Neuromyelitis Optica Spectrum DisordersPhase 4NCT06212245
A Clinical Research Study of Inebilizumab in Neuromyelitis Optica Spectrum Disorders
A Phase 4 study testing Inebilizumab in people with Neuromyelitis Optica Spectrum Disorders, run by Hansoh BioMedical R&D Company at 1 site in China.
Trial summary
To assess the efficacy and safety of Inebilizumab in Chinese adult patients with 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 Disorders
- What is being tested?
- Inebilizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteChina
- Study dates
- 25 Feb 2024to 25 Jun 2025
- Phase
- Phase 4
- 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
Who may be able to join
- Patients who have comprehensive understanding of the study content, process and possible adverse reactions, and sign the informed consent forms voluntarily
- Men and women 18 years or older
- Patients with NMOSD diagnosed according to the definition in the Guidelines for the Diagnosis and Treatment of Neuromyelitis Optica Spectrum Disorders in China
- Patients with positive serum anti-AQP4-IgG results at screening
- A documented history of one or more NMOSD acute relapses that required rescue therapy within the last year, or 2 or more NMOSD acute relapses that required rescue therapy within 2 years prior to screening
- Patients with EDSS score of ≤ 7.5 points
- Patients who and whose sexual partner agree to take highly effective method of contraception from screening
Who cannot join
- Patients who have received any of the following treatments at any time prior to randomization:
- Monoclonal antibodies against CD52: such as alemtuzumab, etc.
- Total lymphoid irradiation
- Bone marrow transplant
- T-cell vaccination therapy
- Receipt of rituximab or other B-cell depleting agents (e.g., Belimumab, Telitacicept) within 6 months prior to screening, unless the patient has B-cell counts above the LLN according to the central laboratory;
Show all 19Show fewer
- Receipt of rituximab or other B-cell depleting agents (e.g., Belimumab, Telitacicept) within 6 months prior to screening, unless the patient has B-cell counts above the LLN according to the central laboratory;
- Patients who have received intravenous injection of immunoglobulin (IVIG) within 1 month prior to randomization;
- Patients who have received immunosuppressant therapy (e.g., cyclophosphamide, methotrexate, mitoxantrone, ciclosporin A, etc.) and biologics (satralizumab, natalizumab, tocilizumab, eculizumab, etc.) within 3 months or 5 half-lives of such drugs (whichever is longer) before randomization;
- Any concomitant disease other than NMOSD that required treatment with oral or IV steroids at doses > 20 mg/day for > 21 days within the 6 months prior to screening;
- Concurrent/previous enrollment in another clinical study involving an investigational treatment within 4 weeks or 5 published half-lives of the investigational treatment, whichever is the longer, prior to enrollment;
- Severe drug allergic history or anaphylaxis to two or more food products or medicine (including known sensitivity to acetaminophen/paracetamol, diphenhydramine or equivalent antihistamine, and methylprednisolone or equivalent glucocorticoid); Known history of allergy or reaction to any component of the investigational product formulation or history of anaphylaxis following any biologic therapy;
- Patients with evidence of alcohol, drug, or chemical abuse, or with history of such abuse within 1 year prior to randomization;
- Female patients who are lactating or pregnant, or plan to become pregnant at any time from signing the informed consent through the study plus 6 months following last dose of investigational product;
- Patients with clinically significant serious active or chronic viral infection, or bacterial infection within 60 days prior to randomization, which requires treatment with anti-infective agents or hospitalization, or might pose an additional risk to the patient in the opinion of the investigator;
- Patients with known history or underlying disease of primary immunodeficiency (congenital or acquired), such as human immunodeficiency virus (HIV) infection or splenectomy, which predisposes the patient to infection;
- Confirmed positive serology results of hepatitis B/C at screening
- Patients with history of malignancy, except squamous or basal cell carcinoma of skin that has been successfully treated with documented success of curative therapy > 3 months prior to randomization;
- Any other conditions that, in the opinion of the investigator, are not suitable for participating in the clinical study.
Trial locations and contacts
1 site in 1 country.
China1 site
IRB of Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality, 100000
Lingling Xu, 010-59975692, ttyyirb@163.com
About this study
Official title: An Open-label Single-arm Clinical Study to Assess the Efficacy and Safety of Inebilizumab in Chinese Adult Patients With Neuromyelitis Optica Spectrum Disorders (NMOSD)
To assess the efficacy and safety of Inebilizumab in Chinese adult patients with neuromyelitis optica spectrum disorders.
- Conditions
- Neuromyelitis Optica Spectrum Disorders
- Being tested
- Inebilizumab
- 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
Participants will receive IV inebilizumab 300 mg
| Study group | Role | What they receive |
|---|---|---|
| Inebilizumab | Experimental | Participants will receive IV inebilizumab 300 mg Receives: Drug: Inebilizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants with NMOSD attack determined by the investigator
The NMOSD attack is defined as the presence of new or worsening symptom(s) related to NMOSD that meet at least one of the 18 protocol-defined attack criteria. These criteria were developed in conjunction with a panel of disease experts and with Food and Drug Administration input, and were intended to be clinically meaningful, objective, quantifiable, and able to be used worldwide.
Measured: Day 1 (Baseline) through Day 197
Secondary outcomes (4)
Percentage of participants with NMOSD attack determined by the investigator
The NMOSD attack is defined as the presence of new or worsening symptom(s) related to NMOSD that meet at least one of the 18 protocol-defined attack criteria. These criteria were developed in conjunction with a panel of disease experts and with Food and Drug Administration input, and were intended to be clinically meaningful, objective, quantifiable, and able to be used worldwide.
