NL-OMON49261已完成2 期
A Multicenter, Single Arm, Open-label Study to Investigate the Efficacy and Safety of Ravagalimab (ABBV-323) in Subjects with Moderate to Severe Ulcerative Colitis Who Failed Prior Therapy - M15-722
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- AbbVie B.V.
- 入组人数
- 6
研究概览
简要总结
Trial ended prematurely
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •· Subjects must voluntarily sign and date an informed consent, approved by an
- •independent ethics committee (IEC)/institutional review board (IRB), prior to
- •the initiation of any screening or study-specific procedures.
- •· Adult male or female, between 18 and 75 years of age, inclusive, at time of
- •the Baseline visit.
- •· Diagnosis of UC for at least 3 months prior to Baseline. Appropriate
- •documentation of biopsy results consistent with the diagnosis of UC or in the
- •assessment of the Investigator, must be available.
- •· Subject meets the following disease activity criteria: Active UC with an
- •Adapted Mayo score of 5 to 9 points and endoscopic subscore of 2 to 3
- •(confirmed by central review).
- •· History of inadequate response, loss of response, or intolerance to one or
- •more of the approved biologic therapies: infliximab, adalimumab, golimumab,
- •vedolizumab, and/or tofacitinib (Note: If tofacitinib was received in a
- •clinical trial, subject must have received open-label drug).
- •- Laboratory values meeting the following criteria:
- •Serum aspartate transaminase (AST) and alanine transaminase (ALT) <= 2 × upper
- •normal (ULN);Total white blood cell (WBC) count >= 3.0 × 109 /L;
排除标准
- •- Subject must not have an active, chronic, or recurrent infection that based
- •on the Investigator's clinical assessment makes the subject an unsuitable
- •candidate for the study
- •- Subject must not have any malignancy except for successfully treated non
- •metastatic cutaneous squamous cell or basal cell carcinoma or localized
- •carcinoma in situ of the cervix.
- •- Subject must not have history of dysplasia of the gastrointestinal tract or
- •evidence of dysplasia in any biopsy performed during the Screening endoscopy
研究者
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