An Observational Biomarker Study in Multiple Sclerosis (MS) Patients

NCT05663853 | Completed

• 1 other identifier: LPX641-001
• Study Type: observational
• Target: 137
• Locations: 1 country
• Sites: 4

Brief 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 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.

Conditions

Multiple Sclerosis, Relapsing-Remitting; Multiple Sclerosis, Primary Progressive; Multiple Sclerosis, Secondary Progressive

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  1 year

• Collect patient demographic data

  The patient demographic data such as age, sex, race, occupation, and disabilities will be collected.

  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.

  1 year

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: participant eligibility is not based on self-representation of gender identity.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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:
• 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.

Sponsors & Collaborators

• LAPIX Therapeutics Inc.: lead

Study Sites (4)

The Johns Hopkins University

Baltimore, Maryland, 21205, United States

Location

MedStar Health

Chevy Chase, Maryland, 20815, United States

Location

Corinne Goldsmith Dickinson Center for MS

New York, New York, 10029, United States

Location

Mellen Center

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting; Multiple Sclerosis, Chronic Progressive

Condition Hierarchy (Ancestors)

Multiple Sclerosis; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Robert Shin, MD,FANA

  Prof of Neurology MedStar Georgetown University Hospital

  PRINCIPAL INVESTIGATOR

• Sylvia Klineova, MD,MS

  Assistant Prof of Neurology Icahn School of Medicine at Mt Sinai

  PRINCIPAL INVESTIGATOR

• Shiv Saidha, MD,MRCPI

  Prof of Neurology, Johns Hopkins Hospital, Baltimore MD

  PRINCIPAL INVESTIGATOR

• Robert Bermel, MD,MBA

  Director Mellen Center for Multiple Sclerosis, Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2022
• First Posted: December 23, 2022
• Study Start: March 28, 2023
• Primary Completion: April 30, 2024
• Study Completion: April 30, 2024
• Last Updated: June 11, 2024

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)