COMPLETED

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

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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:2022-10-10

Study Completion:2025-06-25

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT05507203

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 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 confirmed by endoscopy and histology. Should endoscopy/histology results not be available at screening, results from endoscopies or 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 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 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 confirmed by endoscopy and histology. Should endoscopy/histology results not be available at screening, results from endoscopies or 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 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

Study Locations (Sites)

Digestive Health Specialists of the Southeast

Dothan, Alabama, 36305

United States

Lakeview Clinical Research

Guntersville, Alabama, 35976

United States

GI Alliance

Sun City, Arizona, 85351

United States

Del Sol Research Management, LLC

Tucson, Arizona, 85715

United States

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205-7199

United States

Aurora Care Clinic

Costa Mesa, California, 92627

United States

Gastro Care Institute

Lancaster, California, 93534

United States

California Medical Research Associates Inc.

Northridge, California, 91324

United States

Clinnova Research Solutions

Orange, California, 92868

United States

Peak Gastroenterology Associates

Colorado Springs, Colorado, 80907

United States

Clinical Research Of Brandon, LLC

Brandon, Florida, 33511

United States

Access Research Institute

Brooksville, Florida, 34613

United States

Auzmer Research

Lakeland, Florida, 33813

United States

Cfagi, Llc

Maitland, Florida, 32751

United States

MedOne Clinical Research LLC

Miami, Florida, 33145

United States

Medical Professional Clinical Research Center

Miami, Florida, 33165

United States

Advanced Research Institute, Inc.

New Port Richey, Florida, 34653

United States

Endoscopic Research, Inc.

Orlando, Florida, 32803

United States

Advanced Research Institute, Inc.

Orlando, Florida, 32825

United States

Gastroenterology Associates of Pensacola, PA

Pensacola, Florida, 32503

United States

Theia Clinical Research Centers, LLC

Temple Terrace, Florida, 33617

United States

Digestive Healthcare of Georgia

Atlanta, Georgia, 30309

United States

Atlanta Center for Gastroenterology, P.C.

Decatur, Georgia, 30033

United States

One Health Research Clinic Atlanta, LLC

Norcross, Georgia, 30093

United States

Eagle Clinical Research

Chicago, Illinois, 60621

United States

GI Alliance

Glenview, Illinois, 60026

United States

GI Alliance

Gurnee, Illinois, 60031

United States

Indiana University School of Medicine

Indianapolis, Indiana, 46202

United States

University of Kansas Medical Center Research Institute, Inc.

Kansas City, Kansas, 66160

United States

University of Louisville Research Foundation

Louisville, Kentucky, 40202

United States

GI Alliance - Baton Rouge

Baton Rouge, Louisiana, 70809

United States

Boston Medical Center

Boston, Massachusetts, 02118

United States

Lucida Clinical Trials LLC

New Bedford, Massachusetts, 02740

United States

Digestive Health Center PA

Ocean Springs, Mississippi, 39564

United States

University of Nebraska Medical Center

Omaha, Nebraska, 68198

United States

AGA Clinical Research Associates, LLC

Egg Harbor Township, New Jersey, 08234

United States

Rochester Clinical Research

Rochester, New York, 14609

United States

Charlotte Gastroenterology and Hepatology, P.L.L.C

Charlotte, North Carolina, 28207

United States

Care Access Research Lumberton

Lumberton, North Carolina, 28358

United States

Wilmington Health

Wilmington, North Carolina, 28401

United States

Gastro Health Research

Cincinnati, Ohio, 45249

United States

Wexner Medical Center

Columbus, Ohio, 43210

United States

DSI Research LLC

Springboro, Ohio, 45066

United States

Columbia Digestive Health Research

Columbia, South Carolina, 29204

United States

Gastroenterology Associates, PA

Greenville, South Carolina, 29607

United States

Gastroenterology Center of the MidSouth PC

Germantown, Tennessee, 38138

United States

GI Alliance - Southlake

Austin, Texas, 76092

United States

Central Texas Clinical Research, LLC

Austin, Texas, 78705

United States

Texas Digestive Disease Consultants

Cedar Park, Texas, 78613

United States

Baylor Scott and White

Dallas, Texas, 75246

United States

Cook Children's Medical Center

Fort Worth, Texas, 76104

United States

GI Alliance - Garland

Garland, Texas, 75044

United States

Houston Methodist Hospital

Houston, Texas, 77030

United States

Biopharma Informatic, Inc. Research Center

Houston, Texas, 77043

United States

Biopharma Informatic, LLC

Houston, Texas, 77084

United States

Gastro Health & Nutrition

Katy, Texas, 78754

United States

GI Alliance - San Marcos

San Marcos, Texas, 78130

United States

Texas Gastroenterology Associates

Spring, Texas, 77386

United States

GI Alliance - Webster

Webster, Texas, 77598

United States

Care Access Research LLC

Ogden, Utah, 84403

United States

University of Utah

Salt Lake City, Utah, 84112

United States

Gastroenterology Associates of Tidewater

Chesapeake, Virginia, 23320

United States

Blue Ridge Medical Research

Lynchburg, Virginia, 24502

United States

TPMG Clinical Research Williamsburg

Williamsburg, Virginia, 23188

United States

Collaborators and Investigators

Sponsor: Abivax S.A.

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 Date2022-10-10

Study Completion Date2025-06-25

Study Record Updates

Study Start Date2022-10-10

Study Completion Date2025-06-25

Terms related to this study

Additional Relevant MeSH Terms

Ulcerative Colitis