EUCTR2019-004469-41-IT进行中（未招募）1 期
A Phase 2 Randomized, Double-blind, Placebo-controlled, Parallel-group, Multi-center Study to Evaluate the Safety and Efficacy of Oral PN-943 in Subjects with Moderate to Severe Active Ulcerative Colitis - PN-943-03
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 150
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
- •Part 1 Inclusion Criteria:
- •1. Male and female subjects age 18 (or the minimum country specific age of consent if >18) to 75 years.
- •2. Subject understands the study procedures and agrees to participate in the study by giving written informed consent.
- •3. Diagnosis of UC for = 8 weeks prior to screening supported by appropriate documentation of biopsy results consistent with UC, in the opinion of the investigator; if UC has been present for > 10 years, a total colonoscopy with biopsy must have been performed within 2 years of screening to rule out dysplasia. Subjects must be up-to-date on colorectal cancer surveillance per local standards and guidelines. The colorectal cancer screening may be performed during screening colonoscopy.
- •4. Moderate to severe active UC with an Adapted Mayo Score of 5 to 9, rectal bleeding subscore (RBS) =1, stool frequency subscore (SFS) =1, and endoscopic subscore (ESS) =2 at baseline (pre-randomization) as determined by blinded central read. ESS of =2 must be observed at =15 cm from the anal verge.
- •5. Demonstrated inadequate response, loss of response, or intolerance of at least 1 of the following treatments including oral corticosteroids, immunomodulators, IL-12/23 antagonists, and/or TNFa antagonists as defined in the protocol at inclusion criterias section
- •6. A female participant must be:
- •a) Not of childbearing potential OR
- •b) Of childbearing potential and practicing a highly effective method of contraception (failure rate of <1% when used consistently and correctly) and agrees to remain on a highly effective method while receiving study medication and until 30 days after receiving the last dose of study medication. (Appendix 6).
- •7. A female participant must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for a period of 30 days after receiving the last dose of study medication.
- •8. Women of childbearing potential (WOCBP) must have a negative serum pregnancy test at screening and a negative urine pregnancy test at Day 1 prior to the first dose of study medication.
- •9. Men with partners of child bearing potential must agree to use a highly effective method of contraception (failure rate of <1% when used consistently and correctly) and agree to remain on a highly effective method while receiving study medication and until 90 days after receiving last dose of study medication (Appendix 6).
- •10. A male participant must agree not to donate sperm for the purpose of reproduction during the study and for a minimum of 90 days after receiving the last dose.
- •11. Subject is eligible according to the tuberculosis (TB) screening criteria as stated in the protocol (Appendix 3).
- •For Inclusion criteria of Part 2, please refer to Study protocol.
- •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 135
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 15
排除标准
- •For exclusion criteria related to Part 1 and 2 of study protocol please refer to the study protocol, as the text space in the Appendix is not sufficient.
研究者
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