CTRI/2020/07/026827进行中（未招募）2 期
A phase 2B, multicenter, randomized, double-blind, placebo-controlled dose-ranging study to evaluate the efficacy, safety, and pharmacokinetics of PF-06480605 in adult participants with moderate to severe ulcerative colitis
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- Pfizer Inc
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
入选标准
- •(1) A diagnosis of UC for >=3 months.
- •(2)Participants with moderate to severe active UC as defined by a Total Mayo Score of >=6, and an endoscopic subscore of >=2.
- •(3)Active disease beyond the rectum ( >15 cm of active disease from the anal verge at the screening endoscopy).
- •(4)Must have failed or been intolerant to at least one of the following class of medications: steroids, immunosuppressants, anti-TNFs, anti-integrin inhibitors, anti- IL-12/23 inhibitors, or JAK inhibitors.
排除标准
- •(1)Participants with a diagnosis of ischemic colitis, infectious colitis, radiation colitis, microscopic colitis, indeterminate colitis, or findings suggestive of Crohns disease (eg, skip lesions, fistulae or perianal disease, non necrotizing granulomas, etc.).
- •(2)Participants with an imminent need for surgery or with elective surgery scheduled to occur during the study
- •(3) Chest Radiograph showing abnormalities i.e. the study will accept a Chest x ray or computed tomography scan of the chest examination performed up to 12 weeks prior to screening if available.
- •(4)12 lead electrocardiogram (ECG) that demonstrates clinically relevant abnormalities that may affect participant safety or interpretation of study results
- •(5)Infected with tuberculosis i.e. any evidence of untreated latent or active TB infection.
- •(6)Infected with human immunodeficiency virus, (HIV), Hepatitis B or C viruses
研究者
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