Measured: Day 1 (Baseline) through Day 379
Percentage of Participants With Worsening in Expanded Disability Severity Scale (EDSS) Score
TEDSS and its associated functional system (FS) score provide a system for quantifying disability and monitoring changes in the level of disability over time. EDSS is a scale for assessing neurologic impairment in multiple sclerosis (MS). It 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 indicates improvement. A participant was considered to have a worsening in overall EDSS score of at least 2 if baseline EDSS score was 0, or at least 1 point if baseline EDSS score is 1 to 5, or at least 0.5 point if baseline EDSS score is 5.5 or more.were measured by MRI of the brain, optic nerve, and spinal cord.
Measured: Day 1 (Baseline) through Day 379
Cumulative Number of Active Magnetic Resonance Imaging (MRI) Lesions
The number of new gadolinium-enhancing lesions and new or enlarging T2 lesions were measured by MRI of the brain, optic nerve, and spinal cord.
Measured: Day 1 (Baseline) through Day 379
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)Laboratory measurements as well as their changes or shift as assessed by CTCAE v5.0
An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse event is any AE that resulted in death, life threatening, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, is a congenital anomaly/birth defect in offspring of a study participant, is an important medical event that may jeopardize the participant or may require medical intervention.
Measured: Day 1 (Baseline) through Day 379
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2024
- Study start25 Feb 2024 (estimated)
- Primary completion25 Dec 2024 (estimated)
- Study completion25 Jun 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 DisordersStudies of the same condition, open and under way.
- More trials run by Hansoh BioMedical R&D CompanyThe 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hansoh BioMedical R&D Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Horizon Therapeutics Ireland DAC
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06212245
- Sponsor's protocol ID
- HS-20091-401
- Status last verified
- Jan 2024
- First submitted
- 15 Dec 2023
- Last updated
- 18 Jan 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 18 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label Single-arm Clinical Study to Assess the Efficacy and Safety of Inebilizumab in Chinese Adult Patients With Neuromyelitis Optica Spectrum Disorders (NMOSD)
- ClinicalTrials.gov ID
- NCT06212245
- Acronym / sponsor ID
- HS-20091-401
- Conditions
- Neuromyelitis Optica Spectrum Disorders
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 33 participants (estimated)
- Lead sponsor
- Hansoh BioMedical R&D CompanyIndustry (pharma, biotech, devices)
- Collaborators
- Horizon Therapeutics Ireland DAC
- Study start
- 25 Feb 2024 (estimated)
- Primary completion
- 25 Dec 2024 (estimated)
- Study completion
- 25 Jun 2025 (estimated)
- First posted
- 18 Jan 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.
To assess the efficacy and safety of Inebilizumab in Chinese adult patients with neuromyelitis optica spectrum disorders.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Inebilizumab | Experimental | Drug: InebilizumabParticipants will receive IV inebilizumab 300 mg |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients who have comprehensive understanding of the study content, process and possible adverse reactions, and sign the informed consent forms voluntarily
- Men and women 18 years or older
- Patients with NMOSD diagnosed according to the definition in the Guidelines for the Diagnosis and Treatment of Neuromyelitis Optica Spectrum Disorders in China
- Patients with positive serum anti-AQP4-IgG results at screening
- A documented history of one or more NMOSD acute relapses that required rescue therapy within the last year, or 2 or more NMOSD acute relapses that required rescue therapy within 2 years prior to screening
Key exclusion criteria (19 listed)
- Patients who have received any of the following treatments at any time prior to randomization:
- Receipt of rituximab or other B-cell depleting agents (e.g., Belimumab, Telitacicept) within 6 months prior to screening, unless the patient has B-cell counts above the LLN according to the central laboratory;
- Receipt of rituximab or other B-cell depleting agents (e.g., Belimumab, Telitacicept) within 6 months prior to screening, unless the patient has B-cell counts above the LLN according to the central laboratory;
- Patients who have received intravenous injection of immunoglobulin (IVIG) within 1 month prior to randomization;
- Patients who have received immunosuppressant therapy (e.g., cyclophosphamide, methotrexate, mitoxantrone, ciclosporin A, etc.) and biologics (satralizumab, natalizumab, tocilizumab, eculizumab, etc.) within 3 months or 5 half-lives of such drugs (whichever is longer) before randomization;
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 |
|---|---|---|
| InebilizumabParticipants will receive IV inebilizumab 300 mg | Drug | Inebilizumab |
Primary outcome
Percentage of participants with NMOSD attack determined by the investigator
Time frame: Day 1 (Baseline) through Day 197
The NMOSD attack is defined as the presence of new or worsening symptom(s) related to NMOSD that meet at least one of the 18 protocol-defined attack criteria. These criteria were developed in conjunction with a panel of disease experts and with Food and Drug Administration input, and were intended to be clinically meaningful, objective, quantifiable, and able to be used worldwide.
4 secondary outcomes
Percentage of participants with NMOSD attack determined by the investigator
Time frame: Day 1 (Baseline) through Day 379
Percentage of Participants With Worsening in Expanded Disability Severity Scale (EDSS) Score
Time frame: Day 1 (Baseline) through Day 379
Cumulative Number of Active Magnetic Resonance Imaging (MRI) Lesions
Time frame: Day 1 (Baseline) through Day 379
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)Laboratory measurements as well as their changes or shift as assessed by CTCAE v5.0
Time frame: Day 1 (Baseline) through Day 379
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 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.
IRB of Beijing Tiantan Hospital, Capital Medical University
Beijing, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Inebilizumab in people with Neuromyelitis Optica Spectrum Disorders, run by Hansoh BioMedical R&D Company 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 19 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 18 Jan 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of participants with NMOSD attack determined by the investigator (time frame: Day 1 (Baseline) through Day 197). 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 18 Jan 2024.