RECRUITING

Efficacy and Safety of Obefazimod in Subjects With Moderately to Severely Active Crohn's Disease

Conditions

Moderately to Severely Active Crohn Disease Crohn Disease

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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 study has 3 treatment phases, a 12-Week Induction Phase, a 40-Week Maintenance Phase, and a 48-Week Extension Phase. The objective is to evaluate the efficacy and safety of obefazimod compared to placebo as induction and maintenance therapy in subjects with moderately to severely active CD after inadequate response (no response, loss of response, or intolerance) to conventional therapies and/or advanced therapies. The primary objective for the 48-Week Extension Phase is to evaluate the safety and tolerability of obefazimod compared with placebo in subjects who are enrolled in the Extension Phase.

Official Title

A Phase 2b, Multicenter, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Obefazimod in Subjects With Moderately to Severely Active Crohn's Disease

Quick Facts

Study Start:2024-10-30

Study Completion:2028-04

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06456593

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:18 Years to 75 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Male or female (at birth) 18 to 75 years old and able to understand, sign, and date the written voluntary informed consent at the visit prior to any protocol-specified procedures 2. Able and willing to comply with study visits and procedures as per protocol. 3. Confirmed and documented diagnosis of CD based on endoscopy and histology reports. 4. Moderately to severely active CD as defined by 220 ≤ CDAI ≤ 450 and SES-CD ≥ 6 for ileo-colonic or colonic disease or SES-CD ≥ 4 for isolated ileal disease (per central reading). 5. Documented inadequate response (defined as lack of response or loss of response or intolerance) to at least one of the following treatments: corticosteroids (CS), immunosuppressants (IS), biologic or biosimilar therapies, or janus kinase (JAK) (note: failure to only 5-aminosalicylic acid \[5-ASA\] is not accepted) 6. Women of childbearing potential (WOCBP) and male subjects with WOCBP partner must agree to comply with contraception requirements as stated in section 4.5 (contraception) of this protocol. 7. Subject should be affiliated to a health insurance policy whenever required by a participating country or state. 8. Subject is able and willing to comply with usual public recommendations for sun protection.	1. 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. 2. Current diagnosis of ulcerative colitis (UC) or indeterminate colitis 3. CD without ileal and/or colonic involvement 4. Untreated active external or perianal fistula or abscess. Stable fistula without abscess and with minimal or low drainage may be enrolled. Recent cutaneous and perianal abscesses are not exclusionary if drained and adequately treated at least 3 weeks before screening colonoscopy or 8 weeks before screening colonoscopy for intra-abdominal abscesses, if no additional surgery is anticipated. 5. Symptomatic bowel stricture and/or stenosis not passable in endoscopy 6. Related to CD surgery: 1. Current stoma or ileoanal pouch 2. More than 2 missing complete segments of the following 5 segments: terminal ileum, right colon, transverse colon, left colon, and sigmoid and rectum 3. Combined previous small bowel resections \> 100 cm 4. Surgical bowel resection within the past 3 months prior to baseline 5. Any other manifestation that might require surgery while enrolled in the study 7. Related to CD treatments: 1. Subject who is currently treated with prohibited concomitant therapies for CD as described in the study protocol 2. Subject who has previously received natalizumab (or any other α4β1 