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)

Boston Children's Hospital

Boston, Massachusetts, United States

Brigham and Women's Hospital

Boston, Massachusetts, United States

Mount Sinai

New York, New York, United States

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NCT04263831


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