Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05792462

Efficacy and Safety of Baricitinib in Neuromyelitis Optica Spectrum Disorders

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Tianjin Medical University General Hospital

Tianjin, Tianjin Municipality, 300052, China

Location status: Recruiting

Location contact

Qiang Liu, M.D.,Ph.D.

CONTACT

[email protected]

+8615022439149

Qiang Liu, M.D.,Ph.D.

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or female patients ≥ 18 years old;
  • Diagnosis of NMO or NMO spectrum disorder according to the 2015 International Panel for Neuromyelitis Optica Diagnosis criteria;
  • 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;
  • EDSS <=6.0;
  • Patients were seropositive for AQP4-IgG;
  • Able and willing to give written informed consent and comply with the requirements of the study protocol.

Exclusion criteria

  • 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);
  • Participation in another interventional trial within the last 3 months Tumor disease currently or within last 5 years;
  • Pregnant, breastfeeding, or child-bearing potential during the course of the study Clinically relevant heart, liver, kidney or bone marrow function disorder.
  • Have a history of venous thromboembolism (VTE), or are considered at high risk for VTE by the investigator.

Treatment and study plan

Baricitinib

Drug

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.

Primary outcomes

  1. The number of attacks

    Time frame: From baseline to one year after

    An acute attack was defined as a new neurological worsening lasting for at least 24 hours and occurring more than 30 days after the previous attack

Secondary outcomes

  1. Changes in EDSS

    Time frame: Changes in EDSS from baseline to 52 weeks

    The Expanded Disability Status Scale (EDSS) is a rating system that is frequently used for classifying and standardizing the severity and progression. EDSS ranges from 0 to 10.

  2. Changes in the number of New, and/or Enlarging T2 Hyperintense Lesions as Detected by Optic nerve,brain and spinal cord Magnetic Resonance Imaging (MRI)

    Time frame: From baseline to 52 weeks

    The total number of new and/or enlarging T2 lesions for all participants was calculated as the sum of the individual number of lesions at Weeks 12, 24, and 52

  3. Changes in peripheral blood B cell subsets

    Time frame: From baseline to 52 weeks

    Compare peripheral blood plasma cells before and one year after initial intervention

  4. Changes in serum AQP4 antibodies

    Time frame: From baseline to 52 weeks

    Compare serum AQP4-ab titers before and one year after initial intervention

  5. Incidence of treatment-emergent adverse events [safety and tolerability]

    Time frame: From baseline to 52 weeks

    Adverse events related to belimumab are recorded

Study contacts

Contact information is provided by the study sponsor or research team.

Qiang Liu, M.D.,Ph.D.

CONTACT

[email protected]

+86 15022439149

Sponsors and collaborators

Lead sponsor

Tianjin Medical University General Hospital

Other

Collaborators

  • Tang-Du Hospital
  • The Second Hospital of Shandong University

Registry information

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Mar 31, 2023
Registry last updated
Oct 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.