New York, NYNCT04263831Now EnrollingIRB Ready

Crohn's Disease Clinical Trial in New York, NY

Access cutting-edge crohn's disease treatment through this phase 1/2 clinical trial at a research site in New York. Study-provided care at no cost to qualified participants.

Sponsored by Boston Children's Hospital

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Expert Care in New York

Access crohn's disease specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related crohn's disease treatment provided free

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Check if you qualify for this crohn's disease clinical trial in New York, NY

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Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Local to New York

    Convenient for NY residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit New York site if eligible
  4. 4Begin participation

About This Crohn's Disease Study in New York

The purpose of this study is to determine the safety and maximum effective dose (MED) of Interleukin-2 in subjects with moderate-to-severe crohn's disease.

Sponsor: Boston Children's Hospital

Who Can Participate

Inclusion Criteria

Age 12-80 years. Maximum age limit for subjects recruited at BCH will be 30 years.
A diagnosis of CD made by standard clinical, radiological, endoscopic and histological criteria. a. A subset of patients with Ileostomies or colostomies will be permitted.
Adult subjects with moderate-to-severe CD (CDAI score 220-450) a. a modified CDAI will be used to assess patients with ileostomies/colostomies. Number of liquid stools per day will be substituted for number of bag empties per day.
Evidence of endoscopic inflammation accessible via ileocolonoscopy or ileoscopy
Simple Endoscopic Score for CD (SES-CD) ≥ 6 or ≥ 4 for isolated ileal disease
patients with ileostomies will be assessed as patients with isolated ileal disease via SES-CD.
Failure to tolerate or failure to respond to at least one conventional therapy with the intention of inducing or maintaining remission (including but not limited to oral corticosteroids, oral 5-aminosalicylates, azathioprine and/or 6-mercaptopurine, TNF alpha antagonist, anti-integrins, ustekinumab). Corticosteroid dependency (inability to taper oral corticosteroids without a recurrence of disease activity) is also included in this category.
Stable doses of concomitant medications, as defined in Section 5
A negative pregnancy test within 2 weeks prior to anticipated commencement of the study drug, in female subjects of child-bearing age. Men and women of reproductive potential must agree to use an acceptable method of birth control during treatment and for six months after completion of treatment.
The ability of adult participants who are able to make their own healthcare decisions to provide informed consent or the ability of a legal guardian to provide consent if the participant is a child (less than 18 years of age) or has mild intellectual disability and cannot consent for him or herself. In the event that a legal guardian provides consent, the study participant must be able to demonstrate an understanding of the study at his or her comprehension level and must have the ability to give verbal assent. If the legal guardian is court appointed, then the legal guardian must be able to provide documentation of court appointed guardianship.

Exclusion Criteria

A diagnosis of ulcerative colitis or indeterminate colitis.
Requirement for immediate surgical, endoscopic or radiological intervention for perforation, sepsis, or intra-abdominal or perianal abscess.
History of colorectal cancer or dysplasia.
Positive stool test for Clostridium difficile via GDH/EIA two step testing method. PCR only testing will not be accepted. If patient is GDH positive and EIA negative, enrollment will be permitted.
Current medically significant infection.
Significant laboratory abnormalities;
Hb \< 7.0 g/dL, WBC \< 2.5 x 103/mm3, Plt \< 50 x 103/mm3.
Creatinine ≥ 2x institutional ULN.
Total bilirubin \> 2.0 mg/dL, ALT \> 2x institutional ULN. Elevated unconjugated bilirubin related to Gilbert's syndrome is allowed.
Abnormal thyroid function tests.
Positive serology for HIV, hepatitis B virus (HBV) or hepatitis C virus (HCV).
Positive screening test for tuberculosis (TB).
Treatment with any biologic medication within 4 weeks of first study drug dose (baseline) (see below section on washouts)
Received another IND within 5 half-lives of that agent baseline.
Malignancy within the last 5 years, excluding non-melanoma skin cancer.
Allergy to any component of the study drug.
Pregnant or lactating women.
Inability to comply with the study protocol or inability of the subject or the subject's legal guardian to provide informed consent.
Prior exposure to IL-2.
Uncontrolled cardiac angina or symptomatic congestive cardiac failure (NYHA Class III or IV).

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 (NCT04263831) 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.

Crohn's Disease Treatment Options in New York, NY

If you're searching for crohn's disease treatment options in New York, NY, this clinical trial (NCT04263831) 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 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.

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