🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Writer Login
Latest
Clinical Trials in China / NCT05792462
Active, not recruiting Phase 1

Efficacy and Safety of Baricitinib in Neuromyelitis Optica Spectrum Disorders

NCT05792462 · tracked via the Priya Life Science China tracker
Sponsor
Tianjin Medical University General Hospital
Phase
Phase 1
Started
2023-04-15
Last updated
2026-08-11

Condition(s) studied

NMO Spectrum Disorder

Investigational drug(s) / intervention(s)

Baricitinib

Baricitinib: Baricitinib will be taken orally with a dose of 4mg once daily until the disease relapses or week 96.

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: 1. Male or female patients ≥ 18 years old; 2. Diagnosis of NMO or NMO spectrum disorder according to the 2015 International Panel for Neuromyelitis Optica Diagnosis criteria; 3. Clinical evidence of either at least one relapse requiring rescue therapy (intravenous corticosteroids, intravenous immunoglobulin, plasma exchange or a combination of these therapies) in the year before screening or at least two relapses requiring rescue therapy in the 2 years before screening; 4. Expanded disability status scale (EDSS) score ≤ 6.0; 5. Patients were seropositive for AQP4-IgG; 6. Able and willing to give written informed consent and comply with the requirements of the study protocol. Exclusion Criteria: 1. Current evidence or known history of clinically significant infection (Herpes simplex virus, varicella-zoster virus, cytomegalovirus, Epstein-Barr virus, human immunodeficiency virus, Hepatitis viruses, Syphilis, etc); 2. Participation in another interventional study within the last 3 months; 3. Tumor disease currently or within the last 5 years; 4. Pregnancy, breastfeeding, or child-bearing potential during the course of the study; 5. Patients with clinically relevant heart, liver, kidney or bone marrow dysfunction; 6. History of venous thromboembolism (VTE), or are considered at high risk for VTE by the investigator.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Tianjin Medical University General Hospital Tianjin Tianjin Municipality

On this site

📄 Olumiant (baricitinib) drug profile →

More Tianjin Medical University General Hospital trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05792462 on ClinicalTrials.gov ↗ ← All trials in China