ABX464 for Ulcerative Colitis

Recruiting at 275 trial locations

Overseen By John Hong, MD

Age: Any Age

Sex: Any

Trial Phase: Phase 3

Sponsor: Abivax S.A.

Must not be taking: Antidiarrheals, Probiotics

Disqualifiers: Proctitis, Hepatitis, Heart disease, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

612 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called ABX464 for people with ulcerative colitis (UC), a condition that inflames the colon, causing symptoms like diarrhea and abdominal pain. The researchers aim to determine if ABX464 can bring the condition into remission, reducing or eliminating symptoms. Participants will receive either 25 mg or 50 mg of ABX464, or a placebo, to compare its effectiveness and safety. The trial seeks participants with moderate to severe UC who haven't found success with other treatments like steroids or biologics. As a Phase 3 trial, this study represents the final step before FDA approval, offering early access to a potentially effective treatment.

Will I have to stop taking my current medications?

The trial protocol does not specify if you must stop taking your current medications, but it mentions a 'washout period' requirement before the screening endoscopy. This suggests that you might need to stop certain medications before participating. Please consult with the trial team for specific guidance.

Is there any evidence suggesting that ABX464 is likely to be safe for humans?

Research has shown that ABX464 is safe and well-tolerated in past studies. In one study, 19 patients took 50 mg of ABX464 daily for a year and found it safe and manageable over the long term. Another study also reported excellent safety results for ABX464 in patients with moderate to severe ulcerative colitis over a year.

These results encourage those considering joining a trial. ABX464 appears safe, with no major side effects reported in these studies. However, since individual experiences can vary, discussing any concerns with a healthcare provider is important. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for ulcerative colitis?

ABX464 is unique because it offers a novel approach to treating ulcerative colitis. Unlike standard treatments like mesalamine, corticosteroids, or TNF inhibitors, ABX464 works by enhancing the body's natural anti-inflammatory response through a unique mechanism that involves boosting microRNA-124. This new pathway could potentially lead to better outcomes with fewer side effects, which is why researchers are excited about its potential.

What evidence suggests that ABX464 might be an effective treatment for ulcerative colitis?

Research has shown that ABX464 offers promising results for treating ulcerative colitis. In one study, after 8 weeks, ABX464 outperformed a placebo in easing symptoms and reducing disease severity. This trial will test two different dosages of ABX464, 50 mg and 25 mg, against a placebo. Another study found that 58.4% of patients experienced clinical remission after taking 50 mg daily for 48 weeks. Long-term data indicate that ABX464 can maintain and even improve its effectiveness over time. These findings suggest that ABX464 might be a good option for people with moderate to severe ulcerative colitis. ^{1 4 6 7 8}

Who Is on the Research Team?

Severine Vermeire, MD, PhD

Principal Investigator

UZ Leuven, Belgium

Bruce Sands, MD, PhD

Principal Investigator

Mount Sinai Health System Digestive Disease Institute, New York USA

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Subjects should be affiliated to a health insurance policy whenever required by a participating country or state

Subjects able and willing to comply with study visits and procedures as per protocol.

I am using or willing to use effective birth control methods.

Exclusion Criteria

I have tried 5-ASA therapy for my condition without success.

I have hepatitis B.

Alkaline phosphatase, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) > 2 x ULN

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive ABX464 or placebo daily for 8 weeks to evaluate efficacy and safety in inducing clinical remission

8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• ABX464

Trial Overview 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.

How Is the Trial Designed?

Group I: ABX464 50mg Experimental Treatment 1 Intervention

Subjects will be orally dosed daily in a fed condition (ideally at the same time in the morning) for 8 weeks

Group II: ABX464 25mg Experimental Treatment 1 Intervention

Subjects will be orally dosed daily in a fed condition (ideally at the same time in the morning) for 8 weeks

Group III: Placebo Placebo Group 1 Intervention

Subjects will be orally dosed daily in a fed condition (ideally at the same time in the morning) for 8 weeks

Who Is Running the Clinical Trial?

Abivax S.A.

Lead Sponsor

Trials

22

Recruited

4,400+

Citations

1. ir.abivax.com ir.abivax.com/news-releases/news-release-details/abivax-reports-excellent-one-year-efficacy-and-safety-data

Abivax reports excellent one-year efficacy and safety data of ... ABX464 can induce short-term and, more importantly, maintain and even improve long-term efficacy in patients with in moderate to severe ulcerative colitis.

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40417999/

Obefazimod in patients with moderate-to-severely active ... Obefazimod has demonstrated safety and efficacy in patients with moderate-to-severely active ulcerative colitis (UC) in a phase 2b induction trial.

3. gastrojournal.org gastrojournal.org/article/S0016-50852100459-5/fulltext

Induction and Long-term Follow-up With ABX464 for ... After 8 weeks of treatment, ABX464 appeared to be more effective than placebo in achieving endoscopic improvement and reduction of the MCS and ...

4. academic.oup.com academic.oup.com/ecco-jcc/article/19/5/jjaf074/8149142

Obefazimod in patients with moderate-to-severely active ... In this subset, clinical remission was achieved by 81/119 patients (68.1%) at week 48 and by 76/119 patients (63.8%) at week 96; 89/119 (74.8%) ...

5. abivax.gcs-web.com abivax.gcs-web.com/news-releases/news-release-details/abx464-shows-excellent-long-term-efficacy-data-abivaxs-phase-2b

ABX464 shows excellent long-term efficacy data in Abivax's ... Impressive clinical remission in 58.4% (ITT) of 101 patients after 48 weeks of once-daily oral 50mg ABX464, showing both maintained as well ...

6. abivax.gcs-web.com abivax.gcs-web.com/news-releases/news-release-details/abivax-reports-impressive-12-month-efficacy-and-safety-data

ABIVAX Reports Impressive 12-month Efficacy and Safety ... A total of 19 patients completed the one year ABX464 open label maintenance study and showed good long-term safety and tolerability of 50mg given orally over 52 ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT03368118

NCT03368118 | Study Evaluating the Long-term Safety ... This study is an open-label study aiming at evaluating the long-term safety and the efficacy profile of ABX464 given once a day (o.d) at 50 mg in subjects ...

8. crohnscolitisfoundation.org crohnscolitisfoundation.org/clinical-trials-community/featured-research/abtect-program-abx464-treatment-evaluation-ulcerative

ABTECT Program (ABX464 Treatment Evaluation for ... Abivax reports excellent one-year efficacy and safety data of obefazimod (ABX464) phase 2b maintenance trial in ulcerative colitis, (April 2022) ...