ABTECT-2 - ABX464 Treatment Evaluation for Ulcerative Colitis Therapy -2

Completed · Phase 3 · Has a placebo group

Conditions studied: Ulcerative Colitis

In brief

This is a multicenter, randomized, placebo controlled study to evaluate the efficacy and safety of ABX464 given at 25 or 50 mg QD in inducing clinical remission 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 \[biologics (TNF inhibitors, anti-integrins, anti-IL-23), and/or S1P receptor modulators, and/or JAK inhibitors\].

Key facts

Study ID

NCT05507216

Run by

Abivax S.A.

People needed

636

Starts

2022-12-21

Expected to finish

2025-07-15

Last updated by the study team

2025-10-24

Who can join

Age: 16 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Men or women at least 16 years old; Adolescent subjects will only be enrolled if approved by the country regulatory/health authority. If these approvals have not been granted, only subjects ≥ 18 years old will be enrolled. To be eligible, adolescent subjects must weigh ≥ 40 kg and meet the definition of Tanner Stage 5 at the screening visit.
• Subjects must understand, sign and date the written voluntary informed consent form at the visit prior to any protocol-specific procedures. For under-aged subjects, national requirements regarding consent should also be met.
• Documented diagnosis of UC confirmed by endoscopy and histology. Should endoscopy/histology results not be available at screening, results from endoscopies and biopsies taken at screening may be used.
• Active disease defined by modified Mayo score (MMS) ≥ 5 with rectal bleeding subscore (RBS) ≥ 1 and endoscopy subscore (MES) of 2 or 3 (confirmed by central reader).
• Subjects with documented inadequate response (defined as lack of response or loss of response or intolerance) to at least one of the following treatments: corticosteroids, immunosuppressant, biologic or biosimilar therapies, S1P receptor modulators and/or JAK inhibitors and/or new drugs approved during the study (note: failure to only 5-ASA or sulfasalazine is not accepted).
• Women of childbearing potential (WOCBP) subjects and male subjects with WOCBP partner must agree to comply with the contraception requirements described in the protocol.
• 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.

You may not qualify if…

• Subjects with UC limited to an isolated proctitis (≤ 15cm from anal verge) determined by endoscopy central reading.
• Subjects with primary sclerosing cholangitis or autoimmune hepatitis.
• Subjects who have failed on 5-ASA or sulfasalazine therapy only.
• Subjects with CD or presence or history of fistula, indeterminate colitis, infectious/ischemic colitis or microscopic colitis (lymphocytic and collagenous colitis).
• History or current evidence of toxic megacolon, fulminant colitis, bowel perforation.
• History of colonic cancer or colonic low grade or high grade dysplasia adenomatous polyps, and/or at the screening endoscopy, evidence of colonic cancer or evidence of low grade or high grade dysplasia adenomatous polyps (fully removed or not).
• Recent or planned bowel surgery or history of proctocolectomy or partial colectomy or current stoma.
• Subjects on antidiarrheals including those working on motility (e.g., loperamide, diphenoxylate with atropine, etc.).
• Subjects on probiotics (e.g., Culturelle® [Lactobacillus GG, i-Health, Inc.], Saccharomyces boulardii).
• Subjects who do not meet the washout period requirements prior to the screening endoscopy.
• 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 < 60 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
• Subjects with the following conditions (infection):
• Subjects with chronic or recurrent grade 3 or grade 4 infection within the last 2 months prior to screening or a history of opportunistic infection while not on immunosuppressive therapy.
• Herpes zoster reactivation within the last 2 months prior to screening.
• Subjects with active infection at screening or any major episode of infection that required hospitalization or treatment with intravenous antibiotics within 1 month of screening or during screening. Fungal infection of nail beds is allowed.
• Positive assay or stool culture for pathogens (ova and parasite examination, bacteria) or positive test for Clostridium difficile toxin at screening. If C. difficile is positive, subject may be treated and retested ≥ 2 weeks after completing treatment.
• Subjects with HIV infection.
• Subjects having acute or chronic hepatitis B infection at screening (positive for hepatitis B surface antigen [HbsAg], or negative for HbsAg and positive for anti-hepatitis B core antibody in conjunction with detectable HBV DNA, or detectable HBV DNA).
• Subjects having acute or chronic hepatitis C infection at screening as defined by positive for hepatitis C antibody (subjects successfully treated and without recurrence ≥ 1 year with no detectable HCV RNA [assessed centrally] are eligible).

Where it is running

• University of Alabama -Birmingham — Birmingham, Alabama, United States
• Research Solutions of Arizona, PC — Litchfield Park, Arizona, United States
• Valleywise Health Medical Center — Phoenix, Arizona, United States
• Reliance Research — Scottsdale, Arizona, United States
• Applied Research Center of Arkansas — Little Rock, Arkansas, United States
• National Institute of Clinical Research — Bakersfield, California, United States
• Kindred Medical Institute for Clinical Trials, LLC — Corona, California, United States
• Citrus Valley Gastroenterology — Covina, California, United States
• United Medical Doctors — Murrieta, California, United States
• Hoag Memorial Hospital Presbyterian — Newport Beach, California, United States
• Clinical Applications Laboratories — San Diego, California, United States
• Kaiser Foundation Research Institute, a Division of Kaiser Permanente Hospitals — Aurora, Colorado, United States
• Danbury Hospital — Danbury, Connecticut, United States
• Medical Research Center of Connecticut, LLC — Hamden, Connecticut, United States
• West Central Gastroenterology d/b/a Gastro Florida — Clearwater, Florida, United States
• Superior Associates in Research — Hialeah, Florida, United States
• IHS Health — Kissimmee, Florida, United States
• Infinite Clinical Research Inc — Miami, Florida, United States
• Research Associates of South Florida — Miami, Florida, United States
• Nicklaus Children's Hospital — Miami, Florida, United States
• Sanchez Clinical Research, Inc — Miami, Florida, United States
• Reliant Medical Research, LLC — Miami, Florida, United States
• Ocala GI Research — Ocala, Florida, United States
• Sarkis Clinical Trials - Parent — Ocala, Florida, United States
• Accout Center s.r.o. — Šahy, Slovakia

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.