EUCTR2021-006378-22-HU进行中（未招募）1 期
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 - EMERALD
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 864
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Key Inclusion Criteria:
- •1. Participants who completed 1 of the 52-week of the double-blind placebo-controlled, parent Phase 3 studies (230LE303 and 230LE304) on study treatments with either BIIB059 or placebo to Week 48 and attended the last study assessment visit at Week 52.
- •2. Ability of the participant and/or his/her legally authorized representative (e.g., parent, spouse, or legal guardian), as appropriate and applicable, 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.
- •3. All women of childbearing potential must agree to practice 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.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 844
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 20
排除标准
- •Key Exclusion Criteria:
- •1. Early parent Phase 3 studies treatment terminators (participants who discontinued study treatment before Week 52).
- •2. Early parent Phase 3 studies terminators (participants who withdrew from study participation and did not complete the 52-week treatment period).
- •3. 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.
- •4. Participants who developed moderate-to-severe worsening of organ-specific lupus manifestations that would require a change in immunosuppressive therapy.
- •5. Use of prohibited concurrent medication or therapy during the parent Phase 3 studies.
- •6. Immunization with live or live-attenuated vaccines within 4 weeks prior to Baseline Visit.
- •7. Use of other investigational drugs or off-label drugs used to treat SLE, cutaneous lupus, or lupus nephritis during the parent Phase 3 studies.
- •8. 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.
- •9. 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).
- •10. Inability to comply with study requirements.
- •11. Other unspecified reasons that, in the opinion of the Investigator or Sponsor, make the participant unsuitable for enrollment.
研究者
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