Is NCT07486921 recruiting in New York, NY?

Yes, NCT07486921 is currently recruiting participants at its New York, NY location. This pouchitis clinical trial is actively enrolling qualified participants.

How do I join the pouchitis clinical trial in New York?

To join this clinical trial in New York, 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 New York 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.

Pouchitis Clinical Trial in New York, NY

About This Pouchitis Study in New York

The researchers propose conducting a multi-center, randomized, placebo-controlled study to investigate the potential role of etrasimod for the primary and secondary prevention of pouchitis among high-risk patients submitted to total proctocolectomy (TPC) with ileal-pouch anal anastomosis (IPAA) for medically refractory disease. The trial will be conducted in compliance with this protocol, Good Clinical Practice guidelines, and Institutional Review Board requirements.

Sponsor: Maia Kayal

Who Can Participate

Inclusion Criteria

Male or female aged ≥ 18 years (verified at screening)

Ability to provide written informed consent and to be compliant with protocol assessments (verified at screening)

Diagnosed with UC and underwent TPC with IPAA for medically refractory disease or dysplasia (verified at screening)

Screening may take place at any time from one month to two years after the final surgical stage

High-risk of developing acute pouchitis - defined as fulfilling at least one of the criteria defined in section 2 (verified at screening)

Patients with 1 prior episode of acute pouchitis can be enrolled - after a minimum period of 4 weeks after completion of a course of antibiotics and resolution of symptoms of pouchitis

Symptomatic remission defined by a symptom mPDAI subscore ≤2 points at the baseline visit (verified at screening, baseline)

Adequate hematological function defined by white blood cell count ≥ 3.5 × 109/L with absolute neutrophil count (ANC) ≥ 1.5 × 109/L, absolute lymphocyte count (ALC) ≥ 0.8 × 109/L, platelet count ≥ 100 × 109/L, and hemoglobin ≥ 8 g/dL (verified at screening)

Healthcare professional-confirmed history of varicella or a full course of vaccination against varicella zoster virus (VZV) or a positive antibody test to VZV (verified at screening)

12-lead electrocardiogram (ECG) that showed no clinically significant abnormalities as defined by the clinician's judgement (verified at screening)

Females must be non-pregnant, as determined by qualitative urine hCG testing, non-lactating, and if premenopausal, must agree to using a highly effective contraception method (that can achieve a failure rate of less than 1% per year when used consistently and correctly) during treatment and for one week after stopping treatment with etrasimod (verified at screening)

Exclusion Criteria

Isolated cuffitis (verified at screening pouchoscopy)

Diagnosis of Crohn's disease (verified at screening)

Diagnosis of Crohn's disease-like pouch inflammation (verified at screening) o Crohn's disease-like pouch inflammation is defined as ulcerations of the pre-pouch ileum extending \> 10 cm above the inlet, strictures in the pre-pouch ileum or pouch body outside of the anastomoses, and/or fistulae of the pre-pouch ileum, pouch body, or perineum

Diagnosis of chronic pouchitis (verified at screening) o Chronic pouchitis is defined as persistent (\> 4 weeks) or recurrent (\> 4 episodes/year) symptoms of pouchitis

Anastomotic stenosis or other mechanical complications of the pouch (verified at screening pouchoscopy)

Treatment with probiotics ≤ 3 months prior to screening (verified at screening)

Treatment with topical rectal 5-ASA, or steroids ≤ 2 weeks prior to or during screening (verified at screening)

Any use of a biologic or small molecule approved for moderately to severely active UC or investigational, after TPC with IPAA (verified at screening)

Any prior exposure to a S1P receptor modulator therapy, at any time (verified at screening)

Any investigational or biologic agent within 30 days of screening pouchoscopy (verified at screening)

Have the following cardiovascular history (verified at screening):

In the last 6 months, have experienced a myocardial infarction, unstable angina pectoris, stroke, transient ischemic attack (TIA), decompensated heart failure requiring hospitalization, or Class III or IV heart failure

Have a history or presence of Mobitz type II second-degree or third-degree atrioventricular (AV) block, sick sinus syndrome, or sino-atrial block, unless the patient has a functioning pacemaker

A history of symptomatic bradycardia, recurrent cardiogenic syncope, Mobitz type I second-degree AV block, or severe untreated sleep apnea

Significant QT prolongation (QTcF interval ≥ 450 ms in male or ≥ 470 ms in females)

Arrhythmias requiring treatment with Class Ia or Class III anti-arrhythmic drugs or QT prolonging drugs

Clinically significant or serious active infection ≤ 28 days prior to baseline - including but not limited to (verified at screening):

Positive assay or stool culture for pathogens (ova and parasite examination, bacteria) or

positive test for Clostridioides difficile toxin at screening

Active tuberculosis

Acute or chronic hepatitis B or hepatitis C

HIV infection

Pregnancy, lactation, or a positive urine pregnancy test measured during screening

Severe hepatic impairment (Child Pugh Class C) (verified at screening)

Have a known history of macular edema or retinopathy (verified at screening)

History of cancer within the last 5 years (excluding in situ squamous or basal cell carcinoma of the skin that has been excised and resolved) or current malignancy (verified at screening)

History of posterior reversible encephalopathy syndrome (PRES)

Have a history of any clinically significant medical condition that, in the investigator's opinion, precludes participation in the study (verified at screening)

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 New York?

Yes, this clinical trial (NCT07486921) has an active research site in New York, NY 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.

Pouchitis Treatment Options in New York, NY

If you're searching for pouchitis treatment options in New York, NY, this clinical trial (NCT07486921) 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 New York research site is actively enrolling participants for this phase 2 clinical trial. You'll receive care from experienced pouchitis 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 pouchitis clinical trials near you to find additional studies recruiting in your area.

Pouchitis Clinical Trial in New York, NY

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