Neuromyelitis Optica Spectrum Disorder AttackPhase 2EASE-NMONCT06673394

Eculizumab For Acute Attack of Neuromyelitis Optica Spectrum Disorder

A Phase 2 study testing Complement protein C5 inhibitor and IVMP in people with Neuromyelitis Optica Spectrum Disorder Attack, run by Tianjin Medical University General Hospital.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record

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Trial summary

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Neuromyelitis Optica Spectrum Disorder Attack
What is being tested?: Complement protein C5 inhibitor and IVMP
Type of treatment: Vaccines, Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 0 participants
Where: No sites listed yet
Study dates: 3 Sep 2025to 1 Dec 2026
Phase: Phase 2
Are there results?: None posted in the registry

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 to 80 years
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
Leukocyte and CRP in the normal range
Acute optic neuritis and/or transverse myelitis presenting to the hospital within 10 days of symptom onset. An acute CNS inflammatory attack is defined as:
An acute presentation of neurological symptoms evolving over the course of 4 hours to 21 days that i. Localize to the spinal cord such as weakness, numbness or bowel/bladder dysfunction; or ii. Localize to the optic nerve with loss of visual acuity

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Associated with a change in neurological exam that meet the following thresholds: i. Spinal cord lesions must show a reduction in 1 point on the EDSS scale from baseline; or a reduction of 0.5 if baseline EDSS is at least 5.5.
Optic nerve lesions must show a reduction in visual acuity by at least 2 lines on the vision chart.
Also associated with any of the following objective findings: i. New gadolinium-enhancing MRI lesion in the area of the CNS that correlates with the exam findings, or ii. Cerebrospinal fluid findings of pleocytosis with at least 10 WBC per microliter, or iii. Swelling of the optic nerve head on fundoscopy or swelling of the retinal nerve fiber layer by OCT of at least 25 microns from baseline.
A female subject is eligible to enter the trial if she is:
Not pregnant or nursing;
Of non-childbearing potential (i.e. women who have had a hysterectomy, are post-menopausal, which is defined as >2 years without menses or, in female subjects who have been post-menopausal for <2 years, must be confirmed with Follicle Stimulating Hormone (FSH) and estradiol levels), have both ovaries surgically removed or have current documented tubal ligation) OR
Of child-bearing potential (i.e. women with functional ovaries and no documented impairment of oviductal or uterine function that would cause sterility). This category includes women with oligomenorrhoea (even severe), women who are perimenopausal or have just begun to menstruate.
Subject has a negative serum pregnancy test at screening and agrees to one of the following:
Complete abstinence from intercourse for the period from consent to trial until 6. months after the last dose of investigational product; or, ii. Consistent and correct use of one of the following acceptable methods of birth control for the period from consent into the trial until 6 months after the last dose of investigational product: i.Oral contraceptives (either combined or progesterone only) ii. Injectable progesterone iii. Levonorgestrel implants iv. Estrogenic vaginal ring v. Percutaneous contraceptive patches vi.Intrauterine device (IUD) or intrauterine system (IUS) with a documented failure rate of <1% per year vii.Male partner sterilization (vasectomy with documentation of azoospermia) prior to the female subject's entry into the trial; this male must be the sole partner for the subject viii.Double barrier method: condom and an occlusive cap (diaphragm or cervical/vault caps) with a vaginal spermicidal agent (foam/gel/film/cream/suppository).

Who cannot join

Current evidence or known history of clinically significant infection including:
Chronic or ongoing active infectious disease requiring long term systemic treatment such as, but not limited to: PML, chronic renal infection, chronic chest infection with bronchiectasis, tuberculosis, or active hepatitis C
Previous serious opportunistic or atypical infections
History of positive serology for hepatitis B (unless history of vaccination)
Prior history, or suspicion, of tuberculosis (TB)
History of positive serology for HIV

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Past or current history of medically significant adverse effects (including allergic reactions) from: Corticosteroids / Eculizumab
Current malignancy or history of malignancy in remission within the past 5 years, except for
Cervical carcinoma Stage 1B or less
Non-invasive basal cell and squamous cell skin carcinoma
Cancer diagnoses with a duration of complete response (remission) >5 years
Significant concurrent, uncontrolled medical condition including, but not limited to, cardiac, renal, hepatic, hematological, gastrointestinal, endocrine, immunodeficiency syndrome, pulmonary, cerebral, psychiatric, or neurological disease which could affect the subject's safety, impair the subject's reliable participation in the trial, impair the evaluation of endpoints, or necessitate the use of medication not allowed by the protocol, as determined by the principal investigator of the trial.
Use of an investigational drug or other experimental therapy within 4 weeks, 5 pharmacokinetic half-lives or duration of biological effect (whichever is longer) prior to screening.

About this study

Official title: Eculizumab For Acute Attack of Neuromyelitis Optica Spectrum Disorder (NMOSD): a Multi-Center, Phase 2, Open Label 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.