integrin agonist) 3. Subject who has failed more than three advanced therapies for the treatment of CD, or two different mechanisms of action for advanced therapies of CD 8. History of, or active, malignancy including nonmelanoma skin cancer (subjects with a 5-year disease-free survival are eligible) 9. History of colonic cancer or colonic low grade or high grade dysplasia adenomatous polyps, and/or at the screening endoscopy, evidence of low grade or high grade dysplasia adenomatous polyps (fully removed or not) 10. Subject with history of, or diagnosed with, the following during screening: primary sclerosing cholangitis, autoimmune hepatitis, or primary biliary cirrhosis 11. Serious illness requiring hospitalization (not related to CD) within 4 weeks prior to screening 12. Subject with the following infectious conditions: 1. Chronic or recurrent Grade 3 or Grade 4 infection within the last 2 months prior to screening or history of opportunistic infection while not on immunosuppressive therapy 2. Herpes zoster reactivation within the last 2 months prior to screening 3. Active infection at screening or any major episode of infection that required hospitalization or treatment with IV antibiotics within 1 month of screening or during screening (fungal infection of nail beds is allowed) 4. Positive assay or stool culture for pathogens (ova and parasite examination, bacteria) that required treatment per local medical practice or positive test for Clostridioides difficile (C. difficile) toxin at screening. 5. Subject with human immunodeficiency virus (HIV) infection 6. 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 hepatitis B virus \[HBV\] deoxyribonucleic acid \[DNA\], or detectable HBV DNA). 7. Acute or chronic hepatitis C virus (HCV) infection 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) 8. Active tuberculosis (TB) or untreated latent TB (For subjects with positive or intermediate QuantiFERON test) 13. Subject with uncontrolled ischemic heart disease and/or a history of congestive heart failure 14. Subject with a known family or personal history of congenital or acquired long QT syndrome, or subjects with a marked baseline prolongation of QT/ heart rate-corrected QT (QTc) interval 15. Subject with a history of torsade de pointe (TdP) 16. Acute or chronic clinically relevant pulmonary, hepatic, or renal functional abnormality, encephalopathy, neuropathy or unstable central nervous system pathology such as seizure disorder, or any other clinically significant medical problems. 17. Subjects who received live vaccine within 3 months prior to screening and/or subject who is planning to receive such a vaccine during the study duration 18. Acute or chronic pancreatitis 19. Subject with the following hematological and biochemical laboratory parameters obtained during the screening period: 1. Hemoglobin ≤ 8.0 g/dL1 2. Absolute neutrophil count \< 750/mm3 3. Platelets \< 100,000 /mm3 4. eGFR \< 60 mL/min/1.73 m2 5. Total serum bilirubin \> 1.5 x ULN (except if related to pre-existing and documented Gilbert syndrome) 6. Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) \> 2 x ULN 20. Subject who does not meet the washout period requirements prior to the screening endoscopy as described in the prohibited medication section of the study protocol 21. Use of any investigational or nonregistered product within 3 months or within 5 halflives preceding baseline, whichever is longer, and during the study. 22. Subjects previously treated with obefazimod or with a known hypersensitivity to the active substance or to any of the excipients 23. Illicit drug or alcohol abuse or dependence 24. Subject who is committed to an institution by virtue of an order issued either by the judicial or the administrative authorities 25. 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

