Ulcerative colitis
Conditions
Interventions
Drug: ABX464
- Administered once daily in the morning with food
- Other Names: Obefazimod
Drug: Placebo
- Administered once daily in the morning with food
Sponsors
Shono Masushi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Men or women at least 16 years old. To be eligible, adolescent subjects must weight >= 40 kg and meet the definition of Tanner Stage 5 at the screening visit. 2.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. 3.Documented diagnosis of UC confirmed by endoscopy and histology. Should histology results not be available at screening, results from biopsies taken at screening may be used. 4.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). 5.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 accepted). a.Inadequate response to corticosteroids (CS) is defined as either a CS resistance (i.e., signs and symptoms of persistently active disease despite current or prior course of oral prednisone/prednisolone >= 40 mg/day for at least 2 weeks (For Japan: >= 30 mg/day for at least 2 weeks for moderate UC or >= 40 mg/day for at least 1 week for severe UC), or to budesonide >= 9 mg/day for at least 2 weeks, or to beclomethasone** >= 5 mg/day for at least 2 weeks) or a CS dependence (i.e., failure to taper to = 5 mg/kg intravenously at 0, 2, and 6 weeks), -adalimumab or biosimilars (160 mg subcutaneous dose followed by 80 mg SC, followed by 40 mg SC dose at least 2 weeks apart), -golimumab (200 mg SC dose followed by 100 mg SC dose at least 2 weeks apart), -vedolizumab (300 mg IV at 0, 2, and 6 weeks), -ustekinumab (one single IV using weight-based dosing - 260 mg for subjects with body 55 kg and 85 kg), -Loss of response is defined as recurrence of symptoms during maintenance course following primary response after full induction course (discontinuation despite clinical benefit does not qualify) I
Exclusion criteria
Exclusion criteria: 1.Subjects with UC limited to an isolated proctitis ( 1.5 x ULN -Alkaline phosphatase, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) > 2 x ULN 12.Subjects with the following conditions (infection): -Subjects with chronic or recurrent grade 3 or grade 4 infection within the last 2 months prior to screening or a history of opportunistic infection while not on immunosuppressive therapy. -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), positive serum B-D-glucan test (only for Japan), or positive test for Clostridium difficile toxin at screening. If C. difficile is positive, subject may be treated and retested >= 2 weeks after completing treatment. -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 but positive for anti-hepatitis B core antibody [HBcAb] and/or anti-hepatitis B surface antibody [HBsAb] in conjunction with detectable HBV-DNA). Subjects who were enrolled with positive HBcAb and/or HBsAb in conjunction with undetectable HBV-DNA should be monitored for HBV-DNA every 4 weeks. -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 eligible). Subjects who were enrolled with positive HCV antibody in conjunction with undetectable HCV-RNA should be monitored for HCV-RNA every 4 weeks. -Active tuberculosis (TB) or untreated latent TB are ruled out. For subjects with positive or intermediate QuantiFERON test see section 5.3.8.1 of the current study protocol. 13.Subjects with an uncontroll
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective is to compare the efficacy of ABX464 versus placebo on clinical remission. oProportion of subjects who achieve clinical remission per Modified Mayo Score at week 8. | — |
Countries
Argentina, Belgium, Bosnia, Brazil, Bulgaria, Canada, Croatia, Czech Republic, France, Germany, Greece, Hungary, India, Ireland, Israel, Italy, Japan, Lithuania, Mexico, New Zealand, Poland, Romania, Serbia, Slovenia, Spain, Taiwan, United Kingdom, United States
Contacts
Public ContactjRCT Call Center IQVIA Services Japan G.K.
IQVIA Services Japan G.K
Outcome results
None listed