NCT07225569招募中2 期
A Randomized, Double-blind, Placebo-controlled, Phase 2, Dose-finding Study to Investigate the Efficacy and Safety of SAR445399 in 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
- 招募中
- 发起方
- Sanofi
- 入组人数
- 144
- 试验地点
- 67
- 主要终点
- Percentage of participants achieving Hidradenitis Suppurativa Clinical Response 75 (HiSCR75)
研究概览
简要总结
This is a multinational, randomized, double-blind, placebo-controlled, Phase 2, dose finding study to evaluate the efficacy and safety of different doses of SAR445399 in adult participants with moderate to severe hidradenitis suppurativa.
The purpose of this study is to assess the efficacy and safety of two doses of SAR445399 compared with placebo in adult participants with moderate to severe hidradenitis suppurativa.
The study duration (per participant) will be up to 46 weeks with a total of 16 visits. The treatment duration will be 32 weeks which includes 16-week double-blinded initial treatment period and a 16-week treatment-blinded extension period.
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)
盲法说明
[Specify Complex Masking]
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
- •Participants are eligible to be included in the study only if all of the following criteria apply:
- •Participants with a history of signs and symptoms consistent with hidradenitis suppurativa (HS) for at least 6 months 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), with at least 1 body site being Hurley Stage II or III.
- •Participant must have a total abscess and inflammatory nodule (AN) count of ≥5 at the Baseline Visit.
- •Participant must have had an inadequate response to a trial of an oral antibiotic for treatment of HS, exhibited recurrence after discontinuation of antibiotics or demonstrated intolerance to antibiotics or has a contraindication to oral antibiotics for treatment of their HS as assessed by the Investigator through participant interview and review of medical history.
- •Participants in the biologic-naïve stratum must be naïve to any prior use of biologic therapy with a potential impact on HS; Participants in the biologic-experienced stratum must have documented history of use of at least one dose of biologic therapy for HS.
排除标准
- •Participants are excluded from the study if any of the following criteria apply:
- •Any other active skin disease or condition (eg, bacterial, fungal, or viral infection) that may interfere with assessment of HS.
- •History of recurrent or recent serious infection
- •Known history of or suspected current immunosuppression
- •History of solid organ transplant or stem cell transplant.
- •History of splenectomy
- •History of malignancy or lymphoproliferative disease other than adequately treated or nonmetastatic squamous cell carcinoma of the skin that was excised and completely cured or nonmetastatic basal cell carcinoma of the skin that was excised and completely cured.
- •Any other medical condition or severe, concomitant illness, including psychiatric illness and substance abuse, that may present an unreasonable risk to the study participants, make participants unreliable or may interfere with study assessments
- •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
SAR445399 dose regimen A
Experimental
Participants will receive SAR445399 dose regimen A.
干预措施: SAR445399 (Drug)
Placebo
Placebo Comparator
Participants will receive SAR445399-matching placebo.
干预措施: Placebo (Drug)
SAR445399 dose regimen B
Experimental
Participants will receive SAR445399 dose regimen B.
干预措施: SAR445399 (Drug)
结局指标
主要结局
Percentage of participants achieving Hidradenitis Suppurativa Clinical Response 75 (HiSCR75)
时间窗: Up to Week 16
Hidradenitis Suppurativa Clinical Response 75 (HiSCR75) is defined as ≥75% reduction from baseline in the total abscess and inflammatory nodule \[AN\] count, with no increase from Baseline in abscess or draining tunnel count.
次要结局
- Percentage of participants with improvement from baseline to Week 16 of >=3 points in weekly average HS-Skin Pain NRS item 1a from HS-SAQ, among participants with baseline HS-Skin Pain NRS ≥3(From baseline to Week 16)
- Absolute change from baseline to Week 16 in the Dermatology Life Quality Index (DLQI) total score(From Baseline to Week 16)
- Change from baseline to Week 16 in the Hidradenitis Suppurativa Impact Assessment Questionnaire (HS-IAQ) total score(From Baseline to Week 16)
- Number of participants with TEAEs AESIs, and SAEs including administration site reactions during the double-blinded initial treatment period and the treatment-blinded extension period(Up to End of Study (approximately 46 weeks))
- Number of participants with potentially clinically significant abnormalities in laboratory tests, vital signs, and electrocardiograms (ECGs) during the double- blinded initial treatment period and the treatment-blinded extension period(Up to End of Study (approximately 46 weeks))
- Plasma concentrations of SAR445399 during the double-blinded initial treatment period and the treatment-blinded extension period(Up to End of Study (approximately 46 weeks))
- Incidence of anti-drug antibodies (ADA) of SAR445399 at prespecified timepoints during the double-blinded initial treatment period and the treatment-blinded extension period(Up to End of Study (approximately 46 weeks))
- Absolute change from baseline to Week 16 in draining tunnel count(From Baseline to week 16)
- Percent change from baseline to Week 16 in Hidradenitis Suppurativa Skin Pain Numeric Rating Scale (HS-Skin Pain NRS)(From Baseline to Week 16)
- Percentage of participants achieving Hidradenitis Suppurativa Clinical Response 50 (HiSCR50)(Up to Week 16)
- Absolute change from baseline to Week 16 in International Hidradenitis Suppurativa Severity Score System (IHS4)(From baseline to Week 16)
- Percentage of participants achieving Hidradenitis Suppurativa Clinical Response 90 (HiSCR90)(Up to Week 16)
- Percent change from baseline to Week 16 in draining tunnel count(From Baseline to week 16)
- Percentage of participants with improvement from baseline to Week 16 of >=3 points in weekly average HS-Skin Pain NRS item 1 from HS-SAQ, among participants with baseline HS-Skin Pain NRS ≥3(From baseline to Week 16)
- Absolute change from baseline to Week 16 in the Dermatology Life Quality Index (DLQI) score(From Baseline to Week 16)
- Absolute change from baseline to Week 16 in the total Hidradenitis Suppurativa Quality of Life (HiSQoL) score(From Baseline to Week 16)
- Change from baseline to Week 16 in Weekly average HS-SAQ score items(From Baseline to Week 16)
- Change from baseline to Week 16 in the Hidradenitis Suppurativa Impact Assessment Questionnaire (HS-IAQ) score(From Baseline to Week 16)
- Improvement in Peak Pruritus Numerical Rating Scale (PP-NRS) at Week 16(From Baseline to Week 16)
- Number of participants with Treatment Emergent Adverse Events (TEAEs) Adverse Events of Special Interest (AESIs), and Serious Adverse Events (SAEs) including administration site reactions(Up to End of Study (approximately 30 weeks))
- Number of participants with potentially clinically significant abnormalities in laboratory tests, vital signs, and electrocardiograms (ECGs)(Up to End of Study (approximately 30 weeks))
- Serum concentrations of SAR445399 throughout the study(Up to End of Study (approximately 30 weeks))
- Incidence of anti-drug antibodies (ADA) of SAR445399 at prespecified timepoints(Up to End of Study (approximately 30 weeks))
研究者
研究点 (67)
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