NCT04925934已完成2 期
A Phase 2 Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study of VIB7734 for the Treatment of Moderate to Severely Active Systemic Lupus Erythematosus
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 214
- 试验地点
- 67
- 主要终点
- Number of Participants Achieving a BILAG-2004 Index-based Combined Lupus Assessment (BICLA) Response and an OGC Dose ≤ 7.5 mg/Day and ≤ Baseline Dose of Prednisone or Equivalent at Week 48
研究概览
简要总结
A Phase 2 Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study of VIB7734 for the Treatment of Moderate to Severely Active Systemic Lupus Erythematosus in approximately 195 participants. The study duration will be 48 weeks, with a safety follow-up through week 56.There will be 3 parallel arms - 2 active treatment and 1 placebo.
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
- Double (Participant, Investigator)
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
- •Age ≥ 18 years to ≤ 70 years
- •Willing and able to understand and provide written informed consent.
- •Fulfill the 2019 European League Against Rheumatism/American College of Rheumatology Classification Criteria for SLE
- •Disease duration of at least 6 months
- •Active SLE as indicated by presence of all the following:
- •SLEDAI-2K total score ≥ 6 at Screening, excluding fever, SLE headache, or organic brain syndrome.
- •SLEDAI-2K total score ≥ 4, excluding points attributable to any urine or laboratory results, immunologic measures, fever, SLE headache, or organic brain syndrome at Screening and Baseline (Day 1).
- •At least one of the following BILAG 2004 Index levels of disease at Screening:
- •BILAG A disease in ≥ 1 organ system
- •BILAG B disease in ≥ 2 organ systems d. PGA score ≥ 1 on a 0 to 3 visual analog scale (VAS) at Screening
- •Have at least one of the following at Screening per central lab:
- •ANA ≥ 1:80
- •Anti-dsDNA antibodies elevated to above normal range as established by the central laboratory (ie, positive results)
- •Anti-Smith antibodies elevated to above normal (ie, positive results) Ongoing treatment for SLE
- •Treatment with one or more disease-modifying anti-rheumatic drug (DMARD) or immunosuppressive medication: Any of the following medications each administered at conventional anti-rheumatic doses for treatment of SLE for at least 12 weeks before Screening (unless discontinued or dose adjusted for documented drug-related toxicity or size/weight), and at a stable dose (including route of administration) for a minimum of 8 weeks prior to Screening and maintained through Baseline (Day 1):
- •Treatment with OGC monotherapy (without the concomitant use of DMARDs or immunosuppressants):
- •Average daily dose of PO prednisone ≥ 10 mg but ≤ 40 mg (or prednisone equivalent) for a minimum of 4 weeks prior to Screening and a stable dose for minimum of 2 weeks prior to Screening. The dose of OGC must be kept for a minimum of 2 weeks prior to Randomization. Daily dosing or alternate day dosing of PO prednisone or equivalent is allowed.
- •Women of childbearing potential must have a negative serum pregnancy test at screening and a negative urine pregnancy test at Randomization.
- •Non-sterilized male participants who are sexually active with a woman partner of childbearing potential must agree to use a condom with spermicide from Randomization and until 3 months (approximately 5 half-lives) after receipt of the last dose.
排除标准
- •Any condition that, in the opinion of the Investigator, or the Sponsor/Central Review Committee, would interfere with the evaluation of the IP or interpretation of participant safety or study results (including borderline disease activity)
- •History of allergy, hypersensitivity reaction, or anaphylaxis to any component of the IP or a previous mAb or human Ig therapy
- •Active LN or active severe or unstable neuropsychiatric SLE
- •Current diagnosis of non-SLE vasculitis syndrome, mixed connective tissue disease, or rheumatic (overlap) syndrome
- •Participation in another clinical study with an investigational drug within 4 weeks before Day 1
- •Breastfeeding or pregnant women or women who intend to become pregnant anytime from signing the ICF through 6 months after receiving the last dose of IP
- •Major surgery within 8 weeks prior to Screening or elective surgery planned from Screening through Day
- •Spontaneous or induced abortion, still or live birth, or pregnancy ≤ 4 weeks before Screening
- •Known history of a primary immunodeficiency or an underlying condition such as known human immunodeficiency virus (HIV) infection
- •Hepatitis B, Hepatitis C, active TB, any severe herpes infection, clinically active infection, or opportunistic infection
- •History of clinically significant cardiac disease including unstable angina; and/or myocardial infarction and/or congestive heart failure within 6 months prior to Randomization.
