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ABX464 Maintenance Therapy 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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 years

Awards & highlights

Pivotal Trial

Summary

This trial is to evaluate the long-term effects of ABX464 on ulcerative colitis sufferers who have not responded to other treatments.

Who is the study for?

This trial is for people with moderate to severe ulcerative colitis who didn't get better with standard or advanced treatments. They must have finished a previous ABX464 study and can't be planning pregnancy soon. Participants need valid endoscopy results, agree to use effective contraception, sign consent forms, and commit to the study schedule.

What is being tested?

The trial tests long-term effects of two doses of ABX464 (50mg or 25mg) as daily maintenance therapy compared to a placebo. It's randomized: some get the real drug without knowing if it's high or low dose; others get a fake pill. The treatment lasts 44 weeks followed by an evaluation after another 28 days.

What are the potential side effects?

While specific side effects aren't listed here, participants will be monitored for any adverse reactions due to ABX464 which could include typical drug-related issues like gastrointestinal discomfort, potential allergic reactions, or other organ-specific inflammation.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number and percentage of all causally related TEAEs/SAEs

Number and percentage of all serious adverse events (SAEs)

Number and percentage of all treatment-emergent adverse events (TEAEs)

+1 more

Secondary study objectives

LTE Phase - Proportion of subjects in clinical remission at Year 1

LTE Phase - Proportion of subjects in clinical remission at Year 4

LTE Phase - Proportion of subjects with CS-free clinical remission at LTE Year 1

+23 more

Side effects data

From 2019 Phase 2 trial • 32 Patients • NCT03093259

17%

Abdominal pain

17%

Headache

13%

Abdominal pain upper

Chest pain

Influenza like illness

Nausea

Peripheral vascular disorder

Dyspnoea

Dyspepsia

Haematoma

Oropharyngeal pain

Alopecia

Rhinitis

Hypophosphataemia

Anorectal discomfort

Nasopharyngitis

Oral herpes

Anal fissure

Influenza

Sinusitis

Upper respiratory tract infection

Ligament sprain

AST/ALT ratio

Iron deficiency

Back pain

Poor quality sleep

Skin discolouration

100%

80%

60%

40%

20%

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

6Treatment groups

Experimental Treatment

Placebo Group

Group I: Long Term ExtensionExperimental Treatment1 Intervention

At the end of the maintenance phase (week 44), subjects can continue their allocated treatment for up to 4 years. Once the maintenance phase is unblinded, subjects receiving placebo in the maintenance phase will be allocated to obefazimod 25 mg or can terminate the study.

Group II: ABX464 50mg - Non responder subjects at the end of inductionExperimental Treatment1 Intervention