Moderately to Severely Active Crohn Disease study: Obefazimod
Official title Efficacy and Safety of Obefazimod in Subjects With Moderately to Severely Active Crohn's Disease
ClinicalTrials.gov ID: NCT06456593
What this study is testing
What is Obefazimod?
Obefazimod is an investigational oral medicine being studied for the treatment of moderately to severely active Crohn disease.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study wants to see if obefazimod works and is safe compared to a placebo during induction and maintenance periods. In the final 48‑week part, it will look mainly at safety and how well patients tolerate the drug.
- Who it's for
- It is looking for adults with moderately to severely active Crohn’s disease who did not get enough benefit from standard or advanced therapies.
- What's involved
- Participants will receive either obefazimod or a placebo. They will have regular clinic visits, blood tests, and other safety checks throughout the study phases.
- Time commitment
- The study lasts up to 48 weeks, with visits during the 12‑week induction, 40‑week maintenance, and 48‑week extension periods. Participants will need to attend scheduled appointments during each phase.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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...
- Able and willing to comply with study visits and procedures as per protocol.
- Confirmed and documented diagnosis of CD based on endoscopy and histology reports.
- 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...
- Documented inadequate response (defined as lack of response or loss of response or intolerance) to at least one of the following treatments...
You likely can't join if
- WOCBP subject who is pregnant or breast-feeding at screening, or intends to become pregnant during the study
- Current diagnosis of ulcerative colitis (UC) or indeterminate colitis
- CD without ileal and/or colonic involvement
- Untreated active external or perianal fistula or abscess. Stable fistula without abscess and with minimal or low drainage may be enrolled.
- Symptomatic bowel stricture and/or stenosis not passable in endoscopy
- Current stoma or ileoanal pouch
See the full eligibility criteria
Who can join
- 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
- Able and willing to comply with study visits and procedures as per protocol.
- Confirmed and documented diagnosis of CD based on endoscopy and histology reports.
- 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).
- 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...
- Women of childbearing potential (WOCBP) and male people with WOCBP partner must agree to comply with contraception requirements as stated in section 4.5 (contraception) of this protocol.
- Subject should be affiliated to a health insurance policy whenever required by a participating country or state.
- Subject is able and willing to comply with usual public recommendations for sun protection.
What rules you out
- 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.
- Current diagnosis of ulcerative colitis (UC) or indeterminate colitis
- CD without ileal and/or colonic involvement
- Untreated active external or perianal fistula or abscess. Stable fistula without abscess and with minimal or low drainage may be enrolled.
- Symptomatic bowel stricture and/or stenosis not passable in endoscopy
- Current stoma or ileoanal pouch
- More than 2 missing complete segments of the following 5 segments: terminal ileum, right colon, transverse colon, left colon, and sigmoid and rectum
- Combined previous small bowel resections \> 100 cm
- Surgical bowel resection within the past 3 months prior to baseline
- Any other manifestation that might require surgery while enrolled in the study
- Subject who is currently treated with prohibited concomitant therapies for CD as described in the study protocol
- Subject who has previously received natalizumab (or any other α4β1 integrin agonist)
- 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
- History of, or active, malignancy including nonmelanoma skin cancer (people with a 5-year disease-free survival are eligible)
- 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)
- Subject with history of, or diagnosed with, the following during screening: primary sclerosing cholangitis, autoimmune hepatitis, or primary biliary cirrhosis
- Serious illness requiring hospitalization (not related to CD) within 4 weeks prior to screening
- 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
- Herpes zoster reactivation within the last 2 months prior to screening
- 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)
- 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.
- Subject with human immunodeficiency virus (HIV) infection
- 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...
- Acute or chronic hepatitis C virus (HCV) infection as defined by positive for hepatitis C antibody (people successfully treated and without recurrence ≥ 1 year with no detectable HCV RNA [assessed centrally] are...
- Active tuberculosis (TB) or untreated latent TB (For people with positive or intermediate QuantiFERON test)
- Subject with uncontrolled ischemic heart disease and/or a history of congestive heart failure
- Subject with a known family or personal history of congenital or acquired long QT syndrome, or people with a marked baseline prolongation of QT/ heart rate-corrected QT (QTc) interval
- Subject with a history of torsade de pointe (TdP)
- 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...
- people 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
- Acute or chronic pancreatitis
- Hemoglobin ≤ 8.0 g/dL1
- Absolute neutrophil count \< 750/mm3
- Platelets \< 100,000 /mm3
- eGFR \< 60 mL/min/1.73 m2
- Total serum bilirubin \> 1.5 x ULN (except if related to pre-existing and documented Gilbert syndrome)
- Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) \> 2 x ULN
- 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
- Use of any investigational or nonregistered product within 3 months or within 5 halflives preceding baseline, whichever is longer, and during the study.
- people previously treated with obefazimod or with a known hypersensitivity to the active substance or to any of the excipients
- Illicit drug or alcohol abuse or dependence
- Subject who is 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
The study team makes the final eligibility decision.
Where it is enrolling
- Sun City, Arizona, United States
- Murrieta, California, United States
- Colorado Springs, Colorado, United States
- Brandon, Florida, United States
- Clearwater, Florida, United States
- Lakeland, Florida, United States
- Miami, Florida, United States
- New Port Richey, Florida, United States
- Ocala, Florida, United States
- Orlando, Florida, United States
- Tampa, Florida, United States
- Temple Terrace, Florida, United States
- Evanston, Illinois, United States
- New Bedford, Massachusetts, United States
- Detroit, Michigan, United States
- Uniontown, Pennsylvania, United States
- Rapid City, South Dakota, United States
- Bellaire, Texas, United States
- Cedar Park, Texas, United States
- Dallas, Texas, United States
+ 62 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Sun City, Arizona, United States; Murrieta, California, United States; Colorado Springs, Colorado, United States; Brandon, Florida, United States; Clearwater, Florida, United States; Lakeland, Florida, United States and 76 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.