Neuromyelitis Optica Spectrum Disease (NMOSD)Phase 1/2RIPERT-NMOSDNCT07685678
Study on Efficacy Evaluation of Ripertamab in the Treatment of Neuromyelitis Optica Spectrum Disorders
A Phase 1/2 study testing Ripertamab in people with Neuromyelitis Optica Spectrum Disease (NMOSD) and Ripertamab, run by Zhongming Qiu.
Trial summary
This clinical trial aims to evaluate the safety and efficacy of ripertamab in patients with neuromyelitis optica spectrum disorders (NMOSD). The key research objectives are as follows: 1. To assess the efficacy of ripertamab for the treatment of neuromyelitis optica spectrum disorders. 2. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Neuromyelitis Optica Spectrum Disease (NMOSD), Ripertamab
- What is being tested?
- Ripertamab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 30 Sep 2026to 30 Jun 2030
- Phase
- Phase 1/2
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 and ≤ 75 years at screening.
- Definite diagnosis of NMOSD.
- Expanded Disability Status Scale (EDSS) score ≤ 7.0.
- At least 1 NMOSD relapse requiring rescue treatment within 1 year prior to screening; or at least 2 NMOSD relapses requiring rescue treatment within 2 years prior to screening (including the initial episode).
- Voluntarily sign the informed consent form.
- Female patients of childbearing potential must have a negative pregnancy test (serum β-HCG). Effective contraception shall be used during the study period and for 6 months after treatment discontinuation.
Who cannot join
- Any condition that, in the investigator's opinion, may interfere with the evaluation or administration of the study drug, assessment of patient safety, or interpretation of study results.
- Presence of any uncontrolled active infection or severe infection within 8 weeks prior to the screening period.
- Treatment with rituximab or any B-cell depleting agents within 6 months before screening (subjects with CD19+ or CD20+ B-cell counts above the lower limit of normal are eligible for enrollment).
- Use of tocilizumab, eculizumab, mitoxantrone, or alkylating agents such as cyclophosphamide within 3 months prior to the first dose administration.
- Use of immunosuppressants other than glucocorticoids within 1 month prior to the first dose administration, including but not limited to azathioprine, mycophenolate mofetil, tacrolimus, cyclosporine, methotrexate.
- Receipt of plasma exchange (PE), moderate-volume blood transfusion, or immunomodulatory agents such as interferon beta, interferon gamma, or intravenous immunoglobulin (IVIG) within 1 month prior to the first dose administration.
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- Coexisting other chronic active immune system diseases requiring treatment with glucocorticoids, biologics or immunosuppressants (e.g., rheumatoid arthritis, scleroderma).
- Vaccination with live or attenuated vaccines within 1 month prior to the first dose administration.
- Prior history of bone marrow transplantation, hematopoietic stem cell transplantation, total lymphoid irradiation, or T-cell vaccine therapy.
- Participation in any clinical trial with investigational products within 28 days prior to the first dose or within 5 half-lives of the investigational product, whichever is shorter.
- Positive hepatitis B surface antigen (HBsAg) and/or hepatitis B core antibody (HBcAb) with HBV DNA exceeding the upper limit of normal; positive hepatitis C virus (HCV) antibody with HCV RNA exceeding the upper limit of normal; positive human immunodeficiency virus (HIV) serology; positive treponema pallidum antibody (TP-Ab).
- Known hypersensitivity to any component of Ripertamab.
- History of malignant tumors including malignant thymoma, myeloproliferative or lymphoproliferative disorders, unless the disease is considered cured with adequate treatment and there is no evidence of relapse for ≥3 years before screening. Patients with completely resected non-melanoma skin cancer (e.g., basal cell carcinoma or squamous cell carcinoma) or carcinoma in situ of the cervix are allowed to be enrolled at any time.
- Patients with clinical evidence of other serious major illnesses or those who have recently undergone major surgery, which may confound trial results or expose patients to undue risks. This includes patients with severe renal or hepatic impairment.
- For male subjects without sterilization: refusal to use barrier contraception from screening until 6 months after the end of treatment, and refusal to ask their partners to adopt alternative contraceptive measures including oral contraceptives, intrauterine devices, barrier methods or spermicides.
About this study
This clinical trial aims to evaluate the safety and efficacy of ripertamab in patients with neuromyelitis optica spectrum disorders (NMOSD). The key research objectives are as follows:
- To assess the efficacy of ripertamab for the treatment of neuromyelitis optica spectrum disorders.
- To assess the safety of ripertamab for the treatment of neuromyelitis optica spectrum disorders.
