NCT04263831 · Boston Children's Hospital
Low Dose IL-2 for the Treatment of Crohn's Disease
What this study 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.
View original scientific description
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.
Interventions
DRUG
Interleukin-2 (aldesleukin).
Description of intervention is covered in "Arm", above.
Primary outcome measures
Number of subjects with serious and non-serious adverse events.
Time frame: 8 weeks
Enumeration of the serious and non-serious adverse events seen in the study. Enumeration of any dose limiting toxicity seen in the study.
Maximum effective dose
Time frame: 8 weeks
Identification of the dose cohort at which the MED occurs.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Age 12-80 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-aminosalic
Where
- Boston, Massachusetts
- New York, New York
Collaborators
National Institutes of Health (NIH), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 3, 2026 · Source of record for eligibility and locations