Status:
COMPLETED
Low Dose IL-2 for Ulcerative Colitis
Lead Sponsor:
Scott B. Snapper, MD PHD
Conditions:
Ulcerative Colitis
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
Brief 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 ulcerative colitis.
Detailed Description
Interleukin-2 (IL-2) is a T cell growth factor. IL-2 is currently licensed for the treatment of metastatic renal cell carcinoma and metastatic melanoma, where it promotes the expansion of anti-cancer ...
Eligibility Criteria
Inclusion
- Age 18-70 years.
- A diagnosis of UC made by standard clinical, radiological, endoscopic and histological criteria.
- Moderate to severe UC with a Mayo score of 6-12.
- Failure to tolerate or failure to respond to at least one conventional therapy with the intention of inducing or maintaining remission (examples include oral corticosteroids, oral 5-aminosalicylates, azathioprine and/or 6-mercaptopurine, or a tumor necrosis factor (TNF) antagonist). Corticosteroid dependency (inability to taper oral corticosteroids without a recurrence of disease activity) is also included in this category.
- Stable doses of concomitant medications.
- A negative pregnancy test in the 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.
- Ability to provide informed consent.
Exclusion
- A diagnosis of Crohn's disease or Inflammatory Bowel Disease - Unspecified (IBD-U, a diagnostic classification formerly termed "indeterminate colitis").
- Requirement for immediate surgical, endoscopic or radiological intervention for toxic megacolon, massive hemorrhage, perforation, sepsis, or intra-abdominal or perianal abscess.
- Ileostomy, proctocolectomy or subtotal colectomy with ileorectal anastomosis.
- History of colorectal cancer or dysplasia.
- Positive stool test for Clostridium difficile.
- Current medically significant infection.
- Significant laboratory abnormalities, including;
- Hb \< 8.0 g/dL, WBC \< 2.5 x 103/mm3, Plt \< 100 x 103/mm3.
- Creatinine ≥ 1.5x institutional upper limit of normal (ULN).
- Total bilirubin \> 2.0 mg/dL, ALT \> 2x institutional ULN, GGT \> 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 HCV.
- Positive screening test for tuberculosis (TB).
- First dose of an anti-TNF medication within 4 weeks of anticipated study commencement, or a subsequent dose within 2 weeks of commencement; or ciclosporin or tacrolimus within 2 weeks of anticipated study commencement.
- Received another investigational new drug (IND) within 5 half-lives of that agent before the planned commencement of SC IL-2.
- Malignancy within the last 5 years.
- Allergy to any component of the study drug.
- Pregnant or lactating women.
- Inability to comply with the study protocol or inability to give informed consent.
- Prior exposure to IL-2.
- Uncontrolled cardiac angina or symptomatic congestive cardiac failure (NYHA Class III or IV).
Key Trial Info
Start Date :
February 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2021
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT02200445
Start Date
February 1 2015
End Date
March 1 2021
Last Update
June 15 2023
Active Locations (2)
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1
Boston Children's Hospital
Boston, Massachusetts, United States, 02115
2
Brigham & Women's Hospital
Boston, Massachusetts, United States, 02115