RecruitingPhase 1Phase 2NCT04263831
Low Dose IL-2 for the Treatment of Crohn's Disease
Sponsor
Boston Children's Hospital
Enrollment
30 participants
Start Date
Mar 11, 2021
Study Type
INTERVENTIONAL
Conditions
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.
Eligibility
Min Age: 12 YearsMax Age: 80 Years
Plain Language Summary
Simplified for easier understanding
This study is testing whether low doses of interleukin-2 (IL-2), a protein that regulates the immune system, can treat moderate-to-severe Crohn's disease — a chronic inflammatory bowel disease — by boosting the immune cells that calm inflammation.
**You may be eligible if:**
- You are between 12 and 80 years old (note: enrollment at some centers is limited to age 30 and under)
- You have a confirmed diagnosis of Crohn's disease
- Your disease is moderate to severe based on standard scoring
- Endoscopy (colonoscopy) confirms active inflammation in your bowel
- You have tried and failed other standard Crohn's treatments
**You may NOT be eligible if:**
- You have active infection, cancer, or significant immune system problems
- You are pregnant or breastfeeding
- You have certain serious complications of Crohn's requiring immediate surgery
Talk to your doctor to see if this trial is right for you.
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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Interventions
DRUGInterleukin-2 (aldesleukin).
Description of intervention is covered in "Arm", above.
Locations(3)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT04263831
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