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A Phase 2a/b Study to Assess the Efficacy, Safety and Tolerability of DDY391 in Participants With Sjögren's Disease

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial sites expanded: 9 → 20 locations Eligibility criteria expanded, about 8 words · Secondary endpoints: details revised at 2 of 3 entries Show 2 more changesShow less
    • Eligibility criteria expanded, about 8 words
    • Secondary endpoints: details revised at 2 of 3 entries
  2. Re-verified, no change to tracked fieldsv3
  3. Recruitment opened Trial sites expanded: 0 → 9 locations · Start date changed from estimate of Aug 27, 2026 to Aug 24, 2026v2 Show 2 more changesShow less
    • Trial sites expanded: 0 → 9 locations
    • Start date changed from estimate of Aug 27, 2026 to Aug 24, 2026
  4. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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
To evaluate efficacy, safety, and tolerability of DDY391 up to 52 weeks in participants with Sjögren's disease (SjD) and to determine the dose response relationship of DDY391 in participants with SjD, to support dose selection for Phase 3.
Trial Details
NCT Number NCT07737743
Lead Sponsor Novartis Pharmaceuticals
Conditions Sjögren's Disease
Enrollment 344 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov