A Phase IIa study to evaluate the safety and efficacy of ABX464 50 mg once daily versus Placebo in subjects with Moderate to Severe Active Ulcerative Colitis who have failed or are intolerant to immunomodulators, Anti-TNFa, vedolizumab and/or corticosteroids. - Safety and efficacy study of ABX464 in patients with moderate to severe Active Ulcerative Colitis.

ABIVAX0 sites30 target enrollmentSeptember 19, 2017

ConditionsModerate to severe Ulcerative Colitis.MedDRA version: 20.0Level: LLTClassification code 10066678Term: Acute ulcerative colitisSystem Organ Class: 100000016670 Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Moderate to severe Ulcerative Colitis.
Sponsor: ABIVAX
Enrollment: 30
Status: Active, not recruiting
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

September 19, 2017

End Date

TBD

Last Updated

7 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

ABIVAX

Eligibility Criteria

Inclusion Criteria

•\-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•\-Topical corticosteroids and topical 5\-aminosalicylic acid preparations must have been withdrawn \=2 weeks before the screening visit;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;

Exclusion Criteria

•\-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;