Actively Recruiting
Low Dose IL-2 for the Treatment of Crohn's Disease
Led by Boston Children's Hospital · Updated on 2026-02-03
30
Participants Needed
3
Research Sites
355 weeks
Total Duration
On this page
Sponsors
B
Boston Children's Hospital
Lead Sponsor
N
National Institutes of Health (NIH)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Low Dose IL-2 for the Treatment of Crohn's Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 12 and 80 years (maximum age 30 years for subjects at BCH site)
- Diagnosis of Crohn's disease confirmed by clinical, radiological, endoscopic, and histological criteria
- Moderate-to-severe Crohn's disease with CDAI score between 220 and 450
- Patients with ileostomies or colostomies are allowed
- Evidence of endoscopic inflammation accessible by ileocolonoscopy or ileoscopy with SES-CD score of 6 or higher (or 4 or higher for isolated ileal disease)
- Failure to tolerate or respond to at least one conventional therapy including corticosteroids, 5-aminosalicylates, immunosuppressants, TNF alpha antagonists, anti-integrins, or ustekinumab
- Stable doses of concomitant medications
- Negative pregnancy test within 2 weeks before starting study drug for females of childbearing potential
- Agreement to use acceptable birth control during treatment and for six months after
- Ability to provide informed consent or assent with legal guardian consent if under 18 or with mild intellectual disability
You will not qualify if you...
- Diagnosis of ulcerative colitis or indeterminate colitis
- Need for immediate surgery, endoscopic or radiological intervention for perforation, sepsis, or abscess
- History of colorectal cancer or dysplasia
- Positive stool test for Clostridium difficile by GDH/EIA two-step method (PCR alone not accepted)
- Current significant infection
- Significant lab abnormalities including low hemoglobin (<7.0 g/dL), low white blood cells (<2.5 x10^3/mm3), low platelets (<50 x10^3/mm3), high creatinine (≥2 times upper normal limit), high bilirubin (>2.0 mg/dL) or ALT (>2 times upper normal limit), abnormal thyroid tests
- Positive serology for HIV, hepatitis B, or hepatitis C
- Positive tuberculosis screening
- Treatment with biologic medication within 4 weeks before first study drug dose
- Recent treatment with another investigational drug within 5 half-lives
- Malignancy within 5 years except non-melanoma skin cancer
- Allergy to study drug components
- Pregnant or lactating women
- Inability to comply with study protocol or provide consent
- Prior exposure to IL-2
- Uncontrolled heart conditions such as angina or severe heart failure (NYHA Class III or IV)
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 3 locations
1
Boston Children's Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
2
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
3
Mount Sinai
New York, New York, United States, 10029
Actively Recruiting
Research Team
H
Heidy Cabral
CONTACT
R
Richelle L Bearup, MPH
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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