Recruiting PHASE2 Moderately to Severely Active Crohn Disease

Tests treatment safety and results for Moderately to Severely Active Crohn Disease

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 medicine, given as an once-daily, being studied as a potential treatment for 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: 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.

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

people who meet any of the following exclusion criteria will be excluded from the study:
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...
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. Recent...
Symptomatic bowel stricture and/or stenosis not passable in endoscopy

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

people who meet any of the following exclusion criteria will be excluded from the study:
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. Recent cutaneous and perianal abscesses are not exclusionary if drained and...
Symptomatic bowel stricture and/or stenosis not passable in endoscopy
Related to CD surgery:
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
Related to CD treatments:
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
Subject with the following infectious conditions:
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
Subject with the following hematological and biochemical laboratory parameters obtained during the screening period:
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's taking place

Fairhope, Alabama, United States
Scottsdale, Arizona, United States
Sun City, Arizona, United States
Irvine, California, 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
Miami Lakes, 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
Iowa City, Iowa, United States
New Bedford, Massachusetts, United States
Worcester, Massachusetts, United States

+ 116 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 - 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?

Study sites include Fairhope, Alabama, United States; Scottsdale, Arizona, United States; Sun City, Arizona, United States; Irvine, California, United States; Murrieta, California, United States; Colorado Springs, Colorado, United States and 130 more location(s). Enter your location above to see the nearest site and check your eligibility.

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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.