NCT04982432Unknown2 期
Orismilast for the Treatment of Mild to Severe Hidradenitis Suppurativa (OSIRIS)
Gregor Jemec0 个研究点目标入组 24 人开始时间: 2021年10月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 24
- 主要终点
- Percent change from Baseline in AN (abscesses and nodules) count at Week 16
研究概览
简要总结
The purpose of this study is to assess the efficacy and safety of oral administration of orismilast for treatment of mild, moderate, or severe hidradenitis suppurativa (HS) in adults.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female adult patients, 18 years of age or older.
- •Have mild to severe HS for at least 1 year prior to the baseline visit, as determined by the investigator through participant interview and/or review of the medical history.
- •Have HS lesions in at least 2 distinct anatomic area (right/left axillary, inguinal, inframammary, abdominal, perineal).
- •Has a total inflammatory lesions (AN) count of greater than or equal to
- •Total draining fistula count of less than or equal to
- •A stable analgesic dose for 2 weeks prior to baseline.
排除标准
- •Presence of active skin lesions other than HS that could interfere with the assessment of HS.
- •Receipt of prescription topical therapies for HS within 7 days prior to the baseline visit (Visit 2).
- •Receipt of systemic therapies for HS, within 28 days prior to the baseline visit.
- •Any oral antibiotic within 28 days prior to baseline visit.
- •Receipt of a live vaccine within 14 days prior to screening.
- •Biologic use for indications other than HS within a minimum of 30 days or 5 half-lives of the drug, whichever is longer, prior to baseline.
- •Treatment with any investigational drug of chemical or biologic nature within a minimum of 30 days or 5 half-lives of the drug, whichever is longer, prior to baseline.
研究组 & 干预措施
Orismilast
Experimental
Orismilast tablet, oral administration, multiple titrated doses twice daily, 10 mg up to 40 mg, morning and evening, 16 weeks treatment.
干预措施: Orismilast (Drug)
结局指标
主要结局
Percent change from Baseline in AN (abscesses and nodules) count at Week 16
时间窗: Day 1 to Week 16
Total count of abscess and inflammatory nodules
次要结局
- Change from Baseline in abscess, nodule, and draining fistula counts at Week 16(Day 1 to Week 16)
- Change from Baseline in IHS4 value at Week 16(Day 1 to Week 16)
- Change from Baseline in Patient's Global Assessment of Skin Pain (NRS) at Week 16(Day 1 to Week 16)
- Change from Baseline in HiSQOL Total Score at Week 16(Change from Baseline in HiSQOL Total Score at Week 16)
研究者
Gregor Jemec
Professor
Zealand University Hospital
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