A randomized, double-blind, multicenter phase III study to evaluate the long-term efficacy and safety of ABX464 25 mg or 50 mg once daily as a maintenance therapy in subjects with moderately to severely active ulcerative colitis. – ABTECT Maintenance
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- Abivax SA
- 入组人数
- 1,100
- 试验地点
- 36
- 主要终点
- To evaluate the efficacy of ABX464 versus placebo on the proportion of subjects in clinical remission at Week 44
研究概览
简要总结
This is a multicenter, randomized,blinded study to evaluate the long-term efficacy and safety of ABX464 50mg and25mg administered once daily (QD) as maintenance therapy following completionof 8-week induction treatment (Induction Studies ABX464-105 or ABX464-106) insubjects with moderately to severely active ulcerative colitis who haveinadequate response, no response, a loss of response, or an intolerance toeither conventional therapies [corticosteroids, immunosuppressant (i.e.azathioprine, 6-mercaptopurine, methotrexate)] and/or advanced therapies[biologics (TNF inhibitors, anti-integrins, anti-IL-23), and/or S1P receptormodulators, and/or JAK inhibitors].
This study is the maintenance phaseof the Phase 3 clinical development program sequential to previous inductionstudies ABX464-105 and ABX464-106.
All eligible subjects who havecompleted either one of the induction studies above mentioned, will beencouraged to take part in the present ABX464-107 maintenance study and will berandomized to either a double blind, placebo-controlled part (Part #1) orallocated to ABX464 50mg or 25mg blinded ABX464 treatment arms (Part #2)depending on their clinical response at the end of induction as shown below.
This study consists of a 44-week treatment phaseand a 28-days follow-up period concluding in the End of Study (EOS) visit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •A subject will be eligible to participate in this study if ALL the following criteria are met:
- •Male or female (at birth) at least 16 years old, except in EU/EEA, Israel, Serbia and Ukraine,where subjects must be at least 18 years old at the time of eligibility assessment.
- •Where enrolment of adolescents is allowed, adolescent subjects must weigh > 40 kg and meet the definition of Tanner stage 5 at screening.
- •Subjects must have completed the induction treatment study (ABX464-105 or ABX464-106), and subjects’ clinical response status must be available.
- •Subjects with a valid endoscopy performed at the end of the induction study and results from central reader available at Day
- •Subjects must understand, sign and date the written voluntary informed consent form at the visit prior to any protocol-specific procedures.
- •For under-aged subjects, national requirements regarding consent should also be met.
- •WOCBP subjects and male subjects with a WOCBP partner must agree to comply withcontraception requirements as described in Section 4.4 of this protocol.
- •Subjects must be able and willing to comply with study visits and procedures as per protocol.
- •Subjects should be affiliated to a health insurance policy whenever required by a participating country or state.
排除标准
- •Subjects who meet ANY of the following exclusion criteria will be excluded from the study:
- •Subjects who permanently discontinued the study drug during the induction study (either ABX464-105 or ABX464-106).
- •Subjects who have developed any major illness/condition (eg.
- •primary sclerosis cholangitis, Crohn’s disease, colectomy, diverting ileostomy, colon cancer or colonic adenomas [low or high grade dysplasia]).
- •Subjects with evidence of an unstable clinical condition (eg.
- •toxic megacolon, fulminant colitis, bowel perforation, uncontrolled ischemic disease, congestive heart failure with NYHA class 3 or 4 symptoms) during the induction study that, in the investigator’s judgment, will substantially increase the risk to the subject if he or she participates in the study.
- •Subjects who plan to participate in other investigational studies during the maintenance study.
- •Male or female subjects planning a pregnancy, or pregnant female subjects.
- •Introduction during induction study of prohibited medications, dosages, surgical or nonmedicinal procedures indicated for UC (except antidiarrheals and motility agents for acute diarrhea).
- •Any changes in the laboratory values during the induction period that could jeopardize subject’s safety in the opinion of the investigator.
- •If any doubts, the investigator should contact the sponsor study medical monitor.
- •Subject who is planning to receive live vaccine during the study.
- •Subjects committed to an institution by virtue of an order issued either by the judicial or the administrative authorities.
结局指标
主要结局
To evaluate the efficacy of ABX464 versus placebo on the proportion of subjects in clinical remission at Week 44
时间窗: week 44
次要结局
- • To compare the efficacy of obefazimod versus placebo on endoscopic improvement.(• To compare the efficacy of obefazimod versus placebo on CS-free clinical remission.)