NCT03849599已完成1 期
A Phase 1b Study to Evaluate the Safety of PRV-300 Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 37
- 试验地点
- 3
- 主要终点
- Incidence of Treatment-emergent adverse events (TEAEs),
研究概览
简要总结
The purpose of this study is to evaluate the safety and tolerability of PRV-300 for 12 weeks in subjects with active ulcerative colitis.
Subjects will receive either PRV-300 or placebo treatment. Each group will receive study drug over a total of 12 weeks, followed by an 8-week safety follow-up period.
详细描述
This is a Phase 1b, randomized, double-blind, placebo-controlled, parallel-group, multicenter study in adult subjects with moderately to severely active UC. Randomization will be stratified by Mayo score.
Subjects will receive either PRV-300 or placebo treatment. Each group will receive study drug over a total of 12 weeks, followed by an 8-week safety follow-up period. The total duration of the study will be 20 weeks, excluding the screening period.
The primary objective is to evaluate the safety and tolerability of PRV-300 for 12 weeks in subjects with active UC.
The secondary objectives are to evaluate the effect of PRV-300 for 12 weeks in subjects with active UC on:
- Pharmacodynamics: Changes in gene scores in colonic biopsies over the course of treatment.
- Pharmacokinetics: Peak (Cmax) and trough (Cmin) serum concentrations of PRV-300 in subjects with active UC.
- Immunogenicity: Immunogenicity of PRV-300 in subjects with active UC
- Endoscopic: Trends in endoscopic disease activity in subjects with active UC.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject must be a man or woman aged 18-75 years, inclusive.
- •Subject has a clinical diagnosis of UC at least 3 months before screening.
- •Subject has moderately to severely active UC, defined as a Mayo score of 6 to 12, inclusive, at screening.
- •Subject has a Mayo endoscopic subscore of ≥2 based on central read of the video sigmoidoscopy at screening.
- •Subject must be willing and able to adhere to the prohibitions and restrictions specified in this protocol.
排除标准
- •Subject has severe extensive colitis as evidenced by any of the following:
- •Current hospitalization for the treatment of UC.
- •Investigator judgment that the subject is likely to require a colectomy within 12 weeks of baseline.
- •Temperature ≥37.8 ºC (oral or tympanic) and a heart rate >90 bpm.
- •Subject has UC limited to <15 cm of the colon.
- •Subject has a diagnosis of CD or the presence or history of fistula or indeterminate colitis.
- •Presence of a gastrostomy, jejunostomy, ileostomy or colostomy.
- •Subject has had or is expected to have surgery for active gastrointestinal bleeding, peritonitis, intestinal obstruction, or intra-abdominal or pancreatic abscess requiring surgical drainage, or other conditions that may confound study evaluations from 2 months before screening through the end of this study.
- •Presence of symptomatic colonic or small bowel obstruction
- •History of colonic resection
- •History of colonic mucosal high-grade dysplasia
- •Subject has chronic or recurrent infectious disease
- •Subject has positive serology to human immunodeficiency virus (HIV) 1 or 2, hepatitis B virus (HBV) or hepatitis C virus (HCV) at screening.
- •Subject has any known malignancy or has a history of malignancy (with the exception of basal cell carcinoma; squamous cell carcinoma in situ of the skin; or cervical carcinoma in situ that has been treated with no evidence of recurrence; or squamous cell carcinoma of the skin that has been treated with no evidence of recurrence within 5 years before screening).
- •Subject has ever received PRV-300 (or CNTO 3157) or has known allergies, hypersensitivity, or intolerance to PRV-300 or its excipients; or known or suspected intolerance or hypersensitivity to any biologic medication or known allergies or clinically significant reactions to murine, chimeric, or human proteins, to monoclonal antibodies or antibody fragments; or a history of severe allergic reactions, angioedema, or anaphylaxis that might suggest risk for a reaction to a biologic agent.
- •Subject has any condition for which, in the opinion of the Investigator, participation would not be in the best interest of the subject (eg, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments.
结局指标
主要结局
Incidence of Treatment-emergent adverse events (TEAEs),
时间窗: 12 weeks
Assessment of safety and tolerability
次要结局
未报告次要终点
研究者
研究点 (3)
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