Neuromyelitis Optica Spectrum Disorder AttackPhase 2EASE-NMONCT07184840
Eculizumab For the Acute Attack of Neuromyelitis Optica Spectrum Disorder
A Phase 2 study testing Intravenous Methylprednisolone (IVMP) and Complement protein C5 inhibitor in people with Neuromyelitis Optica Spectrum Disorder Attack, run by Tianjin Medical University General Hospital at 1 site in China.
Trial summary
Neuromyelitis optica spectrum disorder (NMOSD) is a relapsing, inflammatory autoimmune disorder of the central nervous system characterized by the pathogenic anti-aquaporin 4 antibody (AQP4-IgG). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuromyelitis Optica Spectrum Disorder Attack
- What is being tested?
- Intravenous Methylprednisolone (IVMP) and Complement protein C5 inhibitor
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteChina
- Study dates
- 9 Sep 2025to 30 Sep 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Anti-AQP4 antibody seropositive.
- Male or female patients ≥18 years old
- Body weight ≥ 35 kg
- Acute optic neuritis and/or transverse myelitis enrolled within 28 days from the attack, with a change in neurological exam that meet an increase of OSIS at least 2 points of baseline compared to that of prior attack.
- A female subject is eligible to enter the trial if she is:
- Not pregnant or breastfeeding, not intending to conceive during the course of the trial
Who cannot join
- Use of IVIg within 3 weeks prior to screening
- Unresolved meningococcal infection
- Any systemic bacterial or other infection which is clinically significant in the opinion of the Investigator and has not been treated with appropriate antibiotics
- Participation in any other investigational drug study or was exposed to an investigational drug or device within 30 days of screening.
- Has previously received treatment with eculizumab
- Hypersensitivity to murine proteins or to one of the excipients of eculizumab
- Any medical condition that, in the opinion of the Investigator, might interfere with thepatient's participation in the trial, poses any added risk for the patient, or confounds the assessment of the patients
Trial locations and contacts
1 site in 1 country.
China1 site
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, 300052
About this study
Official title: Eculizumab For Acute Attack of Neuromyelitis Optica Spectrum Disorder (NMOSD): a Multi-Center, Phase 2 Trial (EASE-NMO)
Neuromyelitis optica spectrum disorder (NMOSD) is a relapsing, inflammatory autoimmune disorder of the central nervous system characterized by the pathogenic anti-aquaporin 4 antibody (AQP4-IgG). The objectives of this study are to assess the efficacy and safety of eculizumab for treatment of patients with neuromyelitis optica spectrum disorders during acute phase who are anti-aquaporin-4 (AQP4) antibody-positive. Eculizumab, a humanized monoclonal antibody, inhibits the terminal complement protein C5 and prevents its cleavage into C5a and the formation of C5b-9 (MAC), has approved for preventive treatment of NMOSD. Given the high efficacy of C5 inhibition, eculizumab is proposed to potentially provide rapid relief from astrocyte destruction by reducing MAC formation, which could contribute to the fast alleviation of neurological deficit during NMO acute attack. The potential of eculizumab warrants further investigation as a treatment for acute neuromyelitis optica spectrum disorders attacks.
- Being tested
- Intravenous Methylprednisolone (IVMP), Complement protein C5 inhibitor
- Keywords
- Eculizumab, Acute Attack, Neuromyelitis Optica Spectrum Disorder
- Medical subject headings
- Neuromyelitis Optica
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravenous Methylprednisolone (IVMP)Drug
IVMP arm: 1000mg methylprednisolone x5d, oral prednisone 60mg, 5mg weekly decline + antibiotics
Complement protein C5 inhibitorDrug
Also called Eculizumab
IVMP+Eculizumab arm: eculizumab (900 mg) will be administered intravenously once per week for a total of four doses (days 1, 8, 15, and 22) in conjunction with IVMP and oral prednisone (60mg, 5mg weekly decline).
All enrolled patients will receive antibiotic prophylaxis against N meningitidis.
| Study group | Role | What they receive |
|---|---|---|
| Intravenous Methylprednisolone (IVMP) arm | Other | IVMP arm: 1000mg methylprednisolone x5d, oral prednisone 60mg, 5mg weekly decline + antibiotics Receives: Drug: Intravenous Methylprednisolone (IVMP) |
| IVMP+Eculizumab arm | Experimental | IVMP+Eculizumab arm: eculizumab (900 mg) will be administered intravenously once per week for a total of four doses (days 1, 8, 15, and 22) in conjunction with IVMP and oral prednisone (60mg, 5mg weekly decline).
All enrolled patients will receive antibiotic prophylaxis against N meningitidis. Receives: Drug: Intravenous Methylprednisolone (IVMP); Drug: Complement protein C5 inhibitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of improvement in OSIS from baseline to Day 28 by 2 points or more
The Optic-Spinal Impairment Score (OSIS) was developed to measure the disability status of subjects with demyelinating disease. It allows an objective quantification of the level of functioning that could be widely and reproducibly used by researchers and health care providers. OSIS score ranges from 0 to 25, which includes four primary functions: Visual Acuity (VA) (0-8), Motor Function (0-7), Sensory Function (0-5), and Sphincter Function (0-5). The higher scores reflect more severe disability. A decrease of at least 2 points in the overall OSIS score on day 28 compared to the baseline was regarded as a significant improvement.
Measured: Acute attack to Day 28
Secondary outcomes (13)
Change of OSIS from baseline to Day 28
The Optic-Spinal Impairment Score (OSIS) was developed to measure the disability status of subjects with demyelinating disease. It allows an objective quantification of the level of functioning that could be widely and reproducibly used by researchers and health care providers. OSIS score ranges from 0 to 25, which includes four primary functions: Visual Acuity (VA) (0-8), Motor Function (0-7), Sensory Function (0-5), and Sphincter Function (0-5). Higher scores indicate more severe disability. A decrease in the overall OSIS score from baseline was used to measure neurological improvement.
Measured: Acute attack to Day 28
Change of EDSS from baseline to Day 28
EDSS and its associated functional system (FS) score provide a system for quantifying disability and monitoring changes in the level of disability over time. EDSS consists of 7 FS (visual FS, brainstem FS, pyramidal FS, cerebellar FS, sensory FS, bowel and bladder FS, and cerebral FS) which are used to derive EDSS score ranging from 0 (normal neurological exam) to 10 (death from MS). A negative change from baseline in the overall EDSS score indicates neurological improvement.
Measured: Acute attack to Day 28
Proportion of subjects that require plasma exchange or immunoadsorption at day 10 post treatment initiation.
PLEX Rescue was conducted only if a patient was not responding to the IVMP or IVMP+Eculizumab treatment as per the previous definition used; the assessment was made on day 10 after the IVMP/eculizumab initiation.
Measured: Acute attack to Day 10
Change of OSIS from baseline to Day 7, 14, 21, and Week 12.
The Optic-Spinal Impairment Score (OSIS) was developed to measure the disability status of subjects with demyelinating disease. OSIS score ranges from 0 to 25, which includes four primary functions: Visual Acuity (VA) (0-8), Motor Function (0-7), Sensory Function (0-5), and Sphincter Function (0-5). A decrease in OSIS indicates improvement.
Measured: Acute attack to Week 12
Change of EDSS from baseline to Day 7, 14, 21, and Week 12
EDSS and its associated functional system (FS) score provide a system for quantifying disability and monitoring changes in the level of disability over time. A decrease in EDSS indicates improvement.
Measured: Acute attack to Week 12
Changes in Muscle Strength by MRC Scale for patients presenting with an acute relapse of myelitis at Days 7, 14, 21,28 and Week 12.
Muscle Power Assessment (MRC) was developed to assess the muscle power of limbs. A score of 0-5 was used to grade the power. Increasing disability of muscle power is reflected in an decreasing MRC score.
Measured: Acute attack to Week 12
Changes in visual acuity in subjects presenting with an acute relapse of optic neuritis at Days 7, 14, 21,28, and Week 12
Visual Acuity was measured with the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity test on a scale from 100 letters (Snellen equivalent of 20/10) to 0 letters (Snellen equivalent of <20/800). Higher scores indicate better visual acuity and lower scores indicate worse visual acuity.
Measured: Acute attack to Week 12
Changes of pRNFL measured by OCT in subjects presenting with an acute relapse of optic neuritis at Days 28, and Week 12
The peripapillary retinal nerve fiber layer (pRNFL) was analyzed by optical coherence tomography (OCT) measurements
Measured: Acute attack to Week 12
Changes of mGCIPLT measured by OCT in subjects presenting with an acute relapse of optic neuritis at Day 28, and Week 12
The macular ganglion cell-inner plexiform layer (mGCIPL) was analyzed by optical coherence tomography (OCT) measurements
Measured: Acute attack to Week 12
To evaluate the changes of Nfl from baseline to Day 28
Serum neurofilament light chain (NfL): Blood sample will be obtained to determine the level of Nfl.
Measured: Acute attack to Day 28
To evaluate the changes of GFAP from baseline to Day 28
Glial Fibrillary Acidic Protein (GFAP):Blood sample will be obtained to determine the level of GFAP.
Measured: Acute attack to Day 28
To evaluate the changes of complement activity (CH50) from baseline to Day 28
CH50: Blood sample will be obtained to determine the hemolytic activity of serum complement.
Measured: Acute attack to Day 28
To compare the change in MRI lesion size by T2 weighted imaging and T1 post-contrast imaging from baseline to Week 12
MRIs will be analyzed for counting the numbers of new lesions by T2 hyper-intensity in the brain, spinal cord and optic nerve, and the volume of T1 post-contrast enhancement.
Measured: Acute attack to Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2025
- Study start9 Sep 2025
- Primary completion28 Apr 2026
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuromyelitis Optica Spectrum Disorder AttackStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tianjin Medical University General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fu-Dong Shi, Tianjin Medical University General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07184840
- Sponsor's protocol ID
- IRB2024-YX-456-01
- Acronym
- EASE-NMO
- Status last verified
- Sep 2025
- First submitted
- 8 Sep 2025
- Last updated
- 3 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Eculizumab For Acute Attack of Neuromyelitis Optica Spectrum Disorder (NMOSD): a Multi-Center, Phase 2 Trial (EASE-NMO)
- ClinicalTrials.gov ID
- NCT07184840
- Acronym / sponsor ID
- EASE-NMO / IRB2024-YX-456-01
- Keywords
- Eculizumab, Acute Attack, Neuromyelitis Optica Spectrum Disorder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Tianjin Medical University General HospitalUniversity, hospital or other
- Study start
- 9 Sep 2025 (actual)
- Primary completion
- 28 Apr 2026 (actual)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 22 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Neuromyelitis optica spectrum disorder (NMOSD) is a relapsing, inflammatory autoimmune disorder of the central nervous system characterized by the pathogenic anti-aquaporin 4 antibody (AQP4-IgG). The objectives of this study are to assess the efficacy and safety of eculizumab for treatment of patients with neuromyelitis optica spectrum disorders during acute phase who are anti-aquaporin-4 (AQP4) antibody-positive. Eculizumab, a humanized monoclonal antibody, inhibits the terminal complement protein C5 and prevents its cleavage into C5a and the formation of C5b-9 (MAC), has approved for preventive treatment of NMOSD. Given the high efficacy of C5 inhibition, eculizumab is proposed to potentially provide rapid relief from astrocyte destruction by reducing MAC formation, which could contribute to the fast alleviation of neurological deficit during NMO acute attack. The potential of eculizumab warrants further investigation as a treatment for acute neuromyelitis optica spectrum disorders attacks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intravenous Methylprednisolone (IVMP) arm | Other | Drug: Intravenous Methylprednisolone (IVMP)IVMP arm: 1000mg methylprednisolone x5d, oral prednisone 60mg, 5mg weekly decline + antibiotics |
| IVMP+Eculizumab arm | Experimental | Drug: Intravenous Methylprednisolone (IVMP), Drug: Complement protein C5 inhibitorIVMP+Eculizumab arm: eculizumab (900 mg) will be administered intravenously once per week for a total of four doses (days 1, 8, 15, and 22) in conjunction with IVMP and oral prednisone (60mg, 5mg weekly decline). All enrolled patients will receive antibiotic prophylaxis against N meningitidis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Anti-AQP4 antibody seropositive.
- Male or female patients ≥18 years old
- Body weight ≥ 35 kg
- Acute optic neuritis and/or transverse myelitis enrolled within 28 days from the attack, with a change in neurological exam that meet an increase of OSIS at least 2 points of baseline compared to that of prior attack.
- A female subject is eligible to enter the trial if she is:
Key exclusion criteria (7 listed)
- Use of IVIg within 3 weeks prior to screening
- Unresolved meningococcal infection
- Any systemic bacterial or other infection which is clinically significant in the opinion of the Investigator and has not been treated with appropriate antibiotics
- Participation in any other investigational drug study or was exposed to an investigational drug or device within 30 days of screening.
- Has previously received treatment with eculizumab
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intravenous Methylprednisolone (IVMP)IVMP arm: 1000mg methylprednisolone x5d, oral prednisone 60mg, 5mg weekly decline + antibiotics | Drug | IVMP+Eculizumab arm, Intravenous Methylprednisolone (IVMP) arm |
| Complement protein C5 inhibitorAlso: EculizumabIVMP+Eculizumab arm: eculizumab (900 mg) will be administered intravenously once per week for a total of four doses (days 1, 8, 15, and 22) in conjunction with IVMP and oral prednisone (60mg, 5mg weekly decline). All enrolled patients will receive antibiotic prophylaxis against N meningitidis. | Drug | IVMP+Eculizumab arm |
Primary outcome
Proportion of improvement in OSIS from baseline to Day 28 by 2 points or more
Time frame: Acute attack to Day 28
The Optic-Spinal Impairment Score (OSIS) was developed to measure the disability status of subjects with demyelinating disease. It allows an objective quantification of the level of functioning that could be widely and reproducibly used by researchers and health care providers. OSIS score ranges from 0 to 25, which includes four primary functions: Visual Acuity (VA) (0-8), Motor Function (0-7), Sensory Function (0-5), and Sphincter Function (0-5). The higher scores reflect more severe disability. A decrease of at least 2 points in the overall OSIS score on day 28 compared to the baseline was regarded as a significant improvement.
13 secondary outcomes
Change of OSIS from baseline to Day 28
Time frame: Acute attack to Day 28
Change of EDSS from baseline to Day 28
Time frame: Acute attack to Day 28
Proportion of subjects that require plasma exchange or immunoadsorption at day 10 post treatment initiation.
Time frame: Acute attack to Day 10
Change of OSIS from baseline to Day 7, 14, 21, and Week 12.
Time frame: Acute attack to Week 12
Change of EDSS from baseline to Day 7, 14, 21, and Week 12
Time frame: Acute attack to Week 12
Changes in Muscle Strength by MRC Scale for patients presenting with an acute relapse of myelitis at Days 7, 14, 21,28 and Week 12.
Time frame: Acute attack to Week 12
Changes in visual acuity in subjects presenting with an acute relapse of optic neuritis at Days 7, 14, 21,28, and Week 12
Time frame: Acute attack to Week 12
Changes of pRNFL measured by OCT in subjects presenting with an acute relapse of optic neuritis at Days 28, and Week 12
Time frame: Acute attack to Week 12
Changes of mGCIPLT measured by OCT in subjects presenting with an acute relapse of optic neuritis at Day 28, and Week 12
Time frame: Acute attack to Week 12
To evaluate the changes of Nfl from baseline to Day 28
Time frame: Acute attack to Day 28
To evaluate the changes of GFAP from baseline to Day 28
Time frame: Acute attack to Day 28
To evaluate the changes of complement activity (CH50) from baseline to Day 28
Time frame: Acute attack to Day 28
To compare the change in MRI lesion size by T2 weighted imaging and T1 post-contrast imaging from baseline to Week 12
Time frame: Acute attack to Week 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Intravenous Methylprednisolone (IVMP) and Complement protein C5 inhibitor in people with Neuromyelitis Optica Spectrum Disorder Attack, run by Tianjin Medical University General Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 3 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of improvement in OSIS from baseline to Day 28 by 2 points or more (time frame: Acute attack to Day 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2026.