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Tocilizumab in Lung Transplantation

Study acronym: ALL IN LUNG
StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Enrollment reduced 71% 350 → 100 participants
See other at-risk trials from National Institute of Allergy and Infectious Diseases (NIAID)

Record History

  1. Enrollment reduced: 350 → 100 participants Eligibility criteria expanded, about 75 words · Secondary endpoints revised (24) · Site details revised at 4 of 21 sites Show 3 more changesShow less
    • Eligibility criteria expanded, about 75 words
    • Secondary endpoints revised (24)
    • Site details revised at 4 of 21 sites
  2. Site details revised at 3 of 21 sitesv31
  3. Site contacts updated at 2 of 21 sitesv30
  4. Site details revised at 1 of 21 sitesv29
  5. Study sites: 20 to 21v28
Show 26 earlier versionsHide 26 earlier versions
  1. Site details revised at 2 of 20 sitesv27
  2. Site contacts updated at 1 of 20 sitesv26
  3. Study sites: 14 to 20v25
  4. Site contacts updated at 1 of 14 sitesv24
  5. Site details revised at 3 of 14 sitesv23
  6. Site details revised at 2 of 14 sitesv22
  7. Secondary endpoints: details revised at 24 of 24 entriesv21
  8. Study sites: 15 to 14 Secondary endpoints: 25 to 24 · Eligibility criteria shortened, about 4 wordsv20 Show 2 more changesShow less
    • Secondary endpoints: 25 to 24
    • Eligibility criteria shortened, about 4 words

    See this version in full on ClinicalTrials.gov ↗

  9. Site details revised at 2 of 15 sitesv19
  10. Site details revised at 2 of 15 sitesv18
  11. Study sites: 16 to 15 Eligibility criteria expanded, about 14 words · Secondary endpoints revised (25)v17 Show 2 more changesShow less
    • Eligibility criteria expanded, about 14 words
    • Secondary endpoints revised (25)

    See this version in full on ClinicalTrials.gov ↗

  12. Site details revised at 2 of 16 sitesv16
  13. Site details revised at 3 of 16 sitesv15
  14. Site details revised at 1 of 16 sitesv14
  15. Site details revised at 1 of 16 sitesv13
  16. Site details revised at 1 of 16 sitesv12
  17. Site details revised at 2 of 16 sitesv11
  18. Site details revised at 4 of 16 sitesv10
  19. Site details revised at 1 of 16 sitesv9
  20. Site details revised at 1 of 16 sitesv8
  21. Start date changed from estimate of Feb 1, 2024 to Feb 13, 2024 Site details revised at 3 of 16 sitesv7 Show 1 more changeShow less
    • Site details revised at 3 of 16 sites
  22. Start date: Jan 8, 2024 to Feb 1, 2024 Site details revised at 2 of 16 sitesv6 Show 1 more changeShow less
    • Site details revised at 2 of 16 sites
  23. Primary and study completion dates: Oct 31, 2028 to Jan 8, 2029 Start date: Dec 15, 2023 to Jan 8, 2024 · Site details revised at 1 of 16 sitesv5 Show 2 more changesShow less
    • Start date: Dec 15, 2023 to Jan 8, 2024
    • Site details revised at 1 of 16 sites
  24. Trial status: Not Yet Recruiting to Recruiting Site details revised at 16 of 16 sitesv4 Show 1 more changeShow less
    • Site details revised at 16 of 16 sites
  25. Start date: Oct 1, 2023 to Dec 15, 2023 Study sites revised (16)v3 Show 1 more changeShow less
    • Study sites revised (16)

    See this version in full on ClinicalTrials.gov ↗

  26. Study sites: 17 to 16v2
  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.
This is a trial in which 100 primary lung transplant recipients will be randomized (1:1) to receive either Tocilizumab (six doses over 20 weeks) plus standard triple maintenance immunosuppression or placebo (sterile normal saline) plus standard triple maintenance immunosuppression (Tacrolimus, Mycophenolate Mofetil, corticosteroids). The primary objective is to test the hypothesis that treatment with triple maintenance immunosuppression plus Tocilizumab (TCZ) is superior to triple maintenance immunosuppression plus placebo (saline) as defined by a composite endpoint of a) CLAD, b) development of de novo donor specific antibodies (DSA), c) acute cellular rejection ≥A2, d) listed for re-transplantation, and e) death
Trial Details
NCT Number NCT06033196
Lead Sponsor National Institute of Allergy and Infectious Diseases (NIAID)
Conditions Lung Transplant
Enrollment 100 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov