Low Dose IL-2 for the Treatment of Crohn's Disease
ConditionCrohn Disease
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age12-80
SponsorBoston Children's Hospital
About this trial
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 criteria
Qualifiers
Age 12-80 years. Maximum age limit for subjects recruited at BCH will be 30 years.
A diagnosis of CD made by standard clinical, radiological, endoscopic and histological criteria.
Adult subjects with moderate-to-severe CD (CDAI score 220-450)
Evidence of endoscopic inflammation accessible via ileocolonoscopy or ileoscopy
Disqualifiers
A diagnosis of ulcerative colitis or indeterminate colitis.
Requirement for immediate surgical, endoscopic or radiological intervention for perforation, sepsis, or intra-abdominal or perianal abscess.
History of colorectal cancer or dysplasia.
Positive stool test for Clostridium difficile via GDH/EIA two step testing method. PCR only testing will not be accepted. If patient is GDH positive and EIA negative, enrollment will be permitted.
Trial design
Treatments tested in this trial
- Interleukin-2 (aldesleukin).
Treatment groups
30 Participants
are divided into 1 treatment groupSponsors and collaborators
Boston Children's Hospital
Lead sponsor
National Institutes of Health (NIH)
Collaborator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator
Brigham and Women's Hospital
Collaborator
Source ClinicalTrials.gov