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

第2/3相 早期終了 NCT06241573

対象疾患Hidradenitis Suppurativa
第2/3相
スポンサーBoehringer Ingelheim
ステータス早期終了
参加者数39 名
介入(薬剤)Spesolimab
開始日2024年5月8日
完了日2025年4月11日
結果公開日2026年6月17日

概要

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

BENITIONS で見る ClinicalTrials.gov の原文を見る

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