Conditions: Neuromyelitis Optica Spectrum Disorder Attack
Being tested: Complement protein C5 inhibitor, IVMP
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.

Complement protein C5 inhibitorDrug
Also called eculizumab
Investigational 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). Terminal complement complex inhibition by eculizumab predisposes patients to infections by encapsulated bacteria, especially N meningitidis. Meningococcal vaccination will not be effective in this timeframe; instead, all enrolled patients will receive antibiotic prophylaxis against N meningitidis from the time of the first dose of the study drug to 8 weeks after the last administration.
IVMPDrug
Also called methylprednisolone, prednisolone
IVMP arm: 1000mg methylprednisolone x5d, oral prednisone 60mg, 5mg weekly decline + antibiotics

Study groups in NCT06673394
Study group	Role	What they receive
IVMP arm	Other	IVMP arm: 1000mg methylprednisolone x5d, oral prednisone 60mg, 5mg weekly decline + antibiotics Receives: Drug: IVMP
eculizumab arm	Active comparator	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). Terminal complement complex inhibition by eculizumab predisposes patients to infections by encapsulated bacteria, especially N meningitidis. Meningococcal vaccination will not be effective in this timeframe; instead, all enrolled patients will receive antibiotic prophylaxis against N meningitidis from the time of the first dose of the study drug to 8 weeks after the last administration Receives: Drug: Complement protein C5 inhibitor; Drug: IVMP

What is being measured

The primary outcome is the main question the study is designed to answer.

Mean change in OSIS from presentation 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. The OSIS evaluates four primary functions: Visual Acuity (VA) (0-8), Motor Function (0-7), Sensory Function (0-5), and Sphincter Function (0-5). A higher OSIS score indicates a more severe level of disability. The standards for the OSIS scoring are as follows:
Optic-Spinal Impairment Score (OSIS) Visual Acuity (VA) 0 Normal
1. Scotoma but VA (corrected) better than 20/30
2. VA 20/30-20/59
3. VA 20/60-20/100
4. VA 20/I0I-2012004
5. VA 20/20I-20/800.
6. Count fingers only
7. Light perception only
8. No light perception Motor Function
0 Normal
1. Abnormal signs (hyperreflexia, Babinski sign) without weakness
2. Mild weakness (MRC grade 5-or 4+) in affected limb(s)
3. Mo
Measured: Acute attack to week4

Secondary outcomes (1)

Change in EDSS from presentation to Day 28
The Kurtzke Expanded Disability Status Scale (EDSS) 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. The EDSS provides a total score on a scale that ranges from 0 to 10 where 0 is normal and 10 is deceased. Increasing disability is reflected in an increasing EDSS score.
Measured: Acute attack to week4

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

3 Sep 20251 Dec 2026

First posted4 Nov 2024
Study start3 Sep 2025 (estimated)
Primary completion1 Jun 2026 (estimated)
Study completion1 Dec 2026 (estimated)

Why it stopped: The study plan need to be modified after widely discussion with our consultation board, regarding the conscern about the efficiency may not be able to detect the expected differences. We would like to withdraw this study plan and startup a new one.

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: None (open label)
Enrolment: 0 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06673394
Sponsor's protocol ID: EASE-NMO
Acronym: EASE-NMO
Status last verified: Nov 2024
First submitted: 30 Oct 2024
Last updated: 10 Sep 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

RecruitingPhase 1/2
Safety and Efficacy Study of Sivelestat in Neuromyelitis Optica Spectrum Disorder
Neuromyelitis Optica Spectrum Disorder Attack
RecruitingObservational study
A Multicenter Prospective Real-World Effectiveness and Safety of Satralizumab in the Early Treatment of Attacks in NMOSD
Neuromyelitis Optica Spectrum Disorders (NMOSD)
Active, not recruitingPhase 2
Eculizumab For the Acute Attack of Neuromyelitis Optica Spectrum Disorder
Neuromyelitis Optica Spectrum Disorder Attack
RecruitingPhase 4
Therapy in the Acute Phase of NMOSD: A Multicenter Prospective Real-World Study
Neuromyelitis Optica Spectrum Disorder Attack

All Neuromyelitis Optica Spectrum Disorder Attack trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Sep 2025. 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, Open Label Trial (EASE-NMO)
ClinicalTrials.gov ID: NCT06673394
Acronym / sponsor ID: EASE-NMO / EASE-NMO
Conditions: Neuromyelitis Optica Spectrum Disorder Attack
Keywords: Eculizumab, Acute Attack, Neuromyelitis Optica Spectrum Disorder
Phase: Phase 2
Study type: Interventional
Recruitment status: WithdrawnReason stopped: The study plan need to be modified after widely discussion with our consultation board, regarding the conscern about the efficiency may not be able to detect the expected differences. We would like to withdraw this study plan and startup a new one.
Enrolment: 0 participants (actual)
Lead sponsor: Tianjin Medical University General HospitalUniversity, hospital or other
Study start: 3 Sep 2025 (estimated)
Primary completion: 1 Jun 2026 (estimated)
Study completion: 1 Dec 2026 (estimated)
First posted: 4 Nov 2024 (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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
IVMP arm	Other	Drug: IVMPIVMP arm: 1000mg methylprednisolone x5d, oral prednisone 60mg, 5mg weekly decline + antibiotics
eculizumab arm	Active comparator	Drug: Complement protein C5 inhibitor, Drug: IVMPEculizumab 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). Terminal complement complex inhibition by eculizumab predisposes patients to infections by encapsulated bacteria, especially N meningitidis. Meningococcal vaccination will not be effective in this timeframe; instead, all enrolled patients will receive antibiotic prophylaxis against N meningitidis from the time of the first dose of the study drug to 8 weeks after the last administration

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (15 listed)

Anti-AQP4 antibody seropositive.
Male or female patients ≥18 years old
Body weight ≥ 35 kg
Leukocyte and CRP in the normal range
Acute optic neuritis and/or transverse myelitis presenting to the hospital within 10 days of symptom onset. An acute CNS inflammatory attack is defined as:

Key exclusion criteria (13 listed)

Current evidence or known history of clinically significant infection including:
Current malignancy or history of malignancy in remission within the past 5 years, except for
Significant concurrent, uncontrolled medical condition including, but not limited to, cardiac, renal, hepatic, hematological, gastrointestinal, endocrine, immunodeficiency syndrome, pulmonary, cerebral, psychiatric, or neurological disease which could affect the subject's safety, impair the subject's reliable participation in the trial, impair the evaluation of endpoints, or necessitate the use of medication not allowed by the protocol, as determined by the principal investigator of the trial.
Use of an investigational drug or other experimental therapy within 4 weeks, 5 pharmacokinetic half-lives or duration of biological effect (whichever is longer) prior to screening.

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
Complement protein C5 inhibitorAlso: eculizumabInvestigational 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). Terminal complement complex inhibition by eculizumab predisposes patients to infections by encapsulated bacteria, especially N meningitidis. Meningococcal vaccination will not be effective in this timeframe; instead, all enrolled patients will receive antibiotic prophylaxis against N meningitidis from the time of the first dose of the study drug to 8 weeks after the last administration.	Drug	eculizumab arm
IVMPAlso: methylprednisolone, prednisoloneIVMP arm: 1000mg methylprednisolone x5d, oral prednisone 60mg, 5mg weekly decline + antibiotics	Drug	IVMP arm, eculizumab arm

Primary outcome

Mean change in OSIS from presentation to Day 28
Time frame: Acute attack to week4
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. The OSIS evaluates four primary functions: Visual Acuity (VA) (0-8), Motor Function (0-7), Sensory Function (0-5), and Sphincter Function (0-5). A higher OSIS score indicates a more severe level of disability. The standards for the OSIS scoring are as follows: Optic-Spinal Impairment Score (OSIS) Visual Acuity (VA) 0 Normal 1. Scotoma but VA (corrected) better than 20/30 2. VA 20/30-20/59 3. VA 20/60-20/100 4. VA 20/I0I-2012004 5. VA 20/20I-20/800. 6. Count fingers only 7. Light perception only 8. No light perception Motor Function 0 Normal 1. Abnormal signs (hyperreflexia, Babinski sign) without weakness 2. Mild weakness (MRC grade 5-or 4+) in affected limb(s) 3. Mo

1 secondary outcome

Change in EDSS from presentation to Day 28
Time frame: Acute attack to week4

Results and safety

The study was withdrawn before enrolling participants, so there are no results.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2025.
Individual participant dataSharing planned: No

Related trials for Neuromyelitis Optica Spectrum Disorder Attack

RecruitingPhase 1/2
Safety and Efficacy Study of Sivelestat in Neuromyelitis Optica Spectrum Disorder
Neuromyelitis Optica Spectrum Disorder Attack
RecruitingObservational study
A Multicenter Prospective Real-World Effectiveness and Safety of Satralizumab in the Early Treatment of Attacks in NMOSD
Neuromyelitis Optica Spectrum Disorders (NMOSD)
Active, not recruitingPhase 2
Eculizumab For the Acute Attack of Neuromyelitis Optica Spectrum Disorder
Neuromyelitis Optica Spectrum Disorder Attack
RecruitingPhase 4
Therapy in the Acute Phase of NMOSD: A Multicenter Prospective Real-World Study
Neuromyelitis Optica Spectrum Disorder Attack

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.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Complement protein C5 inhibitor and IVMP in people with Neuromyelitis Optica Spectrum Disorder Attack, run by Tianjin Medical University General Hospital.

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 15 inclusion and 13 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: withdrawn, as of the sponsor's last update on 10 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

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?

The study was withdrawn before enrolling participants, so there are no results.

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?

Mean change in OSIS from presentation to Day 28 (time frame: Acute attack to week4). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06673394.

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 10 Sep 2025.