2024-519736-17-00招募中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 Inc.22 个研究点 分布在 4 个国家目标入组 90 人开始时间: 2025年9月10日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 90
- 试验地点
- 22
- 主要终点
- Percentage change from baseline in abscess and inflammatory nodule (AN) count at Week 16
研究概览
简要总结
To assess the effect of tibulizumab on HS lesions in patients with HS
研究设计
- 分配方式
- Randomized
- 主要目的
- Period 1
- 盲法
- Double (Investigator, Subject, Monitor, Analyst)
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Male or female participant aged 18 to 70 years, inclusive, at the time of consent
- •Participant has a total AN count of ≥5 at screening and Day
- •Participant has HS lesions in ≥2 distinct anatomical areas, at least one of which is Hurley Stage II or III at screening and Day
- •For female participant of childbearing potential involved in any sexual intercourse that could lead to pregnancy: the participant must agree to use a highly effective contraceptive method from ≥4 weeks prior to Day 1 until ≥12 weeks after the last study treatment administration and have a negative serum pregnancy test at screening and a negative urine pregnancy test at Day
- •For male participant involved in any sexual intercourse that could lead to pregnancy: the participant must agree to use a highly effective contraceptive method from Day 1 until ≥12 weeks after the last study product administration.
- •Female participant: must agree to not donate oocytes or undergo in vitro fertilization from the first study treatment administration until ≥12 weeks following the last study treatment administration.
- •Male participant: must agree to not donate sperm from the first study treatment administration until ≥12 weeks following the last study treatment administration.
- •Participant has provided written informed consent prior to any trial-related activities.
- •Participant must be willing and able to comply with all study procedures and visits, and must be available for the duration of the study.
- •Participant has ≥6-month history of HS based on the investigator’s judgement (through participant interview and/or review of medical charts) at screening
- •Participant had an inadequate response to an appropriate course of oral antibiotics for the treatment of HS OR demonstrated intolerance to, OR has a contraindication to, OR exhibited recurrence after discontinuation with oral antibiotics for the treatment of their HS based on investigator’s judgement through participant interview and/or review of medical history.
排除标准
- •Female who is breastfeeding, pregnant, or planning to become pregnant during the study.
- •Institutionalized because of legal or regulatory order.
- •In the opinion of the investigator, the participant should not participate in the trial.
- •Presence of another inflammatory condition or skin condition that may interfere with study assessments. Note: Diagnosis of Crohn’s disease or ulcerative colitis is allowed if no active symptomatic disease.
- •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, had a serious infection within 2 months, or had an infection requiring systemic antibiotics within 2 weeks.
- •Active systemic candidiasis. Note: Urogenital candidiasis is allowed.
- •Lifetime history of suicide attempt, had suicidal ideation in the past 6 months, or who, in the investigator's opinion, poses a significant suicide risk.
- •Has any of the following laboratory values (screening visit): a. Hemoglobin <8.5 g/100 mL b. Absolute neutrophil count <1500/mm3 c. Platelet count <100 000/mm3 d. Alanine aminotransferase or aspartate aminotransferase values ≥2 times the upper limit of normal e. Estimated glomerular filtration rate <45 mL/min/1.73 m2
- •Used any of the following: a. Prior use of anti-IL-17 or anti-BAFF therapies. b. B cell-depleting biologics within 12 months. c. Glucagon-like peptide-1 receptor agonists or any other therapy that causes significant weight loss, within 6 months. Note: Use of therapies that cause significant weight loss will be allowed if participant has been on a stable dose for ≥6 months and continues the same dose. d. Marketed (eg, adalimumab) or investigational biological agents within 12 weeks or 5 half‑lives (whichever is longer). e. Receipt of Ig or blood products within 4 weeks. f. Receipt of a live or live-attenuated vaccine within 4 weeks or plans to receive a live or live-attenuated vaccine during the study. g. Systemic non-biologic therapies that could affect HS within 4 weeks. Note: Intranasal corticosteroids, inhaled corticosteroids, eye and ear drops containing corticosteroids, are allowed. h. Systemic antibiotics for the treatment of HS within 4 weeks. Note: Tetracyclines are allowed if stable dose for ≥4 weeks, and current dose maintained during the study. i. Surgical, laser, or intense pulse light intervention in anatomic areas of HS lesions within 4 weeks. j. Nonbiological investigational product or medical device within 4 weeks. k. Analgesics for pain (HS or non-HS related) or opioid analgesics (except tramadol) within 2 weeks. Note: Use of oral, non-opioid analgesics for the management of non-HS medical conditions will be allowed if stable dose for ≥2 weeks and maintain dose during the study. l. Prescription topical medication for the treatment of HS within 2 weeks. Note: Stable use of antiseptics allowed.
- •Positive result for hepatitis B virus hepatitis C virus, or human immunodeficiency virus (HIV). Note: History of hepatitis B infection will be allowed if hepatitis B DNA is undetectable and remains negative.
- •History of anaphylaxis to any biologic therapy or vaccine.
- •History of cancer or lymphoproliferative disease within 5 years. Note: Successfully treated nonmetastatic cutaneous squamous cell or basal cell carcinoma and/or localized carcinoma in situ of the cervix is allowed.
- •History of clinically significant drug or alcohol abuse in the last 6 months.
- •Major surgery within 4 weeks or has a major surgery planned during the study.
- •Clinically significant medical condition that would put the participant at undue risk, interfere with study results, or completion of study.
- •Known or suspected allergy to ZB-106 (tibulizumab) or any component of the investigational product.
- •Unable to tolerate SC drug administration.
结局指标
主要结局
Percentage change from baseline in abscess and inflammatory nodule (AN) count at Week 16
Percentage change from baseline in abscess and inflammatory nodule (AN) count at Week 16
次要结局
- Achieving HiSCR50 at Week 16; Achieving HiSCR75 at Week 16
- Absolute change from baseline in Dermatology Life Quality Index (DLQI) score at Week 16; Absolute change from baseline in Patient's Global Assessment of Hidradenitis Suppurativa (HS-PtGA) score at Week 16; Absolute change from baseline in skin pain numerical rating scale (NRS) at Week 16
- Incidence and severity of treatment emergent adverse events (TEAEs); Absolute change from baseline in vital signs, electrocardiogram (ECG) parameters, and clinical laboratory results
研究者
Shelly Shirkey
Scientific
Zura Bio Inc.
研究点 (22)
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