NCT05849922已完成2 期
A Randomized, Double-blind, Placebo-controlled, Proof-of-concept Study Assessing the Efficacy and Safety of an Anti-TNF-OX40L NANOBODY® Molecule, SAR442970, 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
- 已完成
- 发起方
- Sanofi
- 入组人数
- 86
- 试验地点
- 45
- 主要终点
- Period A (DB Period): Percentage of Biologic and Small Molecule Immunosuppressive-Naïve Participants Who Achieved Hidradenitis Suppurativa Clinical Response (HiSCR50) at Week 16
研究概览
简要总结
This was a Phase 2 study in adult participants with moderate to severe hidradenitis suppurativa (HS). The purpose of the study was to evaluate the efficacy and safety of SAR442970 compared to placebo.
详细描述
The study duration was up to 40 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
- •Participants with a history of signs and symptoms consistent with hidradenitis suppurativa (HS) for at least 1 year prior to Baseline.
- •Participants had to 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 had to be Hurley Stage II or Hurley Stage III.
- •Participant had to 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 had a contraindication to oral antibiotics for treatment of their HS as assessed by the Investigator through participant interview and review of medical history.
- •Participants had to be either biologic and small molecule immunosuppressive-naïve or TNF-experienced.
- •Participant had to have a total abscess and inflammatory nodule (AN) count of ≥3 at the Baseline visit.
- •Participant had to have a draining tunnel count of ≤20 at the Baseline visit.
- •Participant had to have a C-reactive protein (CRP) >3 mg/L at the screening visit.
- •Participant who was a candidate for systemic treatment per Investigator's judgment.
排除标准
- •Any other active skin disease or condition (eg, bacterial, fungal or viral infection) that might have interfered with assessment of HS
- •History of recurrent or recent serious infection
- •Known history of or suspected significant current immunosuppression
- •History of solid organ transplant
- •History of splenectomy
- •History of moderate to severe congestive heart failure
- •Receipt of a live vaccine 12 week prior to Baseline visit or receipt of a killed vaccine 2 weeks prior to Baseline visit
- •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, or nonmetastatic basal cell carcinoma of the skin that was excised and completely cured
- •Participants with a diagnosis of inflammatory conditions other than HS
- •Presence of active suicidal ideation, or positive suicide behavior or participant had a lifetime history of suicide attempt, or participant had had suicidal ideation in the past 6 months as indicated by a positive response using the screening or Baseline version of the Columbia-Suicide Severity Rating Scale (C-SSRS) or as assessed by the Investigator through participant interview and review of medical history
- •A history of an adverse event (AE) to anti-TNF therapy (examples included, but were 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, contraindicated participation in the study
- •Female participants who were breastfeeding or considering becoming pregnant during the study
- •History (within last 2 years prior to Baseline) of prescription drug or substance abuse, including alcohol, considered significant by the Investigator
- •Laboratory exclusion criteria applied.
- •The above information was not intended to contain all considerations relevant to a potential participation in a clinical trial.
研究组 & 干预措施
SAR442970
Experimental
Participants received SAR442970 once every two weeks (Q2W) in Period A (Day 1 to Week 16). Participants received SAR442970 Q2W in Period B (Up to Week 28).
干预措施: SAR442970 (Drug)
Placebo
Placebo Comparator
Participants received placebo Q2W in Period A (Day 1 to Week 16). Participants received SAR442970 Q2W in Period B (Up to Week 28).
干预措施: Placebo (Drug)
结局指标
主要结局
Period A (DB Period): Percentage of Biologic and Small Molecule Immunosuppressive-Naïve Participants Who Achieved Hidradenitis Suppurativa Clinical Response (HiSCR50) at Week 16
时间窗: Week 16
The HiSCR50 was used for assessing HS treatment effectiveness in controlling inflammatory manifestations in the population. HiSCR50 was defined as \>=50% reduction from baseline in the total abscess and inflammatory nodule (AN) count, with no increase from baseline in abscess or draining tunnel count. Baseline was defined as the last available value before the first dose of DB study drug. Percentages are rounded off to the tenth decimal place.
次要结局
- Period A (DB Period): Time to Onset of Achieving Hidradenitis Suppurativa Clinical Response (HiSCR50)(Up to Week 16)
- Period A (DB Period): Percentage of Participants Who Achieved Hidradenitis Suppurativa Clinical Response (HiSCR75) at Week 16(Week 16)
- Period A (DB Period): Percentage of Participants Who Achieved Hidradenitis Suppurativa Clinical Response (HiSCR90) at Week 16(Week 16)
- Period A (DB Period): Percentage of Participants Who Experienced Improvement by at Least 1 International Hidradenitis Suppurativa Severity Score System (IHS4) Stage at Week 16(Week 16)
- Period A (DB Period) + Period B (OLE Period): Serum SAR442970 Concentrations(Baseline (Day 1), Weeks 4, 8, 10, 12 and 16 (Period A); Weeks 18, 20 and 28 (Period B))
- Period A (DB Period): Change From Baseline at Week 16 in Absolute Score in International Hidradenitis Suppurativa Severity Score System (IHS4)(Baseline (Day 1) and Week 16)
- Period A (DB Period): Percentage of Participants Who Experienced a Flare Relative to Baseline at Week 16(Baseline (Day 1) and Week 16)
- Period A (DB Period): Percentage of Participants Who Achieved International Hidradenitis Suppurativa Severity Score System (IHS4)-55 at Week 16(Week 16)
- Period A (DB Period) + Period B (OLE Period): Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (TESAEs) and Treatment-Emergent Adverse Events of Special Interest (TEAESIs)(Period A was assessed from first dose of study drug (Day 1 in Period A) up to last dose of study drug + 75 days, up to 192 days; Period B was assessed from first dose in Period B to last dose of study drug + 75 days, up to 168 days)
- Period A (DB Period): Percentage of Participants Who Achieved at Least 30% Reduction and at Least 1 Unit Reduction From Baseline in Weekly Average of Daily Hidradenitis Suppurativa Skin Pain Numeric Rating Scale (HS-Skin Pain NRS) at Week 16(Baseline (Day 1) and Week 16)
- Period B (OLE Period) + Period A+B (DB+OLE Period): Number of Participants With Anti-SAR442970 Antibody Response(Period B: Placebo-SAR442970 arm were assessed from first dose of study drug in Period B up to approximately 20 weeks. Period A+B: SAR442970-SAR442970 arm were assessed from first dose of study drug in Period A up to 36 weeks)
研究者
研究点 (45)
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