Investigate the safety and efficacy of study drug ABX464 compared with placebo in patients with moderate to severe ulcerative colitis who have failed to other treatments.
- Conditions
- Moderate to Severe Ulcerative ColitisMedDRA version: 20.1Level: LLTClassification code 10066678Term: Acute ulcerative colitisSystem Organ Class: 100000004856Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
- Registration Number
- EUCTR2018-003558-26-IT
- Lead Sponsor
- Abivax
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 232
A patient will be eligible to participate in this study if ALL the following criteria are met:
- Men or women age 18 - 75 years;
- Diagnosis of moderate to severe active UC confirmed by endoscopy and histology at least 12 Weeks prior to screening visit. Moderate to severe active UC defined by MMS of 4 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 [TNF] inhibitors, vedolizumab, JAK inhibitors and/or corticosteroid treatment.
- Patients receiving oral corticosteroids must have been on a stable dose of prednisone or prednisone equivalent (<=16 mg/day) or on beclomethasone diproprionate (<=5mg/day) or on budesonide MMX (<=6mg/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- Topical corticosteroids and topical 5-aminosalicylic acid preparations must have been withdrawn at least 2 Weeks prior to the screening visit;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 [TNF] 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 within 14 days prior to baseline:
o Hemoglobin > 9.0 g dL-1;
o Absolute neutrophil count >= 750 mm-3;
o Platelets >= 100,000 mm-3;
o Total serum creatinine <= 1.3 x ULN (upper limit of normal);
o Creatinine clearance > 50 mL min-1 by the Cockcroft-Gault equation within 60 days prior to baseline;
o Total serum bilirubin < 1.5 x ULN;
o Alkaline phosphatase, AST (SGOT) and ALT (SGPT) < 2 x ULN;
- Patients are able and willing to comply with study visits and procedures as per protocol;
- Patients should understand, sign and date the written voluntary informed consent form at the screening visit prior to any protocol-specific procedures are performed;
- Patients should be affiliated to a social security regimen (for French sites only);
- Females and males receiving the study treatment and their partners
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 known active infections at screening such as infected abdominal abscess, Clostridium difficile (stool antigen and toxin required), CMV, TB colitis 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;
¿ Use of any investigational or non-registered product within 3 months preceding baseline;
¿ Any condition, which in the opinion of the investigator, could compromise the patient's safety or adherence to the study protocol.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method