Brief Summary

This is a multicenter, randomized, placebo-controlled 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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Strong global presence with extensive site network

Enrollment

1,116

participants targeted

Target at P75+ for phase_3

Timeline

49mo left

Started Jan 2023

Longer than P75 for phase_3

Geographic Reach

33 countries

541 active sites

Status

active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

7.3 years study duration

Study Progress45%

Jan 2023May 2030

First Submitted

Initial submission to the registry

September 7, 2022

Completed

3 days until next milestone

First Posted

Study publicly available on registry

September 10, 2022

Completed

4 months until next milestone

Study Start

First participant enrolled

January 16, 2023

Completed

3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2026

Completed

4.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2030

Expected

Last Updated

October 24, 2025

Status Verified

October 1, 2025

Enrollment Period

3.2 years

First QC Date

September 7, 2022

Last Update Submit

October 23, 2025

Conditions

Ulcerative Colitis

Outcome Measures

Primary Outcomes (4)

Rate of subjects in clinical remission at Week 44
The Part 1 primary objective is to compare the efficacy of ABX464 versus placebo on the proportion of subjects in clinical remission \[SFS = 0 or 1, RBS = 0 and endoscopy sub-score = 0 or 1\] at Week 44.
Week 44
Number and percentage of all treatment-emergent adverse events (TEAEs)
The Part 2 primary objective is safety
Week 44
Number and percentage of all serious adverse events (SAEs)
The Part 2 primary objective is safety
Week 44
Number and percentage of all causally related TEAEs/SAEs
The Part 2 primary objective is safety
Week 44

Secondary Outcomes (26)

Proportion of subjects with endoscopic improvement at Week 44
Week 44
Proportion of subjects with corticosteroid-free clinical remission
Week 44
Proportion of subjects with sustained clinical remission at Week 44
Week 44
Proportion of subjects with HEMI per Geboes scoring at Week 44
Week 44
Proportion of subjects with endoscopic remission at Week 44
Week 44
+21 more secondary outcomes