Is NCT06257706 recruiting in Los Angeles, CA?

Yes, NCT06257706 is currently recruiting participants at its Los Angeles, CA location. This crohn's disease clinical trial is actively enrolling qualified participants.

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

To join this clinical trial in Los Angeles, 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 Los Angeles 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 Los Angeles, CA

About This Crohn's Disease Study in Los Angeles

Transmural healing (TMH) is recognized as a potentially important measure of Crohn's disease (CD) activity but not a formal target. Observational studies suggest that TMH may be associated with better long-term outcomes. The study will evaluate TMH using noninvasive intestinal ultrasound (IUS), a patient-friendly technique that can be performed routinely in clinical practice. The aim of the study is to determine if treating to a target of corticosteroid-free (CS-free) IUS outcomes + clinical sym

Sponsor: Alimentiv Inc.

Who Can Participate

Inclusion Criteria

Adults aged 18 to 80 years, inclusive, at the time of consent;

Moderately to severely active CD at baseline defined by a CDAI score of 220 to 450 inclusive and SES-CD, excluding the presence of narrowing component, ≥6 (or ≥4 for participants with isolated ileal disease);

BWT on IUS of \>4.0 mm in the terminal ileum or any colonic segment (excluding the rectum) as assessed by the mean of 2 longitudinal and 2 cross-sectional measurements of the same segment;

Biologic-naïve or have previous exposure (within the last 5 years of the screening date) to no more than 1 advanced therapeutic compound (approved biologic or small molecule drug) for the treatment of their CD. Note: only approximately 15% to 30% of the enrolled population will have had prior exposure to an advanced therapeutic;

Participants may continue stable dose (initiated at least 4 weeks prior to Screening) of 5-ASA for CD;

Persons of childbearing potential must have a negative serum pregnancy test prior to randomization and must use a highly effective method of contraception throughout the study. Females unable to bear children must have documentation of such in the source records;

Able to participate fully in all aspects of this clinical trial;

Written informed consent must be obtained and documented.

Exclusion Criteria

Current or previous treatment with vedolizumab, etrolizumab, or natalizumab;

Previously exposed to 2 or more compounds or classes of an advanced therapeutic compound (approved biologic or small molecule drug) for the treatment of their CD;

Change to oral corticosteroid therapy dosing within 2 weeks prior to randomization or a corticosteroid dose of \>40 mg of prednisone or equivalent at randomization;

Only have inflammation proximal to the terminal ileum that cannot be reached by ileocolonoscopy;

Have a CD complication, such as symptomatic strictures in the small bowel with \>3 cm prestenotic dilatation on any imaging modality, requiring procedural intervention;

Previous extensive colonic resection or missing \>2 segments out of 5 (terminal ileum, right colon, transverse colon, sigmoid and left colon, and rectum), ileorectal anastomosis, or a proctocolectomy;

Ostomy or ileoanal pouch;

Short bowel syndrome;

Fibrotic-only stricture in the ileum or colon without evidence of active inflammation (in the investigator's judgment), including any impassable stenosis;

Abscess \>2 cm, detected by IUS or endoscopy; participants with draining fistulas are not excluded;

Serious underlying disease other than CD that, in the opinion of the investigator, may interfere with the participant's ability to participate fully in the study or would compromise participant safety;

Positive stool test for Clostridioides difficile infection (as demonstrated by positive toxin);

Known HIV or hepatitis B or C infection. If a negative test result is available in the 12 months prior to randomization, retesting is not required;

Known active or latent tuberculosis (TB); if a negative test result is available in the 12 months prior to randomization, confirmatory testing (per standard of care) is not required before randomization;

Other systemic or opportunistic infection (including cytomegalovirus), any other clinically significant extraintestinal infection, or recurring infection within 6 months of randomization;

Has active cerebral/meningeal disease, signs, symptoms, or any history of progressive multifocal leukoencephalopathy (PML) prior to randomization;

Hypersensitivity, allergy, or intolerance to any excipient of vedolizumab or any other contraindication to vedolizumab;

Active severe infection such as sepsis, cytomegalovirus, listeriosis, or opportunistic infection.

Unwillingness to withhold protocol-prohibited medications during the trial;

Concurrent or previous participation in another clinical trial and received any investigational therapy within 30 days prior to randomization;

History of alcohol or drug abuse that in the opinion of the investigator may interfere with the participant's ability to comply with the study procedures;

Prior enrolment in the current study and had received study treatment;

Pregnant, lactating, or intending to become pregnant/impregnate a partner before, during, or within 18 weeks after the last dose; or intending to donate ova or sperm during such time period;

Vaccination with a live or live-attenuated vaccine within 4 weeks prior to randomization, or planned vaccination with a live or live-attenuated vaccine during participation in the study;

Any person performing mandatory military service, deprived of liberty, in a residential care setting, or any person who, due to a judicial decision, cannot take part in clinical studies;

The person is an immediate family member, study site employee, or is in a dependent relationship with a study site employee who is involved in conduct of this study (e.g., spouse, parent, child, sibling).

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 Los Angeles?

Yes, this clinical trial (NCT06257706) has an active research site in Los Angeles, 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 Los Angeles, CA

If you're searching for crohn's disease treatment options in Los Angeles, CA, this clinical trial (NCT06257706) 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 Los Angeles research site is actively enrolling participants for this phase 4 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 Los Angeles, CA

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