Is NCT06721962 recruiting in Louisville, KY?

Yes, NCT06721962 is currently recruiting participants at its Louisville, KY location. This crohn's disease clinical trial is actively enrolling qualified participants.

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

To join this clinical trial in Louisville, 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 Louisville 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 Louisville, KY

About This Crohn's Disease Study in Louisville

This research study is testing an investigational research product called TRX103 as a possible treatment for individuals suffering from Crohn's Disease (CD). The primary purpose of this study is to learn how safe and effective different doses of TRX103 are when administered to individuals with CD.

Sponsor: Tr1X, Inc.

Who Can Participate

Inclusion Criteria

Male and females ≥ 18 and ≤ 65 years of age at time of consent.

Weight of ≥ 40 kg.

Medical history and biological evidence of active bowel inflammation documented by:

Minimum of approximate 1 year of Crohn's disease diagnosis confirmed through Endoscopy, and;

Endoscopic evidence of CD diagnosis at least 3 months prior to and/or at Screening (SES-CD ≥ 6 for ilealcolonic or ≥ 4 isolated ileal disease by central reader)

Active disease defined as moderate to severe active CD at Screening defined by all of the following:

Evidence of mucosal inflammation, defined as SES-CD ≥ 6 (≥ 4 for subjects with isolated ileal disease), and;

CDAI total scores ≥ 220

Subject on treatment with corticosteroids may be included if they meet the following:

prednisone or equivalent dose ≤ 20 mg/day; or

budesonide ≤ 9 mg/day; or

has been on a stable dose for at least 7 days prior to TRX103 dose.

Advanced therapy-refractory disease defined by: Failure of two or more advanced approved therapies. Prior therapies may be inclusive of any combination of the following:

TNF-alpha inhibitors

IL-12/23 inhibitors

Anti-integrins

JAK inhibitors Failure of therapies are defined as either non-response (primary failure), complete loss of response (secondary failure) or intolerant to therapy at a dose indicated for CD.

Primary failure is defined as:

When a subject does not achieve a response after having received the induction doses of a CD approved drug per prescribing information. Induction period is defined as 12-weeks.

A response is defined as CDAI score that reduces by ≥ 100-point from Baseline or by Physician assessment.

Secondary failure, or relapse defined as:

Subjects who respond to the therapy or achieves remission after an induction regimen per prescribing information, but subsequently lose response or relapses during maintenance treatment.

Relapse is defined as an increase in the CDAI score from maintenance of ≥ 100 points and a CDAI score \> 220, and/or SES-CD score ≥ 6 (or ≥ 4 if isolated ileal disease) or by Physician assessment.

Intolerant to therapy, defined as:

When a subject is unable to cope with the side effects or mechanism of actions of the treatment and/or experiences unacceptable side effects when dosed at appropriate therapeutic levels.

Absence of uncontrolled bacterial, viral, or fungal infection at time of enrollment.

Subjects must be able to understand and sign informed consent and be willing and able to complete all specified procedures and visits.

Exclusion Criteria

Prior organ transplant, or allogeneic bone marrow, peripheral blood, or cord blood stem cell transplant. Note: Blood transfusion are not exclusionary if it occurred ≥ 3 years (- 3 months) of TRX103 infusion.

Received another investigational agent or therapy, within 28 days of planned TRX103 infusion (or 5 half-lives, whichever is longer) and/or have not recovered from treatment related toxicities.

Received any approved treatment for CD within the designated washout period (including off-label use of approved therapies) as per the protocol.

Strictures, active fistulae (including perianal), or abscess by computed tomography (CT) or magnetic resonance enterography (MRE) or Endoscopy within 6 months of Screening.

Positive serology for HIV.

Positive hepatitis-B surface antigen. Subject may be included if they are HBV PCR negative.

Hepatitis C virus (HCV RNA detectable in any subject with anti-HCV antibodies).

Subject with active or chronic recurring infections or untreated latent Tuberculosis (TB).

Current diagnosis of ulcerative colitis (UC), indeterminate colitis or CD isolated to colon only (the colitis must be related to CD and inclusive of ileal with or without colonic involvement).

Subjects with the following known complications of Crohn's Disease

active diverticulitis,

active fistulae or abscess,

abscess (abdominal or perianal) - abscess with no evidence of pus when pressed upon are permitted,

impassable fibrotic strictures - Patients with strictures passable by dilation are permitted,

symptomatic bowel strictures - must be confirmed via endoscopy and/or radiologically,

fulminant colitis,

toxic megacolon,

ostomy or ileoanal pouch - previous temporary ostomy pouch, followed by a reversal is permitted,

diagnosed with short gut or short bowel syndrome,

or any other manifestation that might require surgery while enrolled in the study.

Subject with surgical bowel resection within the past 3 months prior to Screening, or a history of \> 2 bowel resections. Note: Surgery for temporary use of an ostomy bag or reconnection of the gut post colostomy use is not considered exclusionary, nor considered as part of the surgical resection if during the reconnection removal of tissue is required to facilitate reattachment.

Subjects that are pregnant, breast feeding, or aim to become pregnant during the 12 month study period. (Subjects, males and females, must agree to use a highly effective method of contraception).

Screening laboratory and other analyses show any of the following abnormal results:

Serum aspartate transaminase or alanine transaminase \> 3.0 × upper limit of normal;

Total white blood cell count \< 2,000/μL;

Estimated glomerular filtration rate by simplified 4-variable Modification of Diet in Renal Disease (MDRD) formula or by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation \< 40 mL/min/1.73 m2;

Hemoglobin \< 8 g/dL;

Bilirubin ≥ 2 x ULN;

Platelet count \< 100,000/μL;

Absolute neutrophil count \< 1,200/μL;

Absolute lymphocytes count \< 750/μL.

Any subject with a history of significant renal, hepatic, pulmonary, or cardiac dysfunction, or on treatment to support cardiac dysfunction.

Any serious illness, uncontrolled inter-current illness, psychiatric illness, active or uncontrolled infection, or other medical condition or history, including laboratory results, which, in the Investigator's opinion:

places the subject at increased risk during participation in the study, and/or;

interferes with the subject's capacity to provide informed consent and their participation in the study, and/or;

interferes with the interpretation of the results.

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 Louisville?

Yes, this clinical trial (NCT06721962) has an active research site in Louisville, KY 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 Louisville, KY

If you're searching for crohn's disease treatment options in Louisville, KY, this clinical trial (NCT06721962) 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 Louisville research site is actively enrolling participants for this phase 1/2 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 Louisville, KY

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