolimab |
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| 开始日期 | 2024年5月8日 |
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| 完成日期 | 2025年4月11日 |
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| 结果公布日 | 2026年6月17日 |
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摘要
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 Dose | 3 Participants |
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| Spesolimab High Dose | 6 Participants |
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| Spesolimab High Dose With Prior Placebo | 5 Participants |
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