Multiple Sclerosis, Relapsing-RemittingNCT05663853
An Observational Biomarker Study in Multiple Sclerosis (MS) Patients
An observational study of Multiple Sclerosis, Relapsing-Remitting and Multiple Sclerosis, Primary Progressive, run by LAPIX Therapeutics Inc. at 4 sites in United States.
Trial summary
All males and females between 18-70 years of age regardless of their race and ethnicity with a confirmed diagnosis of Primary Progressive Multiple Sclerosis (PPMS), Secondary Progressive Multiple Sclerosis (SPMS), and Relapse Remitting Multiple Sclerosis (RRMS) are invited to participate in this Observational study… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis, Relapsing-Remitting, Multiple Sclerosis, Primary Progressive, Multiple Sclerosis, Secondary Progressive
- How many people
- 137 participants
- Where
- 4 sitesUnited States
- Study dates
- 28 Mar 2023to 30 Apr 2024
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects with a confirmed diagnosis of different types of Multiple Sclerosis (MS) namely PPMS, SPMS, and RRMS, by the revised 2017 McDonald criteria.
Who may be able to join
- Subjects with a confirmed diagnosis of different types of Multiple Sclerosis (MS) namely PPMS, SPMS, and RRMS, by the revised 2017 McDonald criteria.
- Male or female MS subjects aged 18 -70 years.
- Body Mass Index (BMI) 18.0-35.0 kg/m2 at screening.
- Subjects have undergone 1.5T and/or 3T MRI brain and /or spinal cord with or without contrast within the past 6 months.
- Subject, or their legally authorized representative/guardian, must be willing and able to provide written informed consent prior to initiation of any study procedures.
- Subjects who are willing and able to adhere to study protocol requirements including but not limited to scheduled visits and laboratory tests.
Who cannot join
- Subjects diagnosed with Clinically Isolated syndrome (CIS) which describes the first episode of neurological symptoms that last at least 24 hours caused by inflammation or demyelination in the central nervous system. It usually occurs in young adults and affects optic nerves, the brainstem, or the spinal cord.
- Subjects with a confirmed diagnosis of NMOSD by the 2015 International Panel for NMO Diagnosis (IPND) criteria.
- Subjects with a confirmed diagnosis of MOGAD by meeting the following criteria:
- Laboratory finding serum positive MOG-IgG by cell-based assay.
- Clinical findings of any of the following presentations:
- i)Acute disseminated encephalomyelitis (ADEM) ii)Optic neuritis, including chronic relapsing optic neuropathy (CRION) iii)Transverse myelitis (short or long segment) iv)Brain or brainstem syndrome compatible with demyelination v)Any combination of the above c) Exclusion of the alternative diagnosis.
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- Subjects with Grade-3 lymphocytopenia (<500-200 /mm3 or <0.5-0.2* 10e9/L) over the past 6 months.
- COVID-19:
- Subject has a known COVID-19 positive status (confirmed by clinical signs and symptoms and/or + ve SARS-CoV-2 NAAT result COVID test) during enrollment.
- OR has had recent COVID-19 vaccination including a booster dose in the past 30 days OR has received anti-viral therapy intended to prevent COVID-19 such as Paxlovid, remdesivir, molnupiravir, interferons, Anti-SARS-CoV-2 monoclonal antibodies, IVIG-SARS-CoV-2, COVID-19 Convalescent plasma, etc. in the past 4-6 weeks.
- Blood loss of >250 mL or donated blood within 56 days, or donated plasma within 7 days, of study screening.
- Subjects with acute illness such as fever (body temperature of ≥100.4°F or ≥ 38°C), vomiting, cough, or diarrhea within 48 hours before the screening period. (Upon recovery these subjects can be rescreened / re-enrolled in the study.
- Recent vaccination with live attenuated vaccines such as influenza, MMR, Herpes zoster, varicella, yellow fever, Rotavirus vaccine, etc., or inactivated vaccines such as Hepatitis A, Rabies vaccine, etc. in the past 30 days.
- Subject has participated in another investigational study involving any investigational product within 60 days to the start of the study, or within 5 half-lives, of the experimental drug, biologic, or device whichever is longer.
- Subjects who have been recently diagnosed or have a documented history of HIV or HIV-related disease conditions, hepatitis B or C, or other infectious diseases.
- History of cancer treatment with either chemo or radiation therapy or both in the past 5 years prior to enrollment in the study.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
The Johns Hopkins University
Baltimore, Maryland, 21205
MedStar Health
Chevy Chase, Maryland, 20815
Mellen Center
Cleveland, Ohio, 44195
Corinne Goldsmith Dickinson Center for MS
New York, New York, 10029
About this study
Official title: A Multicenter Observational Study for Ex-vivo Evaluation of the Likelihood of Response to an Experimental Tolerance Restoration Therapy in Subjects Diagnosed With Multiple Sclerosis (MS)
All males and females between 18-70 years of age regardless of their race and ethnicity with a confirmed diagnosis of Primary Progressive Multiple Sclerosis (PPMS), Secondary Progressive Multiple Sclerosis (SPMS), and Relapse Remitting Multiple Sclerosis (RRMS) are invited to participate in this Observational study being conducted across four sites in the US. Since this is an observational study no medication/drug or treatment will be given to the participants. The investigator will be collecting information about the participant's MS disease, its progression, current medications, radiographic scans, and blood samples. This will help the investigator evaluate the biomarkers and new treatment options to better understand the MS disease process.