1. Male or female (at birth) 18 to 75 years old and able to understand, sign, and date the written voluntary informed consent at the visit prior to any protocol-specified procedures
2. Able and willing to comply with study visits and procedures as per protocol.
3. Confirmed and documented diagnosis of CD based on endoscopy and histology reports.
4. Moderately to severely active CD as defined by 220 ≤ CDAI ≤ 450 and SES-CD ≥ 6 for ileo-colonic or colonic disease or SES-CD ≥ 4 for isolated ileal disease (per central reading).
5. Documented inadequate response (defined as lack of response or loss of response or intolerance) to at least one of the following treatments: corticosteroids (CS), immunosuppressants (IS), biologic or biosimilar therapies, or janus kinase (JAK) (note: failure to only 5-aminosalicylic acid \[5-ASA\] is not accepted)
6. Women of childbearing potential (WOCBP) and male subjects with WOCBP partner must agree to comply with contraception requirements as stated in section 4.5 (contraception) of this protocol.
7. Subject should be affiliated to a health insurance policy whenever required by a participating country or state.
8. Subject is able and willing to comply with usual public recommendations for sun protection.

1. 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.
2. Current diagnosis of ulcerative colitis (UC) or indeterminate colitis
3. CD without ileal and/or colonic involvement
4. Untreated active external or perianal fistula or abscess. Stable fistula without abscess and with minimal or low drainage may be enrolled. Recent cutaneous and perianal abscesses are not exclusionary if drained and adequately treated at least 3 weeks before screening colonoscopy or 8 weeks before screening colonoscopy for intra-abdominal abscesses, if no additional surgery is anticipated.
5. Symptomatic bowel stricture and/or stenosis not passable in endoscopy
6. Related to CD surgery:
1. Current stoma or ileoanal pouch
2. More than 2 missing complete segments of the following 5 segments: terminal ileum, right colon, transverse colon, left colon, and sigmoid and rectum
3. Combined previous small bowel resections \> 100 cm
4. Surgical bowel resection within the past 3 months prior to baseline
5. Any other manifestation that might require surgery while enrolled in the study
7. Related to CD treatments:
1. Subject who is currently treated with prohibited concomitant therapies for CD as described in the study protocol
2. Subject who has previously received natalizumab (or any other α4β1 integrin agonist)
3. Subject who has failed more than three advanced therapies for the treatment of CD, or two different mechanisms of action for advanced therapies of CD
8. History of, or active, malignancy including nonmelanoma skin cancer (subjects with a 5-year disease-free survival are eligible)
9. History of colonic cancer or colonic low grade or high grade dysplasia adenomatous polyps, and/or at the screening endoscopy, evidence of low grade or high grade dysplasia adenomatous polyps (fully removed or not)
10. Subject with history of, or diagnosed with, the following during screening: primary sclerosing cholangitis, autoimmune hepatitis, or primary biliary cirrhosis
11. Serious illness requiring hospitalization (not related to CD) within 4 weeks prior to screening
12. Subject with the following infectious conditions:
1. Chronic or recurrent Grade 3 or Grade 4 infection within the last 2 months prior to screening or history of opportunistic infection while not on immunosuppressive therapy
2. Herpes zoster reactivation within the last 2 months prior to screening
3. Active infection at screening or any major episode of infection that required hospitalization or treatment with IV antibiotics within 1 month of screening or during screening (fungal infection of nail beds is allowed)
4. Positive assay or stool culture for pathogens (ova and parasite examination, bacteria) that required treatment per local medical practice or positive test for Clostridioides difficile (C. difficile) toxin at screening.
5. Subject with human immunodeficiency virus (HIV) infection
6. 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 hepatitis B virus \[HBV\] deoxyribonucleic acid \[DNA\], or detectable HBV DNA).
7. Acute or chronic hepatitis C virus (HCV) infection 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)
8. Active tuberculosis (TB) or untreated latent TB (For subjects with positive or intermediate QuantiFERON test)
13. Subject with uncontrolled ischemic heart disease and/or a history of congestive heart failure
14. Subject with a known family or personal history of congenital or acquired long QT syndrome, or subjects with a marked baseline prolongation of QT/ heart rate-corrected QT (QTc) interval
15. Subject with a history of torsade de pointe (TdP)
16. Acute or chronic clinically relevant pulmonary, hepatic, or renal functional abnormality, encephalopathy, neuropathy or unstable central nervous system pathology such as seizure disorder, or any other clinically significant medical problems.
17. Subjects who received live vaccine within 3 months prior to screening and/or subject who is planning to receive such a vaccine during the study duration
18. Acute or chronic pancreatitis
19. Subject with the following hematological and biochemical laboratory parameters obtained during the screening period:
1. Hemoglobin ≤ 8.0 g/dL1
2. Absolute neutrophil count \< 750/mm3
3. Platelets \< 100,000 /mm3
4. eGFR \< 60 mL/min/1.73 m2
5. Total serum bilirubin \> 1.5 x ULN (except if related to pre-existing and documented Gilbert syndrome)
6. Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) \> 2 x ULN
20. Subject who does not meet the washout period requirements prior to the screening endoscopy as described in the prohibited medication section of the study protocol
21. Use of any investigational or nonregistered product within 3 months or within 5 halflives preceding baseline, whichever is longer, and during the study.
22. Subjects previously treated with obefazimod or with a known hypersensitivity to the active substance or to any of the excipients
23. Illicit drug or alcohol abuse or dependence
24. Subject who is committed to an institution by virtue of an order issued either by the judicial or the administrative authorities
25. 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 Contact

