RECRUITING

Low Dose IL-2 for the Treatment of Crohn's Disease

Conditions

Crohn Disease Inflammatory bowel disease Interleukin 2 Regulatory T Cells

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Low Dose IL-2 for the Treatment of Crohn's Disease

Quick Facts

Study Start:2021-03-11

Study Completion:2025-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04263831

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 80 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Age 18-80 years. Maximum age limit for subjects recruited at BCH will be 30 years. 2. A diagnosis of CD made by standard clinical, radiological, endoscopic and histological criteria. 3. Adult subjects with moderate-to-severe CD (CDAI score 220-450) 4. Evidence of endoscopic inflammation accessible via ileocolonoscopy or ileoscopy 1. Simple Endoscopic Score for CD (SES-CD) ≥ 6 or ≥ 4 for isolated ileal disease 2. patients with ileostomies will be assessed as patients with isolated ileal disease via SES-CD. 5. 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. 6. Stable doses of concomitant medications, as defined in Section 5 7. 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. 8. 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 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. The legal guardian must be able to provide documentation of court appointed guardianship.	1. A diagnosis of ulcerative colitis or indeterminate colitis. 2. Requirement for immediate surgical, endoscopic or radiological intervention for perforation, sepsis, or intra-abdominal or perianal abscess. 3. History of colorectal cancer or dysplasia. 4. 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. 5. Current medically significant infection. 6. Significant laboratory abnormalities; 1. Hb \< 7.0 g/dL, WBC \< 2.5 x 103/mm3, Plt \< 50 x 103/mm3. 2. Creatinine ≥ 2x institutional ULN. 3. Total bilirubin \> 2.0 mg/dL, ALT \> 2x institutional ULN. Elevated unconjugated bilirubin related to Gilbert's syndrome is allowed. 4. Abnormal thyroid function tests. 7. Positive serology for HIV, hepatitis B virus (HBV) or hepatitis C virus (HCV). 8. Positive screening test for tuberculosis (TB). 9. Treatment with any biologic medication within 4 weeks of first study drug dose (baseline) (see below section on washouts) 10. Received another IND within 5 half-lives of that agent baseline. 11. Malignancy within the last 5 years, excluding non-melanoma skin cancer. 12. Allergy to any component of the study drug. 13. Pregnant or lactating women. 14. Inability to comply with the study protocol or inability of the subject or the subject's legal guardian to provide informed consent. 15. Prior exposure to IL-2. 16. Uncontrolled cardiac angina or symptomatic congestive cardiac failure (NYHA Class III or IV).

Inclusion Criteria

Exclusion Criteria

1. Age 18-80 years. Maximum age limit for subjects recruited at BCH will be 30 years.
2. A diagnosis of CD made by standard clinical, radiological, endoscopic and histological criteria.
3. Adult subjects with moderate-to-severe CD (CDAI score 220-450)
4. Evidence of endoscopic inflammation accessible via ileocolonoscopy or ileoscopy
1. Simple Endoscopic Score for CD (SES-CD) ≥ 6 or ≥ 4 for isolated ileal disease
2. patients with ileostomies will be assessed as patients with isolated ileal disease via SES-CD.
5. 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.
6. Stable doses of concomitant medications, as defined in Section 5
7. 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.
8. 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 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. The legal guardian must be able to provide documentation of court appointed guardianship.

1. A diagnosis of ulcerative colitis or indeterminate colitis.
2. Requirement for immediate surgical, endoscopic or radiological intervention for perforation, sepsis, or intra-abdominal or perianal abscess.
3. History of colorectal cancer or dysplasia.
4. 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.
5. Current medically significant infection.
6. Significant laboratory abnormalities;
1. Hb \< 7.0 g/dL, WBC \< 2.5 x 103/mm3, Plt \< 50 x 103/mm3.
2. Creatinine ≥ 2x institutional ULN.
3. Total bilirubin \> 2.0 mg/dL, ALT \> 2x institutional ULN. Elevated unconjugated bilirubin related to Gilbert's syndrome is allowed.
4. Abnormal thyroid function tests.
7. Positive serology for HIV, hepatitis B virus (HBV) or hepatitis C virus (HCV).
8. Positive screening test for tuberculosis (TB).
9. Treatment with any biologic medication within 4 weeks of first study drug dose (baseline) (see below section on washouts)
10. Received another IND within 5 half-lives of that agent baseline.
11. Malignancy within the last 5 years, excluding non-melanoma skin cancer.
12. Allergy to any component of the study drug.
13. Pregnant or lactating women.
14. Inability to comply with the study protocol or inability of the subject or the subject's legal guardian to provide informed consent.
15. Prior exposure to IL-2.
16. Uncontrolled cardiac angina or symptomatic congestive cardiac failure (NYHA Class III or IV).

Contacts and Locations

Study Contact

Jennifer J Mitri

CONTACT

617-525-7322

jjmitri@bwh.harvard.edu

Richelle L Bearup, MPH

CONTACT

617-919-4592

richelle.bearup@childrens.harvard.edu

Principal Investigator

Scott Snapper, MD, PhD

PRINCIPAL_INVESTIGATOR

Boston Children's Hospital

Jessica Allegretti, MD, MPH

PRINCIPAL_INVESTIGATOR

Brigham and Women's Hosptial

Study Locations (Sites)

Boston Children's Hospital

Boston, Massachusetts, 02115

United States

Brigham and Women's Hospital

Boston, Massachusetts, 02115

United States

Mount Sinai

New York, New York, 10029

United States

Collaborators and Investigators

Sponsor: Boston Children's Hospital

Scott Snapper, MD, PhD, PRINCIPAL_INVESTIGATOR, Boston Children's Hospital
Jessica Allegretti, MD, MPH, PRINCIPAL_INVESTIGATOR, Brigham and Women's Hosptial

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-03-11

Study Completion Date2025-12-31

Study Record Updates

Study Start Date2021-03-11

Study Completion Date2025-12-31

Terms related to this study

Keywords Provided by Researchers

Inflammatory bowel disease
Interleukin 2
Regulatory T Cells

Additional Relevant MeSH Terms

Crohn Disease