NCT07277179已完成3 期
A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy, Safety, and Pharmacokinetic Profile and Immunogenicity of Subcutaneous Netakimab in Chinese Adult Patients With Active Ankylosing Spondylitis
SPH-BIOCAD (HK) Limited1 个研究点 分布在 1 个国家目标入组 113 人开始时间: 2023年3月20日最近更新:
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 113
- 试验地点
- 1
- 主要终点
- Proportion of patients achieving ASAS40
研究概览
简要总结
The goal of this clinical trial is to To evaluate the efficacy of subcutaneous (SC) Netakimab in adult Chinese patients with Active Ankylosing Spondylitis. Researchers will compare Netakimab to placebo to see if Netakimab works to treat Ankylosing Spondylitis.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients fully understand the objectives, procedures and possible adverse reactions of this study, voluntarily participate in the study and sign the informed consent form (ICF) approved by the Institutional Ethics Committee (IEC).
- •Male or female aged 18-65 years (inclusive) on the day of signing the ICF.
- •Patients meet the diagnostic criteria for ankylosing spondylitis (New York criteria as modified in 1984) and have a history of back pain for ≥ 3 months, with onset age < 45 years.
- •BASDAI score ≥ 4 at screening and baseline, and a spinal pain score [using a 0-10-point numerical rating scale (NRS)] of ≥
- •Suboptimal or no response to NSAIDs.
- •For patients taking NSAIDs regularly as treatment for ankylosing spondylitis, a stable dose of at least 2 weeks is required to be maintained prior to randomization.
- •At screening, if patients have received or are receiving a TNF-α inhibitor (not more than 1), the duration of administration must be no less than 3 months (at an approved dose) and the patients have a poor efficacy or are intolerant of the TNF-α inhibitor.
- •Female patients should have a negative blood pregnancy test.
排除标准
- •Complete ankylosis of spine joint with syndesmophyte on the cervical vertebra, thoracic vertebra, and lumbar vertebra sides of all intervertebral spaces.
- •Patients who are known to be allergic to any component of the investigational product or other excipients.
- •Prior use of any monoclonal antibody targeting interleukin 17 (IL-17) or interleukin 17 receptor (IL-17R), IL-12/23, or any other monoclonal antibodies for the treatment of ankylosing spondylitis (except for antibodies targeting TNFα)
- •Current or previous tuberculosis (TB) infection or latent TB
- •History of lymphoproliferative disorders such as lymphoma, or current signs and symptoms suggestive of lymphoproliferative disorders.
- •Any active malignancy or history of malignancy (with the exception of squamous carcinoma in situ or basal cell carcinoma of the skin or cervical cancer in situ with curative outcome) within 5 years prior to screening.
- •Major surgery (including joint surgery) within 3 months prior to screening, or surgery planned during the study.
- •Patients who have the following active infections or history of infections:
- •Presence of hepatitis B [hepatitis B surface antigen positive (HBsAg +), or anti-hepatitis B core antibody positive (HBcAb +) and HBV DNA positive], hepatitis C [hepatitis C antibody (anti-HCV Ab) positive and HCV-RNA positive], human immunodeficiency virus (HIV), or syphilis infection.
- •A history of epileptic seizure or convulsion.
- •Chronic intestinal inflammatory disease (except 'rohn's disease, nonspecific ulcerative colitis).
研究组 & 干预措施
Netakimab
Experimental
Netakimab administered by subcutaneous injection until Week 52
干预措施: Netakimab (Drug)
Placebo
Placebo Comparator
Placebo administered by subcutaneous injection until Week 16 then Netakimab subcutaneous injection until 52 week
干预措施: Netakimab (Drug)
Placebo
Placebo Comparator
Placebo administered by subcutaneous injection until Week 16 then Netakimab subcutaneous injection until 52 week
干预措施: Placebo (Drug)
结局指标
主要结局
Proportion of patients achieving ASAS40
时间窗: Week 16
Proportion of patients achieving 40% improvement criteria established by the International Ankylosing Spondylitis Assessment Task Force at Week 16.
次要结局
- Change from baseline in BASDAI(at Week 2, 4, 8, 12, 16, 24, 36, and 52.)
- Proportion of patients achieving ASAS20(at Week 2, 4, 8, 12, 16, 24, 36, and 52.)
- Proportion of patients achieving ASAS40(at Week 2, 4, 8, 12, 24, 36, and 52)
- Proportion of patients achieving ASAS5/6(at Week 2, 4, 8, 12, 16, 24, 36, and 52)
- Change from baseline in BASMI(at Week 2, 4, 8, 12, 16, 24, 36, and 52)
- Change from baseline in BASFI(at Week 2, 4, 8, 12, 16, 24, 36, and 52)
研究者
研究点 (1)
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