ABTECT-1 - ABX464 Treatment Evaluation for Ulcerative Colitis Therapy -1

Study Purpose

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].

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	16 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- 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 weight ≥ 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 > 90 days prior to baseline, confirmed by endoscopy and histology.

Should histology results not be available at screening, results from 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 therapies, S1P receptor modulators and/or JAK inhibitors and/or new drugs approved during the study (note: failure to only 5-ASA is not accepted).

- Women of childbearing potential (WOCBP) subjects and male subjects with WOCBP partner must agree to use highly effective contraception methods.

- 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.

Exclusion Criteria:

- Subjects with ulcerative colitis limited to an isolated proctitis (≤ 15cm from anal verge).

- Subjects with primary sclerosing cholangitis or autoimmune hepatitis.

- Subjects who have failed on 5-ASA 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 colon cancer, past or current evidence of low grade or high grade colonic dysplasia and/or adenomatous polyps that have not been completely removed.

- Recent or planned bowel surgery or history of proctocolectomy or partial colectomy or current stoma.

- Subjects on antidiarrheals (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 < 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.

- Subjects with the following conditions (infection): - Subjects with chronic or recurrent grade 3 or grade 4 infection, or with opportunistic infection within the last 2 months prior to screening.

- 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).

- Active tuberculosis (TB) or untreated latent TB are ruled out.

For subjects with positive or intermediate QuantiFERON test see section 5.3.8.1 of the current study protocol.

- Subjects with an uncontrolled ischemic heart disease and/or a history of congestive heart failure with New York Heart Association (NYHA) class 3 or 4 symptoms.

- Subjects with a family or personal history of congenital or acquired long QT syndrome, or subjects with a marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval [Fridericia or Bazett correction] >450 milliseconds for male and > 460 milliseconds for female).

- Subjects with a history of torsade de pointe (TdP).

- Acute or chronic of clinically relevant pulmonary, hepatic, pancreatic or renal functional abnormality, encephalopathy, neuropathy or unstable central nervous system pathology such as seizure disorder, or any other clinically significant medical problems as determined by physical examination and/or laboratory screening tests and/or medical history (note: treated autoimmune hypothyroidy and autoimmune diabetes are allowed).

- History or active malignancy (subjects with a 5-year disease free survival are eligible).

- Serious illness requiring hospitalization within 4 weeks prior to screening (except UC flare).

- Subjects previously treated with ABX464.

- Pregnant or breast-feeding women.

- Illicit drug or alcohol abuse or dependence.

- Subjects who received live vaccine within 3 months prior to screening and/or who's planning to receive such a vaccine during the study duration.

- Use of any investigational or non-registered product within 3 months or within 5 half-lives preceding baseline, whichever is longer, and during the study.

- Any condition, which in the opinion of the investigator, could compromise the subject's safety or adherence to the study protocol

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05507203
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 3
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Abivax S.A.
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	Argentina, Australia, Austria, Belgium, Bulgaria, Canada, China, Czechia, France, Germany, Greece, Hungary, India, Italy, Korea, Republic of, Netherlands, Poland, Portugal, Spain, Switzerland, Turkey, United Kingdom, United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Ulcerative Colitis

Arms & Interventions

Arms

Experimental: ABX464 50mg

Subjects will be orally dosed daily in a fed condition (regular breakfast) in the morning with a glass of water during 8 weeks

Experimental: ABX464 25mg

Subjects will be orally dosed daily in a fed condition (regular breakfast) in the morning with a glass of water during 8 weeks

Placebo Comparator: Placebo

Subjects will be orally dosed daily in a fed condition (regular breakfast) in the morning with a glass of water during 8 weeks

Interventions

Drug: - ABX464

Administered once daily in the morning with food

Drug: - Placebo

Administered once daily in the morning with food

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Dothan, Alabama

Status

Recruiting

Address

Digestive Health Specialists of the Southeast

Dothan, Alabama, 36305

Site Contact

Travis Rutland, MD

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