2022-500535-36-00撤回3 期
A randomized, double-blind, placebo-controlled, multicenter phase III study to evaluate the efficacy and safety of ABX464 once daily for induction treatment in subjects with moderately to severely active ulcerative colitis
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 发起方
- Abivax
- 入组人数
- 165
- 试验地点
- 43
- 主要终点
- Proportion of subjects who achieve clinical remission per Modified Mayo Score at week 8.
研究概览
简要总结
To compare the efficacy of ABX464 versus placebo on clinical remission.
入排标准
- 年龄范围
- 0 years 至 65+ years（65+ Years, 0-17 Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Men or women at least 16 years old; Adolescent subjects will only be enrolled if approved by the country regulatory/health authority. If these approvals have not been granted, only subjects = 18 years old will be enrolled. To be eligible, adolescent subjects must weight = 40 kg and meet the definition of Tanner Stage 5 at the screening visit.
- •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.
- •Documented diagnosis of UC > 90 days prior to baseline, confirmed by endoscopy and histology. Should histology results not be available at screening, results from biopsies taken at screening may be used.
- •Active disease defined by modified Mayo score (MMS) = 5 with rectal bleeding subscore (RBS) = 1 and endoscopy subscore (MES) of 2 or 3 (confirmed by central reader).
- •Subjects with documented inadequate response (defined as lack of response or loss of response or intolerance) to at least one of the following treatments: corticosteroids, immunosuppressant, biologic therapies, S1P receptor modulators and/or JAK inhibitors and/or new drugs approved during the study (note: failure to only 5-ASA is not accepted).
- •Women of childbearing potential (WOCBP) subjects and male subjects with WOCBP partner must agree to use highly effective contraception methods as stated in Section 4.
- •(Contraception) of the protocol.
- •Subjects 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 with ulcerative colitis limited to an isolated proctitis (≤ 15cm from anal verge).
- •Serious illness requiring hospitalization within 4 weeks prior to screening (except UC flare).
- •Subjects previously treated with ABX
- •Subjects with primary sclerosing cholangitis or autoimmune hepatitis.
- •Pregnant or breast-feeding women.
- •Illicit drug or alcohol abuse or dependence.
- •Subjects who received live vaccine within 3 months prior to screening and/or who’s planning to receive such a vaccine during the study duration.
- •Use of any investigational or non-registered product within 3 months or within 5 half-lives preceding baseline, whichever is longer and during the study.
- •Any condition, which in the opinion of the investigator, could compromise the subject’s safety or adherence to the study protocol.
- •Subjects who have failed on 5-aminosalicylic acid (5-ASA) therapy only.
- •Subjects with Crohn’s disease (CD) or presence or history of fistula, indeterminate colitis, infectious/ischemic colitis or microscopic colitis (lymphocytic and collagenous colitis).
- •Subjects who do not meet the washout period requirements prior to the screening endoscopy as described in the prohibited medication section of the study protocol.
- •History or current evidence of toxic megacolon, fulminant colitis, bowel perforation.
- •History of colon cancer, past or current evidence of low grade or high grade of colonic dysplasia and/or adenomatous polyps that have not been completely removed.
- •Recent or planned bowel surgery or history of proctocolectomy or partial colectomy or current stoma.
- •Subjects on antidiarrheals (e.g., loperamide, diphenoxylate with atropine, etc.).
- •Subjects on probiotics (e.g., Culturelle® [Lactobacillus GG, i-Health, Inc.], Saccharomyces boulardii).
- •Subjects with a known hypersensitivity to the active substance or to any of the excipients.
- •Subjects committed to an institution by virtue of an order issued either by the judicial or the administrative authorities.
- •Subjects with hematological and biochemical laboratory parameters obtained during the screening period, as described in the protocol.
- •Subjects with certain conditions (infection), as described in the protocol.
- •Subjects with an uncontrolled ischemic heart disease and/or a history of congestive heart failure with New York Heart Association (NYHA) class 3 or 4 symptoms.
- •Subjects with a family or personal history of congenital or acquired long QT syndrome, or subjects with a marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval [Fridericia or Bazett correction] >450 milliseconds for male and > 460 milliseconds for female).
- •Subjects with a history of torsade de pointe (TdP).
- •Acute or chronic of clinically relevant pulmonary, hepatic, pancreatic or renal functional abnormality, encephalopathy, neuropathy or unstable central nervous system pathology such as seizure disorder, or any other clinically significant medical problems as determined by physical examination and/or laboratory screening tests and/or medical history (note: treated autoimmune hypothyroidy and autoimmune diabetes are allowed).
- •History or active malignancy (subjects with a 5-year disease free survival are eligible).
结局指标
主要结局
Proportion of subjects who achieve clinical remission per Modified Mayo Score at week 8.
Proportion of subjects who achieve clinical remission per Modified Mayo Score at week 8.
次要结局
- Proportion of subjects who achieve endoscopic improvement at week 8.
- Proportion of subjects who achieve clinical response per MMS at week 8.
- Proportion of subjects with symptomatic remission at week 8.
- Proportion of subjects with HEMI per Geboes scoring at week 8.
- Incidence of all treatment-emergent adverse events (TEAEs), causally related TEAEs, all serious adverse events (SAE) and causally related SAEs classified by severity.
- Incidence of adverse events leading to investigational discontinuation and study discontinuation.
- Incidence of adverse events of special interest (AESIs).
- Incidence of clinically significant laboratory abnormalities.
- Incidence of clinically significant abnormalities regarding vital signs and ECG
研究者
Clinical Operations
Scientific
Abivax
研究点 (43)
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