Neuromyelitis Optica Spectrum DisorderNCT05891379
Inebilizumab in Acute Neuromyelitis Optica Spectrum Disorders
An observational study of Neuromyelitis Optica Spectrum Disorder, run by Xuanwu Hospital, Beijing at 1 site in China.
Trial summary
This study is aimed to observe the effectiveness and safety of inebilizumab in the acute phase of neuromyelitis optica spectrum disorders. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuromyelitis Optica Spectrum Disorder
- What is being tested?
- Inebilizumab and oral immunosuppressant
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 9 Jul 2024to 31 Jul 2025
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: NMOSD patients with acute attacks
Who may be able to join
- 1. Age ≥ 18 years with anti-AQP4-IgG seropositive NMOSD as defined by 2015 NMOSD diagnostic criteria by IPND (International Panel for NMO Diagnosis); 2. In the acute phase of NMOSD (definition of acute phase: new neurological symptoms or aggravation of existing symptoms within 30 days before screening, lasting at least 24 hours without with fever); 3. Patients who plan to receive or are receiving intravenous methylprednisolone therapy; 4. Expanded disability status scale (EDSS) score ≤ 8 and ≥ 2.5 during the screening period; 5. Able and willing to give written informed consent; 6. Women of childbearing potential who agree to use adequate contraception during the study.
Who cannot join
- 1. Lactating and pregnant females; 2. Participate in other interventional studies within 30 days before screening or within 5 half-lives of the investigational agent before enrollment; 3. Combined with severe mental disorders and other conditions and unable to cooperate with follow-up; 4. History of malignancies; 5. Received plasma exchange, immunoadsorption or intravenous immunoglobulin therapy within 1 month before screening; 6. Patients with negative hepatitis B surface antibody (HBsAg) and positive hepatitis B core antibody (HBcAb), or HBsAg-positive virus carriers, or patients with active tuberculosis or positive tuberculosis screening without appropriate treatment history; 7. Other situations that researchers think are not suitable to participate in this study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Xuanwu Hospital, Capital Medical University
Beijing, Beijing Municipality, 100053
Junwei Hao, 010-83198277, haojunwei@vip.163.com
About this study
Official title: Effectiveness and Safety of Inebilizumab in the Acute Phase of Neuromyelitis Optica Spectrum Disorders-a Multicentric, Prospective, Real Word Study
This study is aimed to observe the effectiveness and safety of inebilizumab in the acute phase of neuromyelitis optica spectrum disorders.
Read the detailed description
This is a a multicentric, prospective, real word study of inebilizumab in NMOSD acute attack compared with oral immunosuppressant. A total of 50 patients will be enrolled at approximately 10 centers around China.
- Conditions
- Neuromyelitis Optica Spectrum Disorder
- Being tested
- Inebilizumab, oral immunosuppressant
- Keywords
- Neuromyelitis Optica Spectrum Disorder, inebilizumab, observational study
- Medical subject headings
- Neuromyelitis Optica
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InebilizumabDrug
Inebilizumab: 300mg IV on Day1 and Day 15. The first dose of inelizumab is given during IVMP.
oral immunosuppressantDrug
Oral immunosuppressants (azathioprine or mycolate mofetil) are initiated during IVMP.
| Study group | Role | What they receive |
|---|---|---|
| Exposed group | intravenous Intravenous methylprednisolone (IVMP) plus intravenous inebilizumab Receives: Drug: Inebilizumab | |
| Non-exposed group | IVMP plus oral immunosuppressant (Mycophenolate Mofetil or Azathioprine) Receives: Drug: oral immunosuppressant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Expanded Disability Status Scale (EDSS) score from baseline
Change in Expanded Disability Status Scale (EDSS) score from baseline at the last visit(EDSS : Minimum Score 1, Maximum score 10, higher scores mean a worse outcome).
Measured: 6 months
Secondary outcomes (12)
Change in Expanded Disability Status Scale (EDSS) score from baseline
Change in Expanded Disability Status Scale (EDSS) score from baseline at month 1, month 3(EDSS : Minimum Score 1, Maximum score 10, higher scores mean a worse outcome).
Measured: 1 months, 3 months
Percentage of Participants With Disability Improvement
Disability improvement is defined as a reduction in EDSS score of: A) >=1.0 from the baseline EDSS score when the baseline score was <=5.5 B) >= 0.5 when the baseline EDSS score > 5.5(EDSS : Minimum Score 1, Maximum score 10, higher scores mean a worse outcome).
Measured: 6 months
Change in modified Rankin score (mRS) from baseline
Change in modified Rankin score (mRS) from baseline at month 1, month 3, month 6(mRS : Minimum Score 0, Maximum score 6, higher scores mean a worse outcome).
Measured: 1 months, 3 months, 6 months
Time to first relapse
Measured: 6 months
Number of New, and/or Enlarging T2 Hyperintense Lesions Detected by Magnetic Resonance Imaging (MRI)
Number of New, and/or Enlarging T2 Hyperintense Lesions Detected by Magnetic Resonance Imaging (MRI) at the last visit
Measured: 6 months
Change in Timed 25 Foot Walk Test from baseline
Change in time taken to complete the timed 25 foot walk test from baseline
Measured: 1 months, 3 months , 6 months
Number of NMOSD attacked related rescue treatment
Measured: 6 months
Change in serum GFAP levels from baseline
Change in serum GFAP levels from baseline at the last visit
Measured: 6 months
Change in AQP4-ab titers from baseline
Change in AQP4-ab titers from baseline at the last visit
Measured: 6 months
Change in Low-contrast Visual Acuity (LCVA) from baseline
Change in Low-contrast Visual Acuity (LCVA) at month 3, month 6)(The LCVA test is used to determine the number of letters that can be read on a standardized low-contrast Landolt C Broken Rings Chart held at a distance of 3 meters).
Measured: 3 months, 6 months
Changes in EQ-5D-5L scores from baseline
Changes in EQ-5D scores from baseline at month 1 month, month 3 , month 6(EQ-5D-5L: Minimum Score 5, Maximum score 25, lower scores mean a better quality of life).
Measured: 1 month, 3 months ,6 months
Change in retinal nerve fiber layer (RNFL) loss from baseline
Change in retinal nerve fiber layer (RNFL) loss measured by optical coherence tomography (OCT) from baseline at month 1, month 3，month 6.
Measured: 3 months ,6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2023
- Study start9 Jul 2024
- Primary completion31 Jul 2025 (estimated)
- Study completion31 Jul 2025 (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 DisorderStudies of the same condition, open and under way.
- More trials run by Xuanwu Hospital, BeijingThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xuanwu Hospital, Beijing
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Junwei Hao, MD, Principal investigator, Xuanwu Hospital, Beijing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05891379
- Sponsor's protocol ID
- XMEC-2023-003
- Status last verified
- Jun 2024
- First submitted
- 24 May 2023
- Last updated
- 19 Sep 2024
- 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 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Safety of Inebilizumab in the Acute Phase of Neuromyelitis Optica Spectrum Disorders-a Multicentric, Prospective, Real Word Study
- ClinicalTrials.gov ID
- NCT05891379
- Acronym / sponsor ID
- XMEC-2023-003
- Conditions
- Neuromyelitis Optica Spectrum Disorder
- Keywords
- Neuromyelitis Optica Spectrum Disorder, inebilizumab, observational study
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Xuanwu Hospital, BeijingUniversity, hospital or other
- Study start
- 9 Jul 2024 (actual)
- Primary completion
- 31 Jul 2025 (estimated)
- Study completion
- 31 Jul 2025 (estimated)
- First posted
- 6 Jun 2023 (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.
This study is aimed to observe the effectiveness and safety of inebilizumab in the acute phase of neuromyelitis optica spectrum disorders.
Detailed description
This is a a multicentric, prospective, real word study of inebilizumab in NMOSD acute attack compared with oral immunosuppressant. A total of 50 patients will be enrolled at approximately 10 centers around China.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exposed group | – | Drug: Inebilizumabintravenous Intravenous methylprednisolone (IVMP) plus intravenous inebilizumab |
| Non-exposed group | – | Drug: oral immunosuppressantIVMP plus oral immunosuppressant (Mycophenolate Mofetil or Azathioprine) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- NMOSD patients with acute attacks
Key inclusion criteria (1 listed)
- 1. Age ≥ 18 years with anti-AQP4-IgG seropositive NMOSD as defined by 2015 NMOSD diagnostic criteria by IPND (International Panel for NMO Diagnosis); 2. In the acute phase of NMOSD (definition of acute phase: new neurological symptoms or aggravation of existing symptoms within 30 days before screening, lasting at least 24 hours without with fever); 3. Patients who plan to receive or are receiving intravenous methylprednisolone therapy; 4. Expanded disability status scale (EDSS) score ≤ 8 and ≥ 2.5 during the screening period; 5. Able and willing to give written informed consent; 6. Women of childbearing potential who agree to use adequate contraception during the study.
Key exclusion criteria (1 listed)
- 1. Lactating and pregnant females; 2. Participate in other interventional studies within 30 days before screening or within 5 half-lives of the investigational agent before enrollment; 3. Combined with severe mental disorders and other conditions and unable to cooperate with follow-up; 4. History of malignancies; 5. Received plasma exchange, immunoadsorption or intravenous immunoglobulin therapy within 1 month before screening; 6. Patients with negative hepatitis B surface antibody (HBsAg) and positive hepatitis B core antibody (HBcAb), or HBsAg-positive virus carriers, or patients with active tuberculosis or positive tuberculosis screening without appropriate treatment history; 7. Other situations that researchers think are not suitable to participate in this study.
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 |
|---|---|---|
| InebilizumabInebilizumab: 300mg IV on Day1 and Day 15. The first dose of inelizumab is given during IVMP. | Drug | Exposed group |
| oral immunosuppressantOral immunosuppressants (azathioprine or mycolate mofetil) are initiated during IVMP. | Drug | Non-exposed group |
Primary outcome
Change in Expanded Disability Status Scale (EDSS) score from baseline
Time frame: 6 months
Change in Expanded Disability Status Scale (EDSS) score from baseline at the last visit(EDSS : Minimum Score 1, Maximum score 10, higher scores mean a worse outcome).
12 secondary outcomes
Change in Expanded Disability Status Scale (EDSS) score from baseline
Time frame: 1 months, 3 months
Percentage of Participants With Disability Improvement
Time frame: 6 months
Change in modified Rankin score (mRS) from baseline
Time frame: 1 months, 3 months, 6 months
Time to first relapse
Time frame: 6 months
Number of New, and/or Enlarging T2 Hyperintense Lesions Detected by Magnetic Resonance Imaging (MRI)
Time frame: 6 months
Change in Timed 25 Foot Walk Test from baseline
Time frame: 1 months, 3 months , 6 months
Number of NMOSD attacked related rescue treatment
Time frame: 6 months
Change in serum GFAP levels from baseline
Time frame: 6 months
Change in AQP4-ab titers from baseline
Time frame: 6 months
Change in Low-contrast Visual Acuity (LCVA) from baseline
Time frame: 3 months, 6 months
Changes in EQ-5D-5L scores from baseline
Time frame: 1 month, 3 months ,6 months
Change in retinal nerve fiber layer (RNFL) loss from baseline
Time frame: 3 months ,6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- 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.
Junwei Hao, MD principal investigator
Xuanwu Hospital, Beijing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neuromyelitis Optica Spectrum Disorder, run by Xuanwu Hospital, Beijing 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 19 Sep 2024. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Junwei Hao, MD (010-83198277, haojunwei@vip.163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Expanded Disability Status Scale (EDSS) score from baseline (time frame: 6 months). 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 19 Sep 2024.