ClinicalTrials.gov
Cure8 trial brief
Low Dose IL-2 for the Treatment of Crohn's Disease
Research and clinical trials
Steroids
Clinical Trial Phase 1
Adult patients
Pediatric Patients
Clinicians
Researchers
Patients On Biologics
Why This Matters
The trial explores a new way to boost regulatory T cells using low-dose IL-2, which could offer an alternative mechanism for people with Crohn's disease who haven't responded to existing therapies. It also links immune changes to clinical outcomes to better understand who might benefit.
Who Should Pay Attention
Patients with moderate-to-severe Crohn's disease (including adolescents where eligible), caregivers, gastroenterologists, and researchers interested in Treg-targeted therapies or immunomodulatory approaches.
Study Snapshot
Story typeClinical Reference
Trial phasePhase 1, Phase 2
Enrollment30 participants
Study statusRecruiting
Source depthTrial registry record
What To Know
This is a recruiting interventional trial (Phase 1/2) evaluating daily low-dose subcutaneous IL-2 given for eight weeks in two dose cohorts. The study enrolls adolescents and adults with moderate-to-severe Crohn's disease who have endoscopic inflammation and prior failure of at least one conventional therapy.
Participants will undergo peripheral and mucosal immune profiling to measure effects on CD4+ regulatory T cells and other immune cells; the trial will record adverse events and identify a maximum effective dose (MED).
The protocol allows people with ileostomies/colostomies under specific assessment rules and includes standard safety and pregnancy-prevention requirements. This summary is grounded in the clinicaltrials.gov record for NCT04263831 and describes the trial design and objectives rather than any results.
Keep In Mind
This is a Phase 1b/2a trial focused on safety, dosing (MED), and mechanistic immune studies; it is not a definitive efficacy trial. The trial record describes planned procedures and outcomes but does not report results. Enrollment criteria, dosing cohorts, and exploratory immune assays are defined in the registry.
Source Details
Review the original publication for the complete reporting, methods, and context.
Clinical trial
Evidence type derived from source or registry metadata.
PublicationClinicalTrials.gov
SponsorBoston Children's Hospital
Trial IDNCT04263831
Study typeInterventional
Trial phasePhase 1, Phase 2
Enrollment30 participants
Indexed viaClinicalTrials.gov
Source typeTrial registry record
PublishedJul 29, 2026, 12:00 AM
Content availableTrial registry record
This Cure8 brief is based on source text from the linked article. Cure8 is informational only and is not a substitute for professional medical advice, diagnosis, or treatment.
Understanding role of microbiota in Crohn's disease, ulcerative colitis
The article explains how gut bacteria may contribute to IBD and summarizes common tests and treatments people are likely to encounter. It highlights emerging microbial therapies (probiotics and FMT) that some patients...
‘Getting closer’: Genetic risk scores may help predict inflammatory bowel disease severity
This research suggests genetic risk scores could help identify people with IBD who are more likely to have severe disease, which might eventually inform earlier monitoring or treatment decisions. It’s a step toward more...
New treatments for Crohn's disease being studied - KOAT
New treatment studies and biosimilars could affect future options and access to care. The piece also points out growing pediatric Crohn’s care and supports available (like an infusion center).