NCT06697535RecruitingPhase 2
A Study to Evaluate the Efficacy and Safety of JYP0061 in Patients With Acute Neuromyelitis Spectrum Disease (NMOSD)
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
Source: ClinicalTrials.gov · Last updated 20 Nov 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 35 (estimated)
- First submitted
- 15 Nov 2024
- Start date
- 24 May 2023
- Primary completion date
- 28 Feb 2026
- Lead sponsor
- Guangzhou JOYO Pharma Co., Ltd
- Diseases
- Neuromyelitis optica (NMOSD)
- NCT number
- NCT06697535
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 35
- From 24 May 2023 to the primary completion date, 28 Feb 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Symptoms improved in the acute phase before the study drug was used;
Other illness
- Suspected or clear allergy to similar ingredients or any ingredient in the study drug, or allergic constitution;
Other
- Pregnant or lactating women;
- Unable to complete MRI or gadolinium enhanced examination;
Who the study is looking for
- 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.
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Xiangya Hospital Central South University Coordinator of this site? Confirm its status | Changsha | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.