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Efficacy and Safety of Low-Dose IL-2 in Neuromyelitis Optica Spectrum Disorder

ConditionNeuromyelitis Optica Spectrum Disorder (NMOSD)
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-74
SponsorPeking University People's Hospital

About this trial

Interleukin-2 (IL-2) is an essential cytokine for T-cell proliferation. Low-dose IL-2 has been shown to increase the proportion of regulatory T cells (Tregs), negatively regulate effector T cells such as Th17 and Tfh cells, and improve the peripheral Treg/Th17 balance, thus restoring immune homeostasis. Studies have demonstrated a positive correlation between the Th17/Treg ratio and the severity of various autoimmune diseases. Clinically, low-dose IL-2 has been successfully used in the treatment of diseases such as systemic lupus erythematosus and Sjögren's syndrome. However, the efficacy and safety of IL-2 in neuromyelitis optica spectrum disorder (NMOSD) remain unknown. This clinical trial aims to investigate the safety and biological efficacy of IL-2 in treating NMOSD.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age: 18 to 74 years, inclusive at the time of informed consent.

Diagnosed with NMOSD according to the 2015 international consensus diagnostic criteria for NMOSD.

Expanded Disability Status Scale (EDSS) score between 0 and 6.5.

For women of childbearing potential, contraception must be used for more than 2 weeks after meeting the inclusion criteria, and HCG must be negative at the time of enrollment.

Disqualifiers

Any prior history of receiving whole-body irradiation or bone marrow transplantation.

Any treatment with investigational drugs within 3 months prior to baseline.

Pregnancy or breastfeeding.

Any surgical procedure within 4 weeks prior to baseline (except minor surgeries).

Trial design

Design model

Parallel

Treatments tested in this trial

  • Placebo

    Drug

    placebo s.c. injection every other day for the first 4 weeks and then twice a week for an additional 20 weeks. IL-2 (1 MIU) : placebo = 1:1

  • IL-2 (interleukin 2)

    Drug

    IL-2 (1 MIU) s.c. injection every other day for the first 4 weeks and then twice a week for an additional 20 weeks. IL-2 (1 MIU) : placebo = 1:1

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Placebo ComparatorPlacebo comparator 1 intervention
Group B: Active ComparatorExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Change in the percentage of Tregs at week 4 compared to baseline (week 0)

expressed as a percentage of the total CD4+ cells

Time frame
Week 4

Secondary outcomes

1

Change in the percentage of Tregs at week 2 compared to baseline (week 0)

expressed as a percentage of the total CD4+ cells

Time frame
Week 2
2

Change in the percentage of Tregs at week 24 compared to baseline (week 0)

expressed as a percentage of the total CD4+ cells

Time frame
Week 8, 12, 16, 20, 24
3

Change of Th1, Th2, and Th17 cells to low-dose IL-2 compared to baseline (week 0)

expressed as a percentage of the total CD4+ cells

Time frame
Week 2, 4, 8, 12, 16, 20, 24
4

Cumulative number of active MRI lesions and/or changes in orbital optic nerve MRI lesions

Measure the number of new gadolinium-enhancing lesions and new or enlarged T2 lesions using MRI.

Time frame
Week 24

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Peking University People's Hospital

Lead sponsor

Peking University First Hospital

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: