A Phase IIb, Multi-Center, Long-Term Extension Trial to Evaluate the Safety and Tolerability of Atacicept in Subjects With Systemic Lupus Erythematosus (SLE) Who Completed Protocol EMR-700461-023 (ADDRESS II)
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- EMD Serono
- 入组人数
- 253
- 试验地点
- 84
- 主要终点
- Number of Participants With at Least One Serious Adverse Event (SAE) During the Treatment Period
研究概览
简要总结
This is a multicenter, double-blind, Phase 2b, long-term extension (LTE) to the ADDRESS II core trial (EMR 700461-023) (NCT01972568), to evaluate long-term safety and tolerability of atacicept in participants with systemic lupus erythematosus (SLE). Participants who completed the 24-week core study ADDRESS II core study (NCT01972568) and thus not met any of the discontinuation criteria were invited to enter this long-term extension (LTE) study NCT02070978.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants who had completed the 24-week treatment period of study EMR-700461-023 (ADDRESS II core trial)
- •Women of childbearing potential who had a negative pregnancy test
- •Other protocol defined inclusion criteria were applied
排除标准
- •Active neurological symptoms of SLE that were deemed severe or progressive
- •Diagnosis of any demyelinating disease, such as, but not restricted to, multiple sclerosis (MS) or optic neuritis
- •Pregnancy
- •Active clinically significant viral, bacterial, or fungal infection, or any major episode of infection that in the investigator's opinion makes the participants unsuitable to continued participation in the study
- •Other protocol defined exclusion criteria were applied
研究组 & 干预措施
Atacicept 75 mg
干预措施: Atacicept 75 mg (Drug)
Atacicept 150 mg
干预措施: Atacicept 150 mg (Drug)
Placebo/Atacicept 150 mg
干预措施: Atacicept 150 mg (Drug)
结局指标
主要结局
Number of Participants With at Least One Serious Adverse Event (SAE) During the Treatment Period
时间窗: Baseline (LTE Day 1) up to maximum treatment duration of 143.7 weeks
An Adverse event (AE) was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease associated with the use of study drug, whether or not considered related to the study drug or worsening of pre-existing medical condition, whether or not related to study drug. A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. An AE was considered as 'treatment emergent' if it occurred after the first drug administration of each period or if it was present prior to drug administration but exacerbated after the drug administration. Treatment- Emergent adverse events (TEAEs) during the treatment period exclude those ongoing at the time of study entry into 024 LTE Day 1 and exclude the safety follow-up period.
Number of Participants Who Prematurely Discontinued the Treatment Due to Adverse Event (AE)
时间窗: Baseline (Day 1 of Core study) up to maximum duration of 167.7 weeks
An Adverse event (AE) was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease associated with the use of study drug, whether or not considered related to the study drug or worsening of pre-existing medical condition, whether or not related to study drug. TEAEs were defined as events with an onset date on or after the date of first dose of study treatment in the core study and ongoing at the 024 LTE study entry, occurring during the 024 LTE study and the Safety follow-up Period.
次要结局
- Change From Baseline in Disease Activity as Measured by British Isles Lupus Assessment Group (BILAG) 2004 Score(Baseline: Core study Screening, LTE Day 1, Week 24, Week 48, Week 72 and Week 96)
- Change From Baseline in Systemic Lupus International Collaborating Clinics/American College of Rheumatology (SLICC/ACR) Damage Index Organ Damage Scores(Baseline: Day 1 (Core Study), Day 1 (LTE Study), Week 24, Week 48, Week 72 and Week 96)
- Change From Baseline in Disease Activity as Measured by Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K) Score(Baseline: Screening Visit (Core Study); LTE Day 1, Week 24, Week 48, Week 72 and Week 96)
- Change From Baseline in Disease Activity as Measured by SLEDAI-2K Responder Index-50 (SRI-50) Score(Baseline: Screening Visit (Core Study); LTE Day 1, Week 24, Week 48, Week 72 and Week 96)
- Change From Baseline in Disease Activity as Measured by Physician's Global Assessment (PGA) Score(Baseline: Screening Visit (Core Study); LTE Day1, Week 24, Week 48, Week 72 and Week 96)
- Number of Participants Who Achieved SLE Responder Index (SRI-4) Response (a Disease Activity Composite Index)(Baseline: Core study Screening; LTE Day 1, Week 24, Week 48, Week 72 and Week 96)
- Number of Participants Who Achieved BILAG-based Combined Lupus Assessment (BICLA) Response (a Disease Activity Composite Index)(Baseline: Core study Screening; LTE Day 1, Week 24, Week 48, Week 72 and Week 96)
- Change From Baseline in the Short-Form (SF-36) Health Survey Physical Component Score and Mental Component Score(Baseline (Core Study Day 1); LTE Day 1, Week 24, Week 48, Week 72 and Week 96)
- Percent Change From Baseline in Prednisone-equivalent Corticosteroid Dose(Baseline: Screening Visit (Core Study); LTE Day 1, Week 24, Week 48, Week 72 and Week 96)
- Number of Participants With Patient Global Impression of Change (PGIC)(Baseline (Core Study Day 1); LTE Day 1, Week 24, Week 48, Week 72 and Week 96)
- Number of Participants With Columbia-Suicide Severity Rating Scale (C-SSRS) Score(LTE Day 1, Week 24, Week 48, Week 72 and Week 98)
- Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score(Baseline (Core Study Day 1); LTE Day 1, Week 24, Week 48, Week 72, and Week 96)
- Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score(Baseline: Day 1 (Core study); LTE Day 1, Week 24, Week 48, Week 72 and Week 96)
- Change From Baseline in EuroQoL 5 Dimension Instrument (EQ-5D) Score(Baseline: Day 1 (Core Study), LTE Day 1, Week 24, Week 48, Week 72 and Week 96)
- Change From Baseline in EQ-5D Visual Analogue Scale (VAS) Scores(Baseline: Day 1 (Core Study), LTE Day 1, Week 24, Week 48, Week 72 and Week 96)
- Number of Participants With at Least One Adverse Event(Baseline (Day 1 of Core study) up to maximum duration of 167.7 weeks)