NL-OMON56233已完成2 期
An open-label, long-term extension trial of spesolimab treatment in adult patients with Hidradenitis Suppurativa (HS) - OLE study: spesolimab in HS, extension of 1368-0052 trial.
IQVIA RDS Netherlands B.V.0 个研究点目标入组 3 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 3
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •- Patients who have completed treatment in the parent HS spesolimab trial
- •(1368-0052) without premature discontinuation.
排除标准
- •- Women who are pregnant, nursing, or who plan to become pregnant while in the
- •- Patients who experienced study treatment-limiting adverse events during the
- •1368-0052 parent trial.
- •- Severe, progressive, or uncontrolled condition such as renal, hepatic,
- •haematological, endocrine, pulmonary, cardiac, neurologic, cerebral, or
- •psychiatric disease, or signs and symptoms thereof.
- •- Any condition which in the opinion of the investigator affects the safety of
- •the patient, the patient's ability to participate in this trial or could
- •compromise the quality of data.
- •- Any suicidal behaviour in the past 2 years (i.e. actual attempt, interrupted
- •attempt, aborted attempt, or preparatory acts or behaviour).
- •- Any suicidal ideation of type 4 or 5 on the C-SSRS in the past 3 months (i.e.
- •active suicidal thoughts with method and intent but without specific plan, or
- •active suicidal thoughts with method, intent and plan).
研究者
相似试验
进行中（未招募）
1 期
A study investigating long-term treatment with spesolimab in people with a skin disease called hidradenitis suppurativa who completed a previous clinical trial.MedDRA version: 20.0Level: LLTClassification code 10020041Term: Hidradenitis suppurativaSystem Organ Class: 10040785 - Skin and subcutaneous tissue disordersHidradenitis SuppurativaEUCTR2020-005587-55-NOBoehringer Ingelheim Norway KS45
进行中（未招募）
1 期
A study investigating long-term treatment with spesolimab in people with a skin disease called hidradenitis suppurativa who completed a previous clinical trial.MedDRA version: 20.0Level: LLTClassification code 10020041Term: Hidradenitis suppurativaSystem Organ Class: 100000004858Hidradenitis SuppurativaEUCTR2020-005587-55-ITBOEHRINGER-INGELHEIM ITALIA S.P.A.45
进行中（未招募）
1 期
A study investigating long-term treatment with spesolimab in people with a skin disease called hidradenitis suppurativa who completed a previous clinical trial.Hidradenitis SuppurativaEUCTR2020-005587-55-FRBoehringer Ingelheim France45
进行中（未招募）
1 期
A study investigating long-term treatment with spesolimab in people with a skin disease called hidradenitis suppurativa who completed a previous clinical trial.Hidradenitis SuppurativaMedDRA version: 20.0Level: LLTClassification code 10020041Term: Hidradenitis suppurativaSystem Organ Class: 100000004858EUCTR2020-005587-55-BESCS Boehringer Ingelheim Comm. V45
进行中（未招募）
1 期
A study investigating long-term treatment with spesolimab in people with a skin disease called hidradenitis suppurativa who completed a previous clinical trial.MedDRA version: 20.0Level: LLTClassification code 10020041Term: Hidradenitis suppurativaSystem Organ Class: 100000004858Hidradenitis SuppurativaEUCTR2020-005587-55-DEBoehringer Ingelheim Pharma GmbH & Co. KG45