Clinical Trial

Efficacy and Safety of Baricitinib in Neuromyelitis Optica Spectrum Disorders

Active, Not Recruiting Phase 1

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.

Protocol Amendment History 5 changes

critical Phase changed: Phase 1/2 -> Phase 1 2026-08-12

critical Enrollment closed, study ongoing 2026-08-04

critical Primary endpoint(s) modified 2026-08-04

notable Primary completion pushed: 2025-12-30 -> 2027-03-01 2026-08-04

minor Completion pushed: 2025-12-30 -> 2027-03-01 2026-08-04

Trial Details

NCT Number	NCT05792462
Lead Sponsor	Tianjin Medical University General Hospital Collaborators: Tang-Du Hospital, The Second Hospital of Shandong University
Conditions	NMO Spectrum Disorder
Enrollment	11 participants
Start Date	2023-04-15
Primary Completion	2027-03-01 (estimated)
Study Completion	2027-03-01 (estimated)
Updated on ClinicalTrials.gov	2026-08-11