NCT07384975招募中2 期
A Phase 2a, Multicenter, Randomized, Double-blind, Placebo-controlled Study of NAV-240 in Adult Participants With Moderate-to-Severe Hidradenitis Suppurativa
Navigator Medicines, Inc.41 个研究点 分布在 8 个国家目标入组 150 人开始时间: 2026年1月5日最近更新:
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 150
- 试验地点
- 41
- 主要终点
- Proportion of participants achieving Hidradenitis Suppurativa Clinical Response (HiSCR) 75
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. 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).
Participants will:
- Receive NAV-240 dose 1, NAV-240 dose 2 or placebo as a drip into the veins (intravenous infusion).
- Visit the clinic up to 9 times for checkups and tests over 22 weeks.
- Complete a daily diary about their skin pain.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of stable HS for ≥ 2 months
- •Abscesses and Inflammatory Nodules (lesion) count ≥ 5
- •Inflammatory HS lesions in at least 2 different body regions, one of which must be Hurley Stage II or III
- •Inadequate response to at least one course of antibiotics
- •Topical antiseptics/washes are not required but allowed. If in use, the participant must agree to use one single product consistently through Week
- •Use of oral antibiotics is allowed during the study under the following conditions: the dose and regimen must remain stable until Week
- •Allowed oral antibiotics include doxycycline, minocycline, or tetracycline.
- •Female participants of childbearing potential must have a negative pregnancy test
- •Participants of reproductive potential must use a highly effective method of contraception
排除标准
- •> 20 draining tunnel count
- •Active skin disease (bacterial, fungal, viral infection) that, in the opinion of the Investigator, could interfere with assessment of HS or requires treatment with antibiotic(s) also used to treat HS.
- •Has had major surgery, including HS surgery, within 12 weeks prior to Day 1
- •History of alcohol or drug abuse within the past 2 years.
- •A positive urine drug screen at Screening
- •History or evidence of human immunodeficiency virus (HIV), hepatitis B or hepatitis C virus (HCV), or a positive test at Screening
- •History or current diagnosis of active or latent pulmonary or extrapulmonary TB infection or a positive test at Screening
- •History of moderate to severe heart failure or recent (within past 6 months) cerebrovascular accident, myocardial infarction, or coronary stenting.
- •Any history of malignancy (including lymphoma and leukemia) other than a successfully treated and considered cured non-metastatic cutaneous squamous cell carcinoma, basal cell carcinoma or localized carcinoma in situ
- •History of immune deficiency
研究组 & 干预措施
Placebo
Placebo Comparator
Placebo
干预措施: Placebo to match NAV-240 (Drug)
NAV-240 Dose 1
Experimental
NAV-240 Dose 1
干预措施: NAV-240 (Drug)
NAV-240 Dose 2
Experimental
NAV-240 Dose 2
干预措施: NAV-240 (Drug)
结局指标
主要结局
Proportion of participants achieving Hidradenitis Suppurativa Clinical Response (HiSCR) 75
时间窗: Baseline to Week 16
HiSCR75 is defined as at least a 75% reduction in total abscess and inflammatory nodule count (AN count) with no increase in abscess count and no increase in draining tunnel count relative to baseline.
次要结局
- Change in the International Hidradenitis Suppurativa Severity Score System (IHS4) scores(Baseline to Week 16)
- Proportion of participants achieving skin pain numeric rating scale (NRS) 30 response(Baseline to Week 16)
- Proportion of participants achieving HiSCR50(Baseline to Week 16)
- Proportion of participants achieving a Dermatology Life Quality Index (DLQI) improvement (reduction) of ≥ 4 points among participants with DLQI ≥ 4 at baseline(Baseline to Week 16)
- Proportion of participants with HS flare(Baseline to Week 16)
- Change from baseline in AN count(Baseline to Week 16)
- Change from baseline in the number of draining tunnels(Baseline to Week 16)
研究者
研究点 (41)
Loading locations...
相似试验
招募中
3 期
Study of efficacy and safety of LNP023 in primary IgA nephropathy patients.2024-511067-29-00Novartis Pharma AG102
招募中
2 期
Efficacy and Safety of NB003 in Patients With Advanced Gastrointestinal Stromal Tumors (GIST)NCT07379047Ningbo Newbay Technology Development Co., Ltd255
尚未招募
2 期
Cetuximab β Combined With PRaG Regimen in the Treatment of EGFR-positive Advanced Refractory Solid TumorsNCT07327411Second Affiliated Hospital of Soochow University40
招募中
3 期
A Study to Select a Dose Regimen (Part A) and to Investigate Overall Survival (Part B) With Nanvuranlat Compared With Physician's Best Choice in Participants Aged 18 Years or Older With Biliary Tract CancerNCT07265674J-Pharma Co., Ltd.480
尚未招募
2 期
A Phase II Study of Neoadjuvant Sacituzumab Tirumotecan in Combination With Iparomlimab and Tuvonralimab in Locally Advanced Cervical CancerCervical CancerNCT07348861Zheng Min25