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Efficacy and Safety of Baricitinib in Neuromyelitis Optica Spectrum Disorders

StatusActive, Not Recruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 1 year 2 months later Dec 30, 2025 → Mar 1, 2027
Primary endpoint reworded 1 of 1 changed
See other at-risk trials from Tianjin Medical University General Hospital

Record History

See every version on ClinicalTrials.gov ↗

  1. Phase changed: Phase 1/2 → Phase 1v7
  2. Primary and study completion pushed from Dec 30, 2025 to Mar 1, 2027v6 Show 7 more changesShow less
    • Primary endpoint(s) modified
    • Enrollment closed, study ongoing
    • Enrollment target: estimated 12 to confirmed 11
    • Eligibility criteria expanded, about 6 words
    • Secondary endpoints revised (5)
    • Study description revised
    • Site details revised
  3. Primary endpoint revised
    • Eligibility criteria expanded, about 32 words
    • Collaborators expanded, about 8 words
    • Study description shortened, about 1 word
    v5
  4. Primary completion date: Mar 20, 2024 to Dec 30, 2025
    • Study completion date: Sep 20, 2024 to Dec 30, 2025
    v4
  5. Trial status: Not Yet Recruiting to Recruiting
    • Site details revised
    v3
  6. Start date: Mar 20, 2023 to Apr 15, 2023
    • Secondary endpoints revised (5)
    v2
  7. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Neuromyelitis Optica Spectrum Disorders (NMOSD) is associated with a pathological humoral immune response against the aquaporin-4(AQP-4) water channel. Baricitinib is an oral Janus kinase (JAK)1/JAK2 inhibitor that blocks the upregulated JAK-STAT pathway in patients with neuroimmune disorders, which is important in bone marrow regulation of B cell proliferation and differentiation. Baricitinib may benefit some patients with NMOSD due to the important role of B cells in the pathogenesis of NMOSD. Clinical trials may be needed to observe its efficacy and safety.
Trial Details
NCT Number NCT05792462
Lead Sponsor Tianjin Medical University General Hospital
Collaborators: Tang-Du Hospital, The Second Hospital of Shandong University
Conditions
(from sponsor)		 NMO Spectrum Disorder
Related terms Neuromyelitis Optica
Enrollment 11 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov