Evaluating Eculizumab for Neuromyelitis Optica Spectrum Disorders in Chinese Adults
An Open-label, Single-arm, Multi-Center, Interventional Study to Evaluate the Efficacy, Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Eculizumab in Chinese Adult Participants With Anti-Aquaporin-4 Antibody Positive Neuromyelitis Optica Spectrum Disorders (NMOSD)
This study is testing if the drug Eculizumab can help Chinese adults with Neuromyelitis Optica Spectrum Disorders feel better and stay safe after having at least one attack in the past year.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 21 (estimated) |
| Ages | 18 Years to 130 Years |
| Sex | All |
| Sponsor | Alexion Pharmaceuticals, Inc. Industry-sponsored |
| Drugs / interventions | rituximab, inebilizumab, satralizumab, prednisone, Eculizumab |
| Locations | 10 sites (Beijing and 9 other locations) |
| Trial ID | NCT06724809 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the efficacy, safety, pharmacokinetics, pharmacodynamics, and immunogenicity of Eculizumab in Chinese adults diagnosed with Neuromyelitis Optica Spectrum Disorders (NMOSD). Participants must have a confirmed diagnosis of NMOSD and be anti-AQP4 antibody positive, with a history of at least one attack in the past year. The study will involve administering Eculizumab and monitoring its effects over time. The research is being conducted at multiple sites in China.
Who should consider this trial
Good fit: Ideal candidates include Chinese adults diagnosed with NMOSD who are anti-AQP4 antibody positive and have experienced at least one relapse in the past year.
Not a fit: Patients who do not have NMOSD or are not anti-AQP4 antibody positive may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new effective treatment option for patients suffering from NMOSD.
How similar studies have performed: Previous studies have shown promising results with Eculizumab in treating NMOSD, indicating a potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria:
* Participants with diagnosis of NMOSD as defined by the 2015 international consensus diagnostic criteria
* Anti-AQP4 antibody positive
* At least 1 attack or relapse in the last 12 months prior to the Screening Period
* EDSS score ≤ 7
* If a participant enters the study receiving IST(s) for relapse prevention, the participant must be on a stable maintenance dose of IST(s) as follows, prior to screening and must remain on that dose for the duration of the study, unless the participant experiences a relapse
* Female participants of childbearing potential must have a negative pregnancy test (serum HCG at screening
* Male participants are eligible to participate if they agree to the following during the study intervention Treatment Period and for at least 5 months after the last dose of study intervention:
* Refrain from donating fresh unwashed semen. PLUS, either,
* Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent. OR
* Must agree to use barrier as detailed below:
* Agree to use a male condom when having sexual intercourse with a WOCBP who is not currently pregnant.
Exclusion Criteria:
* Pregnant, breastfeeding, or intending to conceive during the course of the study
* Prior history of N meningitidis infection or unresolved meningococcal disease
* Any systemic bacterial or other infection which is clinically significant in the opinion of the Investigator and has not been treated with appropriate antibiotics
* Presence of fever ≥ 38 C within 7 days prior to study intervention administration on Day 1
* Hypersensitivity to murine proteins or to one of the excipients of study intervention
* Use of rituximab, inebilizumab, or other B cell-depleting therapy within 6 months prior to Day 1 and during the study
* Use of mitoxantrone or satralizumab within 3 months prior to screening and during the study
* Use of IVIg within 3 weeks prior to screening
* If a participant enters the study receiving oral corticosteroid(s) with or without other ISTs, the daily corticosteroid dose must be no more than prednisone 20 mg/day (or equivalent) prior to screening and the participant must remain on that dose for the duration of the study or until the participant experiences a relapse (specific medications listed in Section 6.9.1 may be allowed)
* Has previously received treatment with C5 inhibitors
* Participation in any other investigational drug study or exposure to an investigational drug or device within 5 half-lives of treatment (if known) or 30 days, which is longer, before the first dose administration
Where this trial is running
Beijing and 9 other locations
- Research Site — Beijing, China (Recruiting)
- Research Site — Dongguan, China (Recruiting)
- Research Site — Jinan, China (Recruiting)
- Research Site — Shanghai, China (Recruiting)
- Research Site — Shenyang, China (Not_yet_recruiting)
- Research Site — Taiyuan, China (Recruiting)
- Research Site — Wenzhou City, China (Recruiting)
- Research Site — Wuhan, China (Recruiting)
- Research Site — Wuhan, China (Recruiting)
- Research Site — Zhengzhou, China (Not_yet_recruiting)
Study contacts
- Principal investigator: Xiangjun Chen, M.D — Huashan Hospital
- Study coordinator: Alexion Pharmaceuticals, Inc. (Sponsor)
- Email: clinicaltrials@alexion.com
- Phone: 1-855-752-2356
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.