EUCTR2018-003558-26-HU进行中（未招募）1 期
A randomized, double blind, placebo controlled, parallel group, multiple dose, induction study to evaluate the safety, tolerability and optimal dose of ABX464 compared with placebo in patients with moderate to severe ulcerative colitis who have inadequate response, loss of response, or intolerance with at least one of the following agents: immunosuppressant treatment (i.e. azathioprine, 6-mercaptopurine, methotrexate), tumor necrosis factor alpha [TNF-a] inhibitors, vedolizumab, JAK inhibitors and/or corticosteroid treatment.
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- ABIVAX
- 入组人数
- 232
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •?Men or women age 18 - 75 years;
- •?Diagnosis of moderate to severe active UC (including ulcerative proctitis if proximal extension of disease occurs beyond 10 cm) confirmed by endoscopy and histology at least 12 Weeks prior to screening visit. Moderate to severe active UC defined by MMS of 5 to 9 inclusive (on a scale of 0-9). Moderate to severe active UC should be confirmed at screening visit with a centrally read endoscopy sub-score of at least 2 (on a scale of 0-3);
- •?Patients having either a documented inadequate response, no response, a loss of response, or an intolerance to either immunosuppressant treatment, tumor necrosis factor inhibitors, vedolizumab, JAK inhibitors and/or corticosteroid treatment. Inadequate response, no response, loss of response is defined as:
- •oActive disease or relapse in spite of thiopurines or methotrexate given at an appropriate dose for at least 3 months (i.e. azathioprine 2–2.5 mg/kg/day or mercaptopurine 1–1.5 mg/kg/day in the absence of leukopenia), and/or
- •oActive disease despite corticosteroids treatment (prednisolone up to 0.75 mg/kg/day) over a period of 4 Weeks, and/or
- •oActive disease or relapse in spite of adequate treatment with tumor necrosis factor inhibitors or vedolizumab, and/or
- •oActive disease or relapse in spite of adequate treatment with JAK inhibitors over a period of at least 6 Weeks.
- •?Patients receiving oral corticosteroids must have been on a stable dose of prednisone or prednisone equivalent (=20 mg/day) or on beclomethasone diproprionate (=5mg/day) or on budesonide MMX (=9mg/day) for at least 2 Weeks prior to the screening visit;
- •?Topical corticosteroids and topical 5-aminosalicylic acid preparations must have been withdrawn at least 2 Weeks prior to the screening visit;
- •?Patients who are on oral 5-aminosalicylic acid must have been on a stable dose for at least 4 Weeks prior to the screening visit;
- •?Patients who are receiving immunosuppressants in the form of azathioprine, 6-mercaptopurine, or methotrexate needed to be on a stable dose for at least 4 Weeks prior to screening visit. Patients taking methotrexate also are advised to take folic acid 1 mg/day (or equivalent) supplementation if there is no contraindication;
- •?Patients on probiotics must be on stable doses for at least 2 Weeks
- •prior to the screening visit;
- •?Patients on antidiarrheals must be on stable doses for at least 2 Weeks prior to the screening visit;
- •?Patients who have received tumor necrosis factor inhibitors,
- •vedolizumab or other biologics must have discontinued therapy at least 8 Weeks prior to the screening visit due to lack or insufficient efficacy or intolerance;
- •?Patients previously treated with cyclosporine, tacrolimus or JAK inhibitors must have discontinued therapy at least 4 Weeks prior to the screening visit due to lack or insufficient efficacy or intolerance;
- •?Patients previously treated with tube feeding, defined formula diets, or parenteral alimentation/nutrition must have discontinued treatment 3 Weeks before the screening visit and must be able to take, orally, appropriate amount of food (calories) and liquids to maintain body weight;
- •?Patients with surveillance colonoscopy defined as per ECCO guidelines;
- •?Patients with the following hematological and biochemical laboratory
- •parameters obtained at screening:
- •oHemoglobin > 9.0 g dL-1;
- •oAbsolute neutrophil count = 750 mm-3;
- •oPlatelets = 100,000 mm-3;
- •oTotal serum creatinine = 1.3 x ULN (upper limit of normal);
- •oCreatinine cle
排除标准
- •Patients who meet any of the following exclusion criteria will be
- •excluded from the study:
- •? Patients with Crohn's Disease (CD) or presence or history of fistula,
- •indeterminate colitis (IC), infectious/ischemic colitis or microscopic
- •colitis (lymphocytic and collagenous colitis);
- •? History of toxic megacolon, abdominal abscess, symptomatic colonic
- •stricture or stoma; history or imminent colectomy, colonic malignancy;
- •? History or current evidence of colonic dysplasia or adenomatous colonic
- •polyps. Patient with severe gastrointestinal complications; e.g., short
- •bowel syndromes, recent or planned bowel surgery, Ileostomy and/or
- •colostomy, recent bowel perforation;
- •? History of more than one episode of herpes zoster or a history (single
- •episode) of disseminated zoster;
- •? Patients with active infections at screening such as infected abdominal
- •abscess, Clostridium difficile (stool antigen and toxin required), CMV
- •[(positive immunoglobulin M (IgM)], TB and recent infectious
- •hospitalization;
- •? Patients previously treated with ABX464;
- •? Acute, chronic or history of clinically relevant pulmonary,
- •cardiovascular, hepatic, pancreatic or renal functional abnormality,
- •encephalopathy, neuropathy or unstable CNS pathology such as seizure
- •disorder, angina or cardiac arrhythmias, active malignancy or any other
- •clinically significant medical problems as determined by physical
- •examination and/or laboratory screening tests and/or medical history;
- •? Acute, chronic or history of immunodeficiency or autoimmune disease;
- •? History of malignancy excluding patients considered cured (5 years
- •disease free survivors);
- •? Serious illness requiring systemic treatment and/or hospitalization
- •within 3 Weeks prior to baseline;
- •? Pregnant or breast-feeding women;
- •? Illicit drug or alcohol abuse or dependence;
- •? Patients who received live vaccine 30 days or fewer before first dose of
- •study treatment and/or who's planning to receive such a vaccine during
- •the study duration;
- •XML File Identifier: eH3ov8zJHqwvtwl2fQ2ookflSos=
- •? Use of any investigational or non-registered product within 3 months or
- •within 5 half-lives preceding baseline, whichever is longer and during
- •? Any condition, which in the opinion of the investigator, could
- •compromise the patient's safety or adherence to the study protocol.
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