EUCTR2017-004092-31-BE进行中（未招募）1 期
I6T-MC-AMAPA Phase 3, Multicenter, Open-Label Extension Study to Evaluate the Long-Term Efficacy and Safety of Mirikizumab in Patients with Moderately toSeverely Active Ulcerative Colitis (LUCENT 3) - LUCENT 3
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 960
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Patients from the Phase 2 Study AMAC who in the opinion of the investigator, would derive benefit from
- •treatment with mirikizumab
- •2. Patients from the Phase 3 Study AMBG who in the opinion of the investigator, would derive benefit from
- •treatment with mirikizumab.
- •3. If female, must meet the contraception requirements.
- •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 864
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 96
排除标准
- •1. Would not, in the opinion of the investigator, derive clinical benefit
- •from open-label treatment with mirikizumab.
- •2. Had a reported SAE in originator study or developed other condition
- •prior to Week 0 visit that would disqualify them from treatment with
- •mirikizumab according to originator study criteria.
- •3. Are diagnosed with any medical condition including developing
- •malignancy or suspicion of active malignant disease during the
- •originator study or prior to Week 0, which would have precluded
- •enrollment in a prior mirikizumab study or would have required
- •discontinuation.
- •4. Participants diagnosed with clinically important infection including,
- •but not limited to, hepatitis B, hepatitis C, HIV/AIDS, and active
- •tuberculosis (TB) during either originator study.
研究者
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