NCT06118099终止2 期
A Phase 2, Randomized, Double-blind, Placebo-controlled, Parallel Group, Proof-of-concept Study Assessing the Efficacy and Safety of Amlitelimab in Adult Participants With Moderate to Severe Hidradenitis Suppurativa
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- Sanofi
- 入组人数
- 90
- 试验地点
- 76
- 主要终点
- The clinical response as measured by the percentage of participants achieving HiSCR50 at Week 16
研究概览
简要总结
This is a parallel, Phase 2, 2-arm, double-blind, randomized, multicenter, multinational, placebo-controlled study to evaluate efficacy, safety, pharmacokinetics (PK), and biological effects of treatment of subcutaneous injection of amlitelimab compared with placebo in male and female participants aged 18 to 70 years with moderate to severe hidradenitis suppurativa (HS).
The purpose of this study is to measure standardized clinician reported and participant-reported outcomes (ClinRO and PRO), safety, and drug concentration. An optional long-term extension (LTE) period will assess chronic safety and efficacy over an additional 80 weeks of amlitelimab treatment.
Study details include:
- The study duration will be up to 116 weeks, including a 4-week Screening period, a 16-week double-blind treatment period (DBT), an optional 80-week LTE period and a 16-week post-treatment follow-up period.
- All participants who complete the 16-week DBT period will be offered entry into an optional LTE.
- Participants who do not wish to enter the optional LTE period or who stop treatment prior to Week 16 (Visit 6) or stop investigational medicinal product (IMP) administration prior to completing the LTE period will proceed into the 16-week post-treatment follow-up period.
- The number of planned in clinic visits will be up to six during the DBT period with an additional nine during the LTE period, plus one post-treatment follow-up end-of-study visit. Up to 11 optional in clinic visits are allowed for participants who do not wish to self-administer IMP between scheduled in clinic visits during the LTE period.
详细描述
The study duration per participant will be up to 116 weeks.
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 must be 18 (or country's age of majority if >18) years to 70 years of age inclusive, at the time of signing the informed consent.
- •Participants with a history of signs and symptoms consistent with HS for at least 1 year prior to baseline.
- •Participants must have HS lesions present in at least 2 distinct anatomic areas (eg, left, and right axilla; or left axilla and left inguino-crural fold), 1 of which must be Hurley Stage II or Hurley Stage III.
- •Participant must have had an inadequate response to at least a 12-week trial of an oral antibiotic for treatment of HS
排除标准
- •Participants with a diagnosis of inflammatory conditions other than HS (including but not limited to systemic lupus erythematosus, systemic sclerosis, myositis, rheumatoid arthritis, inflammatory bowel disease, primary biliary cirrhosis, multiple sclerosis, Behcet's disease, sarcoidosis, etc)
- •Any other active skin disease or condition (eg, bacterial, fungal, or viral infection) that may interfere with assessment of HS
- •The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial
研究组 & 干预措施
Amlitelimab
Experimental
Subcutaneous injection (SC) as per protocol.
干预措施: Amlitelimab (Drug)
Placebo
Placebo Comparator
Subcutaneous injection as per protocol.
干预措施: Placebo (Drug)
结局指标
主要结局
The clinical response as measured by the percentage of participants achieving HiSCR50 at Week 16
时间窗: Week 16
Hidradenitis suppurativa clinical response (HiSCR)50 is defined as ≥50% reduction from baseline in the total abscess and inflammatory nodule count (AN count), with no increase from baseline in abscess or draining tunnel count.
次要结局
- Percentage change in AN count at Week 16(Baseline to Week 16)
- Percentage of participants who experience improvement by at least 1 International Hidradenitis Suppurativa Severity Score System (IHS4) stage at Week 16(Week 16)
- Percentage of participants who experience a flare at Week 16(Week 16)
- Incidence of antidrug antibodies (ADA) of amlitelimab at prespecified timepoints in the ADA population(Day 1 up to Week 116)
- Time to onset of achieving HiSCR50(From baseline to Week 16)
- Percentage of participants who experience 5-point reduction in DLQI at Week 16 among participants with baseline DLQI ≥4(Week 16)
- Absolute change from baseline in AN count at Week 16(Baseline to Week 16)
- Percentage of participants achieving HiSCR75 at Week 16(Week 16)
- Percentage of participants achieving HiSCR90 at Week 16(Week 16)
- Change in absolute score from Baseline in IHS4 at Week 16(Baseline to Week 16)
- Percentage of participants achieving IHS4-55 at Week 16(Week 16)
- Percentage of participants with improvement (reduction) in Peak Pruritus Numerical Rating Scale (PP-NRS) ≥4 from Baseline at Week 16 among participants with baseline PP-NRS ≥4(Week 16)
- Change from Baseline in the total Hidradenitis Suppurativa Quality of Life (HiSQOL) score at Week 16(Baseline to Week 16)
- Incidence of treatment-emergent adverse events (TEAEs), adverse event of special interest (AESIs), and serious adverse events (SAEs) including local injection site reactions in the Safety Population(Baseline up to Week 116)
- Percentage of participants achieving at least 30% reduction and at least 1 unit reduction from Baseline in weekly average of daily HS-Skin Pain NRS at Week 16 among participants with baseline NRS ≥3(Week 16)
- Serum amlitelimab concentrations measured at prespecified time points in the PK population(Day 1 up to Week 116)
- Incidence of potentially clinically significant abnormalities in laboratory tests, vital signs, and electrocardiograms in the Safety Population(Baseline up to Week 116)
研究者
研究点 (76)
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