ABX464 Maintenance Therapy for Ulcerative Colitis
Recruiting in Palo Alto (17 mi)
+591 other locations
Overseen BySeverine Vermeire, MD, PhD
Age: Any Age
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Recruiting
Sponsor: Abivax S.A.
Disqualifiers: Crohn's disease, Colon cancer, others
Pivotal Trial (Near Approval)
Prior Safety Data
Trial Summary
What is the purpose of this trial?This is a multicenter, randomized, placebo-controlled study to evaluate the long-term efficacy and safety of ABX464 50mg and 25mg administered once daily (QD) as maintenance therapy in subjects with moderately to severely active ulcerative colitis who have inadequate response, no response, a loss of response, or an intolerance to either conventional therapies \[corticosteroids, immunosuppressant (i.e. azathioprine, 6-mercaptopurine, methotrexate)\] and/or advanced therapies \[biologics (TNF inhibitors, anti-integrins, anti-IL-23), and/or S1P receptor modulators, and/or JAK inhibitors\].
This study is the maintenance phase of both previous induction studies ABX464-105 and ABX464-106.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop your current medications, but it mentions that certain medications and procedures for ulcerative colitis are prohibited during the study. It's best to discuss your current medications with the study team to see if they are allowed.
How does the drug ABX464 differ from other drugs for ulcerative colitis?
ABX464 is unique because it is being studied as a maintenance therapy specifically for ulcerative colitis, which means it could help keep the disease in remission over the long term. Unlike some existing treatments that focus on reducing immune system activity, ABX464 may offer a novel approach, potentially improving adherence and reducing the need for corticosteroids.
12345Eligibility Criteria
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.Participant Groups
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.
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
Subjects will be orally dosed during 44 weeks
Group III: ABX464 25mg - Non responder subjects at the end of inductionExperimental Treatment1 Intervention
Subjects will be orally dosed during 44 weeks
Group IV: ABX464 50mg - Responder subjects at the end of inductionPlacebo Group1 Intervention
Subjects will be orally dosed during 44 weeks
Group V: ABX464 25mg - Responder subjects at the end of inductionPlacebo Group1 Intervention
Subjects will be orally dosed during 44 weeks
Group VI: Placebo - Responder subjects at the end of inductionPlacebo Group1 Intervention
Subjects will be orally dosed during 44 weeks
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
Nature Coast Clinical Research, LLCInverness, FL
Susquehanna Research Group, LLCHarrisburg, PA
Rochester Clinical ResearchRochester, NY
Applied Research Center of ArkansasLittle Rock, AR
More Trial Locations
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Who is running the clinical trial?
Abivax S.A.Lead Sponsor
References
Current and emerging maintenance therapies for ulcerative colitis. [2016]Ulcerative colitis (UC) is a chronic idiopathic intestinal disease that requires life-long maintenance therapy to maintain clinical remission. This article reviews the current literature on maintenance treatments in UC. It examines the natural history of the condition and the proposed benefits of treatment. These include improving quality of life parameters, decreasing corticosteroid intake, the prevention of relapse, the prevention of colorectal cancer and the avoidance of colectomy. The immunosuppressive era appears to be reducing the need for elective colectomy in UC. The article explores the classes of drug currently used for maintenance of UC, reviews the literature around adherence issues, and summarizes emerging agents in this space.
Randomised trial of once- or twice-daily MMX mesalazine for maintenance of remission in ulcerative colitis. [2022]Maintenance treatment in ulcerative colitis should be as convenient as possible, to increase the chance of compliance. MMX mesalazine is a once-daily, high-strength (1.2 g/tablet) formulation of 5-aminosalicylic acid. This study evaluated the safety and efficacy of MMX mesalazine dosed once or twice daily as maintenance therapy in patients with ulcerative colitis.
[Overview and update on treatment in ulcerative colitis]. [2023]Ulcerative colitis is characterized by a chronic intestinal inflammation limited to the mucosa of the colon, of variable proximal extent. Main symptoms are diarrhea, possibly bloody, and abdominal pain. It evolves with phases of relapse and remission. The diagnosis of ulcerative colitis is made based on clinical, endoscopic, and histologic findings. Currently, the various drug treatment options act by, among other things, reducing the activity of the immune system locally or systemically. In mild to moderate forms, 5-ASA remains the mainstay of both induction and maintenance treatment. In more severe flares, cortisone is the treatment of choice. To limit the prolonged/repeated intake of corticosteroids, there are several options of biologics with distinct ranges of action and safety profiles for inducing and/or maintaining remission. Therapeutic goals are evolving and go beyond achieving clinical remission. Endoscopic and histological remission are new targets to further improve quality of life and limit long-term complications, such as colorectal cancer.
New keys to maintenance treatment in ulcerative colitis. [2021]Maintenance treatment in ulcerative colitis often fails to prevent flares and long term complications. The first key to maintenance is to use effective therapy, even when patients become asymptomatic. The second key is to communicate the importance of adherence to patients, and to help them achieve long term adherence. Simplified dosing schedules are of some benefit, but the bond between patient and doctor, and the patient's belief in the efficacy of the therapy are essential. Decreased co-pays (a fixed amount paid by patients seeking care that is not reimbursed my medical insurance) have been associated with increased adherence, and incentives for patients may be a cost-effective approach to improving adherence. While the most substantial data on the association between adherence and clinical outcomes is in 5-ASAs, non-adherence can also limit the efficacy of thiopurines and biologics. The third key to maintenance treatment is monitoring and maintaining control of inflammation. Decreased histologic and endoscopic damage to the colon has been associated with decreased risk of colon cancer. The most cost-effective way to monitor smoldering inflammation is not known, but endoscopy, structured symptom indices, and biomarkers may be valuable approaches. The fourth key to maintenance treatment is optimizing immunomodulator therapy with thiopurines, and possibly methotrexate in the future. The fifth key to maintenance treatment in ulcerative colitis is maintaining biologic efficacy by avoiding low trough levels and being vigilant for subclinical inflammation and symptom recurrence at the end of dose intervals. Combination therapy with immunomodulators improves trough levels in Crohn's, and may prove to have benefits for the maintenance of biologic efficacy in ulcerative colitis.
[Management of diagnosis and treatment in ulcerative colitis]. [2016]Ulcerative colitis (UC) is a chronic inflammatory bowel disease limited to the mucosa and affecting the rectum and the colon continuously. Salicylates are the first line treatment for moderate forms. Corticosteroids are used to induce remission, but are not given as maintenance therapy. Thiopurines are indicated as maintenance therapy in case of failure of salicylates or cortico-dependence. Anti TNF alpha are indicated in cortico-resistant severe flares or if cortico- dependence. Vedolizumab (anti-integrin) is the first non anti-TNF alpha biotherapy available for the treatment of UC. Severe acute colitis is a medical emergency; diagnosis is based on Lichtiger score. An emergency colectomy for severe acute colitis is indicated in cases of surgical complication or resistance to medical therapy. UC patients with extension beyond splenic flexure are at risk of colorectal cancer, increasing with the duration of the disease, severity of mucosal inflammation, family history of colorectal cancer, and the existence of sclerosing cholangitis. Annual surveillance colonoscopy is required in patients with sclerosing cholangitis regardless of the extension of their UC.