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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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

NMO Spectrum Disorder Autoimmune Diseases Autoimmune Diseases of the Nervous System Cranial Nerve Diseases Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Eye Diseases Immune System Diseases Myelitis, Transverse Nervous System Diseases Neuromyelitis Optica Optic Nerve Diseases Optic Neuritis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Tianjin Medical University General Hospital

Tianjin, Tianjin Municipality, 300052, China

About this study

The investigators primarily aim to observe the number of relapses 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 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;
  • Expanded disability status scale (EDSS) score ≤ 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 study within the last 3 months;
  • Tumor disease currently or within the last 5 years;
  • Pregnancy, breastfeeding, or child-bearing potential during the course of the study;
  • Patients with clinically relevant heart, liver, kidney or bone marrow dysfunction;
  • 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 96.

Primary outcomes

  1. The number of relapses

    Time frame: From baseline to 96 weeks

    A relapse was defined as new-onset neurological symptoms or worsening of existing neurological function (vision loss, limb weakness or sensory symptoms, or bladder or bowel dysfunction) lasting more than 24 h, not attributable to an identifiable cause such as intercurrent infection, and preceded by at least 30 days of clinical stability.

Secondary outcomes

  1. Changes in EDSS scores

    Time frame: Changes in EDSS from baseline to 96 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 lesions on T2-weighted imaging (T2WI) and gadolinium-enhancing lesions on T1-weighted imaging (T1WI).

    Time frame: From baseline to 96 weeks

    The total number of new and/or enlarging lesions on T2-weighted imaging (T2WI) and gadolinium-enhancing lesions on T1-weighted imaging (T1WI) for all participants was calculated as the sum of the individual number of lesions at Weeks 24, 48, and 96

  3. Changes in the number of peripheral blood B cell subsets

    Time frame: From baseline to 96 weeks

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

  4. Changes in serum AQP4-IgG titer

    Time frame: From baseline to 96 weeks

    Compare serum AQP4-IgG titers before and two year after initial intervention

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

    Time frame: From baseline to 96 weeks

    Adverse events related to baricitinib are recorded

Interested in participating?

Active, not recruiting

This study is active but is not currently recruiting participants.

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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
2027
Study completion
2027
First posted
Mar 31, 2023
Registry last updated
Aug 11, 2026

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.

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