- - 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
- - 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
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
- - Women of childbearing potential (WOCBP) subjects and male subjects with WOCBP partner
must agree to use highly effective contraception methods.
- - 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.
- - Subjects with ulcerative colitis limited to an isolated proctitis (≤ 15cm from anal
- - Subjects with primary sclerosing cholangitis or autoimmune hepatitis.
- - Subjects who have failed on 5-ASA therapy only.
- - Subjects with CD or presence or history of fistula, indeterminate colitis,
infectious/ischemic colitis or microscopic colitis (lymphocytic and collagenous
- - 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 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
- - Subjects on antidiarrheals (e.g., loperamide, diphenoxylate with atropine, etc.).
- - Subjects on probiotics (e.g., Culturelle® [Lactobacillus GG, i-Health, Inc.
- - Subjects who do not meet the washout period requirements prior to the screening
- - Subjects with the following hematological and biochemical laboratory parameters
obtained during the screening period:
- Hemoglobin ≤ 8.0 g dL-1.
- - Absolute neutrophil count < 750 mm-3.
- - Platelets < 100,000 mm-3.
- - Creatinine clearance < 50 mL.
min-1 (Cockroft-Gault formula)
- - Total serum bilirubin > 1.5 x ULN.
- - Alkaline phosphatase, aspartate aminotransferase (AST) and alanine
aminotransferase (ALT) > 2 x ULN.
- - Subjects with the following conditions (infection):
- Subjects with chronic or recurrent grade 3 or grade 4 infection, or with
opportunistic infection within the last 2 months prior to screening.
- - Herpes zoster reactivation within the last 2 months prior to screening.
- - Subjects with active infection at screening or any major episode of infection
that required hospitalization or treatment with intravenous antibiotics within 1
month of screening or during screening.
Fungal infection of nail beds is allowed.
- - Positive assay or stool culture for pathogens (ova and parasite examination,
bacteria) or positive test for Clostridium difficile toxin at screening.
difficile is positive, subject may be treated and retested ≥ 2 weeks after
- - Subjects with HIV infection.
- - Subjects having acute or chronic hepatitis B infection at screening (positive for
hepatitis B surface antigen [HbsAg], or negative for HbsAg and positive for
anti-hepatitis B core antibody in conjunction with detectable HBV DNA, or
detectable HBV DNA).
- - Subjects having acute or chronic hepatitis C infection at screening as defined by
positive for hepatitis C antibody (subjects successfully treated and without
recurrence ≥ 1 year with no detectable HCV RNA [assessed centrally] are
- - Active tuberculosis (TB) or untreated latent TB are ruled out.
For subjects with
positive or intermediate QuantiFERON test see section 188.8.131.52 of the current
- - 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
- - History or active malignancy (subjects with a 5-year disease free survival are
- - Serious illness requiring hospitalization within 4 weeks prior to screening (except UC
- - Subjects previously treated with ABX464.
- - 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