NCT06993610进行中（未招募）2 期
A Phase 2, Multi-Center Study Consisting of a Randomized, Placebo-Controlled Period, Followed by an Open-Label Extension Period to Assess the Efficacy, Safety, and Tolerability of Tibulizumab in Adults With Hidradenitis Suppurativa
Zura Bio Inc106 个研究点 分布在 6 个国家目标入组 225 人开始时间: 2025年5月16日最近更新:
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 225
- 试验地点
- 106
- 主要终点
- [Period 1] Percent change from baseline in abscess and inflammatory nodule (AN) count at 16 weeks
研究概览
简要总结
The study is a Phase 2, multi-center, randomized, double-blind, placebo-controlled study to evaluate the effects of tibulizumab over 16 weeks (Period 1) in adults with hidradenitis suppurativa, followed by a 16-week open-label extension period in which all participants will receive tibulizumab (Period 2)
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, 18 to 70 years of age
- •≥6-month history of Hidradenitis suppurativa (HS)
- •Total AN (abscess and inflammatory nodule) count ≥5
- •HS lesions in ≥2 distinct anatomical areas, at least one of which is Hurley Stage II or III
排除标准
- •Draining tunnel count >20
- •Presence of another inflammatory condition or a skin condition that may interfere with study assessments
- •Known to have immune deficiency or is immunocompromised
- •Evidence or suspicion of active or latent tuberculosis
- •History of opportunistic, chronic, or recurrent infection requiring chronic antibiotic use, serious or life-threatening infection within 2 months, or had an infection requiring systemic antibiotics within 2 weeks
- •Has active systemic candidiasis
- •Unable to tolerate subcutaneous drug administration
研究组 & 干预措施
Tibulizumab Dose A
Experimental
Subcutaneous injection
干预措施: Tibulizumab Dose A (Biological)
Tibulizumab Dose B
Experimental
Subcutaneous injection
干预措施: Tibulizumab Dose B (Biological)
Placebo
Placebo Comparator
Subcutaneous injection
干预措施: Placebo (Other)
结局指标
主要结局
[Period 1] Percent change from baseline in abscess and inflammatory nodule (AN) count at 16 weeks
时间窗: Week 16
AN count is calculated based on the sum of the abscesses and inflammatory nodules across different anatomical areas
次要结局
- [Period 1] Achieving HiSCR75 at Week 16(Week 16)
- [Period 1] Achieving HiSCR50 at Week 16(Week 16)
- [Period 1] Absolute change from baseline in Dermatology Life Quality Index (DLQI) score at Week 16(Week 16)
- [Period 1] Absolute change from baseline in Patient's Global Assessment of Hidradenitis Suppurativa (HS-PtGA) score at Week 16(Week 16)
- [Period 1] Absolute change from baseline in Skin Pain Numeric Rating Scale (NRS) at Week 16(Week 16)
- [Period 1] Safety and tolerability of tibulizumab(Week 16)
研究者
研究点 (106)
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