NL-OMON54068已完成3 期
A Phase 3, Multicentre, Open-Label, Long-Term Extension Study to Evaluate the Long-Term Efficacy and Safety of Mirikizumab in Patients with Crohn's Disease - VIVID-2
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Eli Lilly
- 入组人数
- 8
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
- •Some of the important criteria for study participants to be eligible for
- •inclusion in the study are (please refer section 5.1 of the protocol for more
- •1. They have given written informed consent
- •2. They have participated in the Phase 2 Study AMAG and have:
- •a. completed the last visit of participation in the AMAG study and remained on
- •mirikizumab treatment in either the maintenance dosing period 3 or in the AMAG
- •extension period, and
- •b. in the opinion of the investigator, would derive clinical benefit from
- •continued treatment with mirikizumab.
- •It is preferred that participants receive the first dose of AMAX study drug
- •within approximately 6-8 weeks of the last dosing visit in AMAG. A maximum of
- •18 weeks will be allowed between the last dose in AMAG and the first dose in
- •AMAX to accommodate situations where due to circumstances outside the patient's
- •control, a patient may not be able to complete all required assessments within
- •the recommended shorter window.
- •3. They have participated in the Phase 3 Study AMAM and have:
- •a. completed Week 52 of the AMAM study, including the Week 52 endoscopy for
- •evaluation of Responder/Non-responder status, and in the opinion of the
- •investigator would derive clinical benefit from treatment with mirikizumab.
- •It is preferred that participants receive the first dose of AMAX study drug
- •within approximately 6-8 weeks after the last dosing visit in AMAM. A maximum
- •of 18 weeks will be allowed between the last dose in AMAM and the first dose in
- •AMAX to accommodate situations where due to circumstances outside the patient's
- •control, a patient may not be able to complete all required assessments within
- •the recommended shorter window.
- •4. They are willing and able to complete the scheduled study assessments,
- •including endoscopy, self-administer investigational product (or have caregiver
- •administer investigational product), and complete patient electronic and paper
- •5. They have clinically acceptable central laboratory test results at study
- •entry which would not have resulted in permanent discontinuation of treatment
- •in the originator study.
- •6. Contraception
- •a. Male Participants: No male contraception is required
- •b. Female Participants:
- •i. Women of childbearing potential: must test negative for pregnancy prior to
- •initiation of treatment as indicated by a negative urine pregnancy test at
- •Visit 1/Week 0 of this study
- •ii. must agree to either remain abstinent, if complete abstinence is their
- •preferred and usual lifestyle, or remain in same-sex relationships, if part of
- •their preferred and usual lifestyle, without sexual relationships with males.
- •Periodic abstinence (for example, calendar, ovulation, symptothermal, or
- •post-ovulation methods), declaration of abstinence just for the duration of a
- •trial, and withdrawal are not acceptable methods of contraception,
- •iii. must use a combination of 2 effective methods of contraception or 1 highly
- •effective method of contraception for the entirety of the study. Abstinence or
- •contraception must continue following completion of study drug administration
- •for 16 weeks.
- •iv. Women not of childbearing potential may participate and include those who
- •a) infertile due to surgical sterilization (total hysterectomy, bilateral
- •salpingo-oophorectomy, bilat
排除标准
- •Some of the important criteria for study participants to be excluded from the
- •study are (please refer section 5.2 of the protocol for more details):
- •3. They had a reported serious adverse event (SAE) in originator study or
- •developed other condition prior to AMAX Week 0 that would disqualify them from
- •treatment with mirikizumab according to originator study criteria.
- •4. Had permanently discontinued study drug in the originator study or had a
- •temporary interruption of study drug in originator study such that, in the
- •opinion of the investigator or Sponsor, restarting of mirikizumab would pose an
- •unacceptable risk for the participant in Study AMAX.
- •5. Presence of significant uncontrolled neuropsychiatric disorder or judged at
- •risk of suicide in the opinion of the investigator
- •6. Have a known hypersensitivity to any component of this investigational
- •product or monoclonal antibodies or has experienced an acute systemic
- •hypersensitivity event with previous study drug administration that precludes
- •mirikizumab therapy.
- •7. Are pregnant, lactating, or planning to become pregnant while enrolled in
- •the study or within 16 weeks after receiving the last dose of study drug.
- •9. Intend to receive a Bacillus Calmette Guerin (BCG) vaccination or a live
- •attenuated vaccine during the study.
- •10. Have any history or current evidence of cancer of the gastrointestinal
- •11. Have any current sporadic adenoma without dysplasia that has not been
- •removed. Once completely removed, the patient is eligible for the study.
- •12. Have any evidence of colonic dysplasia.
- •13. Are currently enrolled in any other clinical study involving an
- •investigational product or any other type of medical research judged not to be
- •scientifically or medically compatible with this study.
研究者
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