Using Baricitinib to treat Neuromyelitis Optica Spectrum Disorders
Efficacy and Safety of Baricitinib in Neuromyelitis Optica Spectrum Disorders
PHASE1; PHASE2 · Tianjin Medical University General Hospital · NCT05792462
This study is testing if the medication Baricitinib can help people with Neuromyelitis Optica Spectrum Disorders by reducing the number of attacks they experience.
Quick facts
| Phase | PHASE1; PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 12 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | Tianjin Medical University General Hospital (other) |
| Drugs / interventions | Baricitinib |
| Locations | 1 site (Tianjin, Tianjin Municipality) |
| Trial ID | NCT05792462 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the efficacy and safety of Baricitinib, an oral JAK1/JAK2 inhibitor, in patients diagnosed with Neuromyelitis Optica Spectrum Disorders (NMOSD). The primary objective is to monitor the frequency of attacks following the initiation of Baricitinib treatment. Secondary outcomes include assessing the safety profile of the drug and its impact on the Expanded Disability Status Scale (EDSS). The study aims to provide insights into how Baricitinib may influence the immune response in NMOSD patients.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with a confirmed diagnosis of NMOSD and a history of recent attacks requiring rescue therapy.
Not a fit: Patients with clinically significant infections or those participating in other interventional trials may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce the frequency of attacks in patients with NMOSD.
How similar studies have performed: While the use of JAK inhibitors in neuroimmune disorders is a growing area of interest, this specific application of Baricitinib in NMOSD is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 attack requiring rescue therapy (intravenous corticosteroids, intravenous immunoglobulin, plasma exchange, or a combination of these therapies) in the year before screening or at least two attacks requiring rescue therapy in the 2 years before screening; 4. EDSS \<=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 trial within the last 3 months Tumor disease currently or within last 5 years; 3. Pregnant, breastfeeding, or child-bearing potential during the course of the study Clinically relevant heart, liver, kidney or bone marrow function disorder. 4. Have a history of venous thromboembolism (VTE), or are considered at high risk for VTE by the investigator.
Where this trial is running
Tianjin, Tianjin Municipality
- Tianjin Medical University General Hospital — Tianjin, Tianjin Municipality, China (RECRUITING)
Study contacts
- Principal investigator: Qiang Liu, M.D.,PhD — Tianjin Medical University General Hospital
- Study coordinator: Qiang Liu, M.D.,Ph.D.
- Email: qliu@tmu.edu.cn
- Phone: +86 15022439149
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: NMO Spectrum Disorder