Neuromyelitis Optica Spectrum DisordersPhase 2NCT06697535
A Study to Evaluate the Efficacy and Safety of JYP0061 in Patients With Acute Neuromyelitis Spectrum Disease (NMOSD)
A Phase 2 study testing JYP0061, Intravenous Glucocorticoids and Oral Glucocorticoids in people with Neuromyelitis Optica Spectrum Disorders, run by Guangzhou JOYO Pharma Co., Ltd at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Neuromyelitis Optica Spectrum Disorders
- What is being tested?
- JYP0061, Intravenous Glucocorticoids and Oral Glucocorticoids
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteChina
- Study dates
- 24 May 2023to 30 Jul 2026
- Phase
- Phase 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Xiangya Hospital，Central South University
Changsha, Hunan, 410008
Huan Yang, M.D, Yangh69@126.com
About this study
Official title: 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
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.
Read the detailed description
This study will be an open-label, multicenter phase 2 clinical trial. After being informed about the study and potential risks, all subjects giving written informed consent will undergo a 2-week screening period to determine eligibility for study entry. And then subjects will be treated with low-dose JYP0061 in combination with reduced dose glucocorticoids or standard dose glucocorticoids. The efficacy and safety measures will be conducted according to the protocol. If JYP0061 is effective and safe for acute NMOSD patients, then subjects will be treated with high-dose JYP0061 or standard dose glucocorticoid. The efficacy and safety measures will be conducted according to the protocol.
- Conditions
- Neuromyelitis Optica Spectrum Disorders
- Being tested
- JYP0061, Intravenous Glucocorticoids, Oral Glucocorticoids
- Medical subject headings
- Neuromyelitis Optica
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JYP0061Drug
Also called Experimental Drug Group
Administered orally with a dose reduction over time as specified in Arm descriptions. Tablets are taken within a specific time frame after meals.
Intravenous GlucocorticoidsDrug
Also called Methylprednisolone
Administered intravenously with a gradually decreasing dose over time, as specified in the Standard Dose Glucocorticoids arm.
Oral GlucocorticoidsDrug
Also called Prednisone
Administered orally with a tapered dosing schedule, as specified in the Standard Dose Glucocorticoids arm, with adjustments based on participant response.
| Study group | Role | What they receive |
|---|---|---|
| Low-dose JYP0061 + Reduced Dose Glucocorticoids (Group A) | Experimental | Participants in this group will receive JYP0061, starting with a higher dose for the initial weeks, followed by a reduced maintenance dose. In addition, participants will receive a regimen of glucocorticoids, starting with intravenous administration and transitioning to oral dosing with a gradually tapering dose over time. Receives: Drug: JYP0061; Drug: Intravenous Glucocorticoids; Drug: Oral Glucocorticoids |
| Standard Dose Glucocorticoids (Groups B1 and B2) | Active comparator | Participants in this group will receive a standard glucocorticoid regimen, starting with intravenous glucocorticoids at higher doses, with doses tapering over time, and then transitioning to an oral glucocorticoid regimen that also tapers gradually. During the second phase, adjustments may be made based on the participant's clinical response. Receives: Drug: Intravenous Glucocorticoids; Drug: Oral Glucocorticoids |
| High-dose JYP0061 (Group C) | Experimental | Participants in this group will receive a higher dose of JYP0061 for the initial weeks, followed by a lower maintenance dose for the remainder of the study period. Receives: Drug: JYP0061 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants achieving clinical recovery based on EDSS after 6 weeks of treatment
This outcome assesses the clinical efficacy of JYP0061 in acute-phase NMOSD patients. The proportion of participants achieving various levels of recovery-Complete Recovery (CR), Good Recovery (GR), Moderate Recovery (MR), and Poor Recovery (PR)-will be evaluated based on the Expanded Disability Status Scale (EDSS) after 6 weeks of treatment.
Measured: 6 weeks after the first administration of the medication.
Secondary outcomes (2)
Maximum Plasma Concentration (Cmax) of JYP0061 in NMOSD Participants
This outcome measures the maximum plasma concentration (Cmax) of JYP0061 in participants with NMOSD, assessed at Weeks 2, 4, 6, 14, and 26 following administration.
Measured: Weeks 2, 4, 6, 14, and 26.
Apparent Clearance (CL/F) of JYP0061 in NMOSD Participants
This outcome measures the apparent clearance (CL/F) of JYP0061 in participants with NMOSD, assessed at Weeks 2, 4, 6, 14, and 26 following administration.
Measured: Weeks 2, 4, 6, 14, and 26.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2024
- Study start24 May 2023
- Primary completion28 Feb 2026 (estimated)
- Study completion30 Jul 2026 (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 DisordersStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangzhou JOYO Pharma Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06697535
- Sponsor's protocol ID
- JYP0061M202
- Status last verified
- Nov 2024
- First submitted
- 15 Nov 2024
- Last updated
- 20 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06697535
- Acronym / sponsor ID
- JYP0061M202
- Conditions
- Neuromyelitis Optica Spectrum Disorders
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Guangzhou JOYO Pharma Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 24 May 2023 (actual)
- Primary completion
- 28 Feb 2026 (estimated)
- Study completion
- 30 Jul 2026 (estimated)
- First posted
- 20 Nov 2024 (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.
