Neuromyelitis Optica Spectrum DisorderPhase 3NCT05314010
A Study of MIL62 in Patients With Neuromyelitis Optica Spectrum Disorder (NMOSD)
A Phase 3 study testing MIL62 in people with Neuromyelitis Optica Spectrum Disorder, run by Beijing Mabworks Biotech Co., Ltd. at 1 site in China.
Trial summary
This study will evaluate the safety and efficacy of MIL62 in patients with Neuromyelitis Optica Spectrum Disorder. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Neuromyelitis Optica Spectrum Disorder
- What is being tested?
- MIL62
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 102 participants
- Where
- 1 siteChina
- Study dates
- 18 Aug 2022to Mar 2027
- Phase
- Phase 3
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who meet the diagnostic criteria for NMOSD established by the International Panel for NMO Diagnosis (IPND) in 2015 and are seropositive for AQP4-IgG.
- Male or female patients aged 18 to 70 years, inclusive of the endpoints..
- Expanded Disability Status Scale(EDSS) score ≤ 7.
- Phase Ib: At least 1 attack of NMOSD requiring rescue treatment within 2 years prior to screening. Phase III: At least 1 attack of NMOSD requiring rescue treatment within 1 year prior to screening; or at least 2 attacks of NMOSD requiring rescue treatment within 2 years prior to screening, including the first attack.
- Glucocorticoid treatment prior to screening is allowed, and within 14 days before the first administration, the dose should be ≤20 mg/day of prednisone or its equivalent dose of glucocorticoids.
- Patients who had an attack of the disease before screening must have stable or improved attack symptoms for at least 4 weeks prior to the first administration.
- Voluntarily sign the informed consent form.
Who cannot join
- Subjects who have received Rituximab, Inebilizumab, Ozanimod, Telitacicept, or any B-cell depleting drugs within 6 months prior to the screening period are allowed to enroll if their CD19 or CD20 positive B-cell counts are above the lower limit of normal; or if their CD4 positive T-lymphocyte counts are < 200 cells/μL.
- Having used Tocilizumab, Satralizumab, Eculizumab, Efgartigimod, or other non-B-cell depleting biological agents with therapeutic effects on NMOSD, or mitoxantrone, or alkylating agents such as cyclophosphamide within 3 months prior to the first administration.
- Phase Ib: Subjects who have used immunosuppressants such as azathioprine, mycophenolate mofetil, tacrolimus, cyclosporine, methotrexate, and cyclophosphamide before the first administration are eligible for enrollment, provided that the interval since discontinuing the drugs exceeds 5 times their half-life. Phase III: Subjects who have used immunosuppressants other than glucocorticoids within 1 month prior to the first administration, including but not limited to azathioprine, mycophenolate mofetil, tacrolimus, cyclosporine, and methotrexate, are excluded (exclusion is not required if the continuous use duration is ≤7 days).
- Within 28 days prior to the first administration, plasma exchange (PE), moderate blood transfusion, or immunomodulatory drugs such as interferon β, interferon γ, or intravenous immunoglobulin (IVIG) have been used.
- Live vaccines or attenuated vaccines were administered within 28 days prior to the first dose.
Trial locations and contacts
1 site in 1 country.
China1 site
Ethics Committee of Chinese PLA General Hosptial
Beijing, Beijing Municipality
About this study
Official title: A Multicenter, Phase Ib/III Study to Evaluate the Safety and Efficacy of MIL62 in Patients With Neuromyelitis Optica Spectrum Disorder (NMOSD)
This study will evaluate the safety and efficacy of MIL62 in patients with Neuromyelitis Optica Spectrum Disorder.
- Conditions
- Neuromyelitis Optica Spectrum Disorder
- Being tested
- MIL62, Placebo
- Medical subject headings
- Neuromyelitis Optica
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MIL62Drug
Phase 1b: Participants will receive intravenous (IV) infusions of MIL62 at doses of 500 mg or 1000 mg on Week (W) 1 Day (D) 1, W3D1, W25D1, W27D1, W53D1, W79D1, W105D1, W131D1, W157D1, W183D1, and W209D1. Participants initially assigned to the 500 mg dose group who exhibit good tolerance may be escalated to the 1000 mg dose starting from W25D1.
Phase 3 (Randomised Controlled Period [RCP]): Participants will receive IV MIL62 1000 mg or placebo matched to MIL62 on W1D1, W3D1, W25D1, and W27D1. The administration protocol for placebo is identical to that of MIL62.
Phase 3 (Open-Label Period [OLP]): Participants who enter the OLP will receive IV MIL62 1000 mg on W1D1, W27D1, W53D1, W79D1, W105D1, and W131D1, along with matching placebo on W3D1.
PlaceboOther
Phase 3 (RCP): Participants will receive IV placebo matched to MIL62 on W1D1, W3D1, W25D1, and W27D1.
Phase 3 (OLP): Participants entering the OLP will receive IV MIL62 1000 mg on W1D1, W3D1, W27D1, W53D1, W79D1, W105D1, and W131D1.
| Study group | Role | What they receive |
|---|---|---|
| MIL62 | Experimental | Not described Receives: Drug: MIL62 |
| Placebo | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase 1b: The incidence and severity of all adverse events (AE)
Measured: Up to Week 234
Phase 3: Time to First Adjudicated Relapse (TFR) during RCP.
The time from the date of randomization to the date of the first clinical relapse as assessed by the Clinical Endpoint Committee(CEC). The criteria for NMOSD relapse are the occurrence of new objective neurological symptoms or worsening of objective neurological symptoms; meeting any one of the relapse criteria specified in the protocol is sufficient.
Measured: Up to 52 weeks
Secondary outcomes (8)
Time to first adjudicated relapse
Measured: Up to Week 208
Annualized relapse rate
Measured: Up to Week 208
Change from baseline of Expanded Disability Status Scale (EDSS) score
Measured: Up to Week 208
Annualized cumulative active lesions rate on MRI
Measured: Up to Week 208
Annualised NMOSD-related inpatient hospitalisation rate.
Measured: Up to Week 208
Mean Change in T-score from Baseline in the EQ5D Scale.
Measured: Up to Week 208
Percentage of Participants with Adverse Events (AEs).
Severity Determined According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0
Measured: Up to Week 208
Peripheral B-cell Counts at Specified Timepoints.
Measured: Up to Week 208
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2022
- Study start18 Aug 2022
- Primary completion21 Feb 2025
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Neuromyelitis Optica Spectrum DisorderStudies of the same condition, open and under way.
- More trials run by Beijing Mabworks Biotech Co., Ltd.The 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Mabworks Biotech Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05314010
- Sponsor's protocol ID
- MIL62-CT303
- Status last verified
- Oct 2024
- First submitted
- 29 Mar 2022
- Last updated
- 25 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wu L, Gu L, Fan W, Wei M, Dai T, Li X, Xiao L, Li B, Tian DS, Duan R, Li X, Xu Y, Meng H, Chen T, Gao F, Zhai F, Feng J, Yang H, Zhu R, Zhang CJ, Meng Q, Deng B, Meng Z, Qiu F, Zhou H, Qiu W, Zhang Q, Liu H, Wu Z, Wang Z, Meng L, Li Z, Zang W, Xiang F, Liang J, Liu S, Liu X, Chen J, Li F, Huang D; BeInmost Study Group. Obinutuzumab beta for aquaporin-4-positive neuromyelitis optica spectrum disorder: a phase 3 randomized controlled trial. Nat Med. 2026 Aug 10. doi: 10.1038/s41591-026-04583-4. Online ahead of print.
PubMed 42575985Wu L, Wei M, Gao F, Zhang H, Wang J, Xiang F, Gao S, Liu R, Yin J, Guo Y, Liu X, Liang J, Liu S, Li F, Huang D. Safety and Efficacy of Obinutuzumab beta (MIL62), a Novel Glycoengineered Type II Anti-CD20 Monoclonal Antibody, in Patients with Neuromyelitis Optica Spectrum Disorder: A Multicenter, Single-Arm, Phase Ib Clinical Trial. Neurol Ther. 2026 Aug;15(4):1845-1862. doi: 10.1007/s40120-026-00960-w. Epub 2026 May 24.
PubMed 42177718
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Phase Ib/III Study to Evaluate the Safety and Efficacy of MIL62 in Patients With Neuromyelitis Optica Spectrum Disorder (NMOSD)
- ClinicalTrials.gov ID
- NCT05314010
- Acronym / sponsor ID
- MIL62-CT303
- Conditions
- Neuromyelitis Optica Spectrum Disorder
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Beijing Mabworks Biotech Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 18 Aug 2022 (actual)
- Primary completion
- 21 Feb 2025 (actual)
- Study completion
- Mar 2027 (estimated)
- First posted
- 6 Apr 2022 (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 will evaluate the safety and efficacy of MIL62 in patients with Neuromyelitis Optica Spectrum Disorder.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MIL62 | Experimental | Drug: MIL62 |
| Placebo | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients who meet the diagnostic criteria for NMOSD established by the International Panel for NMO Diagnosis (IPND) in 2015 and are seropositive for AQP4-IgG.
- Male or female patients aged 18 to 70 years, inclusive of the endpoints..
- Expanded Disability Status Scale(EDSS) score ≤ 7.
- Phase Ib: At least 1 attack of NMOSD requiring rescue treatment within 2 years prior to screening. Phase III: At least 1 attack of NMOSD requiring rescue treatment within 1 year prior to screening; or at least 2 attacks of NMOSD requiring rescue treatment within 2 years prior to screening, including the first attack.
- Glucocorticoid treatment prior to screening is allowed, and within 14 days before the first administration, the dose should be ≤20 mg/day of prednisone or its equivalent dose of glucocorticoids.
Key exclusion criteria (5 listed)
- Subjects who have received Rituximab, Inebilizumab, Ozanimod, Telitacicept, or any B-cell depleting drugs within 6 months prior to the screening period are allowed to enroll if their CD19 or CD20 positive B-cell counts are above the lower limit of normal; or if their CD4 positive T-lymphocyte counts are < 200 cells/μL.
- Having used Tocilizumab, Satralizumab, Eculizumab, Efgartigimod, or other non-B-cell depleting biological agents with therapeutic effects on NMOSD, or mitoxantrone, or alkylating agents such as cyclophosphamide within 3 months prior to the first administration.
- Phase Ib: Subjects who have used immunosuppressants such as azathioprine, mycophenolate mofetil, tacrolimus, cyclosporine, methotrexate, and cyclophosphamide before the first administration are eligible for enrollment, provided that the interval since discontinuing the drugs exceeds 5 times their half-life. Phase III: Subjects who have used immunosuppressants other than glucocorticoids within 1 month prior to the first administration, including but not limited to azathioprine, mycophenolate mofetil, tacrolimus, cyclosporine, and methotrexate, are excluded (exclusion is not required if the continuous use duration is ≤7 days).
- Within 28 days prior to the first administration, plasma exchange (PE), moderate blood transfusion, or immunomodulatory drugs such as interferon β, interferon γ, or intravenous immunoglobulin (IVIG) have been used.
- Live vaccines or attenuated vaccines were administered within 28 days prior to the first dose.
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 |
|---|---|---|
| MIL62Phase 1b: Participants will receive intravenous (IV) infusions of MIL62 at doses of 500 mg or 1000 mg on Week (W) 1 Day (D) 1, W3D1, W25D1, W27D1, W53D1, W79D1, W105D1, W131D1, W157D1, W183D1, and W209D1. Participants initially assigned to the 500 mg dose group who exhibit good tolerance may be escalated to the 1000 mg dose starting from W25D1. Phase 3 (Randomised Controlled Period [RCP]): Participants will receive IV MIL62 1000 mg or placebo matched to MIL62 on W1D1, W3D1, W25D1, and W27D1. The administration protocol for placebo is identical to that of MIL62. Phase 3 (Open-Label Period [OLP]): Participants who enter the OLP will receive IV MIL62 1000 mg on W1D1, W27D1, W53D1, W79D1, W105D1, and W131D1, along with matching placebo on W3D1. | Drug | MIL62 |
| PlaceboPhase 3 (RCP): Participants will receive IV placebo matched to MIL62 on W1D1, W3D1, W25D1, and W27D1. Phase 3 (OLP): Participants entering the OLP will receive IV MIL62 1000 mg on W1D1, W3D1, W27D1, W53D1, W79D1, W105D1, and W131D1. | Other | Placebo |
Primary outcome
Phase 1b: The incidence and severity of all adverse events (AE)
Time frame: Up to Week 234
Phase 3: Time to First Adjudicated Relapse (TFR) during RCP.
Time frame: Up to 52 weeks
The time from the date of randomization to the date of the first clinical relapse as assessed by the Clinical Endpoint Committee(CEC). The criteria for NMOSD relapse are the occurrence of new objective neurological symptoms or worsening of objective neurological symptoms; meeting any one of the relapse criteria specified in the protocol is sufficient.
8 secondary outcomes
Time to first adjudicated relapse
Time frame: Up to Week 208
Annualized relapse rate
Time frame: Up to Week 208
Change from baseline of Expanded Disability Status Scale (EDSS) score
Time frame: Up to Week 208
Annualized cumulative active lesions rate on MRI
Time frame: Up to Week 208
Annualised NMOSD-related inpatient hospitalisation rate.
Time frame: Up to Week 208
Mean Change in T-score from Baseline in the EQ5D Scale.
Time frame: Up to Week 208
Percentage of Participants with Adverse Events (AEs).
Time frame: Up to Week 208
Peripheral B-cell Counts at Specified Timepoints.
Time frame: Up to Week 208
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 25 Sep 2025.
- Derived from this study: PubMed 42575985Wu L, Gu L, Fan W, Wei M, Dai T, Li X, Xiao L, Li B, Tian DS, Duan R, Li X, Xu Y, Meng H, Chen T, Gao F, Zhai F, Feng J, Yang H, Zhu R, Zhang CJ, Meng Q, Deng B, Meng Z, Qiu F, Zhou H, Qiu W, Zhang Q, Liu H, Wu Z, Wang Z, Meng L, Li Z, Zang W, Xiang F, Liang J, Liu S, Liu X, Chen J, Li F, Huang D; BeInmost Study Group. Obinutuzumab beta for aquaporin-4-positive neuromyelitis optica spectrum disorder: a phase 3 randomized controlled trial. Nat Med. 2026 Aug 10. doi: 10.1038/s41591-026-04583-4. Online ahead of print.
- Derived from this study: PubMed 42177718Wu L, Wei M, Gao F, Zhang H, Wang J, Xiang F, Gao S, Liu R, Yin J, Guo Y, Liu X, Liang J, Liu S, Li F, Huang D. Safety and Efficacy of Obinutuzumab beta (MIL62), a Novel Glycoengineered Type II Anti-CD20 Monoclonal Antibody, in Patients with Neuromyelitis Optica Spectrum Disorder: A Multicenter, Single-Arm, Phase Ib Clinical Trial. Neurol Ther. 2026 Aug;15(4):1845-1862. doi: 10.1007/s40120-026-00960-w. Epub 2026 May 24.
- 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 3 study testing MIL62 in people with Neuromyelitis Optica Spectrum Disorder, run by Beijing Mabworks Biotech Co., Ltd. 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 7 inclusion and 5 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 25 Sep 2025. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Phase 1b: The incidence and severity of all adverse events (AE) (time frame: Up to Week 234). The study lists 2 primary outcomes in all. 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 NCT05314010, which also lists 2 linked publications.
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 25 Sep 2025.