A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Assess the Efficacy and Safety of Budesonide Foam (2 mg/25 mL BID for 2 Weeks, Followed by 2 mg/25 mL QD for 4 Weeks) Versus Placebo in Subjects With Active Mild to Moderate Ulcerative Proctitis or Proctosigmoiditis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 281
- 主要终点
- Percentage of Participants Who Achieved Remission
研究概览
简要总结
The purpose of this study is to establish the efficacy profile of rectally administered budesonide foam, as compared to an equivalent volume of rectally administered placebo foam over the same dosing schedule, in participants who present with a diagnosis of active, mild to moderate, ulcerative proctitis (UP) or ulcerative proctosigmoiditis (UPS). During the study, eligible participants will be allowed to maintain previously established oral 5-aminosalicylic acid (5-ASA) treatment at doses up to 4.8 grams/day (g/day).
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Voluntarily sign written informed consent.
- •Male or non-pregnant and non-lactating females.
- •Confirmed diagnosis (by endoscopy procedure) of active, mild to moderate UP or UPS, with disease extending at least 5 centimeters (cm) but no further than 40 cm from the anal verge.
- •Must possess a baseline MMDAI score between 5 and 10.
排除标准
- •History or current diagnosis of Crohn's disease and indeterminate colitis.
- •Prior gastrointestinal surgery except appendectomy and hernia.
- •Concomitant active gastrointestinal disease or distortion of intestinal anatomy.
- •History of diverticulitis, collagenous colitis, celiac disease, recurrent pancreatic or known gallbladder disease.
- •Uncontrolled, previously diagnosed type 1 or 2 diabetes mellitus.
- •Uncontrolled abnormal thyroid function.
- •Unstable significant cardiovascular, endocrine, neurologic or pulmonary disease.
- •Hemoglobin levels less than (<) 7.5 grams /deciliter (g/dL).
- •History of sclerosing cholangitis, cirrhosis, or hepatic impairment.
- •Renal disease manifested by greater than (>) 2.0 milligrams/deciliter (mg/dL) serum creatinine.
- •History of avascular hip necrosis, active tuberculosis, ocular herpes simplex or ocular varicella zoster, malignant disease, and HIV or hepatitis B or C.
- •Adrenal insufficiency.
- •Active systemic or cutaneous infection or toxic megacolon, fistula, perforation or abscess.
- •History of uncontrolled psychiatric disorders or seizure disorders.
- •History of asthma requiring ongoing use of inhaled steroids.
- •Recent history of drug or alcohol abuse.
- •Positive stool test for bacterial pathogens, Clostridium difficile toxin, or ovum and parasites.
- •Vaccination within 28 days prior to randomization.
- •Allergies to budesonide or to any other items used in its preparation.
- •Participation in another clinical trial in the past 30 days.
- •Pregnant or at risk of pregnancy.
- •Taking a prohibited medication. Some medications to treat UP/UPS are prohibited during participation in the study, including laxatives and anti-diarrhea medications; however, oral 5-ASA agents at doses up to 4.8 g/day and daily fiber supplements are allowed. Other medications (e.g., antibiotics, anti-seizure and anti-coagulant medicines) are also prohibited.
研究组 & 干预措施
Budesonide
Participants who were diagnosed with active mild to moderate UP or UPS, will receive 2 milligrams (mg)/25 milliliter (mL) of budesonide foam, rectally twice daily for a period of 2 weeks followed by 2 mg/25 mL of budesonide foam, rectally once daily for a period of 4 weeks.
干预措施: Budesonide (Drug)
Placebo
Participants who were diagnosed with active mild to moderate UP or UPS will receive 25 mL of placebo matching to budesonide foam twice daily for a period of 2 weeks followed by once daily for a period of 4 weeks.
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage of Participants Who Achieved Remission
时间窗: Week 6
Remission was a combined assessment of clinical and endoscopic variables, defined as an endoscopy score of less than or equal to (\<=) 1, a rectal bleeding score of 0, and an improvement or no change from baseline in stool frequency subscales of the Modified Mayo Disease Activity Index (MMDAI) at the end of 6 weeks of treatment. MMDAI was used to assess the overall disease activity for each participant. MMDAI evaluated 4 indices: stool frequency, rectal bleeding, physician's global assessment (PGA) and endoscopy findings each on a scale of 0 to 3 with a maximum total score of 12. Stool frequency MMDAI subscore ranged from 0-3, where 0 indicated normal number of stools per day and 3 indicated 5 or more stools than normal. Rectal bleeding MMDAI subscore ranged from 0-3, where 0 indicated no blood seen and 3 indicated blood alone passed. Endoscopy MMDAI subscore ranged from 0-3, where 0 indicated normal or inactive disease and 3 indicated severe disease (spontaneous bleeding, ulceration).
次要结局
- Percentage of Participants Who Achieved a Score of 0 for Rectal Bleeding Subscale and a Combined Score of <=2 for Bowel Frequency (BF) and Physician's Global Assessment (PGA) in the MMDAI Subscales at End of Week 6(Week 6)
- Percentage of Participants Who Achieved Improvement of >=1 Point From Baseline in the MMDAI Rectal Bleeding Subscale Score at End of Week 6(Week 6)
- Mean Change From Baseline to Week 6 in MMDAI Total Score and Subscale Scores(Baseline, Week 6)
- Percentage of Participants Who Achieved a Rectal Bleeding MMDAI Subscale Score of 0 at End of Week 6(Week 6)
- Number of Scheduled Assessments With Rectal Bleeding Responder Classification(Weeks 1, 2, 4, and 6)
- Percentage of Participants Who Achieved Improvement of >=1 Point From Baseline in the MMDAI Endoscopy Subscale Score at End of Week 6(Week 6)
- Percentage of Participants Who Achieved an Endoscopy MMDAI Subscale Score of 0 or 1 at End of Week 6(Week 6)
- Percentage of Participants Who Achieved >=3 Point Improvement From Baseline in the MMDAI Total Score Including Improvement of >=1 Point From Baseline in the MMDAI Rectal Bleeding Subscale Score and MMDAI Endoscopy Subscale at End of Week 6(Week 6)
- Percentage of Participants Who Achieved an MMDAI Total Score of <= 3 With Greater Than or Equal to (>=2) Points of Improvement From Baseline at the End of Week 6(Week 6)