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.
Detailed description
This study will be an open-label, multicenter phase 2 clinical trial. After being informed about the study and potential risks, all subjects giving written informed consent will undergo a 2-week screening period to determine eligibility for study entry. And then subjects will be treated with low-dose JYP0061 in combination with reduced dose glucocorticoids or standard dose glucocorticoids. The efficacy and safety measures will be conducted according to the protocol. If JYP0061 is effective and safe for acute NMOSD patients, then subjects will be treated with high-dose JYP0061 or standard dose glucocorticoid. The efficacy and safety measures will be conducted according to the protocol.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low-dose JYP0061 + Reduced Dose Glucocorticoids (Group A) | Experimental | Drug: JYP0061, Drug: Intravenous Glucocorticoids, Drug: Oral GlucocorticoidsParticipants in this group will receive JYP0061, starting with a higher dose for the initial weeks, followed by a reduced maintenance dose. In addition, participants will receive a regimen of glucocorticoids, starting with intravenous administration and transitioning to oral dosing with a gradually tapering dose over time. |
| Standard Dose Glucocorticoids (Groups B1 and B2) | Active comparator | Drug: Intravenous Glucocorticoids, Drug: Oral GlucocorticoidsParticipants in this group will receive a standard glucocorticoid regimen, starting with intravenous glucocorticoids at higher doses, with doses tapering over time, and then transitioning to an oral glucocorticoid regimen that also tapers gradually. During the second phase, adjustments may be made based on the participant's clinical response. |
| High-dose JYP0061 (Group C) | Experimental | Drug: JYP0061Participants in this group will receive a higher dose of JYP0061 for the initial weeks, followed by a lower maintenance dose for the remainder of the study period. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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;
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 |
|---|---|---|
| JYP0061Also: Experimental Drug GroupAdministered orally with a dose reduction over time as specified in Arm descriptions. Tablets are taken within a specific time frame after meals. | Drug | High-dose JYP0061 (Group C), Low-dose JYP0061 + Reduced Dose Glucocorticoids (Group A) |
| Intravenous GlucocorticoidsAlso: MethylprednisoloneAdministered intravenously with a gradually decreasing dose over time, as specified in the Standard Dose Glucocorticoids arm. | Drug | Low-dose JYP0061 + Reduced Dose Glucocorticoids (Group A), Standard Dose Glucocorticoids (Groups B1 and B2) |
| Oral GlucocorticoidsAlso: PrednisoneAdministered orally with a tapered dosing schedule, as specified in the Standard Dose Glucocorticoids arm, with adjustments based on participant response. | Drug | Low-dose JYP0061 + Reduced Dose Glucocorticoids (Group A), Standard Dose Glucocorticoids (Groups B1 and B2) |
Primary outcome
Proportion of participants achieving clinical recovery based on EDSS after 6 weeks of treatment
Time frame: 6 weeks after the first administration of the medication.
This outcome assesses the clinical efficacy of JYP0061 in acute-phase NMOSD patients. The proportion of participants achieving various levels of recovery-Complete Recovery (CR), Good Recovery (GR), Moderate Recovery (MR), and Poor Recovery (PR)-will be evaluated based on the Expanded Disability Status Scale (EDSS) after 6 weeks of treatment.
2 secondary outcomes
Maximum Plasma Concentration (Cmax) of JYP0061 in NMOSD Participants
Time frame: Weeks 2, 4, 6, 14, and 26.
Apparent Clearance (CL/F) of JYP0061 in NMOSD Participants
Time frame: Weeks 2, 4, 6, 14, and 26.
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 20 Nov 2024.
- Individual participant dataSharing planned: No
Related trials for Neuromyelitis Optica Spectrum Disorders
Not yet recruiting
Neurogenetics and Multi-omics of Neuroinflammatory Diseases in Multiplex Families to Improve Patients Health
Multiple Sclerosis, Neuromyelitis Optica Spectrum Disorder
Recruiting
Impact of a Structured Wellness Behavioral Intervention on Quality of Life in NMOSD
Neuromyelitis Optica Spectrum Disorder (NMOSD)
RecruitingObservational study
Observational Safety Study in Women With Neuromyelitis Optica Spectrum Disorder (NMOSD) Exposed to UPLIZNA® During Pregnancy
Neuromyelitis Optica Spectrum Disorder, Pregnancy Related
RecruitingPhase 2
Efgartigimod for the Treatment of Acute Optic Neuritis
Optic Neuritis
Active, not recruitingObservational study
Biobank For MS And Other Demyelinating Diseases
Multiple Sclerosis, Transverse Myelitis
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing JYP0061, Intravenous Glucocorticoids and Oral Glucocorticoids in people with Neuromyelitis Optica Spectrum Disorders, run by Guangzhou JOYO Pharma Co., Ltd at 1 site in China.
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 5 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 20 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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 phase mean?
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?
Contact Yang huan, M.D. (+86 731-84327919, yangh69@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants achieving clinical recovery based on EDSS after 6 weeks of treatment (time frame: 6 weeks after the first administration of the medication.). 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 20 Nov 2024.