A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study of the Efficacy and Safety of INCB054707 in Participants With Hidradenitis Suppurativa
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 209
- 试验地点
- 40
- 主要终点
- Mean Change From Baseline in Abscess and Inflammatory Nodule (AN) Count at Week 16
研究概览
简要总结
To evaluate the efficacy and safety of INCB054707 in participants with hidradenitis suppurativa over a 16-week placebo-controlled treatment period followed by a 36-week open-label extension period. All eligible participants will be invited to continue treatment for an additional 48-week Long-term extension period (also open label).
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)
盲法说明
Triple
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
- •HS disease duration of at least 3 months before screening.
- •Willingness to avoid pregnancy or fathering children.
- •Active HS in at least 2 distinct anatomical areas.
- •Participants agree NOT to use topical antiseptics on the areas affected by HS lesions during the placebo-controlled 16-week treatment period
排除标准
- •Draining fistula count of > 20 at screening or baseline.
- •Women who are pregnant (or who are considering pregnancy) or lactating.
- •Medical history including thrombocytopenia, coagulopathy or platelet dysfunction, Q-wave interval abnormalities, current or history of certain infections, cancer, lymphoproliferative disorders and other medical conditions at the discretion of the investigator.
- •History of failure to treatment of inflammatory diseases with JAK inhibitors.
- •Have evidence of active or latent or inadequately treated infection with Mycobacterium tuberculosis.
- •Participants known to be infected with HIV, Hepatitis B, or Hepatitis C.
- •Laboratory values outside of the protocol-defined ranges.
研究组 & 干预措施
INCB054707 15 mg
Participants will receive INCB054707 15 milligrams (mg) for 16 weeks in the Placebo-controlled Treatment Period, followed by INCB054707 75 mg for 36 weeks in the Open-label Extension Period. Participants will have the option to continue open-label treatment for an additional 48 weeks.
干预措施: INCB054707 (Drug)
INCB054707 45 mg
Participants will receive INCB054707 45 mg for 16 weeks in the Placebo-controlled Treatment Period, followed by INCB054707 75 mg for 36 weeks in the Open-label Extension Period. Participants will have the option to continue open-label treatment for an additional 48 weeks.
干预措施: INCB054707 (Drug)
INCB054707 75 mg
Participants will receive INCB054707 75 mg for 52 weeks in the Placebo-controlled Treatment Period (16 weeks) plus the Open-label Extension Period (36 weeks). Participants will have the option to continue open-label treatment for an additional 48 weeks.
干预措施: INCB054707 (Drug)
Placebo followed by INCB054707 75 mg
Participants will receive placebo for 16 weeks in the Placebo-controlled Treatment Period, followed by INCB054707 75 mg for 36 weeks in the Open-label Extension Period. Participants will have the option to continue open-label treatment for an additional 48 weeks.
干预措施: Placebo (Drug)
结局指标
主要结局
Mean Change From Baseline in Abscess and Inflammatory Nodule (AN) Count at Week 16
时间窗: Baseline; Week 16
Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The mixed model repeated measure (MMRM) included the fixed effects of treatment group (placebo and INCB054707 15, 45, and 75 mg), stratification factors (disease severity \[Hurley Stage I, II, and III\] and geographical region \[North America and outside of North America\]), visit (Weeks 2, 4, 6, 8, 12, and 16), treatment by visit interaction, and covariates of Baseline measurement and Baseline measurement by visit interaction. The variance-covariance matrix of the within-participant errors in MMRM are modeled as unstructured.
次要结局
- Percentage of Participants Who Achieved a Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 16(Baseline; Week 16)
- Percentage of Participants Who Achieved a HiSCR at Weeks 2 Through 12(Baseline; Weeks 2, 4, 6, 8, and 12)
- Percentage of Participants Who Achieved AN50, AN75, AN90, and AN100 From Weeks 2 to 16(Baseline; Weeks 2, 4, 6, 8, 12, and 16)
- Mean Change From Baseline in AN Count at Weeks 2 to 12(Baseline; Weeks 2, 4, 6, 8, and 12)
- Percentage of Participants Who Achieved HiSCR75 From Weeks 2 to 16(Baseline; Weeks 2, 4, 6, 8, 12, and 16)
- Mean Change From Baseline in Draining Fistula Count From Weeks 2 to 16(Baseline; Weeks 2, 4, 6, 8, 12, and 16)
- Mean Change From Baseline in Abscess, Inflammatory Nodule (IN), and Draining Fistula (DF) (ANF) Count From Weeks 2 to 16(Baseline; Weeks 2, 4, 6, 8, 12, and 16)
- Mean Change From Baseline in the Severity of the Disease, as Assessed by the International Hidradenitis Suppurativa Severity Score System (IHS4) Score, From Weeks 2 to 16(Baseline; Weeks 2, 4, 6, 8, 12, and 16)
- Percentage of Participants With a Total AN Count of 0 to 2 From Weeks 2 to 16(Weeks 2, 4, 6, 8, 12, and 16)
- Number of Participants With Treatment-emergent Adverse Events (TEAEs)(up to Week 16)