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Study to Evaluate Rilzabrutinib in Adults and Adolescents With Persistent or Chronic Immune Thrombocytopenia (ITP)

Study acronym: LUNA 3
StatusCompleted
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Trial completed Show 5 more changesShow less
    • Study completion date changed from estimate of Aug 26, 2026 to Sep 2, 2026
    • Eligibility criteria shortened, about 10 words
    • Secondary endpoints: details revised at 11 of 13 entries
    • Site details revised at 9 of 155 sites
    • Publications: 3 to 4
  2. Results first posted: Feb 23, 2026
    • Primary endpoints revised (2)
    • Secondary endpoints: 12 to 13
    v32
  3. Primary endpoints revised (2)
    • Secondary endpoints revised (12)
    • Eligibility criteria shortened, about 3 words
    v31
  4. Enrollment target: estimated 194 to confirmed 232
    • Primary completion date changed from estimate of Jun 5, 2025 to Jan 15, 2025
    • Study completion date: Nov 20, 2026 to Aug 26, 2026
    v30
  5. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 155 of 155 sites
    v29
Show 27 earlier versionsHide 27 earlier versions
  1. Eligibility criteria expanded, about 9 words
    • Secondary endpoints revised (12)
    v28
  2. Eligibility criteria revised
    • Secondary endpoints revised (12)
    v27
  3. Study sites: 153 to 155v26
  4. Site contacts updated at 10 of 153 sitesv25
  5. Primary completion date: Apr 2024 to Jun 5, 2025v24 Show 4 more changesShow less
    • Enrollment target: 224 to 194
    • Study sites: 130 to 153
    • Study completion date: Oct 2025 to Nov 20, 2026
    • Eligibility criteria revised
  6. Study sites: 129 to 130v23
  7. Re-verified, no change to tracked fieldsv22
  8. Primary completion date: Oct 2023 to Apr 2024
    • Study completion date: Jun 2025 to Oct 2025
    v21
  9. Primary endpoints: 1 to 2
    • Eligibility criteria expanded, about 27 words
    • Secondary endpoints: 11 to 12
    v20
  10. Study sites: 113 to 129v19
  11. Study sites revised (113)v18
  12. Site contacts updated at 1 of 113 sitesv17
  13. Study sites: 109 to 113v16
  14. Study sites: 87 to 109v15
  15. Study sites: 86 to 87v14
  16. Study sites: 61 to 86v13
  17. Primary endpoint revisedv12 Show 5 more changesShow less
    • Enrollment target: 194 to 224
    • Study sites: 48 to 61
    • Eligibility criteria expanded, about 424 words
    • Secondary endpoints: 1 to 11
    • Study description shortened, about 94 words
  18. Study sites: 24 to 48v11
  19. Primary completion date: Sep 2023 to Oct 2023
    • Study completion date: May 2025 to Jun 2025
    v10
  20. Study sites: 18 to 24v9
  21. Study sites: 3 to 18v8
  22. Study completion date: Jun 2025 to May 2025v7
  23. Primary completion date: Oct 2023 to Sep 2023v6
  24. Study sites: 2 to 3v5
  25. Start date changed from estimate of Dec 2020 to Dec 14, 2020
    • Site details revised at 1 of 2 sites
    v4
  26. Study sites: 1 to 2
    • Start date: Nov 2020 to Dec 2020
    v3
  27. Trial status: Not Yet Recruiting to Recruiting
    • Site details revised
    • Study title shortened, about 1 word
    v2
  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.
Sanofi
284 trials monitored
See 12 trials at risk
This was a randomized, double-blind study of rilzabrutinib in patients with persistent or chronic ITP, with an average platelet count of \<30,000/μL (and no single platelet count \>35,000/μL) on two counts at least 5 days apart in the 14 days before treatment begins. Patients received rilzabrutinib or placebo 400mg twice daily. For each patient, the study lasted up to 60 weeks from the start of the Screening Period to the End of Study (EOS) visit. This included Screening (up to 4 weeks) through a 12 to 24-week Blinded Treatment Period followed by a 28-week Open-Label Period. Followed by a 4-week post dose follow-up. For adult participants, the maximum duration of the long-term extension (LTE) period was 12 months from the date of the last adult participant to enter the LTE. For pediatric participants, the maximum duration of the LTE period was 12 months from the date of the last pediatric participant to enter the LTE.
Trial Details
NCT Number NCT04562766
Lead Sponsor Principia Biopharma, a Sanofi Company
Conditions
(from sponsor)		 Immune Thrombocytopenia
Related terms Purpura, Thrombocytopenic, Idiopathic
Enrollment 232 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov