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

ID#: NCT04263831

Age: 18 - 80 years

Gender: All

Healthy Subjects: No

Study Phase: Phase 1/Phase 2

Recruitment Status: Recruiting

Start Date: March 11, 2021

End Date: December 31, 2024

Contact Information:
Jennifer J Mitri
Richelle L Bearup, MPH
Summary: 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.

Inclusion 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. a. A subset of patients with Ileostomies or colostomies will be permitted.

3. 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.

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.

Exclusion Criteria:

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).