Read the detailed description
Multiple sclerosis (MS) is a chronic disabling disorder of the central nervous system with inflammatory etiology and genetic and environmental factors. It affects females more than males (2-3:1ratio). The National Multiple Sclerosis Society estimates 2.8 million people are affected by Multiple Sclerosis (MS) globally, with around 1 million patients in the US alone.
This is an observational protocol designed to collect clinical and radiographical data and blood samples from patients with a confirmed diagnosis of multiple sclerosis (MS). The blood samples are collected to conduct research on the likelihood of response to LAPIX's novel small molecule therapy and to better understand the MS disease process. Since this is an observational study, no drug or device will be administered to the participants and randomization will not be performed. There will be no alterations/modifications to the current treatment plan or modalities of the enrolled participants. This multicenter study will be conducted across four US sites that will enroll 200 MS patients. The total duration of this observational study (including the screening period and Visit-1) will be 7 days. However, both the screening period and Visit-1 can be combined into a single visit. There will be no follow-up period.
- Conditions
- Multiple Sclerosis, Relapsing-Remitting, Multiple Sclerosis, Primary Progressive, Multiple Sclerosis, Secondary Progressive
- Medical subject headings
- Multiple Sclerosis, Relapsing-Remitting, Multiple Sclerosis, Chronic Progressive
What is being measured
The primary outcome is the main question the study is designed to answer.
Collect clinical information pertaining to MS disease
The clinical information includes the date of MS diagnosis, duration of MS, date of last clinical attack, progressive/non-progressive course of the disease, MS medications and treatment modalities, comorbidities, concomitant medications, and vaccination record.
Measured: 1 year
Collect radiographical data
The radiographical data collected but not limited to is the evidence of contrast-enhancing lesions, new T2 lesions, new hyperintense T2 lesions, and hypointense T1 lesions.
Measured: 1 year
Collect patient demographic data
The patient demographic data such as age, sex, race, occupation, and disabilities will be collected.
Measured: 1 year
Evaluate factors affecting the pharmacological response to LAPIX's lead immune-tolerance restoration molecule ex-vivo.
The relationship between ex-vivo exposure to LAPIX's immune-tolerance restoration therapy and pharmacological changes (ex-vivo E-R analysis) will be conducted by the mathematical fitting of the data to an appropriate 3, 4, or 5-parameters E-R model. EC50 and EC90 will be determined by model fitting.
If potential correlations are found, a more formal statistical analysis may be conducted as appropriate.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2022
- Study start28 Mar 2023
- Primary completion30 Apr 2024
- Study completion30 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple Sclerosis, Relapsing-RemittingStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 137 participants (actual)
Sponsor and investigators
- Lead sponsor
- LAPIX Therapeutics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Robert Shin, MD,FANA, Principal investigator, Prof of Neurology MedStar Georgetown University HospitalSylvia Klineova, MD,MS, Principal investigator, Assistant Prof of Neurology Icahn School of Medicine at Mt SinaiShiv Saidha, MD,MRCPI, Principal investigator, Prof of Neurology, Johns Hopkins Hospital, Baltimore MDRobert Bermel, MD,MBA, Principal investigator, Director Mellen Center for Multiple Sclerosis, Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05663853
- Sponsor's protocol ID
- LPX641-001
- Status last verified
- Oct 2023
- First submitted
- 8 Dec 2022
- Last updated
- 11 Jun 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 11 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Observational Study for Ex-vivo Evaluation of the Likelihood of Response to an Experimental Tolerance Restoration Therapy in Subjects Diagnosed With Multiple Sclerosis (MS)
- ClinicalTrials.gov ID
- NCT05663853
- Acronym / sponsor ID
- LPX641-001
- Conditions
- Multiple Sclerosis, Relapsing-Remitting, Multiple Sclerosis, Primary Progressive, Multiple Sclerosis, Secondary Progressive
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 137 participants (actual)
- Lead sponsor
- LAPIX Therapeutics Inc.Industry (pharma, biotech, devices)
- Study start
- 28 Mar 2023 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 30 Apr 2024 (actual)
- First posted
- 23 Dec 2022 (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.
All males and females between 18-70 years of age regardless of their race and ethnicity with a confirmed diagnosis of Primary Progressive Multiple Sclerosis (PPMS), Secondary Progressive Multiple Sclerosis (SPMS), and Relapse Remitting Multiple Sclerosis (RRMS) are invited to participate in this Observational study being conducted across four sites in the US. Since this is an observational study no medication/drug or treatment will be given to the participants. The investigator will be collecting information about the participant's MS disease, its progression, current medications, radiographic scans, and blood samples. This will help the investigator evaluate the biomarkers and new treatment options to better understand the MS disease process.
Detailed description
Multiple sclerosis (MS) is a chronic disabling disorder of the central nervous system with inflammatory etiology and genetic and environmental factors. It affects females more than males (2-3:1ratio). The National Multiple Sclerosis Society estimates 2.8 million people are affected by Multiple Sclerosis (MS) globally, with around 1 million patients in the US alone.
This is an observational protocol designed to collect clinical and radiographical data and blood samples from patients with a confirmed diagnosis of multiple sclerosis (MS). The blood samples are collected to conduct research on the likelihood of response to LAPIX's novel small molecule therapy and to better understand the MS disease process. Since this is an observational study, no drug or device will be administered to the participants and randomization will not be performed. There will be no alterations/modifications to the current treatment plan or modalities of the enrolled participants. This multicenter study will be conducted across four US sites that will enroll 200 MS patients. The total duration of this observational study (including the screening period and Visit-1) will be 7 days. However, both the screening period and Visit-1 can be combined into a single visit. There will be no follow-up period.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects with a confirmed diagnosis of different types of Multiple Sclerosis (MS) namely PPMS, SPMS, and RRMS, by the revised 2017 McDonald criteria.
Key inclusion criteria (6 listed)
- Subjects with a confirmed diagnosis of different types of Multiple Sclerosis (MS) namely PPMS, SPMS, and RRMS, by the revised 2017 McDonald criteria.
- Male or female MS subjects aged 18 -70 years.
- Body Mass Index (BMI) 18.0-35.0 kg/m2 at screening.
- Subjects have undergone 1.5T and/or 3T MRI brain and /or spinal cord with or without contrast within the past 6 months.
- Subject, or their legally authorized representative/guardian, must be willing and able to provide written informed consent prior to initiation of any study procedures.
Key exclusion criteria (16 listed)
- Subjects diagnosed with Clinically Isolated syndrome (CIS) which describes the first episode of neurological symptoms that last at least 24 hours caused by inflammation or demyelination in the central nervous system. It usually occurs in young adults and affects optic nerves, the brainstem, or the spinal cord.
- Subjects with a confirmed diagnosis of NMOSD by the 2015 International Panel for NMO Diagnosis (IPND) criteria.
- Subjects with a confirmed diagnosis of MOGAD by meeting the following criteria:
- i)Acute disseminated encephalomyelitis (ADEM) ii)Optic neuritis, including chronic relapsing optic neuropathy (CRION) iii)Transverse myelitis (short or long segment) iv)Brain or brainstem syndrome compatible with demyelination v)Any combination of the above c) Exclusion of the alternative diagnosis.
- Subjects with Grade-3 lymphocytopenia (<500-200 /mm3 or <0.5-0.2* 10e9/L) over the past 6 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Collect clinical information pertaining to MS disease
Time frame: 1 year
The clinical information includes the date of MS diagnosis, duration of MS, date of last clinical attack, progressive/non-progressive course of the disease, MS medications and treatment modalities, comorbidities, concomitant medications, and vaccination record.
Collect radiographical data
Time frame: 1 year
The radiographical data collected but not limited to is the evidence of contrast-enhancing lesions, new T2 lesions, new hyperintense T2 lesions, and hypointense T1 lesions.
Collect patient demographic data
Time frame: 1 year
The patient demographic data such as age, sex, race, occupation, and disabilities will be collected.
Evaluate factors affecting the pharmacological response to LAPIX's lead immune-tolerance restoration molecule ex-vivo.
Time frame: 1 year
The relationship between ex-vivo exposure to LAPIX's immune-tolerance restoration therapy and pharmacological changes (ex-vivo E-R analysis) will be conducted by the mathematical fitting of the data to an appropriate 3, 4, or 5-parameters E-R model. EC50 and EC90 will be determined by model fitting. If potential correlations are found, a more formal statistical analysis may be conducted as appropriate.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2024.
- Individual participant dataSharing planned: No
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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.
Robert Shin, MD,FANA principal investigator
Prof of Neurology MedStar Georgetown University Hospital
Sylvia Klineova, MD,MS principal investigator
Assistant Prof of Neurology Icahn School of Medicine at Mt Sinai
Shiv Saidha, MD,MRCPI principal investigator
Prof of Neurology, Johns Hopkins Hospital, Baltimore MD
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, Relapsing-Remitting and Multiple Sclerosis, Primary Progressive, run by LAPIX Therapeutics Inc. at 4 sites in United States.
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 6 inclusion and 16 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: finished, as of the sponsor's last update on 11 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Collect clinical information pertaining to MS disease (time frame: 1 year). The study lists 4 primary outcomes in all. 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 11 Jun 2024; AzTrials last refreshed its copy on 30 Oct 2026.