Read more
Study participants are required to:
Receive a single intravenous infusion of ripertamab. Attend follow-up examinations and laboratory tests at the study site at Week 1, Week 9, Week 17, Week 25, Week 33, Week 41, Week 49, Week 57, Week 65, Week 73, Week 81, Week 89, Week 97.
Maintain a daily symptom diary and record the number of rescue treatments.
- Being tested
- Ripertamab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RipertamabDrug
Administer Ripertamab Injection 500 mg intravenously on W1D1, W25D1, W49D1 and W73D1 of the treatment period
| Study group | Role | What they receive |
|---|---|---|
| Arm/Group | Experimental | Treatment group Receives: Drug: Ripertamab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Within 49 weeks, the relapse criterion for NMOSD is new-onset objective neurological symptoms or deterioration of existing objective neurological symptoms.
Measured: Within 49 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2026
- Study start30 Sep 2026 (estimated)
- Primary completion1 Jan 2030 (estimated)
- Study completion30 Jun 2030 (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 Disease (NMOSD)Studies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhongming Qiu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zhongming Qiu, Xinqiao Hospital of Chongqing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07685678
- Sponsor's protocol ID
- 2026-120
- Acronym
- RIPERT-NMOSD
- Status last verified
- May 2026
- First submitted
- 29 Jun 2026
- Last updated
- 21 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on Efficacy Evaluation of Ripertamab in the Treatment of Neuromyelitis Optica Spectrum Disorders
- ClinicalTrials.gov ID
- NCT07685678
- Acronym / sponsor ID
- RIPERT-NMOSD / 2026-120
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Zhongming QiuUniversity, hospital or other
- Study start
- 30 Sep 2026 (estimated)
- Primary completion
- 1 Jan 2030 (estimated)
- Study completion
- 30 Jun 2030 (estimated)
- First posted
- 6 Jul 2026 (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 clinical trial aims to evaluate the safety and efficacy of ripertamab in patients with neuromyelitis optica spectrum disorders (NMOSD). The key research objectives are as follows:
- To assess the efficacy of ripertamab for the treatment of neuromyelitis optica spectrum disorders.
- To assess the safety of ripertamab for the treatment of neuromyelitis optica spectrum disorders.
Study participants are required to:
Receive a single intravenous infusion of ripertamab. Attend follow-up examinations and laboratory tests at the study site at Week 1, Week 9, Week 17, Week 25, Week 33, Week 41, Week 49, Week 57, Week 65, Week 73, Week 81, Week 89, Week 97.
Maintain a daily symptom diary and record the number of rescue treatments.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm/Group | Experimental | Drug: RipertamabTreatment group |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥ 18 and ≤ 75 years at screening.
- Definite diagnosis of NMOSD.
- Expanded Disability Status Scale (EDSS) score ≤ 7.0.
- At least 1 NMOSD relapse requiring rescue treatment within 1 year prior to screening; or at least 2 NMOSD relapses requiring rescue treatment within 2 years prior to screening (including the initial episode).
- Voluntarily sign the informed consent form.
Key exclusion criteria (15 listed)
- Any condition that, in the investigator's opinion, may interfere with the evaluation or administration of the study drug, assessment of patient safety, or interpretation of study results.
- Presence of any uncontrolled active infection or severe infection within 8 weeks prior to the screening period.
- Treatment with rituximab or any B-cell depleting agents within 6 months before screening (subjects with CD19+ or CD20+ B-cell counts above the lower limit of normal are eligible for enrollment).
- Use of tocilizumab, eculizumab, mitoxantrone, or alkylating agents such as cyclophosphamide within 3 months prior to the first dose administration.
- Use of immunosuppressants other than glucocorticoids within 1 month prior to the first dose administration, including but not limited to azathioprine, mycophenolate mofetil, tacrolimus, cyclosporine, methotrexate.
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 |
|---|---|---|
| RipertamabAdminister Ripertamab Injection 500 mg intravenously on W1D1, W25D1, W49D1 and W73D1 of the treatment period | Drug | Arm/Group |
Primary outcome
Within 49 weeks, the relapse criterion for NMOSD is new-onset objective neurological symptoms or deterioration of existing objective neurological symptoms.
Time frame: Within 49 weeks
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 21 Sep 2026.
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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.
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 1/2 study testing Ripertamab in people with Neuromyelitis Optica Spectrum Disease (NMOSD) and Ripertamab, run by Zhongming Qiu.
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 15 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: opening soon, as of the sponsor's last update on 21 Sep 2026. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Within 49 weeks, the relapse criterion for NMOSD is new-onset objective neurological symptoms or deterioration of existing objective neurological symptoms. (time frame: Within 49 weeks). 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 21 Sep 2026.