COMPLETED

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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 \[biologics (TNF inhibitors, anti-integrins, anti-IL-23), and/or S1P receptor modulators, and/or JAK inhibitors\].

Official Title

A Randomized, Double-blind, Placebo-controlled, Multicenter Phase III Study to Evaluate the Efficacy and Safety of ABX464 Once Daily for Induction Treatment in Subjects With Moderately to Severely Active Ulcerative Colitis

Quick Facts

Study Start:2022-12-21

Study Completion:2025-07-15

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT05507216

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:16 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD, ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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 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.	* 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). * Active tuberculosis (TB) or untreated latent TB are ruled out. For subjects with positive or intermediate QuantiFERON test see 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). * Serious illness requiring hospitalization within 4 weeks prior to screening (except UC flare). * Subjects previously treated with ABX464. * Subjects with a known hypersensitivity to the active substance or to any of the excipients. * WOCBP subject who is pregnant or breast-feeding at screening, or intends to become pregnant during the study, or male subject with WOCBP partner who intends to be pregnant during the study. * 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. * Subjects committed to an institution by virtue of an order issued either by the judicial or the administrative authorities. * Any condition, which in the opinion of the investigator, could compromise the subject's safety or adherence to the study protocol.

Inclusion Criteria

Exclusion 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 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.

* 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).
* Active tuberculosis (TB) or untreated latent TB are ruled out. For subjects with positive or intermediate QuantiFERON test see 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).
* Serious illness requiring hospitalization within 4 weeks prior to screening (except UC flare).
* Subjects previously treated with ABX464.
* Subjects with a known hypersensitivity to the active substance or to any of the excipients.
* WOCBP subject who is pregnant or breast-feeding at screening, or intends to become pregnant during the study, or male subject with WOCBP partner who intends to be pregnant during the study.
* 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.
* Subjects committed to an institution by virtue of an order issued either by the judicial or the administrative authorities.
* Any condition, which in the opinion of the investigator, could compromise the subject's safety or adherence to the study protocol.

Contacts and Locations

Principal Investigator

Severine Vermeire, MD, PhD

PRINCIPAL_INVESTIGATOR

UZ Leuven, Belgium

Bruce Sands, MD, PhD

PRINCIPAL_INVESTIGATOR

Mount Sinai Health System Digestive Disease Institute, New York USA

Study Locations (Sites)

University of Alabama -Birmingham

Birmingham, Alabama, 35205

United States

Research Solutions of Arizona, PC

Litchfield Park, Arizona, 85340

United States

Valleywise Health Medical Center

Phoenix, Arizona, 85008

United States

Reliance Research

Scottsdale, Arizona, 85260

United States

Applied Research Center of Arkansas

Little Rock, Arkansas, 72212

United States

National Institute of Clinical Research

Bakersfield, California, 93309

United States

Kindred Medical Institute for Clinical Trials, LLC

Corona, California, 92879

United States

Citrus Valley Gastroenterology

Covina, California, 91723

United States

United Medical Doctors

Murrieta, California, 92563

United States

Hoag Memorial Hospital Presbyterian

Newport Beach, California, 92663

United States

Clinical Applications Laboratories

San Diego, California, 92103

United States

Kaiser Foundation Research Institute, a Division of Kaiser Permanente Hospitals

Aurora, Colorado, 80014

United States

Danbury Hospital

Danbury, Connecticut, 06810

United States

Medical Research Center of Connecticut, LLC

Hamden, Connecticut, 06518

United States

West Central Gastroenterology d/b/a Gastro Florida

Clearwater, Florida, 33762

United States

Superior Associates in Research

Hialeah, Florida, 33012

United States

IHS Health

Kissimmee, Florida, 34741

United States

Infinite Clinical Research Inc

Miami, Florida, 33133

United States

Research Associates of South Florida

Miami, Florida, 33134

United States

Nicklaus Children's Hospital

Miami, Florida, 33155-3009

United States

Sanchez Clinical Research, Inc

Miami, Florida, 33157

United States

Reliant Medical Research, LLC

Miami, Florida, 33165

United States

Ocala GI Research

Ocala, Florida, 34471

United States

Sarkis Clinical Trials - Parent

Ocala, Florida, 34474

United States

Arnold Palmer Hospital For Children

Orlando, Florida, 32806

United States

Omega Research Orlando, LLC

Orlando, Florida, 32808

United States

GCP Clinical Research, LLC

Tampa, Florida, 33609

United States

Guardian Angel Research Center

Tampa, Florida, 33614

United States

Alliance Clinical Research

Tampa, Florida, 33615

United States

Iowa Digestive Disease Center

Clive, Iowa, 50325

United States

The University of Iowa

Iowa City, Iowa, 52242

United States

Cotton O'Neil Clinical Research Center

Topeka, Kansas, 66606

United States

Tandem Clinical Research, LLC

Marrero, Louisiana, 70072

United States

University of Maryland Medical Center

Baltimore, Maryland, 21201

United States

NECCR Primacare Research, LLC

Fall River, Massachusetts, 02721

United States

University of Michigan

Ann Arbor, Michigan, 48109

United States

Clinical Research Institute of Michigan, LLC

Chesterfield, Michigan, 48047

United States

Michigan Center of Medical Research

Farmington Hills, Michigan, 48334

United States

Gastrointestinal Associates, PA

Flowood, Mississippi, 39232

United States

BVL Clinical Research

Liberty, Missouri, 64068

United States

AIG Digestive Disease Research

Florham Park, New Jersey, 07932

United States

NY Scientific Corp.

Brooklyn, New York, 11235

United States

Mount Sinai

New York, New York, 10029

United States

Plains Clinical Research Center, LLC

Fargo, North Dakota, 58104

United States

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106

United States

Hightower Clinical

Oklahoma City, Oklahoma, 73102

United States

Board of Regents of the University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104

United States

Susquehanna Research Group, LLC

Harrisburg, Pennsylvania, 17110

United States

Frontier Clinical Research, LLC

Uniontown, Pennsylvania, 15401

United States

Rapid City Medical Center, LLC

Rapid City, South Dakota, 57701

United States

Digestive Health Research, LC

Hermitage, Tennessee, 37076

United States

Vanderbilt University Medical Center

Nashville, Tennessee, 37232

United States

Texas Clinical Research Institute, LLC

Arlington, Texas, 76012

United States

Inquest Clinical Research

Baytown, Texas, 77521

United States

Valley Institute of Research

Fort Worth, Texas, 76164

United States

Mt.Olympus Medical Research

Katy, Texas, 77494

United States

Digestive System Healthcare

Pasadena, Texas, 77505

United States

LinQ Research, LLC

Pearland, Texas, 77584

United States

Tyler Research Institute, LLC

Tyler, Texas, 75703

United States

Gastroenterology Consultants and Endoscopy Center of Southwest Virginia

Roanoke, Virginia, 24014

United States

The Vancouver Clinic

Vancouver, Washington, 98664

United States

Collaborators and Investigators

Sponsor: Abivax S.A.

Severine Vermeire, MD, PhD, PRINCIPAL_INVESTIGATOR, UZ Leuven, Belgium
Bruce Sands, MD, PhD, PRINCIPAL_INVESTIGATOR, Mount Sinai Health System Digestive Disease Institute, New York USA

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-12-21

Study Completion Date2025-07-15

Study Record Updates

Study Start Date2022-12-21

Study Completion Date2025-07-15

Terms related to this study

Additional Relevant MeSH Terms

Ulcerative Colitis