ABX464 for Ulcerative Colitis

No longer recruiting at 400 trial locations

Overseen By Laurence Desroys Du Roure, PharmD

Age: Any Age

Sex: Any

Trial Phase: Phase 3

Sponsor: Abivax S.A.

Must not be taking: Antidiarrheals, Probiotics

Disqualifiers: Proctitis, Sclerosing cholangitis, Hepatitis, 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment, ABX464, to determine its effectiveness for people with ulcerative colitis who haven't found success with other treatments. The goal is to see if this medication can lead to remission, meaning a reduction or disappearance of symptoms. Participants will be randomly assigned to take either 25 mg or 50 mg of the medication daily, or a placebo, for eight weeks. The trial seeks individuals with moderate to severe ulcerative colitis who haven't responded well to treatments like steroids or biologics and continue to experience symptoms. Those who have tried other medications but still have active symptoms might find this trial suitable. As a Phase 3 trial, this study represents the final step before FDA approval, offering a chance to participate in a potentially groundbreaking treatment.

Will I have to stop taking my current medications?

The trial does not specify if you must stop taking your current medications, but it mentions a 'washout period' (time without taking certain medications) before the screening endoscopy. It's best to discuss your specific medications with the trial team.

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

Research has shown that ABX464 was safe in earlier studies with people who have ulcerative colitis. In one study, ABX464 was well-tolerated for a year, and more than half of the participants experienced significant symptom improvement. Another study found that ABX464 was safe for patients with moderate to severe ulcerative colitis and helped reduce their symptoms. These results suggest that ABX464, at the doses tested, was manageable for participants. However, as with any treatment, individual reactions may vary, so discussing potential risks and benefits with a healthcare provider before joining a trial is important. ^{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, immunosuppressants, or biologics, ABX464 offers a novel approach. This treatment is unique because it targets inflammation by modulating RNA biogenesis, a different mechanism of action that may offer benefits over traditional therapies. Researchers are excited about ABX464 because it has the potential to deliver significant improvements in managing ulcerative colitis symptoms with a convenient oral daily dose. The hope is that this new mechanism not only provides effective symptom control but also offers a safer profile with fewer side effects compared to existing options.

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

Research has shown that ABX464 can help treat moderate to severe ulcerative colitis. In previous studies, many patients experienced a significant reduction in symptoms, with 58.4% achieving clinical remission after 48 weeks of treatment. Participants in this trial will receive either ABX464 at different dosages or a placebo. In the short term, ABX464 has outperformed a placebo in easing symptoms. The treatment is known for its safety and effectiveness over the long term. These findings suggest that ABX464 could be a promising option for people who haven't had success with other treatments. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

This trial is for men and women at least 16 years old with moderate to severe ulcerative colitis who haven't responded well or are intolerant to certain therapies like corticosteroids, immunosuppressants, biologics, S1P receptor modulators, or JAK inhibitors. Participants must have a confirmed diagnosis of UC for over 90 days and active disease. They should agree to use effective contraception if applicable.

Inclusion Criteria

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

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

I have not responded well to treatments like steroids, immunosuppressants, or biologics.

Exclusion Criteria

I am currently taking medication for diarrhea.

Pregnant or breast-feeding women.

Subjects with the following hematological and biochemical laboratory parameters obtained during the screening period: Hemoglobin ≤ 8.0 g dL-1, Absolute neutrophil count < 750 mm-3, Platelets < 100,000 mm-3, Creatinine clearance < 50 mL.min-1 (Cockroft-Gault formula), Total serum bilirubin > 1.5 x ULN, 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-1 is testing the effectiveness and safety of ABX464 in doses of either 25 mg or 50 mg daily compared to a placebo in achieving clinical remission in patients with ulcerative colitis. The study randomly assigns participants to receive either ABX464 or a placebo alongside their standard treatments.

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-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 ...