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Efficacy and Safety of IMVT-1402 in Adult Participants With Primary Sjogren's Disease With Moderate to Severe Systemic Disease Activity

StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Enrollment closed, study ongoing
    • Trial sites reduced: 121 → 96 locations
    v15
  2. Site details revised at 5 of 121 sitesv14
  3. Site details revised at 8 of 121 sitesv13
  4. Site details revised at 1 of 121 sitesv12
  5. Site details revised at 6 of 121 sitesv11
Show 9 earlier versionsHide 9 earlier versions
  1. Re-verified, no change to tracked fieldsv10
  2. Site details revised at 13 of 121 sitesv9
  3. Study completion date: Jul 2028 to Jul 2029
    • Eligibility criteria expanded, about 13 words
    • Study description revised
    v8
  4. Site details revised at 8 of 121 sitesv7
  5. Site details revised at 21 of 121 sitesv6
  6. Site details revised at 12 of 121 sitesv5
  7. Study sites: 3 to 121v4
  8. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 3
    • Start date changed from estimate of Jun 2025 to Jun 30, 2025
    v3
  9. Interventions: IMVT-1402 (Drug), IMVT-1402 (Drug), Placebo (Drug) to IMVT-1402 (Drug), Placebo (Drug)
    • Eligibility criteria shortened, about 28 words
    • Study description shortened, about 30 words
    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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
This is a Phase 2b, multicenter, randomized, double-blinded, placebo-controlled study to assess the efficacy and safety of IMVT-1402 in adult participants with moderate to severe systemic primary Sjogren's disease (SjD).
Trial Details
NCT Number NCT06979531
Lead Sponsor Immunovant Sciences GmbH
Conditions
(from sponsor)		 Primary Sjögren's Syndrome
Enrollment 180 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov