ABX464 for Ulcerative Colitis

Not currently recruiting at 48 trial locations

Overseen By Paul Gineste, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Abivax S.A.

Must be taking: ABX464

Disqualifiers: Major illness, Unstable condition, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

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

Compensation: Varies

Number of Visits: Unknown

Duration: 54 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the long-term safety and effectiveness of a drug called ABX464 for individuals with ulcerative colitis, a condition causing inflammation and sores in the colon. All participants will receive 25 mg of ABX464 once daily. This study targets those who participated in related ABX464 studies and showed improvement, such as the absence of rectal bleeding. Participants must be willing to continue treatment and attend regular check-ups. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group.

Do I have to stop taking my current medications for the ABX464 trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor to get a clear answer based on your specific situation.

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

Studies have shown that ABX464 is generally well-tolerated by people with ulcerative colitis. In past research, no serious safety issues arose with ABX464. For example, a study with 120 patients found the treatment safe over one year. Other research also supports the safety and effectiveness of ABX464 for people with moderate-to-severe ulcerative colitis. While mild side effects might occur, current evidence considers the treatment safe for long-term use. ^{1 2 3 4 5}

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

Unlike the standard treatments for ulcerative colitis, which often include anti-inflammatory drugs and immunosuppressants, ABX464 works through a novel mechanism by enhancing the expression of a specific microRNA, miR-124. This approach targets inflammation in a unique way, potentially reducing symptoms more effectively while minimizing side effects. Researchers are excited about ABX464 because it could offer a new pathway to manage ulcerative colitis, especially for patients who do not respond well to existing therapies.

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

Research has shown that ABX464 effectively treats moderate to severe ulcerative colitis. One study demonstrated that ABX464 improved colon health more than a placebo, as reflected in endoscopic scores. After one year, 58.4% of patients taking ABX464 experienced clinical remission, with greatly reduced symptoms. Another study found that 68.1% of patients were in remission at 48 weeks, and 63.8% remained in remission at 96 weeks. These results suggest that ABX464 works well in the short term and remains effective over time. ^{1 2 4 6 7}

Who Is on the Research Team?

Bram Verstockt, MD

Principal Investigator

Universitaire Ziekenhuizen KU Leuven

Are You a Good Fit for This Trial?

This trial is for individuals with moderate to severe active Ulcerative Colitis who completed previous ABX464-102 or ABX464-104 studies and showed endoscopic improvement. Participants must be willing to continue treatment, comply with study procedures, use effective contraception, and have signed the consent form.

Inclusion Criteria

Subjects who previously completed the ABX464-102 or ABX464-104 clinical studies

Subjects able and willing to comply with study visits and procedures;

Subjects must understand, sign and date the written voluntary informed consent form at the visit prior to any protocol-specific procedures;

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive ABX464 at 25 mg once daily for a maximum period of 54 months

54 months

Quarterly visits

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 The long-term safety and efficacy of a drug called ABX464 at a dose of 25 mg daily are being tested in subjects from earlier related trials. The treatment lasts up to 54 months with quarterly check-ups and an additional month of follow-up for safety.

How Is the Trial Designed?

Group I: ABX464 -25mg Experimental Treatment 1 Intervention

All subjects will receive ABX464 given at 25 mg QD.

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-excellent-efficacy-and-safety-abx464-phase-2b

Abivax reports excellent efficacy and safety of ABX464 in ... Primary endpoint (statistically significant reduction of Modified Mayo Score[1]) was met with once-daily ABX464 (25mg, 50mg, 100mg) at week ...

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 ...