NCT03569371已完成2 期
A Phase 2, Open-Label, Single-Arm Study of the Safety of INCB054707 in Participants With Hidradenitis Suppurativa
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Number of Participants With Treatment-emergent Adverse Events (TEAEs)
研究概览
简要总结
The purpose of this study is to assess the safety of INCB054707 in men and women with moderate to severe hidradenitis suppurativa (HS).
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of HS (confirmed by a dermatologist) with a disease duration of at least 6 months before screening.
- •Stable course of HS for at least 90 days before screening, as determined by the investigator.
- •HS lesions present in at least 2 distinct anatomic areas, 1 of which must be Hurley Stage II or III at screening and baseline.
- •Total AN count of at least 3 at screening and baseline.
- •Male participants must agree to use contraception per protocol-defined criteria.
排除标准
- •Women of childbearing potential or who are currently pregnant or lactating.
- •Presence of > 20 draining fistulas at screening and baseline.
- •Participants with concurrent conditions or history of other diseases as follows:
- •Any clinically significant medical condition other than HS, as determined by the investigator, that is not adequately controlled with appropriate treatment.
- •Any other active skin disease or condition (eg, bacterial, fungal, or viral infection) that may interfere with the course, severity, or assessments of HS.
- •Active systemic viral infection or any active viral infection that, based on the investigator's clinical assessment, make the participant an unsuitable candidate for the study.
- •Current herpes zoster infection, a history of recurrent herpes zoster, a history of disseminated herpes simplex, or a history of herpes zoster.
- •History of malignancy, including lymphoma and leukemia within 5 years before baseline, other than a successfully treated nonmetastatic cutaneous squamous cell carcinoma, basal cell carcinoma, or localized carcinoma in situ of the cervix.
- •Albinism.
- •Prolonged QT interval corrected for heart rate using Fridericia's formula (QTcF), defined as ≥ 450 msec.
- •Positive test result for tuberculosis (TB) from the QuantiFERON-TB Gold test, or equivalent, at screening (or, if 2 indeterminate tests or not available, then as evaluated by a purified protein derivative test with a result of < 5 mm of induration within 3 months of screening) or a history of active TB.
- •Positive serology test results for HIV, HBsAg, hepatitis B virus (HBV) core antibody, or HCV (HCV antibody with positive HCV-RNA) at screening.
- •Decreased blood cell counts at screening as per protocol-defined parameters.
- •Severely impaired liver function (Child-Pugh Class C) or alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels ≥ 1.5 × upper limit of normal (ULN).
- •Impaired renal function with serum creatinine > 1.5 mg/dL.
- •Use of prohibited medications per protocol-defined criteria.
- •Known or suspected allergy to INCB054707 or any component of the study drug.
- •Known history of clinically significant drug or alcohol abuse in the last year prior to baseline.
- •Any condition that would, in the investigator's judgment, interfere with full participation in the study, including administration of study drug and attending required study visits; pose a significant risk to the participant; or interfere with interpretation of study data.
研究组 & 干预措施
INCB054707
Experimental
干预措施: INCB054707 (Drug)
结局指标
主要结局
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
时间窗: Up to approximately 12 weeks.
A TEAE is any adverse event (AE) either reported for the first time or worsening of a pre-existing event after first dose of study drug.
次要结局
- Apparent Oral Volume of Distribution of INCB054707(Vc/F)(Postdose Day1, week 2 and 6.)
- Mean Change From Baseline in the HS Pain Numeric Rating Scale (NRS) Scores at Each Visit(Weeks 1,2,4,6,8 and FollowUp)
- Mean Change From Baseline in the Modified Sartorius Scale Score(Week 8.)
- Mean Change From Baseline in the Number of Draining Fistulas Count at Each Visit(Up to approximately 12 weeks.)
- Apparent Oral Clearance of INCB054707(CL/F)(Postdose Day1, week 2 and 6)
- Absorption Constant of INCB054707 (Ka)(Postdose Day1, week 2 and 6.)
- Apparent Inter-compartmental Clearance(Q/F)(Postdose Day1, week 2 and 6.)
- Proportion of Participants at Each Category of Hurley Stage(Baseline and Week 8.)
- Proportion of Participants With Change From Baseline to Week 8 in Hurley Stage(Week 8.)
- Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category(Up to approximately 12 weeks.)
- Proportion of Participants Requiring Rescue Lesional Treatment(Up to approximately 12 weeks.)
- Number of Interventions With Rescue Lesional Treatment(Up to approximately 12 weeks.)
- Proportion of Participants With a Hidradenitis Suppurativa Clinical Response (HiSCR) at Each Visit(Weeks 1,2,4,6,8 and FollowUp)
- Proportion of Participants Achieving an AN Count of 0 to 2 at Each Visit(Weeks 1,2,4,6,8 and FollowUp)
- Proportion of Participants at Each Scoring Category of the Dermatology Life Quality Index (DLQI) at Each Visit(Up to approximately 12 weeks.)
研究者
研究点 (1)
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