NCT06028230终止2 期
A Parallel-group Treatment, Phase 2, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of SAR444656 in Adult Participants With Moderate to Severe Hidradenitis Suppurativa
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- Sanofi
- 入组人数
- 70
- 试验地点
- 52
- 主要终点
- Percent change from baseline in total abscess and inflammatory nodule (AN) count
研究概览
简要总结
This is a parallel, Phase 2, 3-arm study to evaluate the efficacy, safety, PK, and biological effects of SAR444656 compared with placebo in adult participants with moderate to severe HS aged ≥18 to 70 years.
Study details include:
- Screening period: up to 4 weeks (30 days)
- Treatment duration: up to 16 weeks
- Follow-up period: up to 4 weeks
- Total study duration: up to 24 weeks
- Number of visits: 14
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
- •Participant with a history of signs and symptoms consistent with HS for at least 1 year prior to baseline.
- •Participant must have HS lesions present in at least 2 distinct anatomic areas, one of which must be Hurley Stage II or Hurley Stage III.
- •Participant must have had an inadequate response after at least one-month of oral antibiotic treatment for HS, as assessed by the Investigator.
- •Participant must have a total AN count of ≥5 at the baseline visit.
- •Participant must have a draining tunnel count of ≤20 at the baseline visit.
- •Participant must be willing and able to complete the diary for the duration of the study as required by the study protocol.
- •Contraceptive use by men with a partner of childbearing potential and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
排除标准
- •Participant with any other active skin disease or condition (eg, bacterial, fungal, or viral infection) that may interfere with assessment of HS.
- •Any active or chronic infection requiring systemic treatment (eg, antibiotics, antivirals, antifungals, antihelminthics) within 30 days prior to baseline.
- •Known history of or suspected significant suppressed immune response, including history of invasive opportunistic or helminthic infections despite infection resolution or otherwise recurrent infections of abnormal frequency or prolonged duration.
- •Participant with history of solid organ transplant.
- •Participant with history of splenectomy.
- •Participant with history of any malignancy or lymphoproliferative disease, except if the participant has been free from disease for ≥5 years. Successfully treated non-metastatic cutaneous squamous cell carcinoma, basal cell carcinoma, or localized carcinoma in situ of the cervix are allowed.
- •Participant with a diagnosis of chronic immune-mediated, inflammatory conditions other than HS
- •Participant with family history of sudden death or long QT syndrome.
- •Participant with history of congenital or drug-induced long QT syndrome.
- •Participant with congestive heart failure (New York Heart Association Class 2 to 4), greater than Class 1 angina pectoris, acute coronary syndrome within prior 6 months, known structural heart disease.
- •Participant with history of any major cardiovascular events (eg, myocardial infarction, unstable angina pectoris, coronary revascularization, stroke, or transient ischemic attack) at any time prior to screening.
- •Participant with history of ventricular fibrillation, ventricular tachycardia, torsades de pointes, atrial fibrillation, syncope not explained by non-cardiac etiology.
- •Participant with uncontrolled hypertension defined as consistent systolic blood pressure ≥150 mmHg or consistent diastolic blood pressure ≥90 mmHg despite antihypertensive medication.
- •Participant received prescription topical therapies for the treatment of HS within 14 days prior to the baseline visit.
- •Prior or active treatment with any systemic biologic (anti-TNF) therapy, anti-IL17 therapy, anti-IL1/anti-IL1 receptor therapy except for up to 20% of the total study population. Furthermore, this 20% of biologic-experienced participants must fulfilled one or more of the following conditions:
- •Discontinued due to treatment related toxicity and/or
- •Discontinuation is not related to lack or loss of therapeutic response.
- •The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
研究组 & 干预措施
SAR444656 dose 1
Experimental
Participants will receive SAR444656 dose 1 orally
干预措施: SAR444656 (KT-474) (Drug)
SAR444656 dose 2
Experimental
Participants will receive SAR444656 dose 2 orally
干预措施: SAR444656 (KT-474) (Drug)
Placebo
Placebo Comparator
Participants will receive placebo orally
干预措施: Placebo (Drug)
结局指标
主要结局
Percent change from baseline in total abscess and inflammatory nodule (AN) count
时间窗: Week 16
The AN count is the sum of the abscess count and inflammatory nodule count at any given clinical assessment. It is derived from the lesion counts obtained as part of the HS clinical parameters.
次要结局
- Proportion of participants with improvement from baseline in Hurley Stage(Week 16)
- Plasma SAR444656 concentration(Up to Week 16)
- Absolute change from baseline in International Hidradenitis Suppurativa Severity Score System (IHS4)(Week 16)
- Change from baseline in participants reported daily worst pain using HS-Skin Pain-Numerical Rating Scale (HS-Skin Pain-NRS)(Week 16)
- Proportion of participants achieving AN50 (at least 50% reduction in the AN count relative to baseline)(Week 16)
- Change from baseline in the amount of analgesic(Up to Week 16)
- Proportion of participants achieving Hidradenitis Suppurativa Clinical Response 50 (HiSCR 50)(Week 16)
- Proportion of participants achieving improvement defined as at least 30% reduction and at least 1 unit reduction in participant daily worst pain using HS-Skin pain-NRS(Week 16)
- Proportion of participants achieving AN count ≤2(Week 16)
- Incidence of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and adverse events of special interest (AESIs), investigational medicinal product (IMP) discontinuation due to TEAEs(Up to Week 20)
研究者
研究点 (52)
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