Investigate the efficacy and safety of study drug ABX464 50 mg once daily versus placebo with patients with moderate to severe Active Ulcerative Colitis.
- Conditions
- Moderate to severe Ulcerative Colitis.MedDRA version: 20.0Level: LLTClassification code 10066678Term: Acute ulcerative colitisSystem Organ Class: 100000016670Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
- Registration Number
- EUCTR2017-000937-30-FR
- Lead Sponsor
- ABIVAX
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 30
-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 Mayo Clinic Score (MCS) of 6 to 12 inclusive (on a scale of 0-12). Moderate to severe active UC should be confirmed at screening visit with a centrally read MCS endoscopy score of at least 2 (on a scale of 0-3);
-Subjects 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 =2 weeks before the screening visit;
-Topical corticosteroids and topical 5-aminosalicylic acid preparations must have been withdrawn =2 weeks before the screening visit;
-Subjects who are on oral 5-aminosalicylic acid must have been on a stable dose =4 weeks before the screening visit;
-Subjects who are receiving immunosuppressants in the form of azathioprine, 6-mercaptopurine, or methotrexate needed to be on a stable dose for 4 weeks before the screening visit. Subjects taking methotrexate also are advised to take folic acid 1 mg/day (or equivalent) supplementation if there is no contraindication;
-Subjects on probiotics (e.g., Culturelle® [Lactobacillus GG, i-Health, Inc.], Saccharomyces boulardii) must be on stable doses for 2 weeks before the screening visit;
-Subjects on antidiarrheals (e.g., loperamide, diphenoxylate with atropine) must be on stable doses for 2 weeks before the screening visit;
-Subjects who have previously received anti-tumor necrosis factor (TNF) therapy or vedolizumab must have discontinued therapy =8 weeks before the screening visit;
-Subjects previously treated with cyclosporine or tacrolimus must have discontinued therapy =4 weeks before the screening visit;
-Subjects previously treated with tube feeding, defined formula diets, or parenteral alimentation/nutrition must have discontinued treatment 3 weeks before the screening visit;
-Subjects with hematological and biochemical laboratory parameters as follows and within 14 days of baseline:
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 clearance > 50 mL min-1 by the
Cockcroft-Gault equation within 60 days of entry;
oTotal serum bilirubin < 1.5 x ULN;
oAlkaline phosphatase, AST (SGOT) and ALT (SGPT) < 1.5 x
ULN;
-Subjects should be able and willing to comply with study visits and procedures as per protocol;
-Subjects should understand, sign and date the written voluntary informed consent form at the screening visit prior to any protocol-specific procedures being performed;
-Subjects should be affiliated to a social security regimen (for French sites only);
-Females and males receiving the study treatment and their partners must agree to use a highly effective contraceptive method during the study and for 3 months after end of study or early termination. Contraception should be in place at least 2 weeks prior to study participation. Women must be surgically sterile or if of childbearing potential must use a highly effective contraceptive method. Women of childbearing potential (WOCBP) will enter the study after confirmed menstrual period and a negative pregnancy test. Highly effective methods of contraception include true abstinence, int
-Subject with Crohn's Disease (CD), indeterminate colitis (IC) or presence or history of fistula with CD;
-History of toxic megacolon, abdominal abscess, symptomatic colonic stricture or stoma; history or is at imminent risk of colectomy;
-History or current evidence of colonic dysplasia or adenomatous colonic polyps. Subject with severe gastrointestinal complications; e.g., short bowel syndromes, obstructing strictures, recent or planned bowel surgery, Ileostomy and/or colostomy, recent bowel perforation;
-Subject with significant and known active infections at screening such as Infected abscess, positive for Clostridium difficile (stool antigen and toxin), CMV, TB and recent infectious hospitalization;
- Acute, chronic or history of clinically relevant pulmonary, cardiovascular, hepatic, pancreatic or renal functional abnormality, encephalopathy, neuropathy or unstable CNS pathology, angina or cardiac arrhythmias, 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 unless there has been surgical excision that is considered to have achieved cure;
- Active malignancy that may require chemotherapy or radiation therapy;
- Seizure disorder or any history of prior seizure;
- Serious illness requiring systemic treatment and/or hospitalization within 3 weeks prior to baseline;
- Pregnant or breast-feeding woman;
- Active 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 subject'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