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Efficacy and Safety of Baricitinib in Neuromyelitis Optica Spectrum Disorders

NCT05792462 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2024-10-16

No results posted yet for this study

Summary

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.

Conditions

  • NMO Spectrum Disorder

Interventions

DRUG

Baricitinib

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.

Sponsors & Collaborators

  • Tang-Du Hospital

    collaborator OTHER

  • The Second Hospital of Shandong University

    collaborator OTHER

  • Tianjin Medical University General Hospital

    lead OTHER

Principal Investigators

  • Qiang Liu, M.D.,PhD · Tianjin Medical University General Hospital

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-15
Primary Completion
2025-12-30
Completion
2025-12-30

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05792462 on ClinicalTrials.gov