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LUNA 4NCT07007962

Study to Evaluate the Efficacy and Safety of Oral Rilzabrutinib in Adults With Immune Thrombocytopenia (ITP) Who Failed First-line Treatment

StatusRecruiting
PhasePhase 3
SponsorSanofi
Primary completion (estimated)
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Record History

All 11 versions: 11 with changes below. See every version on ClinicalTrials.gov ↗

  1. Eligibility criteria expanded, about 10 words
    • Trial sites expanded: 36 → 54 locations
    • Secondary endpoints revised (6)
    • Publications: details revised at 1 of 1 entry
  2. Trial sites expanded: 30 → 36 locationsv10
  3. Trial sites expanded: 24 → 30 locationsv9
  4. Trial sites expanded: 20 → 24 locationsv8
  5. Trial sites expanded: 10 → 20 locationsv7
Show 5 earlier versionsHide 5 earlier versions
  1. Eligibility criteria expanded, about 15 words
    • Study sites: 6 to 10
    • Secondary endpoints revised (6)
    v6
  2. Study sites: 2 to 6v5
  3. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 2
    • Start date changed from estimate of Oct 1, 2025 to Oct 24, 2025
    v4
  4. Start date: Sep 15, 2025 to Oct 1, 2025v3
  5. Start date: Jul 21, 2025 to Sep 15, 2025v2
  1. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Durable platelet response
Timeframe: Until Week 28

Secondary (6)

Overall platelet response
Duration of platelet response
Change from baseline in the immune thrombocytopenia bleeding scale (IBLS) score at the end of week 28
Percentage of participants able to discontinue or reduce CS dose by at least 50% or to ≤5 mg/day (prednisone equivalent) from baseline at the end of week 28
Frequency and severity of treatment emergent adverse events (TEAEs, including serious adverse events [SAEs], bleeding TEAEs, adverse events of special interest [AESI] and adverse events leading to discontinuation)
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Percentage of participants with potential clinical significant abnormal (PCSA)

Arms and interventions

rilzabrutinibExperimental

400 mg BID

Drugs: rilzabrutinib

Sites

54 sites in 10 countries

United States 18, Spain 9, Italy 6, France 5, Germany 5, Poland 4, Hungary 3, Czechia 2, Austria 1, Norway 1