Evaluating JYP0061 for treating acute Neuromyelitis Optica Spectrum Disorders
Efficacy and Safety of JYP0061 in Patients With Acute Neuromyelitis Spectrum Disease (NMOSD): a Multicenter, Randomized, Open-label, Positive-controlled, Two-stage Exploratory Phase 2 Trial
This study is testing a new treatment called JYP0061 to see if it can help people with acute Neuromyelitis Optica Spectrum Disorders feel better and stay safe while using it.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 35 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Guangzhou JOYO Pharma Co., Ltd Industry-sponsored |
| Locations | 1 site (Changsha, Hunan) |
| Trial ID | NCT06697535 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to assess the efficacy and safety of JYP0061 in patients diagnosed with acute Neuromyelitis Optica Spectrum Disorders (NMOSD). Participants will receive either low-dose JYP0061 in combination with reduced or standard doses of glucocorticoids, or high-dose JYP0061, depending on the initial treatment's effectiveness. The study will be conducted as an open-label, multicenter phase 2 trial, with a 2-week screening period to determine eligibility. Efficacy and safety evaluations will be systematically conducted throughout the trial according to the established protocol.
Who should consider this trial
Good fit: Ideal candidates for this study are patients with acute NMOSD who test positive for Aquaporin 4 immunoglobulin G.
Not a fit: Patients who are pregnant, lactating, or have a known allergy to the study drug components may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients suffering from acute NMOSD.
How similar studies have performed: While this approach is being evaluated in this trial, similar studies have shown promise in treating NMOSD with novel therapies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Neuromyelitis spectrum disease (NMOSD) patients according to 2015 International consensus diagnostic criteria. * Positive Aquaporin 4 immunoglobulin G (AQP4-IgG) * Patients with acute NMOSD * Female serum pregnancy test results were negative at the time of screening, subject (including partner) had no child-rearing plan and voluntarily adopted double contraceptive (non-oral contraceptives) within 6 months from screening to the last study drug administration, and had no sperm/egg donation plan; * Have fully understood this study, voluntarily participate in the experiment, and voluntarily sign the written informed consent. Exclusion Criteria: * Pregnant or lactating women; * Suspected or clear allergy to similar ingredients or any ingredient in the study drug, or allergic constitution; * Symptoms improved in the acute phase before the study drug was used; * Unable to complete MRI or gadolinium enhanced examination;
Where this trial is running
Changsha, Hunan
- Xiangya Hospital，Central South University — Changsha, Hunan, China (Recruiting)
Study contacts
- Study coordinator: Yang huan, M.D.
- Email: yangh69@126.com
- Phone: +86 731-84327919
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.