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ABX464 for Ulcerative 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

Study Summary

This trial is testing a new drug to see if it helps people with Ulcerative Colitis and if it is safe to use long-term.

Eligible Conditions

Ulcerative Colitis

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ weeks 48 and 96

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Proportion of patients with clinical remission at week 48 compared to baseline of induction study (ABX464-103)

Secondary outcome measures

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

Chest pain

Influenza like illness

Nausea

Oropharyngeal pain

Haematoma

Peripheral vascular disorder

Dyspnoea

Dyspepsia

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

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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Abivax S.A.Lead Sponsor

20 Previous Clinical Trials

4,048 Total Patients Enrolled

7 Trials studying Ulcerative Colitis

2,785 Patients Enrolled for Ulcerative Colitis

Severine VERMEIRE, MDPrincipal InvestigatorUniversitaire Ziekenhuizen KU Leuven

1 Previous Clinical Trials

32 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research endeavor open to participants over 70 years of age?

"This medical study is open to participants aged between 18 and 75."

Answered by AI

To what extent might ABX464 be injurious to human health?

"There is preliminary evidence to suggest ABX464's safety, thus it was rated a 2 on our scale. We do not yet have any clinical data that supports its efficacy."

Answered by AI

Is enrollment for this research endeavor open at present?

"According to information accessed through clinicaltrials.gov, this particular medical trial is not currently accepting patients; the initial posting date was on January 13th 2020 and it hasn't been updated since December 21st 2021. Nonetheless, there are 409 other studies actively seeking participants at present."

Answered by AI

What type of individuals are eligible to partake in this experiment?

"This clinical trial is seeking 217 participants with ulcerative colitis or colitis between the ages of 18 and 75. To be eligible, applicants must have completed a 16-week induction period on ABX464-103, belong to a social security regimen (for French sites only), consent to participating in study visits and procedures as required by protocol, agree to using an effective contraceptive method during the study and for 6 months post completion of their participation (180 days) as well as meet criteria at week 48 that includes having achieved 2 points reduction from baseline Modified Mayo Score plus 30%, decrease rectal bleeding sub-score ≥ 1 point or absolute"

Answered by AI

What is the magnitude of patients engaged in this scientific endeavor?

"The trial is not currently enrolling patients, as the posting dates were January 13th 2020 and December 21st 2021. However, 406 studies for colitis and ulcerative diseases are presently open, with 3 trials recruiting participants to ABX464 specifically."

Answered by AI

Are there a substantial number of facilities offering this medical trial across North America?

"This study is being conducted by 5 operating sites, with Mount Sinai Hospital in Toronto, The Ottawa Hospital - General Campus in Ottawa and LHSC - Victoria Hospital in London being amongst the most prominent. Additionally there are another two medical centres involved."

Answered by AI

Does this research represent a pioneering investigation into the subject?

"ABX464 is the subject of three ongoing trials, which have taken place in multiple nations and urban centres since 2019. The original investigation was sponsored by Abivax S.A., included 40 participants across a Phase 2 drug approval process and has been followed up with nine further clinical studies."

Answered by AI

Recent research and studies

The Lancet Gastroenterology & HepatologyJournal

ABX464 (obefazimod) for Moderate-to-severe, Active Ulcerative Colitis: A Phase 2b, Double-blind, Randomised, Placebo-controlled Induction Trial and 48 Week, Open-label Extension

Vermeire, Severine, Bruce E Sands, Herbert Tilg, Zsolt Tulassay, Radoslaw Kempinski, Silvio Danese, Ivan Bunganič, et al.. 2022. “ABX464 (obefazimod) for Moderate-to-severe, Active Ulcerative Colitis: A Phase 2b, Double-blind, Randomised, Placebo-controlled Induction Trial and 48 Week, Open-label Extension”. The Lancet Gastroenterology & Hepatology. Elsevier BV. doi:10.1016/s2468-1253(22)00233-3.

clinicaltrials.govStudy

Efficacy and Safety Study of ABX464 as Maintenance Therapy in Patients With Moderate to Severe Ulcerative Colitis

2020. "Efficacy and Safety Study of ABX464 as Maintenance Therapy in Patients With Moderate to Severe Ulcerative Colitis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04023396.

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