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

StatusRecruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 6 months later Dec 31, 2026 → Jul 1, 2027
See other at-risk trials from Boston Children's Hospital

Record History

See every version on ClinicalTrials.gov ↗

  1. Notable Primary completion pushed from Dec 31, 2026 to Jul 1, 2027
    • Study completion date: Dec 31, 2027 to Dec 30, 2027
    • Site contacts updated at 1 of 3 sites
    v15
  2. Notable Primary completion date: Dec 31, 2026 to Jul 1, 2027
    • Site contacts updated at 2 of 3 sites
    • Collaborators: 2 to 3
    v14
  3. Notable Primary completion date: Dec 31, 2025 to Dec 31, 2026
    • Study completion date: Dec 31, 2025 to Dec 31, 2027
    v13
  4. Minor Eligibility criteria expanded, about 18 words
    • Site contacts updated at 3 of 3 sites
    • Study description shortened, about 1 word
    v12
  5. Notable Primary completion date: Dec 31, 2023 to Dec 31, 2025
    • Study completion date: Dec 31, 2024 to Dec 31, 2025
    v11
Show 9 earlier versionsHide 9 earlier versions
  1. Notable Primary completion date: Dec 31, 2024 to Dec 31, 2023
    • Study completion date: Dec 31, 2025 to Dec 31, 2024
    v10
  2. Minor Secondary endpoints: details revised at 1 of 2 entries
    • Study description revised
    v9
  3. Notable Primary completion date: Dec 31, 2023 to Dec 31, 2024
    • Study completion date: Dec 31, 2024 to Dec 31, 2025
    v8
  4. Minor Study sites: 2 to 3v7
  5. Minor Eligibility criteria expanded, about 95 words
    • Site contacts updated at 2 of 2 sites
    • Collaborators expanded, about 15 words
    v6
  6. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Mar 1, 2021 to Mar 11, 2021
    • Site details revised at 2 of 2 sites
    v5
  7. Notable Start date: Dec 1, 2020 to Mar 1, 2021v4
  8. Notable Start date: Oct 1, 2020 to Dec 1, 2020v3
  9. Notable Start date: Jul 1, 2020 to Oct 1, 2020v2
  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT04263831
Lead Sponsor Boston Children's Hospital
Collaborators: National Institutes of Health (NIH), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Brigham and Women's Hospital
Conditions
(from sponsor)
Crohn Disease
Related terms Crohn Disease, Inflammatory Bowel Diseases
Enrollment 30 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov