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ABX464 for Colitis

Phase 2
Waitlist Available
Led By Severine VERMEIRE, MD
Research Sponsored by Abivax S.A.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up weeks 48 and 96
Awards & highlights
No Placebo-Only Group

Summary

This trial tests a 50mg pill of ABX464 for patients with moderate to severe Ulcerative Colitis who were in a previous study. The pill aims to reduce gut inflammation by calming the immune system.

Eligible Conditions
  • Colitis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~weeks 48 and 96
This trial's timeline: 3 weeks for screening, Varies for treatment, and weeks 48 and 96 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Proportion of patients with clinical remission at week 48 compared to baseline of induction study (ABX464-103)
Secondary study objectives
Change in Modified Mayo Score and in partial Modified Mayo Score
Clinical response at week 48
Endoscopic changes at week 48
+10 more

Side effects data

From 2019 Phase 2 trial • 32 Patients • NCT03093259
17%
Abdominal pain
17%
Headache
13%
Abdominal pain upper
9%
Chest pain
9%
Influenza like illness
9%
Nausea
4%
Peripheral vascular disorder
4%
Dyspnoea
4%
Dyspepsia
4%
Haematoma
4%
Oropharyngeal pain
4%
Alopecia
4%
Rhinitis
4%
Hypophosphataemia
4%
Anorectal discomfort
4%
Nasopharyngitis
4%
Oral herpes
4%
Anal fissure
4%
Influenza
4%
Sinusitis
4%
Upper respiratory tract infection
4%
Ligament sprain
4%
AST/ALT ratio
4%
Iron deficiency
4%
Back pain
4%
Poor quality sleep
4%
Skin discolouration
100%
80%
60%
40%
20%
0%
Study treatment Arm
ABX464
Placebo

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: ABX464 50mgExperimental Treatment1 Intervention
All subjects will receive ABX464 administered at 50 mg o.d for an overall period of 96 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ABX464
2021
Completed Phase 2
~310

Find a Location

Who is running the clinical trial?

Abivax S.A.Lead Sponsor
21 Previous Clinical Trials
4,230 Total Patients Enrolled
6 Trials studying Colitis
2,173 Patients Enrolled for Colitis
Severine VERMEIRE, MDPrincipal InvestigatorUniversitaire Ziekenhuizen KU Leuven
1 Previous Clinical Trials
32 Total Patients Enrolled
~37 spots leftby Nov 2025
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