Low Dose IL-2 for the Treatment of Crohn's Disease

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Boston Children's Hospital
Study ID
NCT04263831
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
12 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Interleukin-2 (aldesleukin). — DRUG
    Description of intervention is covered in "Arm", above.

Study Details

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.

Key Dates

Start date
Mar 11, 2021
Status verified
Jan 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2027

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Interleukin-2
    Study drug: Interleukin-2 (aldesleukin, Proleukin, IL-2). Each subject will receive an 8-week course of once-daily, subcutaneously administered IL-2. There will be two dose cohorts. Each subject will be recruited into a single dose cohort and receive a single dose level of IL-2 throughout the study. The dose levels will be as follows: Cohort 1: 1.0x10\^6 IU/m\^2/day. Cohort 2: 1.25x10\^6 IU/m\^2/day.

Primary Outcome Measure

Number of subjects with serious and non-serious adverse events. [ Time Frame: 8 weeks ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Boston Children's HospitalBostonMassachusetts02115
Ashrita Iyengar
[email protected]
617-919-4592
Richelle L Bearup, MPH
[email protected]
617-919-4592
Brigham and Women's HospitalBostonMassachusetts02115
Heidy Cabral
[email protected]
617-525-7322
Mount SinaiNew YorkNew York10029
Sari Feldman
[email protected]
212.824.7669
Jean Fred Colombel, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Boston, MA

By condition
Crohn's disease
By specialty
GastroenterologyInflammatory bowel diseaseAutoimmune disease
By research site
Boston Children's Hospital· Boston, MABrigham and Women's Hospital· Boston, MAMount Sinai· New York, NY

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