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Two Arm, Double-blind, Phase III Study Assessing Efficacy and Safety of Ianalumab Versus Placebo, in Participants With Sjögren's Disease With High Symptom Burden

Study acronym: THALASSA
StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial sites expanded: 19 → 26 locations Eligibility criteria expanded, about 20 words · Secondary endpoints: details revised at 7 of 9 entries Show 2 more changesShow less
    • Eligibility criteria expanded, about 20 words
    • Secondary endpoints: details revised at 7 of 9 entries
  2. Trial sites expanded: 14 → 19 locationsv4
  3. Trial sites expanded: 2 → 14 locations Primary completion date: Aug 13, 2029 to Aug 14, 2029 · Completion date: Aug 12, 2033 to Aug 13, 2033 · Start date changed from estimate of Jul 15, 2026 to Jul 16, 2026v3 Show 3 more changesShow less
    • Primary completion date: Aug 13, 2029 to Aug 14, 2029
    • Completion date: Aug 12, 2033 to Aug 13, 2033
    • Start date changed from estimate of Jul 15, 2026 to Jul 16, 2026
  4. Recruitment opened Study sites: 0 to 2 · Primary completion date: Aug 14, 2029 to Aug 13, 2029 · Completion date: Aug 13, 2033 to Aug 12, 2033v2 Show 3 more changesShow less
    • Study sites: 0 to 2
    • Primary completion date: Aug 14, 2029 to Aug 13, 2029
    • Completion date: Aug 13, 2033 to Aug 12, 2033
  5. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 demonstrate the efficacy and safety of ianalumab (VAY736) 300 mg administered subcutaneously (s.c.) monthly for 52 weeks in adult participants with Sjögren's disease who have high symptom burden.
Trial Details
NCT Number NCT07621809
Lead Sponsor Novartis Pharmaceuticals
Conditions Sjögren´s Disease
Enrollment 570 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov