Is NCT06456593 recruiting in Irvine, CA?

Yes, NCT06456593 is currently recruiting participants at its Irvine, CA location. This crohn's disease clinical trial is actively enrolling qualified participants.

How do I join the crohn's disease clinical trial in Irvine?

To join this clinical trial in Irvine, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Irvine clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Crohn's Disease Clinical Trial in Irvine, CA

About This Crohn's Disease Study in Irvine

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 sa

Sponsor: Abivax S.A.

Who Can Participate

Inclusion Criteria

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 therapies, or janus kinase (JAK) (note: failure to only 5-aminosalicylic acid \[5-ASA\] is not accepted)

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.

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.

Exclusion Criteria

Subjects 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 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.

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 (subjects 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 virus \[HBV\] deoxyribonucleic acid \[DNA\], or detectable HBV DNA).

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)

Active tuberculosis (TB) or untreated latent TB (For subjects 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 subjects 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 significant medical problems.

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

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.

Subjects 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

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Irvine?

Yes, this clinical trial (NCT06456593) has an active research site in Irvine, CA that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Crohn's Disease Treatment Options in Irvine, CA

If you're searching for crohn's disease treatment options in Irvine, CA, this clinical trial (NCT06456593) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Irvine research site is actively enrolling participants for this phase 2 clinical trial. You'll receive care from experienced crohn's disease specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all crohn's disease clinical trials near you to find additional studies recruiting in your area.

Crohn's Disease Clinical Trial in Irvine, CA

Expert Care in Irvine

IRB Approved

No-Cost Care

Apply for This Irvine Location

Why Participate?

Simple Process