NCT06697535 A Study to Evaluate the Efficacy and Safety of JYP0061 in Patients With Acute Neuromyelitis Spectrum Disease (NMOSD)
| NCT ID | NCT06697535 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Guangzhou JOYO Pharma Co., Ltd |
| Condition | Neuromyelitis Optica Spectrum Disorders |
| Study Type | INTERVENTIONAL |
| Enrollment | 35 participants |
| Start Date | 2023-05-24 |
| Primary Completion | 2026-02-28 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 35 participants in total. It began in 2023-05-24 with a primary completion date of 2026-02-28.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this clinical trial is to evaluate the efficacy and safety, of JYP0061 in acute NMOSD patients. The main questions it aims to answer are: efficacy and safety of JYP0061 in acute NMOSD patients. Participants will be treated with low-dose JYP0061 in combination with reduced dose glucocorticoids or standard dose glucocorticoids or high-dose JYP0061. Efficacy and safety evaluations will be conducted according to the protocol.
Eligibility 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;
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06697535 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Neuromyelitis Optica Spectrum Disorders. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06697535 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06697535 currently recruiting?
Yes, NCT06697535 is actively recruiting participants. Contact the research team at yangh69@126.com for enrollment information.
Where is the NCT06697535 trial being conducted?
This trial is being conducted at Changsha, China.
Who is sponsoring the NCT06697535 clinical trial?
NCT06697535 is sponsored by Guangzhou JOYO Pharma Co., Ltd. The trial plans to enroll 35 participants.