NCT05792462

Efficacy and Safety of Baricitinib in Neuromyelitis Optica Spectrum Disorders

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: Tianjin Medical University General Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The investigators primarily aim to observe the number of attacks from initiation of baricitinib treatment. The secondary outcomes are to determine: The safety profile of baricitinib in participants with NMO and whether baricitinib improves Expanded Disability Status Scale (EDSS), et al.

Conditions

• NMO Spectrum Disorder

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-04-15
• Primary completion: 2025-12-30
• Completion: 2025-12-30
• First posted: 2023-03-31
• Last updated: 2024-10-16

Locations

1 site across 1 country: China