A Phase 2b, Randomized, Double-Blind Long-Term Extension Study to Evaluate Pharmacokinetics, Efficacy, Safety, and Tolerability of TEV-48574 in Adult Patients with Moderate to Severe Ulcerative Colitis or Crohn’s Disease who completed the treatment phase of the Dose-Ranging Study (RELIEVE UCCD LTE)
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 187
- 试验地点
- 53
- 主要终点
- 1.Clinical remission based on modified (9-point rectal bleeding, stool frequency, and endoscopy) Mayo score of ≤2 points defined by a stool frequency subscore of 0 or 1, rectal bleeding subscore of 0, and an endoscopic subscore of 0 or 1, where a score of 1 does not include “friability” at week 44 in patients with UC
研究概览
简要总结
The primary objective of the study is to evaluate the efficacy of 2 different maintenance dose regimens of TEV 48574 subcutaneous (sc) administered every 4 weeks (Q4W) in adult patients with IBD (moderate to severe UC or CD) as assessed by maintenance of clinical remission (UC) and endoscopic response (CD) at end of maintenance period (EOM).
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 主要目的
- Ole Period
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •1.Maintenance Period: Adults of male and female sex (without restrictions based on gender) who achieved clinical response and/or clinical remission at week 14 of TV48574-IMM-20036 (the 14-week DRF study) or in the re-induction period of this study. OLE Period: Adults of male and female sex (without restrictions based on gender) who have clinical response and/or clinical remission at week 44 of the maintenance period of this study.
- •Re-induction Period: Adults of male and female sex (without restrictions based on gender) who did not achieve clinical response and/or clinical remission at week 14 of the TV48574-IMM-20036 DRF study
排除标准
- •1.Patients who discontinued the DRF study before scheduled week 14 visit (any reason including lack of efficacy, safety, or personal reasons).
- •The patient has any concomitant conditions or treatments that could interfere with study conduct, influence the interpretation of study observations/results, or put the patient at increased risk during the study as judged by the investigator and/or the clinical study physician.
- •Patient anticipates requiring major surgery during this study.
- •The patient is currently pregnant or lactating or is planning to become pregnant or to lactate during the study or for at least 50 days after administration of the last dose of IMP in case of early termination. Any woman becoming pregnant during the study will be withdrawn from the study.
结局指标
主要结局
1.Clinical remission based on modified (9-point rectal bleeding, stool frequency, and endoscopy) Mayo score of ≤2 points defined by a stool frequency subscore of 0 or 1, rectal bleeding subscore of 0, and an endoscopic subscore of 0 or 1, where a score of 1 does not include “friability” at week 44 in patients with UC
1.Clinical remission based on modified (9-point rectal bleeding, stool frequency, and endoscopy) Mayo score of ≤2 points defined by a stool frequency subscore of 0 or 1, rectal bleeding subscore of 0, and an endoscopic subscore of 0 or 1, where a score of 1 does not include “friability” at week 44 in patients with UC
2. Endoscopic response, defined as a decrease in Simple Endoscopic Score for Crohn’s Disease (SES-CD) of at least 50% from dose-range finding (DRF) study baseline at week 44 in patients with CD
2. Endoscopic response, defined as a decrease in Simple Endoscopic Score for Crohn’s Disease (SES-CD) of at least 50% from dose-range finding (DRF) study baseline at week 44 in patients with CD
次要结局
- 1. Clinical response, based on modified (9-point rectal bleeding, stool frequency, and endoscopy) Mayo score of at least 2 points AND at least a 30% reduction from DRF study baseline with either a decrease in rectal bleeding subscore of at least 1 or an absolute rectal bleeding subscore of less than or equal to 1 at week 44 in patients with UC
- 2. Endoscopic improvement from DRF study baseline based on Mayo endoscopic subscore of 0 or 1 at week 44 in patients with UC
- 3. Endoscopic remission based on Mayo endoscopic subscore of 0 at week 44 in patients with UC
- 4. Corticosteroid-free clinical remission based on the modified Mayo score at week 44, defined by clinical remission (see primary endpoint) and corticosteroid free for ≥12 weeks preceding week 44, in patients with UC.
- 5. Clinical response based on Crohn’s Disease Activity Index (CDAI): ≥100-point decrease in CDAI score from DRF study baseline in patients with CD at week 44
- 6. Clinical remission based on CDAI score <150 at week 44 in patients with CD
- 7. Corticosteroid-free endoscopic response based on SES-CD at week 44, defined by endoscopic response (see primary endpoint) and corticosteroid-free for ≥12 weeks preceding week 44, in patients with CD
- 8. Corticosteroid-free clinical remission based on CDAI at week 44, defined by a CDAI score of <150 points and corticosteroid-free for ≥12 weeks preceding week 44, in patients with CD
- 9. Adverse events Adverse events can include any of the following clinically significant changes in clinical laboratory test results (serum chemistry, hematology, and urinalysis), vital signs measurements (blood pressure, pulse rate, body temperature, and respiratory rate), 12-lead electrocardiogram (ECG), and injection site reactions
- 10. Patients who stopped the investigational medicinal product due to adverse events
- 11. Treatment-emergent anti-drug antibody (ADA)
- 12. Neutralizing ADA in ADA positive patients throughout the study
研究者
Medical Information
Scientific
Teva Branded Pharmaceutical Products R&D Inc.