A PHASE 2B, RANDOMIZED, DOUBLE-BLIND, PARALLEL-GROUP, PLACEBO-CONTROLLED STUDY WITH AN OPEN LABEL EXTENSION TO EVALUATE THE SAFETY AND EFFICACY OF PF-06826647 IN PARTICIPANTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- Pfizer
- 试验地点
- 24
- 主要终点
- Number of Participants With Clinical Laboratory Abnormalities
研究概览
简要总结
The purpose of this study is to evaluate efficacy and safety of PF-06826647 in moderate to severe ulcerative colitis
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
- •Participants with moderate to severe UC as defined by a total Mayo score of ≥6, with a rectal bleeding subscore of ≥1 and an endoscopic subscore of ≥2;
- •Participants must have inadequate response to, loss of response to, or intolerance to at least one conventional therapy for UC: Oral, intravascular, or intramuscular corticosteroids; Immunosuppressants (azathioprine [AZA], 6-MP, or methotrexate [MTX]); Anti-tumor necrosis factor (TNF) inhibitors (eg, infliximab, adalimumab, or golimumab); Anti-integrin inhibitors (eg, vedolizumab); JAK inhibitor (eg, tofacitinib); Anti-IL-12/IL-23 inhibitors (eg, ustekinumab).
排除标准
- •Presence of indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, radiation colitis, and diverticular disease associated with colitis, or Crohn's disease
- •Participants displaying clinical signs of fulminant colitis or toxic megacolon;
- •Participants with evidence of colonic dysplasia, adenomas or neoplasia.
研究组 & 干预措施
Placebo
Placebo
干预措施: Placebo (Drug)
PF-06826647 100 mg once a day (QD)
PF-06826647 100 mg once a day (QD)
干预措施: PF-06826647 100 mg QD (Drug)
PF-06826647 300 mg QD
PF-06826647 300 mg QD
干预措施: PF-06826647 300 mg QD (Drug)
PF-06826647 600 mg QD
PF-06826647 600 mg QD
干预措施: PF-06826647 600 mg QD (Drug)
Open Label Extension, PF-06826647 400 mg QD
PF-06826647 400 mg QD
干预措施: PF-6826647 400 mg QD (Drug)
结局指标
主要结局
Number of Participants With Clinical Laboratory Abnormalities
时间窗: At Week 60
Following parameters will be analyzed for laboratory examination: hematology (hemoglobin, hematocrit, red blood cell count, platelet count, white blood cell count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes); liver function (aspartate aminotransferase, alanine aminotransferase, total bilirubin, lactate dehydrogenase, alkaline phosphatase, albumin, total protein); renal function (blood urea nitrogen, creatinine, uric acid); electrolytes (sodium, potassium, chloride, calcium, phosphate, bicarbonate); clinical chemistry (glucose, creatine kinase); immunology (CRP); urinalysis (dipstick \[urine specific gravity, decimal logarithm of reciprocal of hydrogen ion activity {pH} of urine, glucose, protein, blood, ketones, bilirubin\], microscopy \[urine RBC, WBC, urate crystals, calcium, oxalate, miscellaneous \[urine mucus and leucocytes\]).
Percentage of participants achieving endoscopic response
时间窗: At Week 8
Endoscopic response is defined by Mayo endoscopic index \< 2
Number of Adverse Events (AEs), Serious Adverse Events (SAEs) based on severity and withdrawals due to adverse events (AEs)
时间窗: At Week 60
Percentage of participants with clinically significant changes in Electrocardiogram (ECG)
时间窗: At Week 60
Clinical significant changes in ECG
Number of Participants With Categorical changes from baseline in Vital Signs Data
时间窗: At Week 60
Number of participants with increase from baseline in sitting SBP and DBP of greater than or equal to 30 mmHg at Week 60.
次要结局
- Percentage of participants achieving endoscopic remission(At Week 8 and 60)
- Number of Participants With Clinical Laboratory Abnormalities(At Week 8)
- Percentage of participants achieving clinical remission(At Week 8 and 60)
- Change from baseline in total Mayo score(At Week 8 and 60)
- Percentage of participants with clinically significant changes in Electrocardiogram (ECG)(At Week 8)
- Number of Participants With Categorical Vital Signs Data(At Week 8)
- Percentage of participants achieving mucosal healing(At Week 8 and 60)
- Percentage of participants achieving clinical response(At Week 8 and 60)
- Mean change from baseline in partial Mayo score over time(Up to 60 weeks)
- Number of Adverse Events (AEs), Serious Adverse Events (SAEs) based on severity and withdrawals due to adverse events (AEs)(At Week 8)