Laurence Desroys du Roure, Pharm.D

CONTACT

+33 6 3003 1132

laurence.desroysduroure@abivax.com

Study Locations (Sites)

IMC Gulf Coast Gastroenterology, PC

Fairhope, Alabama, 36532

United States

Scottsdale Gastroenterology Specialists

Scottsdale, Arizona, 85260

United States

GI Alliance -Gurnee

Sun City, Arizona, 85351

United States

Hoag Hospital

Irvine, California, 92618

United States

United Medical Doctors

Murrieta, California, 92563

United States

Peak Gastroenterology Associates

Colorado Springs, Colorado, 80907

United States

Clinical Research Of Brandon, LLC

Brandon, Florida, 33511

United States

West Central Gastroenterology d/b/a Gastro Florida

Clearwater, Florida, 33762

United States

Auzmer Research

Lakeland, Florida, 33813

United States

Center For Advanced Gastroenterology, LLC

Maitland, Florida, 32751

United States

Wellness Clinical Research

Miami Lakes, Florida, 33016

United States

Research Associates of South Florida, LLC

Miami, Florida, 33134

United States

Advanced Research Institute, Inc.

New Port Richey, Florida, 34653

United States

Sarkis Clinical Trials - Parent

Ocala, Florida, 34474

United States

Orlando Health, Inc.

Orlando, Florida, 32806

United States

GCP Clinical Research, LLC

Tampa, Florida, 33609

United States

Theia Clinical Research Centers, LLC

Temple Terrace, Florida, 33617

United States

Northwestern University

Evanston, Illinois, 60208

United States

University of Iowa Health Care

Iowa City, Iowa, 52242

United States

Lucida Clinical Trials, LLC

New Bedford, Massachusetts, 02740

United States

University of Massachusetts, Worcester

Worcester, Massachusetts, 01655

United States

Henry Ford Columbus Center

Detroit, Michigan, 48202

United States

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756

United States

OSU Inflammatory Bowel Disease Center

Hilliard, Ohio, 43026

United States

Susquehanna Research Group, LLC

Harrisburg, Pennsylvania, 17110

United States

UPMC

Pittsburgh, Pennsylvania, 15213

United States

Frontier Clinical Research, LLC

Uniontown, Pennsylvania, 15401

United States

Rapid City Medical Center, LLC

Rapid City, South Dakota, 57701

United States

Vanderbilt University Medical Center

Nashville, Tennessee, 37212

United States

Central Texas Clinical Research, LLC

Austin, Texas, 78705

United States

Inquest Clinical Research

Baytown, Texas, 77521

United States

Novel Research, LLC

Bellaire, Texas, 77401

United States

GI Alliance

Cedar Park, Texas, 78613

United States

Baylor University Hospital

Dallas, Texas, 75246

United States

GI Alliance - Garland

Garland, Texas, 75044

United States

Texas Digestive Specialists

Harlingen, Texas, 78550

United States

Houston Methodist Hospital

Houston, Texas, 77030

United States

GI Alliance - Gurnee

Mansfield, Texas, 76063

United States

Southern Star Research Institute, LLC

San Antonio, Texas, 78229

United States

Tyler Research Institute, LLC

Tyler, Texas, 75701

United States

University of Utah

Salt Lake City, Utah, 84108

United States

Richmond VA Medical Center

Richmond, Virginia, 23249

United States

Gastroenterology Consultants of Southwest Virginia.

Roanoke, Virginia, 24014

United States

University of Washington

Seattle, Washington, 98195

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 Date2024-10-30

Study Completion Date2028-04

Study Record Updates

Study Start Date2024-10-30

Study Completion Date2028-04

Terms related to this study

Keywords Provided by Researchers

Crohn Disease

Additional Relevant MeSH Terms

Moderately to Severely Active Crohn Disease