Efficacy and Safety of Baricitinib in Neuromyelitis Optica Spectrum Disorders

Sponsor
Tianjin Medical University General Hospital
Study ID
NCT05792462
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • NMO Spectrum Disorder

Eligibility Criteria

Sex
ALL
Age
18 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • Baricitinib — DRUG
    Baricitinib will be taken orally with a dose of 4mg once daily until the disease relapses or week 48, with a final evaluation at week 52.

Study Details

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.

Key Dates

Start date
Apr 15, 2023
Status verified
Oct 2024
Primary completion
Dec 30, 2025
Completion
Dec 30, 2025

Study Design

Enrollment
12 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Baricitinib
    Baricitinib will be taken orally with a dose of 2mg once daily until the disease relapses or week 48, with a final evaluation at week 52.

Primary Outcome Measure

The number of attacks [ Time Frame: From baseline to one year after ]

Central Contacts

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