CTIS2022-500537-84-01招募中1 期
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 - ABX464-107
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- Abivax
- 入组人数
- 1,241
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 65+（—）
- 性别
- All
入选标准
- •Inclusion criteria for the maintenance study: 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 1., Subjects must understand, sign and date the written voluntary informed consent form at the visit prior to any protocol-specific procedures. For underaged subjects, national requirements regarding consent should also be met., Women Of Child Bearing Potential (WOCBP) subjects and male subjects with a WOCBP partner must agree to comply with contraception requirements as described in the study 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., Inclusion criteria for the Long-Term Extension: 1.Subject must have completed the maintenance phase., Inclusion criteria for the Long-Term Extension: 2. Investigator and subject must assess and agree that the subject has received, and will continue to receive benefit from being in the study.
排除标准
- •Exclusion Criteria for the maintenance study: Subjects who permanently discontinued the study drug during the induction study (either ABX464-105 or ABX464-106)., Exclusion criteria for the LTE: 1. Subject continues to satisfy exclusion criteria listed above for the maintenance phase., Exclusion criteria for the LTE: 2. Introduction during maintenance phase of prohibited medications, dosages, surgical or non-medicinal procedures indicated for UC (except antidiarrheals and motility agents for acute diarrhea)., 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 non-medicinal 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.
研究者
相似试验
招募中
3 期
A clinical research evaluating the long term efficacy and safety of 2 different doses of obefazimod given once daily in subjects with moderate to severe ulcerative colitisCTRI/2023/05/053075Abivax SA
招募中
3 期
ABTECT - MaintenanceJPRN-jRCT2031230257jRCT Inquiries IQVIA Contact person80
进行中（未招募）
1 期
ABTECT-Maintenance – ABX464 Treatment Evaluation for ulcerative Colitis TherapyCTIS2022-500537-84-00Abivax1,036
进行中（未招募）
不适用
A randomized, double-blind, multi-center phase III study comparing everolimus (RAD001) plus best supportive care versus placebo plus best supportive care in patients with advanced gastric cancer after progression on prior systemic chemotherapyadvanced gastric cancerMedDRA version: 9.1Level: PTClassification code 10017758Term: Gastric cancerEUCTR2008-006544-20-DEovartis Pharma Services AG633
进行中（未招募）
不适用
A randomized, double-blind, multi-center phase III study comparing everolimus (RAD001) plus best supportive care versus placebo plus best supportive care in patients with advanced gastric cancer after progression on prior systemic chemotherapyEUCTR2008-006544-20-NLovartis Pharma Services AG633