2024-513031-24-00招募中3 期
A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 3 Study Evaluating the Efficacy and Safety of Subcutaneous Anifrolumab in Adult Patients with Systemic Lupus Erythematosus
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 96
- 试验地点
- 40
- 主要终点
- BICLA a composite binary response defined by meeting all criteria as per protocol page 25 and 52
研究概览
简要总结
To compare efficacy of anifrolumab with placebo on overall disease activity in patients with SLE.
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
- •Patients who have a diagnosis of paediatric or adult SLE according to the ACR 1997 revised criteria for ≥ 24 Weeks prior to signing the ICF
- •Women of childbearing potential must have a negative urine pregnancy test at randomisation (Day 1), prior to administration of study intervention
- •Women of non-childbearing potential must be postmenopausal or have been surgically sterilised (for example: bilateral oophorectomy, or complete hysterectomy), which should be documented in the patient’s medical records
- •Age-specific requirements may apply for a postmenopausal state
- •Females of childbearing potential must use 1 highly effective methods of contraception, plus a male condom, from Screening until 16 Weeks after the final dose of study intervention, unless the patient is surgically sterile (eg, bilateral oophorectomy, tubal ligation, or complete hysterectomy), has a sterile/non-fertile male partner, is at least 12 months postmenopausal, or practices sustained abstinence consistent with the patient’s lifestyle
- •Females who have been or are sexually active with an intact cervix must have documentation of a cervical cancer screening (Pap smear or human papilloma virus [HPV] tests as per local guidelines) with a normal test result within 2 years prior to randomisation. Any abnormal cervical cancer screening result documented within 2 years prior to randomisation must be repeated to confirm patient eligibility
- •Females aged < 25 years, who have never been sexually active or have well-documented HPV vaccination records may not require a cervical cancer screening test.
- •To be eligible a patient must have a total SLEDAI-2K ≥ 6 points, with ≥ 4 points coming from clinical components (“Clinical” SLEDAI-2K”) at Screening (for additional details see a,b,c,d)
- •At Screening, BILAG-2004 with at least 1 of the following as confirmed by Disease Activity Central Review Team: (a) BILAG-2004 level A disease in ≥ 1 organ system (b) BILAG-2004 level B disease in ≥ 2 organ systems
- •Physician’s Global Assessment (PGA) score ≥ 1.0 on a 0 to 3 VAS at Screening
- •Antinuclear antibody, and/or Anti-dsDNA and/or anti-Smith positive at Screening.
- •Must be on stable background standard therapy with antimalarials and/or immunosuppressant(s) and glucocorticoids alone or in combination
- •All fertile males who are sexually active must use condom from Day 1 until at least 16 Weeks after receipt of the final dose of study intervention. It is strongly recommended that the female partner of a male patient also use an effective method of contraception from Table 9 throughout this period.
- •Male patients must not donate sperm during the course of the study and for 16 Weeks after the last dose of the study intervention
- •Negative serum β-human chorionic gonadotropin (β-hCG) test at Screening (females of childbearing potential only).
排除标准
- •Active severe or unstable neuropsychiatric SLE
- •Active severe SLE-driven renal disease
- •Known history of a primary immunodeficiency, splenectomy, or any underlying condition that predisposes the patient to infection, or a positive result for human immunodeficiency virus (HIV) infection confirmed by central laboratory at Screening
- •Any severe case herpes zoster infection at any time prior to Week 0 (Day 1)
- •Opportunistic infection requiring hospitalization or IV antimicrobial treatment within 3 years of randomization
- •History of cancer, apart from: a. Squamous or basal cell carcinoma of the skin treated with documented success of curative therapy ≥ 3 months prior to Week 0 (Day 1) or b. Cervical cancer in situ treated with apparent success with curative therapy ≥ 1 year prior to Week 0 (Day 1)
- •Any history of severe COVID-19 infection eg, prolonged hospitalisation [hospitalisation for observational purposes is not exclusionary] or any prior COVID-19 infection with documented long COVID and/or clinically significant unresolved sequelae. Any mild/asymptomatic COVID-19 infection (lab confirmed or suspected based on clinical symptoms) within the last 6 Weeks prior to first dosing
- •Lactating, breastfeeding or pregnant females or females who intend to become pregnant or begin breastfeeding anytime from initiation of Screening until 16 Weeks following last dose of study intervention
结局指标
主要结局
BICLA a composite binary response defined by meeting all criteria as per protocol page 25 and 52
BICLA a composite binary response defined by meeting all criteria as per protocol page 25 and 52
次要结局
- Proportion of patients who are BICLA responders at Week 52 and have maintained low (or reduced) OSC use through Week 52 maintained low (or reduced) OSC use is defined as per protocol pages 26 and 52.
- The time from first dose of study intervention during the Double-Blind Study Period to first BICLA response sustained through Week 52
- Time to flare through Week 52 where flare is defined as either 1 or more new BILAG-2004 A or 2 or more new BILAG 2004 B items compared to the previous visit
研究者
Clinical Study Information Center
Scientific
AstraZeneca AB
研究点 (40)
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