- •History of cancer within the past 5 years except, in situ carcinoma of the cervix, cutaneous basal cell or squamous cell carcinoma with curative therapy.
- •Receipt of a live-attenuated vaccine within 4 weeks before Day 1 Administration of inactivated (killed) vaccines is acceptable
- •The use of immunosuppressants, biologics and DMARDS within the protocol defined washout periods
研究组 & 干预措施
VIB7734 SC (dosing interval 1)
Experimental
干预措施: VIB7734 (Drug)
VIB7734 SC (dosing interval 2)
Experimental
干预措施: VIB7734 (Drug)
Placebo SC (dosing interval 3)
Placebo Comparator
干预措施: Placebo (Other)
结局指标
主要结局
Number of Participants Achieving a BILAG-2004 Index-based Combined Lupus Assessment (BICLA) Response and an OGC Dose ≤ 7.5 mg/Day and ≤ Baseline Dose of Prednisone or Equivalent at Week 48
时间窗: Week 48
A BICLA response required improvement in all domains affected at baseline, assessed by the BILAG 2004, no worsening of other BILAG 2004 domains, no worsening of SLEDAI-2K or PGA scores compared with baseline, no use of restricted medications beyond the protocol-allowed threshold, and no discontinuation of IP.
次要结局
- Number of Participants With a Cutaneous Lupus Erythematosus Disease Area and Severity Index-Activity (CLASI-A) Score ≥ 10 at Baseline Achieving ≥ 50% Reduction From Baseline in CLASI-A Score at Week 12(Week 12)
- Number of Participants Who Experienced AEs of Special Interest (AESI)(Up to Week 56)
- Number of Participants Achieving an SLE Responder Index (SRI)-4 Response and an OGC Dose ≤ 7.5 mg/Day and ≤ Baseline Dose of Prednisone or Equivalent at Week 48(Week 48)
- Number of Participants Achieving Lupus Low Disease Activity State (LLDAS) at Week 48(Week 48)
- Serum Concentration of Daxdilimab(Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44, Week 48)
- Number of Participants With Anti-drug Antibodies (ADA) to Daxdilimab(Baseline to Week 56)
- Number of Participants With an OGC Dose ≥ 10 mg/Day of Prednisone or Equivalent at Baseline Who Maintained an OGC Dose ≤ 7.5 mg/Day From Week 36 Through Week 48(Week 36 up to Week 48)
- Change From Baseline in Plasmacytoid Dendritic Cell (pDCs) Expression in Blood(Baseline, Week 4, Week 8, Week 12, Week 20, Week 24, Week 32, Week 36, Week 44, Week 48, Week 52, Week 56)
- Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs)(Up to Week 56)
研究者
研究点 (67)
Loading locations...
相似试验
已完成
2 期
A Study to Evaluate the Efficacy and Safety of VIB4920 in Participants With Sjögren's SyndromeSjögren's SyndromeNCT04129164Amgen183
已完成
2 期
A Study to Evaluate the Safety and Efficacy of VIB4920 in Participants With Rheumatoid ArthritisRheumatoid ArthritisNCT04163991Amgen78
进行中（未招募）
2 期
A Phase 2b, Study Evaluating Miricorilant in Adult Patients With Nonalcoholic Steatohepatitis/Metabolic Dysfunction-Associated Steatohepatitis (MONARCH)Nonalcoholic Steatohepatitis (NASH)Metabolic Dysfunction-associated Steatohepatitis (MASH)NCT06108219Corcept Therapeutics175
已完成
2 期
A Phase 2b Diabetic Kidney Disease StudyDiabetic Kidney DiseaseNCT04170543AstraZeneca609
招募中
2 期
Evaluate Azvudine in Preventing SARS-Cov-2 Infection in Household Contacts of Covid-19 in ChinaCOVID-19NCT05682599Shanghai Henlius Biotech300