Neuromyelitis Optica Spectrum Disorder (NMOSD)Phase 1/2NCT06557174
A Study to Evaluate IMC-002 in Neuromyelitis Optica Spectrum Disorder (NMOSD) Patients
A Phase 1/2 study testing IMC-002 and mycophenolate mofetil， MMF in people with Neuromyelitis Optica Spectrum Disorder (NMOSD), run by ImmuneCare Biopharmaceuticals (Shanghai) Co., Ltd..
Trial summary
The purpose of this study is to evaluate the efficacy and safety of IMC-002 in the treatment of NMOSD. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Neuromyelitis Optica Spectrum Disorder (NMOSD)
- What is being tested?
- IMC-002 and mycophenolate mofetil， MMF
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- No sites listed yet
- Study dates
- 10 Oct 2024to 10 Jul 2026
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 to 70 years, inclusive, at the time of informed consent
- Have a diagnosis of AQP4 antibody seropositive NMOSD according to the International Panel for NMO Diagnosis (IPND) criteria
- Confirmation of NMOSD diagnosis with AQP4+ antibodies
- The EDSS score should be ≤7.0
- Have clinical evidence of at least 1 documented attack or relapse (including first attack) in the last 2 years prior to screening
Who cannot join
- Have received rituximab or other anti-CD20 drugs treatment within 6 months
- Have been used any monoclonal antibodies or research drugs for immunomodulatory effects within 3 months or within 5 half-life periods of the drug.
- Females who are pregnant or lactating.
- Have active infection at screening, or recent serious infection (i.e., requiring intravenous antimicrobial therapy or hospitalization) ; history of or existing infection of human immunodeficiency virus(HIV), hepatitis C virus (HCV), or Mycobacterium tuberculosis. Patients must have negative test results for HCV antibody, HIV 1 and HIV 2 antibodies, and a mycobacterium tuberculosis test (test method to be determined).
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Phase Ib/III Multi-center, Randomized and Positive Control Study to Evaluate IMC-002 Safety and Efficacy in in Neuromyelitis Optica Spectrum Disorder (NMOSD) Patients
The purpose of this study is to evaluate the efficacy and safety of IMC-002 in the treatment of NMOSD.
Read the detailed description
This is a phase Ib/III study, including 2 stage, phase Ib study to find the dose for phase II study between 0.8mg/kg、1.2mg/kg dose level, Phase III study is a multi-center, randomized, double-blind, positive control study to evaluate the safety and efficacy of IMC-002 in Neuromyelitis Optica Spectrum Disorder (NMOSD)
- Being tested
- IMC-002, mycophenolate mofetil， MMF
- Medical subject headings
- Neuromyelitis Optica
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IMC-002Drug
intravenous injection: Weekly administered for a period of first 4 weeks, then rest for 20 weeks. After the administration of the testing drug, if the subject's symptoms get worsen, a rescue therapy need to be adopted as based on Investigator's judgement, the testing drug injection should be discontinued.
mycophenolate mofetil， MMFDrug
daily oral 0.2g
| Study group | Role | What they receive |
|---|---|---|
| IMC-002 | Experimental | intravenous injection of 0.8mg/kg、1.2mg/kg Receives: Drug: IMC-002 |
| mycophenolate mofetil， MMF | Active comparator | mycophenolate mofetil will be administrated as monotherapy control for 0.2g daily oral. Receives: Drug: mycophenolate mofetil， MMF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of relapse-free patients
Measured: Up to Week 24
Secondary outcomes (2)
Time to first relapse (TFR)
Measured: Up to Week 24
Mean change from baseline in Expanded Disability Status Scale (EDSS) score over the course of the study
The Expanded Disability Status Scale ranges from 0 to 10 in 0.5 unit increments. Higher results represent higher levels of disability
Measured: Baseline (Day -28 to Day -1) to Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2024
- Study start10 Oct 2024 (estimated)
- Primary completion10 Nov 2025 (estimated)
- Study completion10 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 Disorder (NMOSD)Studies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 116 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ImmuneCare Biopharmaceuticals (Shanghai) Co., Ltd.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06557174
- Sponsor's protocol ID
- IMC002-N-01
- Status last verified
- Aug 2024
- First submitted
- 11 Aug 2024
- Last updated
- 16 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib/III Multi-center, Randomized and Positive Control Study to Evaluate IMC-002 Safety and Efficacy in in Neuromyelitis Optica Spectrum Disorder (NMOSD) Patients
- ClinicalTrials.gov ID
- NCT06557174
- Acronym / sponsor ID
- IMC002-N-01
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 116 participants (estimated)
- Lead sponsor
- ImmuneCare Biopharmaceuticals (Shanghai) Co., Ltd.University, hospital or other
- Study start
- 10 Oct 2024 (estimated)
- Primary completion
- 10 Nov 2025 (estimated)
- Study completion
- 10 Jul 2026 (estimated)
- First posted
- 16 Aug 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 purpose of this study is to evaluate the efficacy and safety of IMC-002 in the treatment of NMOSD.
