NCT07170917招募中2 期
A Randomized, Double-blind, Placebo-controlled, Dose-ranging Phase 2 Study of Brivekimig Followed by a Maintenance Period 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
- 208
- 试验地点
- 84
- 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 Phase 2b, global, multicenter, sequential, randomized, double-blind, placebo-controlled, parallel group, dose-ranging study in participants with moderate to severe hidradenitis suppurativa.
The purpose of the main study is to assess the efficacy and safety of brivekimig in a dose-ranging study of participants with moderate to severe HS.
Study details include:
The study duration (per participant) will be up to approximately 164 weeks for participants transitioning into the long-term extension (LTE) period and will be up to approximately 60 weeks for participants not transitioning into the LTE period.
The randomized treatment duration will be up to approximately 152 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants with a diagnosis of moderate to severe 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 inguinocrural fold), one of which must be Hurley Stage II or Hurley Stage III.
- •Participant must have had an inadequate response to a trial of an oral antibiotic for treatment of HS, exhibited recurrence after discontinuation of antibiotics, 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 must be either biologic-naive or biologic-experienced.
- •Participant must have a total abscess and inflammatory nodule (AN) count of ≥5 at the Baseline visit.
- •Participant must have a draining tunnel count of ≤20 at the Baseline visit.
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 significant immunosuppression
- •History of solid organ transplant or stem cell transplant
- •History of splenectomy
- •History of moderate to severe congestive heart failure.
- •History of demyelinating disease (including myelitis) or neurologic symptoms suggestive of demyelinating disease
- •Participants with a 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
- •History of any other condition which, in the opinion of the Investigator, would put the participant at risk by participation in the protocol
- •Active suicidality and therefore significant suicide risk, as judged by the Investigator
- •A history of an Adverse Event (AE) attributed to or related to anti-TNF therapy (examples include, but are not limited, to serum sickness or anaphylaxis) for an HS or non-HS indication that would contraindicate readministration of an anti-TNF class therapy
- •Sensitivity to any of the study interventions, or components thereof, or drug or other allergy that, in the opinion of the Investigator, contraindicates participation in the study
- •History (within last 2 years prior to Baseline visit) of prescription drug or substance abuse, including alcohol, considered significant by the Investigator
- •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
Placebo
Placebo Comparator
Participants will receive Brivekimig matching placebo.
干预措施: Placebo (Drug)
Brivekimig dose regimen A
Experimental
Participants will receive Brivekimig dose regimen A.
干预措施: Brivekimig (Drug)
Brivekimig dose regimen B
Experimental
Participants will receive Brivekimig dose regimen B.
干预措施: Brivekimig (Drug)
Brivekimig dose regimen C
Experimental
Participants will receive Brivekimig dose regimen C.
干预措施: Brivekimig (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
- Number of participants with treatment-emergent adverse events (TEAE), serious adverse events (SAE) and laboratory anomalies.(Up to End of Study (approximately 164 weeks))
- Serum brivekimig concentration throughout the study.(From Baseline to Week 160)
- Incidence of treatment-emergent (TE) anti-drug antibody responses.(Up to End of Study (approximately 164 weeks))
- Percentage of participants achieving Hidradenitis Suppurativa Clinical Response 50 (HiSCR50)(Up to Week 16)
- Percentage of participants achieving Hidradenitis Suppurativa Clinical Response 90 (HiSCR90)(Up to Week 16)
- Change from Baseline in draining tunnel count at Week 16.(From Baseline to Week 16)
- Percentage of participants achieving response on the Hidradenitis Suppurativa Skin Pain Numeric Rating Scale from the HS Symptom Assessment Questionnaire (HS-SAQ skin pain NRS) at week 8(From Baseline to Week 8)
- Change from Baseline in Hidradenitis Suppurativa Quality of Life (HiSQOL) total score at Week 16.(From Baseline to Week 16)
- Change from Baseline in Dermatology Life Quality Index (DLQI) total score at Week 16.(From Baseline to Week 16)
- Number of participants with treatment-emergent adverse events (TEAE), serious adverse events (SAE) and laboratory anomalies.(Up to End of Study (approximately 60 weeks))
- Serum brivekimig concentration throughout the study.(Up to End of Study (approximately 60 weeks))
- Incidence of treatment-emergent (TE) anti-drug antibody responses.(Up to End of Study (approximately 60 weeks))
- Change from Baseline in International Hidradenitis Suppurativa Severity Score System (IHS4) at Week 16(From Baseline to Week 16)
研究者
研究点 (84)
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