NCT05020730招募中2 期
A 12-Week Double-Blind, Placebo-Controlled Randomized Phase 2 Trial With a 12-Week Open-Label Extension to Determine the Immunomodulatory Activity of PTM-001 in Patients With Hidradenitis Suppurativa
Phoenicis Therapeutics1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2022年5月5日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Effect of PTM-001 on IL-1β protein levels in lesional skin biopsies
研究概览
简要总结
Study PTM-001-01 is a 12-week, randomized, placebo controlled, double blind study with a 12 week open-label extension to examine the immunomodulatory activity of PTM-001 in participants with Hidradenitis Suppurativa (HS). Participants will be randomized to receive PTM-001 (400 mg) or matching placebo every day for 12 weeks after which all participants will receive open-label PTM-001 400 mg daily for an additional 12 weeks. Randomization will be stratified by Hurley Stage.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Had onset of symptoms consistent with HS at least 6 months prior to Screening.
- •Has had active HS for at least 2 months.
- •Has ≥ 5 HS abscesses or inflammatory nodules at Screening.
- •Agrees to maintain baseline wound care and antibiotic therapy, including oral antibiotics, for the duration of the trial.
- •Agrees to use contraception
排除标准
- •Has other skin disease or condition that can interfere with HS assessment.
- •Has a positive test for TB, HIV, hepatitis B and/or hepatitis C at Screening.
- •Has a history of retinopathy or known clinically significant cardiovascular or hematologic conditions.
- •Has taken any biologic drug within 3 serum half-lives. A list of potential biologics and their half-lives
- •Has started oral antibiotics within 28 days of Study Day
- •Has, within 2 weeks prior to Day 1, received a medication prohibited based on cytochrome P450 (CYP3A4) interaction
- •Has such extensive disease that, in the opinion of the Investigator, it is difficult to discriminate between active lesions and scarring.
- •Has more than 15 active tunnels at Screening.
- •Is pregnant, nursing or considering becoming pregnant.
- •Has a history of malignancy except non-melanoma skin cancer or cervical carcinoma in situ.
研究组 & 干预措施
PTM-001 400 mg daily for 12 weeks
Experimental
干预措施: PTM-001 (Drug)
Placebo daily for 12 weeks
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Effect of PTM-001 on IL-1β protein levels in lesional skin biopsies
时间窗: Baseline to Week 12
次要结局
- Change in clinical status using the Hurley Staging(Baseline to Week 12)
- Demonstrate a change in IL-1β, IL-1⍺, IL-23p19, IL-17A, IL-5, IL-6, TNF⍺, HBD-2 protein levels in serum(Baseline to Week 12)
- Demonstrate a change in serum amyloid A levels(Baseline to Week 12)
- Demonstrate a change in IL-1⍺, IL-23p19, IL-17A, IL-5, IL-6, TNF⍺, HBD-2 protein levels in lesional skin biopsies(Baseline to Week 12)
- Demonstrate a change in IL-1β, IL-1⍺, IL-23p19, IL-17A, IL-5, IL-6, TNF⍺, HBD-2 mRNA expression in lesional skin biopsies(Baseline to Week 12)
- Change in Pain, as measured using a 10-point numerical rating scale, 1 through 10, with 10 being the worst.(Baseline to Week 12)
- Change in Quality of Life using Dermatology Life Quality Index (DLQI)(Baseline to Week 12)
- Change in clinical status using the International Hidradenitis Suppurative Severity Score System (IHS4)(Baseline to Week 12)
- Change in clinical status using the Hidradenitis Suppurative Clinical Response (HiSCR)(Baseline to Week 12)
- Change in clinical status using the Hidradenitis Suppurative Area and Severity Index-Revised (HASI-R)(Baseline to Week 12)
- Change in abscesses and inflammatory nodules count (AN count)(Baseline to Week 12)
- Change in clinical status using the Hidradenitis Suppurative Physician Global Assessment (HS-PGA)(Baseline to Week 12)
研究者
研究点 (1)
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