2024-510730-40-00招募中3 期
A Phase 3 Multicenter, Randomized, Double-Blind Placebo-Controlled Study to Evaluate the Efficacy and Safety of Lutikizumab (ABT-981) in Adult and Adolescent Subjects with Moderate to Severe Hidradenitis Suppurativa
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 475
- 试验地点
- 95
- 主要终点
- The primary endpoint is the achievement of HiSCR 75 at Week 16. HiSCR 75 is defined as at least a 75% reduction from baseline in the total AN count, with no increase in abscess count and no increase in draining fistula count relative to baseline.
研究概览
简要总结
The primary objective is to assess the efficacy of lutikizumab versus placebo for the treatment of the signs and symptoms of moderate to severe HS in subjects 16 years of age and older.
入排标准
- 年龄范围
- 0 years 至 65+ years（18-64 Years, 65+ Years, 0-17 Years）
- 接受健康志愿者
- 否
入选标准
- •Subjects must be ≥ 16 years of age (or ≥ 18 in countries where <18 is not permitted) at the screening visit.
- •Diagnosis of moderate to severe HS for at least 6 months prior to Baseline as determined by the investigator (i.e., through medical history and interview of subject).
- •Total AN count of ≥ 5 at Baseline.
- •HS lesions present in at least two distinct anatomic areas at Baseline.
- •At least 1 anatomic area of HS involvement characterized as Hurley Stage II or higher at Baseline.
- •Subjects must have had an inadequate response per investigator's judgement to a 12-week trial (or an adequate trial per local treatment guidelines) of oral antibiotics for treatment of HS or demonstrated intolerance to oral antibiotics for HS treatment.
排除标准
- •Laboratory values meeting the following criteria within the screening period prior to the first dose of study drug: • Serum AST > 2 × ULN; • Serum ALT > 2 × ULN; • Serum total bilirubin > 2.0 mg/dL, except for subjects with isolated elevation of indirect bilirubin relating to Gilbert syndrome; • Total WBC count < 3,000/µL; • ANC < 2,000/µL; • Platelet count < 100,000/µL; • Hemoglobin < 9.0 g/dL.
结局指标
主要结局
The primary endpoint is the achievement of HiSCR 75 at Week 16. HiSCR 75 is defined as at least a 75% reduction from baseline in the total AN count, with no increase in abscess count and no increase in draining fistula count relative to baseline.
The primary endpoint is the achievement of HiSCR 75 at Week 16. HiSCR 75 is defined as at least a 75% reduction from baseline in the total AN count, with no increase in abscess count and no increase in draining fistula count relative to baseline.
次要结局
- Ranked Secondary Endpoints: Achievement of NRS30 (at least a 30% reduction and at least 2-units reduction from Baseline in the Patient's Global Assessment of HS-related skin pain NRS) at Week 8 among subjects with NRS ≥ 3 at Baseline. The NRS30 is based on worst skin pain in a 24-hour recall period (maximal daily pain); "
- Change from Baseline in DLQI at Week 16;
- Change from Baseline in HSIA at Week 16
- Change from Baseline in HSSA Worst Drainage Score at Week 16;
- Change from Baseline in Draining Fistula at Week 16;
- Achievement of HiSCR 90 (at least a 90% reduction in the total AN count with no increase in abscess count and no increase in draining fistula count relative to Baseline) at Week 16;
- Change from Baseline in the Patient's Global Assessment of HS-related Skin Pain (NRS) at Week 8;
- Change from Baseline in HSSA at Week 16;
- Change from Baseline in HS-related odor (smell), based on HSSA Question 8, at Week 16;
- Occurrence of HS flare, defined as at least one occurrence of a ≥ 25% increase in AN count with a minimum absolute increase of 2 relative to Baseline during the first 16 weeks (Period 1).
研究者
Global Clinical Trials Helpdesk
Scientific
AbbVie Deutschland GmbH & Co. KG
研究点 (95)
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