ABTECT - Maintenance

ID#: NCT05535946

Age: 16 years - 66+

Gender: All

Healthy Subjects: No

Study Phase: Phase 3

Recruitment Status: Recruiting

Start Date: January 16, 2023

End Date: June 01, 2025

Contact Information:
Sharon Skare,, CPhil
Summary: This is a multicenter, randomized study to evaluate the long-term efficacy and safety of ABX464 50mg and 25mg administered once daily (QD) as maintenance therapy in subjects with moderately to severely active ulcerative colitis who have inadequate response, no response, a loss of response, or an intolerance to either conventional therapies [corticosteroids, immunosuppressant (i.e. azathioprine, 6-mercaptopurine, methotrexate)] and/or advanced therapies [biologics (TNF inhibitors, anti-integrins, anti-IL-23), and/or S1P receptor modulators, and/or JAK inhibitors]. This study is the maintenance phase of both previous induction studies ABX464-105 and ABX464-106. All eligible subjects who have completed either one of the induction studies above mentioned, will be given the opportunity to take part in the present ABX464-107 maintenance study and will be randomized to either a double blind, placebo-controlled part (Part #1) or allocated to ABX464 50mg or 25mg open label treatment arms (Part #2) depending on their clinical response at the end of induction. This study consists of a 44-week treatment phase and a 28-days follow-up period consisting in the End of Study (EOS) visit.

Inclusion Criteria:

- Subjects must have completed the induction treatment study (ABX464-105 or ABX464-106), and patients' clinical response status must be available.

- Subjects with a valid endoscopy performed at the end of the induction study and results from central reader available at Day 1.

- 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.

- 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.

- Subjects must be 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

Exclusion Criteria:

- Subjects who permanently discontinued the study treatment during the induction study (either ABX464-105 or ABX464-106).

- 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.

- Subjects who plan to participate in other investigational studies during the maintenance study.

- Male or female planning a pregnancy within the coming 12 months