NL-OMON54675招募中3 期
A phase 3 multicenter, long-term extension study to evaluate the long-term safety and efficacy of Upadacitinib (ABT-494) in subjects with ulcerative colitis (UC). - M14-533
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- AbbVie B.V.
- 入组人数
- 40
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. Subject has not responded at the end of the induction period (Week 8) in
- •study M14-234 (substudie 1), who has been an inadequate responder during the
- •maintenance period of study M14-234 (Substudy 3), or who has responded and
- •successfully completed study M14-234.
- •During the COVID-19 pandemic, for subjects with missing endoscopy due to the
- •COVID-19 pandemic in studies M14-234 SS2, SS3 and M14-675 those following
- •subjects may be enrolled if the below criteria is met:
- •* Subjects who achieved clinical response defined by Partial Adapted Mayo Score
- •at Week 8 of Studies M14-234 SS2 and M14-675
- •* Subjects who achieved clinical response defined by Partial Adapted Mayo Score
- •at Week 16 in the extended treatment period of Studies
- •M14-234 SS2 and M14-675
- •Note: If endoscopy is missing at Week 8 but can be performed at Week 16, Week
- •16 endoscopy should be performed. However, the status of
- •clinical response will be defined by Partial Adapted Mayo Score and clinical
- •responders may enter Study M14-533 Cohort 1.
- •* Subjects who have completed the 52-week treatment in Study M14-234 SS3 if the
- •PI considers it is safe to continue based on phone/video
- •call, subject's medical history and findings from the last endoscopy.
- •2. Women of childbearing potential (refer to section 5.2.4 of the protocol)
- •must have a negative urine pregnancy test at Week 0 visit.
- •3. If female, subject must meet the contraception criteria.
- •4. Subject is judged to be in otherwise good health as determined by the
- •principal investigator based upon clinical evaluations performed during the
- •preceding studies.
- •5. Must be able and willing to give written informed consent and to comply with
- •the requirements of this study protocol.
排除标准
- •1. For any reason subject is considered by the investigator to be an unsuitable
- •2. Female subject with a positive pregnancy test at Baseline (final visit of
- •the preceding studies) or who is considering becoming pregnant during the study
- •and within 30 days after the last dose of study drug.
- •3. Known hypersensitivity to upadacitinib or its excipients or had any adverse
- •event (AE) during the preceding studies, that in the investigator's judgment
- •makes the participant unsuitable for this study
- •4. Subject with an active or recurrent infection that based on the
- •investigator's clinical assessment makes the subject an unsuitable candidate
- •for the study. Subjects with ongoing infections undergoing treatment may be
- •enrolled BUT NOT dosed until the infection has been successfully treated.
- •5. Current evidence of active tuberculosis; Current evidence of latent
- •tuberculosis and for any reason the subject cannot take full course of TB
- •prophylaxis treatment
- •6. Subject with a poorly controlled medical condition, such as uncontrolled
- •diabetes, unstable ischemic heart disease, moderate or severe congestive heart
- •failure, recent cerebrovascular accidents and any other condition which, in the
- •opinion of the investigator or sponsor, would put the subject at risk by
- •participation in this study.
研究者
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