Can a Immune-Boosting protein calm the attacks behind NMOSD?
NCT ID NCT07809724
First seen Sep 09, 2026 · Last updated Sep 10, 2026 · Updated 1 time
Summary
Researchers are testing low-dose interleukin-2 (IL-2), an immune signaling protein, in adults with neuromyelitis optica spectrum disorder (NMOSD), a condition where the immune system attacks the optic nerves and spinal cord. The trial enrolls about 60 people aged 18 to 74 who receive either IL-2 or a placebo as injections under the skin for 24 weeks. The main goal is to see whether IL-2 raises the share of regulatory T cells, a type of immune cell that helps keep inflammation in check, and to track side effects.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- low-dose interleukin-2 (IL-2), a lab-made immune signaling protein given as an injection under the skin
- What this could lead to
- If it works, low-dose IL-2 could offer a new way to calm the immune attacks that drive NMOSD, possibly alongside or instead of current treatments.
- What could go wrong
- This is a small Phase II trial testing immune-cell changes, not whether patients feel better or have fewer attacks. The approach may fail to rebalance the immune system enough to matter, and injections can cause flu-like reactions or other side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 60 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Aug 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 74 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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. * Able to provide written informed consent and demonstrate the ability and willingness to comply with the study protocol requirements. Exclusion Criteria: * 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). * Evidence of other demyelinating diseases or progressive multifocal leukoencephalopathy (PML). * Evidence of severe uncontrolled comorbidities that may hinder participation. * Other neurological disorders, hematological / hematopoietic disorders, congenital/acquired severe immunodeficiencies. * Heart failure (≥NYHA Class III), renal insufficiency, liver insufficiency, or respiratory failure. * White blood cell count \<3000/ml, lymphocyte count \<1000/ml, platelet count \<150,000/ml. * Evidence of chronic active hepatitis B or C. * Substance abuse or alcoholism history within 1 year prior to baseline. * Evidence of active tuberculosis (excluding participants undergoing chemoprophylaxis for latent tuberculosis infection). * Intolerance to IL-2: hypersensitivity reactions to the active substance or any of its excipients (e.g. shock, allergic reactions). * Active suicidal ideation within the past 6 months before screening, or a history of suicide attempts within the past 3 years.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Department of Rheumatology and Immunology, Peking University People's Hospital
Beijing, Beijing Municipality, 100044, China
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