A Phase 2a, Multicenter, Randomized, Double-blind, Placebo-controlled Study of NAV-240 in Adult Participants with Moderate-to-Severe Hidradenitis Suppurativa
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 145
- 试验地点
- 25
- 主要终点
- The main endpoint of this study is the percentage of participants achieving Hidradenitis Suppurativa Clinical Response (HiSCR) 75 at Week 16, meaning at least a 75% reduction in inflamed skin bumps [abscess and inflammatory nodule (AN) count ] with no increase in number of abscesses or draining tunnels (channels under the skin that leak fluid or pus) compared to the baseline (start of the study).
研究概览
简要总结
The main objective of this study is to determine if NAV-240 works more effectively than a dummy treatment (placebo) for participants with moderate-to-severe HS.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Participants of age ≥18 to ≤70 years at the time of consent.
- •Participants must have had stable HS for at least 2 months, with no significant improvement or worsening.
- •Have at least 5 AN and inflamed skin lesions in at least 2 different areas of the body, one of which must have moderate to severe symptoms (classified as Hurley Stage II or Hurley Stage III).
- •Inadequate response to at least one course of antibiotics, as determined by the study doctor.
排除标准
- •Participants have more than 20 draining tunnels.
- •Have an active skin infection or inflammatory condition that could make it difficult to properly evaluate HS.
- •Has undergone major surgery, including surgery for HS or has plans for major surgery during the study period.
研究组 & 干预措施
NAV-240
干预措施: NAV-240 (Drug)
NaCl 0,9 % B. Braun, solution pour perfusion
干预措施: NaCl 0,9 % B. Braun, solution pour perfusion (Drug)
结局指标
主要结局
The main endpoint of this study is the percentage of participants achieving Hidradenitis Suppurativa Clinical Response (HiSCR) 75 at Week 16, meaning at least a 75% reduction in inflamed skin bumps [abscess and inflammatory nodule (AN) count ] with no increase in number of abscesses or draining tunnels (channels under the skin that leak fluid or pus) compared to the baseline (start of the study).
The main endpoint of this study is the percentage of participants achieving Hidradenitis Suppurativa Clinical Response (HiSCR) 75 at Week 16, meaning at least a 75% reduction in inflamed skin bumps [abscess and inflammatory nodule (AN) count ] with no increase in number of abscesses or draining tunnels (channels under the skin that leak fluid or pus) compared to the baseline (start of the study).
次要结局
- Percentage of participants achieving skin pain numeric rating scale (NRS) 30 response at Week 16, meaning at least 30% and 2-point reduction in pain scores from baseline, for those with initial NRS scores of 3 or higher.
- Percentage of participants achieving HiSCR 50 at Week 16 (50% fewer inflamed skin bumps with no increase in abscesses or draining tunnels).
- Percentage of participants achieving meaningful improvement in quality of life [Dermatology Life Quality Index (DLQI) reduction (improvement) of 4 or more points] at Week 16 among those with initial DLQI scores of 4 or higher.
- Percentage of participants experiencing a HS flare (worsening) at Week 16, defined as at least 25% increase in AN Count with an absolute increase of 2 or more compared to baseline.
- Change in disease severity (measured by the International Hidradenitis Suppurativa Severity Score System or IHS4) from baseline to Week 16.
- Change in AN count and the number of draining tunnels from baseline to Week 16.
- Number of participants with treatment-related side effects, serious side effects, and specific side effects of special concern.
研究者
Navigator Medicines Study Information Center
Scientific
Navigator Medicines Inc.