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A Study to Assess the Tolerability of Ianalumab (VAY736) With Investigator's Choice Thrombopoietin Receptor Agonist (IC TPO-RA) in Patients With Primary Immune Thrombocytopenia (ITP)

Study acronym: VAY2EXPLORE
StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 9 months later across 2 updates Apr 1, 2028 → Jan 18, 2029
See other at-risk trials from Novartis

Record History

  1. Site contacts updated at 5 of 16 sites
  2. Study sites: 15 to 16
  3. Study sites: 13 to 15
  4. Primary completion pushed from May 9, 2028 to Jan 18, 2029 Primary endpoints: details revised at 1 of 1 entry · Completion date: Sep 13, 2030 to Aug 31, 2030 · Eligibility criteria expanded, about 11 words · 2 more Show 5 more changesShow less
    • Primary endpoints: details revised at 1 of 1 entry
    • Completion date: Sep 13, 2030 to Aug 31, 2030
    • Eligibility criteria expanded, about 11 words
    • Secondary endpoints: details revised at 3 of 4 entries
    • Site contacts updated at 1 of 13 sites
  5. Study sites: 12 to 13v14
Show 3 earlier versionsHide 3 earlier versions
  1. Study sites: 11 to 12v13
  2. Study sites: 10 to 11v12
  3. Study sites: 9 to 10v11
  1. Primary completion pushed from Apr 1, 2028 to May 9, 2028 Trial sites expanded: 5 → 9 locations · Completion pushed from Aug 10, 2030 to Sep 13, 2030 · Start date changed from estimate of Jun 29, 2026 to Aug 4, 2026v10 Show 3 more changesShow less
    • Trial sites expanded: 5 → 9 locations
    • Completion pushed from Aug 10, 2030 to Sep 13, 2030
    • Start date changed from estimate of Jun 29, 2026 to Aug 4, 2026
  2. Completion date: Aug 8, 2030 to Aug 10, 2030v9
  3. Study sites: 4 to 5v8
  4. Primary completion moved earlier from Jan 10, 2029 to Apr 1, 2028 Completion moved earlier from Sep 18, 2030 to Aug 8, 2030 · Study sites: 3 to 4v7 Show 2 more changesShow less
    • Completion moved earlier from Sep 18, 2030 to Aug 8, 2030
    • Study sites: 3 to 4
  5. Study sites: 2 to 3v6
  6. Primary completion pushed from Mar 3, 2027 to Jan 10, 2029 Completion pushed from Mar 31, 2027 to Sep 18, 2030 · Start date: Nov 11, 2026 to Jun 29, 2026v5 Show 2 more changesShow less
    • Completion pushed from Mar 31, 2027 to Sep 18, 2030
    • Start date: Nov 11, 2026 to Jun 29, 2026
  7. Primary completion moved earlier from Dec 26, 2028 to Mar 3, 2027 Start date: Jun 29, 2026 to Nov 11, 2026 · Completion moved earlier from Sep 5, 2030 to Mar 31, 2027 · Study sites: 1 to 2v4 Show 3 more changesShow less
    • Start date: Jun 29, 2026 to Nov 11, 2026
    • Completion moved earlier from Sep 5, 2030 to Mar 31, 2027
    • Study sites: 1 to 2
  8. Primary completion pushed from Jun 9, 2028 to Dec 26, 2028 Recruitment opened · Completion pushed from Mar 13, 2030 to Sep 5, 2030 · Study sites: 0 to 1 · 1 morev3 Show 4 more changesShow less
    • Recruitment opened
    • Completion pushed from Mar 13, 2030 to Sep 5, 2030
    • Study sites: 0 to 1
    • Start date: Jun 30, 2026 to Jun 29, 2026
  9. Primary completion moved earlier from Dec 26, 2028 to Jun 9, 2028 Completion moved earlier from Aug 8, 2030 to Mar 13, 2030 · Start date: Jun 29, 2026 to Jun 30, 2026v2 Show 2 more changesShow less
    • Completion moved earlier from Aug 8, 2030 to Mar 13, 2030
    • Start date: Jun 29, 2026 to Jun 30, 2026
  10. 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.
Novartis
555 trials monitored
See 31 trials at risk
The purpose of this study is to investigate the tolerability of ianalumab (9 mg/kg) with investigator's choice thrombopoietin receptor agonist (IC TPO-RA) in participants diagnosed with primary immune thrombocytopenia (ITP) who have been treated with at least one but no more than four prior treatments, and with no change in IC TPO-RA dose in at least the last 14 days prior to the start of ianalumab.
Trial Details
NCT Number NCT07421167
Lead Sponsor Novartis Pharmaceuticals
Conditions Primary Immune Thrombocytopenia (ITP), Primary Evans Syndrome (ES)
Enrollment 164 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov