ClinicalTrials.gg
RecruitingNCT07762872SATURNUpdated Aug 13, 2026

A Multicenter Prospective Real-World Effectiveness and Safety of Satralizumab in the Early Treatment of Attacks in NMOSD

An observational study in Neuromyelitis Optica Spectrum Disorders (NMOSD), sponsored by Junwei Hao, MD. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-13.

Sponsored by Junwei Hao, MD · Observational

From the registry’s dates

  • Started Jul 2026; still recruiting 3 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
50
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

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.

Planned enrollment
18th of 21
50 · median 300
Started
2026
with 11 others
Observational
21 of 72
13 open now
Primary completion
2027-07
later than 25 of 42 live
Registered
72nd of 72
by date

Among the 72 studies in Neuromyelitis Optica with a site in China, this one is the 18th largest by planned enrollment of the 21 observational ones that give a count, is one of 12 that started in 2026, is one of 21 observational ones, reaches primary completion later than 25 of the 42 other live ones, and was the 72nd registered.

Neuromyelitis Optica

178 studies on the registry are indexed under Neuromyelitis Optica; 78 are open to participants now.

Browse Neuromyelitis Optica studies →

Open to participants now

37 of the 72 studies in Neuromyelitis Optica with a site in China are open now. Recruiting first, the newest first:

31 more — sign in →

All 37 open studies →

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 →

Who these studies take

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 and older · all sexes · no healthy volunteers.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 72 studies in Neuromyelitis Optica with a site in China, or all of them as a file.
02

Study summary

This study is a multicenter, prospective cohort study designed to enroll 50 NMOSD patients who receive Satralizumab treatment during the early phase of an NMOSD attack. Follow-up visits will be conducted at baseline, 3 months, and 6 months to record and assess EDSS scores, modified Rankin Scale (mRS) scores, EQ-5D scores, Activities of Daily Living (ADL) scores, relapse events, safety data, and exploratory endpoints (e.g., blood inflammatory markers and visual function), with the aim of evaluating the efficacy and safety of Satralizumab in the early treatment of NMOSD-thereby providing patients with more effective therapeutic options and further optimizing the clinical management of NMOSD.

03

Conditions studied

  • Neuromyelitis Optica Spectrum Disorders (NMOSD)

Browse trials for

Keywords

  • NMOSD
  • Satralizumab
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with NMOSD (AQP4-IgG-positive) at early phase of an NMOSD attack, and age ≥ 18 years. The EDSS score ≤ 8.5 during an acute relapse in NMOSD.

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.

Inclusion criteria

  • Diagnosis of AQP4-IgG-positive NMOSD* and age ≥ 18 years; EDSS score ≤ 8.5 during an acute relapse in NMOSD patients; NMOSD patients experiencing an acute relapse who are scheduled to receive or are currently receiving recommended acute-phase treatments-including intravenous methylprednisolone, IVIG, PE, or PA; Receiving Satralizumab treatment; Patient understands the study procedures and has signed the form indicating willingness to participate in the study.

Exclusion criteria

Exclusion Criteria:

  • Patients with NMOSD who received other biologics (e.g., rituximab, inebilizumab, tocilizumab, eculizumab) either within the past 6 months prior to this acute exacerbation or during the current acute phase; Patients with to Satralizumab, including: known allergy to Satralizumab or any inactive ingredient, active infection, active or therapy-naive latent tuberculosis; Pregnant or lactating women; Patients with concomitant Neoplasm malignant or other severe diseases; Patients currently enrolled in other interventional clinical studies; Patients assessed by the investigator/research staff as having a Critical illness or any Mental disorder or Cognitive disorder that may interfere with the study and who are unable to complete the key assessments required by this protocol; patients assessed by the investigator/research staff as unlikely to attend scheduled follow-up assessments under routine clinical care.
Terms in these criteria, in plain language(3)

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.

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.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

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.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
50 participants (estimated)
Target follow-up
3 Months
Patient registry
Yes

Groups and cohorts

  • Satralizumab Treatment Group

    NMOSD patients receiving Satralizumab at early phase of an NMOSD attack

    Drug: Satralizumab

Interventions

  • As recommended in the prescribing information, patients will receive subcutaneous satralizumab Injection as part of their routine treatment. The loading dose is 120 mg administered at Weeks 0, 2, and 4, followed by a maintenance dose of 120 mg every 4 weeks. Maintenance treatment is recommended for a minimum duration of 24 weeks.

06

What researchers measure

Primary outcomes

  1. EDSS

    Change in EDSS score between at baseline and at 6 months of treatment

    Time frame: 24 weeks

Secondary outcomes

  1. EDSS

    Change in EDSS score between at baseline and at 3 months of treatment

    Time frame: 12 weeks

  2. mRS

    Changes in mRS between at baseline and at 3 months of treatment

    Time frame: 12 weeks

  3. EQ-5D

    Changes in EQ-5D between at baseline and at 3 months of treatment

    Time frame: 12 weeks

  4. ADL score

    Changes in ADL score between at baseline and at 3 months of treatment

    Time frame: 12 weeks

  5. mRS

    Changes in mRS between at baseline and at 6 months of treatment

    Time frame: 24 weeks

  6. EQ-5D

    Changes in EQ-5D between at baseline and at 6 months of treatment

    Time frame: 24 weeks

  7. ADL score

    Changes in ADL score between at baseline and at 6 months of treatment

    Time frame: 24 weeks

  8. relapse

    Relapse events occurring within 6 months of treatment

    Time frame: 24 weeks

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: Yes — Individual's age, gender, EDSS, mRS, ADL, EQ-5D, laboratory parameters and adverse event records, etc.

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Jul 2026 (actual). Primary completion is estimated for Jul 2027, 12 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 7, 2026
First posted
Aug 13, 2026
StartActual
Jul 20, 2026
Primary completionEst.
Jul 20, 2027
CompletionEst.
Jan 20, 2028
Last update
Aug 13, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 13, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07762872
Lead sponsor
Junwei Hao, MD
Collaborators
The First Hospital of Hebei Medical University, The Second Hospital of Hebei Medical University, First Affiliated Hospital of Harbin Medical University, Shandong Provincial Hospital, Chifeng Municipal Hospital
Responsible party
Junwei Hao, MD (Professor, Xuanwu Hospital, Beijing) — Sponsor-investigator
First posted
Aug 13, 2026
Start date
Jul 20, 2026
Primary completion
Jul 20, 2027 (estimated)
Completion
Jan 20, 2028 (estimated)
Last update
Aug 13, 2026

Study contacts

Xixi Yang, MD, PhD
Contact
xyang891@outlook.com
+86 15601179281
Zheng Liu, MD, PhD
Contact
lzwcy@xwhosp.org
+86 13754093891
Junwei Hao, MD, PhD
principal investigator · Xuanwu Hospital Department of Neurology

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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