Health TrialsbyHealthPanel

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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • Interleukin-2 (aldesleukin).

    Drug

    Description of intervention is covered in "Arm", above.

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: Interleukin-2Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Number of subjects with serious and non-serious adverse events.

Enumeration of the serious and non-serious adverse events seen in the study. Enumeration of any dose limiting toxicity seen in the study.

Time frame
8 weeks
2

Maximum effective dose

Identification of the dose cohort at which the MED occurs.

Time frame
8 weeks

Secondary outcomes

1

Clinical Response

This is a composite endpoint. CDAI scores will be used to assess clinical activity. Moderate to severe CD, denoted by a CDAI score 220-450, is an inclusion criterion. Definition of Clinical Response. CDAI-100 response (≥100-point decrease in the CDAI score) at week 8 Composite Outcome: Clinical response and at least a 50% decrease in fecal calprotectin or CRP

Time frame
8 weeks
2

Immunological Response

Enumeration of the number of subjects with a change in the absolute number of immune cells in the peripheral blood and lamina propria of subjects during the 8 weeks of treatment, and during the 4 weeks following cessation of treatment.

Time frame
12 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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
Apply now