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Anti-inflammatory

ABX464 for Ulcerative Colitis

Verified Trial
Phase 3
Recruiting
Led By Severine Vermeire, MD, PhD
Research Sponsored by Abivax S.A.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Men or women at least 16 years old; Adolescent subjects will only be enrolled if approved by the country regulatory/health authority. If these approvals have not been granted, only subjects ≥ 18 years old will be enrolled. To be eligible, adolescent subjects must weight ≥ 40 kg and meet the definition of Tanner Stage 5 at the screening visit.
Active disease defined by modified Mayo score (MMS) ≥ 5 with rectal bleeding subscore (RBS) ≥ 1 and endoscopy subscore (MES) of 2 or 3 (confirmed by central reader).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 weeks
Awards & highlights
Pivotal Trial

Summary

This trial studies how well a new drug works to treat ulcerative colitis in people who aren't responding to other treatments.

Who is the study for?
This trial is for men and women at least 16 years old with ulcerative colitis (UC) that's moderately to severely active. They should have tried other UC treatments like corticosteroids, immunosuppressants, or biologics without success or couldn't tolerate them. Participants need to understand the study and consent to it, use effective birth control if necessary, and be able to follow the study schedule.
What is being tested?
ABTECT-2 is testing ABX464 at doses of 25 or 50 mg daily against a placebo in people with UC who haven't responded well to standard therapies. The goal is to see if ABX464 can induce clinical remission. This multicenter trial randomly assigns participants into different groups in a controlled environment.
What are the potential side effects?
While specific side effects for ABX464 are not listed here, common side effects from drugs treating UC may include headache, nausea, fatigue, abdominal pain, and potential increased risk of infection.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am at least 16 years old, weigh over 40 kg, and have fully developed physically.
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My condition involves active disease with specific scores for bleeding and endoscopy.
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I have not responded well to treatments like steroids, immunosuppressants, or biologics.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 weeks 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 subjects who achieve clinical remission per Modified Mayo Score at week 8
Secondary study objectives
Proportion of subjects who achieve clinical response per MMS at week 8
Proportion of subjects who achieve endoscopic improvement at week 8
Hemiarthroplasty
+1 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

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: ABX464 50mgExperimental Treatment1 Intervention
Subjects will be orally dosed daily in a fed condition (regular breakfast) in the morning with a glass of water during 8 weeks
Group II: ABX464 25mgExperimental Treatment1 Intervention
Subjects will be orally dosed daily in a fed condition (regular breakfast) in the morning with a glass of water during 8 weeks
Group III: PlaceboPlacebo Group1 Intervention
Subjects will be orally dosed daily in a fed condition (regular breakfast) in the morning with a glass of water during 8 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
3,835 Total Patients Enrolled
6 Trials studying Ulcerative Colitis
1,340 Patients Enrolled for Ulcerative Colitis
Severine Vermeire, MD, PhDPrincipal InvestigatorUZ Leuven, Belgium
1 Previous Clinical Trials
1,050 Total Patients Enrolled
Bruce Sands, MD, PhDPrincipal InvestigatorMount Sinai Health System Digestive Disease Institute, New York USA
1 Previous Clinical Trials
1,050 Total Patients Enrolled

Media Library

ABX464 (Anti-inflammatory) Clinical Trial Eligibility Overview. Trial Name: NCT05507216 — Phase 3
Ulcerative Colitis Research Study Groups: ABX464 50mg, ABX464 25mg, Placebo
Ulcerative Colitis Clinical Trial 2023: ABX464 Highlights & Side Effects. Trial Name: NCT05507216 — Phase 3
ABX464 (Anti-inflammatory) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05507216 — Phase 3
~210 spots leftby Nov 2025
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