NL-OMON51320尚未招募3 期
A Multicenter, Randomized, Dose-Blind, Phase 3 Long-Term Extension Study to Evaluate Continuous Safety and Efficacy of Litifilimab (BIIB059) in Adult Participants with Active Systemic Lupus Erythematosus. - 230LE306 EMERALD
适应症
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- Biogen
- 入组人数
- 12
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
- 年龄范围
- 18 至 99（—）
入选标准
- •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
- •2. 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.
- •3. 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
- •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:
- •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
- •> 55 years of age, 52 continuous weeks of natural (spontaneous) amenorrhea
- •alternative medical cause and a serum FSH level >= 40 mIU/mL, or at least 5
- •years of natural (spontaneous) amenorrhea without an alternative medical cause.
排除标准
- •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
- •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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