moderately to severely active ulcerative colitis
Conditions
Interventions
Placebo group:Placebo
50mg dose group:ABX464-50 mg QD
25mg dose group:ABX464-25 mg QD
Sponsors
The First Affiliated Hospital,Sun Yat-sen University
Eligibility
Sex/Gender
All
Age
16 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Subjects must have completed the induction treatment study (ABX464-105 or ABX464-106), and subjects’ clinical response status must be available; 2. Subjects with a valid endoscopy performed at the end of the induction study and results from central reader available at Day 1; 3. 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; 4. Women of childbearing potential (WOCBP) subjects and male subjects with WOCBP partner must agree to use highly effective contraception methods as stated in Section 4.4. (Contraception) of this protocol; 5. Subjects must be able and willing to comply with study visits and procedures as per protocol; 6. Subjects should be affiliated to a health insurance policy whenever required by a participating country or state.
Exclusion criteria
Exclusion criteria: 1. Subjects who permanently discontinued the study treatment during the induction study (either ABX464-105 or ABX464-106); 2. Subjects who have developed any major illness/condition or evidence of an unstable clinical condition (except UC) during the induction study that, in the investigator's judgment, will substantially increase the risk to the participant if he or she participates in the study; 3. Subjects who plan to participate in other investigational studies during the maintenance study; 4. Pregnant or breast-feeding women or male subject of a pregnant partner; 5. Male or female subjects planning a pregnancy within the coming 12 months; 6. Subjects who have not adhered to abstinence of prohibited and/or concomitant medications; 7. Any changes in the laboratory values during the induction period that correspond with the following. • Hemoglobin 1.5 × ULN • Alkaline phosphatase, aspartate aminotransferase (AST), and alanine aminotransferase (ALT) > 2 × ULN
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| clinical remission;symptomatic remission;corticosteroid-free clinical remission; | — |
Secondary
| Measure | Time frame |
|---|---|
| endoscopic improvement;sustained clinical remission;HEMI per Geboes;endoscopic remission; | — |
Countries
China
Contacts
Public ContactBaili Chen
The First Affiliated Hospital, Sun Yat-sen University
Outcome results
None listed