Detailed description
This is a phase Ib/III study, including 2 stage, phase Ib study to find the dose for phase II study between 0.8mg/kg、1.2mg/kg dose level, Phase III study is a multi-center, randomized, double-blind, positive control study to evaluate the safety and efficacy of IMC-002 in Neuromyelitis Optica Spectrum Disorder (NMOSD)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IMC-002 | Experimental | Drug: IMC-002intravenous injection of 0.8mg/kg、1.2mg/kg |
| mycophenolate mofetil， MMF | Active comparator | Drug: mycophenolate mofetil， MMFmycophenolate mofetil will be administrated as monotherapy control for 0.2g daily oral. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18 to 70 years, inclusive, at the time of informed consent
- Have a diagnosis of AQP4 antibody seropositive NMOSD according to the International Panel for NMO Diagnosis (IPND) criteria
- Confirmation of NMOSD diagnosis with AQP4+ antibodies
- The EDSS score should be ≤7.0
- Have clinical evidence of at least 1 documented attack or relapse (including first attack) in the last 2 years prior to screening
Key exclusion criteria (4 listed)
- Have received rituximab or other anti-CD20 drugs treatment within 6 months
- Have been used any monoclonal antibodies or research drugs for immunomodulatory effects within 3 months or within 5 half-life periods of the drug.
- Females who are pregnant or lactating.
- Have active infection at screening, or recent serious infection (i.e., requiring intravenous antimicrobial therapy or hospitalization) ; history of or existing infection of human immunodeficiency virus(HIV), hepatitis C virus (HCV), or Mycobacterium tuberculosis. Patients must have negative test results for HCV antibody, HIV 1 and HIV 2 antibodies, and a mycobacterium tuberculosis test (test method to be determined).
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 |
|---|---|---|
| IMC-002intravenous injection: Weekly administered for a period of first 4 weeks, then rest for 20 weeks. After the administration of the testing drug, if the subject's symptoms get worsen, a rescue therapy need to be adopted as based on Investigator's judgement, the testing drug injection should be discontinued. | Drug | IMC-002 |
| mycophenolate mofetil， MMFdaily oral 0.2g | Drug | mycophenolate mofetil， MMF |
Primary outcome
Proportion of relapse-free patients
Time frame: Up to Week 24
2 secondary outcomes
Time to first relapse (TFR)
Time frame: Up to Week 24
Mean change from baseline in Expanded Disability Status Scale (EDSS) score over the course of the study
Time frame: Baseline (Day -28 to Day -1) to Week 24
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2024.
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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. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing IMC-002 and mycophenolate mofetil， MMF in people with Neuromyelitis Optica Spectrum Disorder (NMOSD), run by ImmuneCare Biopharmaceuticals (Shanghai) Co., Ltd..
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: status not confirmed, as of the sponsor's last update on 16 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact jinhua zhou (02138016387, jinhua.zhou@immuneonco.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of relapse-free patients (time frame: Up to Week 24). 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 16 Aug 2024.