2023-505635-13-00招募中3 期
230LE306 (EMERALD): A Multicenter, Randomized, Dose-Blind, Phase 3 Long-Term Extension Study to Evaluate Continuous Safety and Efficacy of BIIB059 in Adult Participants with Active Systemic Lupus Erythematosus (SLE)
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 248
- 试验地点
- 47
- 主要终点
- Incidence of Treatment Emergent Adverse Events (TEAEs)
研究概览
简要总结
To evaluate the long-term safety and tolerability of litifilimab in participants with active SLE
研究设计
- 研究类型
- Interventional
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
- 否
入选标准
- •Participants who completed 1 of the 52-week of the double-blind placebo-controlled, parent Phase 3 studies (230LE303 (NCT04895241) and 230LE304 (NCT04961567)) on study treatments with either litifilimab or placebo to Week 48 and attended the last study assessment visit at Week 52
- •Ability of the participant to understand the purpose and risks of the study, to provide informed consent, and to authorize the use of confidential health information in accordance with national and local privacy regulations.
- •All women of childbearing potential must agree to practice highly effective contraception during the study and for 126 days (18 weeks) after their last dose of study treatment. In addition, participants should not donate eggs during the study and for at least 126 days (18 weeks) after their last dose of study treatment. Where applicable, if not previously confirmed in the parent Phase 3 study, postmenopausal status must be confirmed as follows: for women ≤ 55 years of age, 52 continuous weeks of natural (spontaneous) amenorrhea without an alternative medical cause and a serum FSH level ≥ 40 mIU/mL; for women > 55 years of age, 52 continuous weeks of natural (spontaneous) amenorrhea without an alternative medical cause and a serum FSH level ≥ 40 mIU/mL, or at least 5 continuous years of natural (spontaneous) amenorrhea without an alternative medical cause.
排除标准
- •Early parent Phase 3 studies treatment terminators (participants who discontinued study treatment before Week 52)
- •Inability to comply with study requirements.
- •Other unspecified reasons that, in the opinion of the Investigator or Sponsor, make the participant unsuitable for enrolment.
- •Early parent Phase 3 studies terminators (participants who withdrew from study participation and did not complete the 52-- week treatment period)
- •Participants who have developed any other medical diseases, conditions, or abnormalities, rendering their participation in the LTE study unsuitable in the opinion of the Investigator.
- •Participants who developed moderate-to-severe worsening of organ-specific lupus manifestations that would require a change in antimalarials and/or immunosuppressive therapy (initiation of new treatment or increase in dose above the allowed maximum dose as specified in Table 3 and Table 4, since the preceding scheduled study visit, and not previously discussed with the Sponsor).
- •Use of prohibited concurrent medication or therapy during the parent Phase 3 studies
- •Immunization with live or live-attenuated vaccines within 4 weeks prior to Baseline Visit.
- •Use of other investigational drugs or off-label drugs used to treat SLE, cutaneous lupus, or lupus nephritis during the parent Phase 3 studies.
- •Female participants who are pregnant, currently breastfeeding, or planning to become pregnant during the study and for 126 days (18 weeks) after the last dose of study treatment.
- •Current enrollment or a plan to enroll in any interventional clinical study in which an investigational treatment or approved therapy for investigational use is administered (participation in observational registries is allowed).
结局指标
主要结局
Incidence of Treatment Emergent Adverse Events (TEAEs)
Incidence of Treatment Emergent Adverse Events (TEAEs)
Number of Serious Adverse Events (SAEs)
Number of Serious Adverse Events (SAEs)
次要结局
- Proportion of participants who achieved an SRI-4 response by visit
- Proportion of participants with at least 4 joints (both swollen and tender) at baseline who achieved a Joint-50 response by visit
- Proportion of participants with a CLASI-A score ≥ 10 at baseline who achieved a CLASI-50, CLASI-70, and CLASI-90 response by visit
- Proportion of participants who achieved a BICLA response by visit 4
- Annualized severe SFI Flare Rate where severe flare is defined using the SFI definition
- Percentage of time spent in LLDAS 5
- Proportion of participants with sustained LLDAS
- Duration of sustained LLDAS as defined by the number of visits in LLDAS
- Annual change from baseline value from the parent Phase 3 studies in SDI score
- Cumulative exposure to OCS over time
- Proportion of participants with OCS ≤ 7.5 mg by visit
- Proportion of participants with OCS ≤ 5 mg by visit
- Participant-reported outcome measures: LupusQoL, SF-36 (Acute Version), EQ-5D-3L, FACIT-Fatigue, PHQ-9, WPAI:Lupus, and PtGA
- Change in standard laboratory parameters and ECG results
- Incidence of antibodies to litifilimab
研究者
Clinical Trials Information Desk
Scientific
Biogen Idec Research Limited
研究点 (47)
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