A Phase 2 interventional study of Placebo and IL-2 (interleukin 2) in Neuromyelitis Optica Spectrum Disorder (NMOSD), sponsored by Peking University People's Hospital. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 74 Years. Per ClinicalTrials.gov, last updated 2026-09-09.
Sponsored by Peking University People's Hospital · Phase 2, Interventional, and Treatment
Among 72 studies in Neuromyelitis Optica with a site in China — 37 open to participants now, 43 under way, 7 of them phase 3. Neuromyelitis Optica · China.
Among the 72 studies in Neuromyelitis Optica with a site in China, this one is the 15th largest by planned enrollment of the 51 interventional ones that give a count, is one of 12 that started in 2026, is one of 8 in phase 2, reaches primary completion later than 35 of the 42 other live ones, and was the 54th registered.
178 studies on the registry are indexed under Neuromyelitis Optica; 78 are open to participants now.
Browse Neuromyelitis Optica studies →37 of the 72 studies in Neuromyelitis Optica with a site in China are open now. Recruiting first, the newest first:
Alexion Pharmaceuticals, Inc. · Sites in China
Junwei Hao, MD · Sites in China
Hoffmann-La Roche · Sites in China, United States, Argentina and 6 more countries
Tongji Hospital · Sites in China
Chinese PLA General Hospital · Sites in China
A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →
Of the 50 Neuromyelitis Optica studies recruiting now, 29 (58%) set no upper age limit and 16 (32%) stop at 75 or younger; 11 take children under 18; 9 take healthy volunteers.
This study: 18 Years to 74 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
72 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 23 · Phase 2 17 · Phase 3 9 · Phase 4 6
First in 2009; this study’s year is marked. 12 started in 2026.
This study's planned enrollment of 60 is above the median of 29 across 108 interventional studies indexed under Neuromyelitis Optica.
Median enrollment 23 across the 51 interventional studies, 300 across the 21 observational. Of the 17 that completed or were terminated, 0 (0%) have results posted.
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18 of 72 have an industry lead sponsor. The 10 most frequent:
Peking University People's Hospital is the lead sponsor of 609 studies on the registry; 247 are open to participants now.
Peking University People's Hospital has 1 study filed under Neuromyelitis Optica — fewer than ten, so there is no comparison to draw.
19 of the studies in Neuromyelitis Optica with a site in China that are under way reach primary completion within a year, 4 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06724809Phase 3Alexion Pharmaceuticals, Inc.Efficacy, Safety, PK, PD, and ADA of Eculizumab in Chinese Adults With NMOSD | 2026-12-07 |
| NCT07420296Phase 3Tianjin Medical University General HospitalModified Zipper Therapy for AQP4-IgG Positive Neuromyelitis Optica Spectrum Disorder | 2026-12-31 |
| NCT05199688Phase 3Hoffmann-La RocheA Study to Evaluate Pharmacokinetics, Efficacy, Safety, Tolerability, and Pharmacodynamics of Satralizumab in Pediatric Patients With Aquaporin-4 Antibody Positive Neuromyelitis Optica Spectrum Disorder (NMOSD) | 2027-03-31 |
| NCT06413654Phase 3Shanghai Jiaolian Drug Research and Development Co., LtdA Clinical Study of B001 Injection in the Treatment of Neuromyelitis Optica Spectrum Disorders(NMOSD) | 2027-10-31 |
| NCT05145361Shanghai Pharmaceuticals Holding Co., LtdClinical Study of B001 Injection in Subjects With Neuromyelitis Optic Spectrum Disorder (NMOSD) | 2026-12-15 |
Among the 72 studies in Neuromyelitis Optica with a site in China, from their registry updates:
Nothing recorded among them since 2026-09-25.
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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.
In the NMOSD-IL2 trial, 60 patients with NMOSD will participate in a randomized, double-blind, placebo-controlled clinical study. The participants will be allocated in a 1:1 ratio to the intervention and placebo groups, with 30 patients in each group. The intervention group will receive subcutaneous injections of IL-2 (1 MIU) every other day for 4 weeks, followed by twice-weekly injections for an additional 20 weeks. The placebo group will receive parallel dosing.
The primary efficacy criteria will be the percentage change in Treg levels relative to baseline at week 4, indicating the biological response to IL-2.
Secondary efficacy endpoints will include: (i) the maintenance of regulatory T cells during the 24 weeks treatment period with low-dose IL-2 compared to placebo, and (ii) disease activity and relapse rates, as assessed by clinical scores and MRI evaluations, in the IL-2 treatment group compared to the placebo group.
Expected impact: This trial will determine whether NMOSD responds to IL-2 therapy.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
placebo s.c. injection every other day for the first 4 weeks and then twice a week for an additional 20 weeks
Drug: Placebo
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
Drug: IL-2 (interleukin 2)
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 (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
Also known as: Human recombinant IL-2
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
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
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
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
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
Change of cumulative total activity (CUA)
Cumulative number of new Gd-enhanced T1-weighted lesions and new or enlarged T2-weighted lesions, without repeat counting
Time frame: Week 24
Change in the Expanded Disability Status Scale (EDSS) compared to baseline (week 0)
The Expanded Disability Status Scale (EDSS) ranges from 0 to 10, with higher scores indicating greater neurological disability and a worse outcome. A score of 0 indicates a normal neurological examination, whereas a score of 10 indicates death due to neurological disease. Change from baseline will be calculated as the score at each follow-up visit minus the baseline score; a negative change indicates improvement and a positive change indicates worsening.
Time frame: Week 4, 8, 16, 24
Change in the Modified Rankin Scale (mRS) score compared to baseline (week 0)
The Modified Rankin Scale (mRS) ranges from 0 to 6, with higher scores indicating greater disability and a worse outcome. A score of 0 indicates no symptoms, whereas a score of 6 indicates death. Change from baseline will be calculated as the score at each follow-up visit minus the baseline score; a negative change indicates improvement and a positive change indicates worsening.
Time frame: Week 4, 8, 16, 24
Percentage of patients with relapses
Time frame: Week 24
Percentage of disease free patients, defined as those with no clinical symptoms and no active lesions on MRI
Time frame: Week 24
Safety endpoints: IL-2-related adverse events
Assessment of IL-2-related adverse events (AEs) and recording of the AE incidence.
Time frame: Week 2, 4, 8, 12, 24
Start is estimated for Aug 2026; primary completion for Aug 2028, 23 months later.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Interleukin-2
Peking University People's Hospital →