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A Study to Evaluate the Efficacy, Safety, and Tolerability of IMVT-1402 in Adult Participants With Active, Difficult to Treat Rheumatoid Arthritis

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

Record History

See every version on ClinicalTrials.gov ↗

  1. Re-verified, no change to tracked fieldsv15
  2. Trial status: Recruiting to Active, Not Recruiting
    • Study sites: 82 to 83
    v14
  3. Site details revised at 4 of 82 sitesv13
  4. Study sites: 83 to 82v12
  5. Site details revised at 3 of 83 sitesv11
Show 9 earlier versionsHide 9 earlier versions
  1. Study sites: 80 to 83v10
  2. Study sites: 75 to 80v9
  3. Study sites: 77 to 75v8
  4. Study sites: 74 to 77v7
  5. Primary endpoint revisedv6 Show 4 more changesShow less
    • Study sites: 73 to 74
    • Eligibility criteria expanded, about 16 words
    • Secondary endpoints revised (2)
    • Study description shortened, about 134 words
  6. Study sites: 37 to 73v5
  7. Study sites: 38 to 37v4
  8. Study sites: 22 to 38v3
  9. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 22
    • Start date changed from estimate of Dec 2024 to Jan 10, 2025
    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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 Phase 2b, multicenter, double-blind, placebo-controlled, randomized withdrawal study is designed to assess the efficacy and safety of IMVT-1402 in adult participants with active, difficult-to-treat, anti-citrullinated protein autoantibody (ACPA) positive rheumatoid arthritis (RA).
Trial Details
NCT Number NCT06754462
Lead Sponsor Immunovant Sciences GmbH
Conditions
(from sponsor)		 Rheumatoid Arthritis
Related terms Arthritis, Rheumatoid, Autoimmune Diseases
Enrollment 120 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov