NCT03607487已完成2 期
A Phase 2, Dose-Escalation, Placebo-Controlled 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
- 35
- 试验地点
- 4
- 主要终点
- Number of Treatment-emergent Adverse Events (TEAEs)
研究概览
简要总结
The purpose of this study is to evaluate the safety of INCB054707 over an 8-week treatment period in men and women with moderate to severe hidradenitis suppurativa.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
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 Hurley Stage III at screening.
- •Total AN count of at least 3 at screening and baseline.
- •Willingness to avoid pregnancy or fathering children.
排除标准
- •Women who are currently pregnant or lactating.
- •Presence of > 20 draining fistulas at screening and baseline.
- •Participants with protocol-defined concurrent conditions or history of other diseases.
- •Prolonged QT interval corrected for heart rate using Fridericia's formula (QTcF), defined as ≥ 450 msec.
- •Positive test result for tuberculosis from the QuantiFERON-TB Gold test, or T-SPOT.TB test at screening.
- •A history of active tuberculosis (treated or untreated) or a history of untreated latent tuberculosis.
- •Positive serology test results for HIV, hepatitis B surface antigen, hepatitis B virus core antibody, or hepatitis C virus (HCV antibody with positive HCV-RNA) at screening.
- •Decreased blood cell counts at screening per protocol-defined criteria.
- •Severely impaired liver function (Child-Pugh Class C) or alanine aminotransferase or aspartate aminotransferase levels ≥ 1.5 × upper limit of normal at screening.
- •Impaired renal function with serum creatinine > 1.5 mg/dL at screening.
- •Use of protocol-prohibited medications.
- •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 before baseline.
研究组 & 干预措施
Cohort 1
Experimental
INCB054707 at the Cohort 1 dose or placebo.
干预措施: INCB054707 (Drug)
Cohort 1
Experimental
INCB054707 at the Cohort 1 dose or placebo.
干预措施: Placebo (Drug)
Cohort 2
Experimental
INCB054707 at the Cohort 2 dose or placebo.
干预措施: INCB054707 (Drug)
Cohort 2
Experimental
INCB054707 at the Cohort 2 dose or placebo.
干预措施: Placebo (Drug)
Cohort 3
Experimental
INCB054707 at the Cohort 3 dose or placebo.
干预措施: INCB054707 (Drug)
Cohort 3
Experimental
INCB054707 at the Cohort 3 dose or placebo.
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Treatment-emergent Adverse Events (TEAEs)
时间窗: Up to 12 weeks
TEAE is defined as any adverse event either reported for the first time or worsening of a pre-existing event after first dose of study drug. Grading was performed using guidance from the CTCAE v 4.03. A grade 3 and above would constitute as "severe".
次要结局
- Mean Change From Baseline in the Number of Draining Fistulas Count at Each Visit.(Baseline,Weeks 1, 2, 4, 6, 8 and Follow-up (Up to 3 months))
- Proportion of Participants Achieving an AN Count of 0 to 2 at Each Visit(Baseline,Weeks 1, 2, 4, 6, 8, Early Termination and Follow-up (Up to 3 months))
- Apparent Oral Clearance of INCB054707(Predose Day 1, Week 4, and 8, Postdose Day1, week 2,4,6, and 8)
- Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period(Up to 12 weeks)
- Apparent Oral Volume of Distribution of INCB054707(Predose Day 1, Week 4, and 8, Postdose Day1, week 2,4,6, and 8)
- Proportion of Participants Achieving a Hidradenitis Suppurativa Clinical Response (HiSCR) at Each Visit(Weeks 1, 2, 4, 6, 8, Early Termination and Follow-up (Up to 3 months))
- Mean Change From Baseline in the Hidradenitis Suppurativa Pain Numeric Rating Scale (HS Pain NRS) Scores at Each Visit(Baseline,Weeks 1, 2, 4, 6, 8, Early Termination and Follow-up (Up to 3 months))
- Actual Measurements in HS-PGIC at Each Visit(Up to 12 weeks)
- Mean Change From Baseline in the Modified Sartorius Scale Score(From baseline up to week 8)
- Proportion of Participants at Each Category of Hurley Stage(Baseline and Week 8)
- Proportion of Participants With Change From Baseline Hurley Stage(Baseline and Week 8)
研究者
研究点 (4)
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