Phase 2, Randomized, Parallel-group, Double-blind, Placebo-controlled Study of Sonelokimab in Patients With Active Moderate to Severe Hidradenitis Suppurativa
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 234
- 试验地点
- 58
- 主要终点
- Hidradenitis Suppurativa Clinical Response 75
研究概览
简要总结
This is a study to demonstrate the clinical efficacy and safety of the nanobody® sonelokimab administered subcutaneously (sc) compared with placebo in the treatment of adult participants with moderate to severe hidradenitis suppurativa.
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
- Triple (Participant, 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
- •Participant is ≥18 years of age;
- •Participant has been diagnosed with hidradenitis suppurativa as determined by the investigator and has a history of signs and symptoms of hidradenitis suppurativa dating back at least 6 months prior to the Screening Visit;
- •Participant has a total abscess and/or inflammatory nodule (AN) count of ≥5;
- •Participant has hidradenitis suppurativa lesions present in ≥2 distinct anatomical areas, at least one of which must contain single or multiple fistulas (i.e., be Hurley Stage II or III);
- •Participant had an inadequate response to appropriate systemic antibiotics for treatment of hidradenitis suppurativa (or demonstrated intolerance to, or had a contraindication to, systemic antibiotics for treatment of their HS), in the investigator's opinion;
- •Participant must be, in the opinion of the investigator, at both the Screening Visit and study treatment initiation, a suitable candidate for treatment with adalimumab per approved local product information.
排除标准
- •Participants with known hypersensitivity to sonelokimab or any of its excipients;
- •Participants with known hypersensitivity to adalimumab or any of its excipients;
- •Participant has a draining fistula count of ≥20 at the Screening Visit;
- •Participant has any other active skin disease or condition that may, in the opinion of the investigator, interfere with the assessment of hidradenitis suppurativa;
- •Prior exposure to more than 2 biologic response modifiers;
- •Participant has a diagnosis of ulcerative colitis or Crohn's disease.
研究组 & 干预措施
Placebo
Subjects randomized to this arm will receive placebo during the Double-Blind Treatment Period and will be re-randomized to receive a sonelokimab dosage regimen during Part B.
干预措施: Placebo (Other)
adalimumab
Subjects randomized to this arm will receive adalimumab during the Double-Blind Treatment Period and will be reallocated to receive sonelokimab dosage regimen during Part B.
干预措施: Adalimumab (Drug)
sonelokimab dose 1 (120 mg)
Subjects randomized to this arm will receive assigned sonelokimab dosage regimen and placebo to maintain the blinding with adalimumab and placebo arms during the Treatment Period.
干预措施: Sonelokimab (M1095) (Drug)
sonelokimab dose 2 (240 mg)
Subjects randomized to this arm will receive assigned sonelokimab dosage regimen and placebo to maintain the blinding with adalimumab and placebo arms during the Treatment Period.
干预措施: Sonelokimab (M1095) (Drug)
结局指标
主要结局
Hidradenitis Suppurativa Clinical Response 75
时间窗: Week 12
Percentage of participants achieving Hidradenitis Suppurativa Clinical Response 75 (HiSCR75), where HiSCR75 is defined as at least a 75% reduction from baseline in abscess and inflammatory nodule (AN) count, with no increase from baseline in abscess or draining fistula count.
Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) 75 at Week 12
时间窗: At Week 12
HiSCR75 was defined as at least a 75% reduction from baseline in abscess and inflammatory nodule (AN) count, with no increase from baseline in abscess or draining fistula count. A non-responder imputation (NRI) method was used for missing data.
次要结局
- Hidradenitis Suppurativa Clinical Response 50(Week 12)
- Reduction from Numerical Rating Scale (NRS30) in Patient's Global Assessment of Skin Pain (PGA Skin Pain)(Week 12)
- Change in International Hidradenitis Suppurativa Severity Score System(Week 12)
- Dermatology Life Quality Index (DLQI)(Week 12)
- Percentage of Participants Achieving HiSCR50 at Week 12(At Week 12)
- Change From Baseline in International Hidradenitis Suppurativa Severity Score System (IHS4) at Week 12(Baseline and Week 12)
- Percentage of Participants Achieving a Dermatology Life Quality Index (DLQI) Total Score of ≤5 at Week 12(At Week 12)
- Percentage of Participants Achieving a Numerical Rating Scale (NRS) 30 in Patient's Global Assessment (PGA) of Skin Pain at Week 12, in Participants With Baseline NRS ≥3(At Week 12)