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Janus Kinase (JAK) Inhibitors to Preserve C-Peptide Production in New Onset Type 1 Diabetes (T1D)

StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 4 months later Jun 30, 2026 → Oct 30, 2026
See other at-risk trials from National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Record History

  1. Primary completion pushed from Jun 30, 2026 to Oct 30, 2026 Completion pushed from Jun 30, 2027 to Oct 30, 2027 · Eligibility criteria expanded, about 8 wordsv19 Show 2 more changesShow less
    • Completion pushed from Jun 30, 2027 to Oct 30, 2027
    • Eligibility criteria expanded, about 8 words

    See this version in full on ClinicalTrials.gov ↗

  2. Re-verified, no change to tracked fieldsv18
  3. Trial status: Recruiting to Active, Not Recruiting Site details revised at 30 of 30 sitesv17 Show 1 more changeShow less
    • Site details revised at 30 of 30 sites
  4. Study sites: 27 to 30 Eligibility criteria expanded, about 42 wordsv16 Show 1 more changeShow less
    • Eligibility criteria expanded, about 42 words

    See this version in full on ClinicalTrials.gov ↗

  5. Study sites: 20 to 27 Eligibility criteria expanded, about 15 wordsv15 Show 1 more changeShow less
    • Eligibility criteria expanded, about 15 words

    See this version in full on ClinicalTrials.gov ↗

Show 13 earlier versionsHide 13 earlier versions
  1. Re-verified, no change to tracked fieldsv14
  2. Study sites: 18 to 20v13
  3. Eligibility criteria expanded, about 52 wordsv12 See this version in full on ClinicalTrials.gov ↗
  4. Study sites: 16 to 18v11
  5. Study sites: 15 to 16v10
  6. Study sites: 14 to 15v9
  7. Study sites: 12 to 14v8
  8. Study sites: 9 to 12v7
  9. Site contacts updated at 1 of 9 sitesv6
  10. Study sites: 6 to 9 Start date changed from estimate of Sep 2023 to Oct 19, 2023 · Eligibility criteria shortened, about 1 wordv5 Show 2 more changesShow less
    • Start date changed from estimate of Sep 2023 to Oct 19, 2023
    • Eligibility criteria shortened, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  11. Study sites: 3 to 6 Start date: Aug 2023 to Sep 2023v4 Show 1 more changeShow less
    • Start date: Aug 2023 to Sep 2023
  12. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 3 · Start date: Jul 31, 2023 to Aug 2023 · Eligibility criteria expanded, about 62 wordsv3 Show 3 more changesShow less
    • Study sites: 0 to 3
    • Start date: Jul 31, 2023 to Aug 2023
    • Eligibility criteria expanded, about 62 words

    See this version in full on ClinicalTrials.gov ↗

  13. Start date: May 30, 2023 to Jul 31, 2023v2
  1. 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.
A multi-center, placebo-controlled, double blind, 1:1:1 randomized control clinical trial testing two different JAK Inhibitors abrocitnib, ritlecitinib, and placebo in subjects with recent onset Stage 3 Type 1 Diabetes within 100 days of diagnosis.
Trial Details
NCT Number NCT05743244
Lead Sponsor National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborators: Pfizer
Conditions Diabetes Mellitus, Type 1
Enrollment 78 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov