ABTECT - Maintenance
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: ABX464 50mg - Responder subjects at the end of induction Subjects will be orally dosed during 44 weeks |
Drug: ABX464
Administered once daily in the morning with food
Other Names:
|
| Experimental: ABX464 25mg - Responder subjects at the end of induction Subjects will be orally dosed during 44 weeks |
Drug: ABX464
Administered once daily in the morning with food
Other Names:
|
| Placebo Comparator: Placebo - Responder subjects at the end of induction Subjects will be orally dosed during 44 weeks |
Drug: Placebo
Administered once daily in the morning with food
|
| Experimental: ABX464 50mg - Non responder subjects at the end of induction Subjects will be orally dosed during 44 weeks |
Drug: ABX464
Administered once daily in the morning with food
Other Names:
|
| Experimental: ABX464 25mg - Non responder subjects at the end of induction Subjects will be orally dosed during 44 weeks |
Drug: ABX464
Administered once daily in the morning with food
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Rate of subjects in clinical remission [SFS = 0 or 1, RBS = 0 and endoscopy sub-score = 0 or 1 (friability is scored as 2)] at Week 44 [Week 44]
The study primary objective is to evaluate the efficacy of ABX464 versus placebo on the proportion of subjects in clinical remission at Week 44.
Secondary Outcome Measures
- Proportion of subjects with endoscopic improvement (Mayo Endoscopic Subscore (MES) = 0 or 1) at Week 44 [Week 44]
To evaluate the efficacy of ABX464 versus placebo on endoscopic improvement.
- Proportion of subjects with symptomatic remission (SFS = 0 or 1 and RBS = 0) at Week 44 [Week 44]
To evaluate the efficacy of ABX464 versus placebo on symptomatic remission
- Proportion of subjects with corticosteroid-free clinical remission (clinical remission at Week 44 and corticosteroid free for at least 12 weeks prior to Week 44 in the subpopulation with corticosteroids at maintenance study entry) [Week 44]
To evaluate the efficacy of ABX464 versus placebo on corticosteroid-free clinical remission.
- Proportion of subjects with sustained clinical remission at Week 44 [Week 44]
To evaluate the efficacy of ABX464 versus placebo to sustain clinical remission.
- Proportion of subjects with HEMI per Geboes scoring at Week 44 [Week 44]
To evaluate the efficacy of ABX464 on histologic-endoscopic mucosal improvement (HEMI) versus placebo
- Proportion of subjects with endoscopic remission (MES = 0) at Week 44. [Week 44]
To evaluate the efficacy of ABX464 versus placebo on endoscopic remission.
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Abivax S.A.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ABX464-107