multiple sclerosis
Conditions
Interventions
frexalimab SC:frexalimab administered subcutaneously
frexalimab IV:Frexalimab intravenous administration
Sponsors
West China Hospital of Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: Group A (RMS) 1. Participants must be between 18 and 55 years of age (inclusive) at the time of signing the informed consent form. 2. Participants must have a diagnosis of RMS according to the 2017 Revised McDonald Diagnostic Criteria(24). 3. Participant must have an Expanded Disability Status Scale (EDSS) score of = 5.5 at the first visit (screening visit). 4. Participants must meet at least one of the following conditions prior to screening: - Documented =1 relapse within the past year, or - Documented =2 relapses within the past two years, or - Documented =1 GdE lesion on MRI scan within the past year. Note: For the first 2 criteria, an initial episode of clinical demyelinating in MS should be counted as one relapse. Group B (nrSPMS) 1. Participants must have a previous diagnosis of RRMS according to the 2017 Revised McDonald Diagnostic Criteria(24). 2. Participants must be between 18 and 60 years of age (inclusive) at the time of signing the informed consent form. 3. Participants must have a current diagnosis of SPMS according to the 2013 Revised Criteria for the Clinical Course (25) (26). 4. Participants must have a record of observed disability progression within 12 months prior to screening. 5. Participants must be clinically relapse-free for at least 24 months. 6. Participants must have an EDSS score between 3.0 and 6.5 points (inclusive) at the first visit (screening visit). Participants who meet the specific criteria for Cohorts A and B will only be eligible for enrollment in the study if they meet all of the following criteria at the same time. All 1. Participants participating in clinical studies should use contraceptive measures that comply with local regulations regarding contraceptive methods. (1) Male participants: Male participants are eligible to participate in the study if they agree to comply with the following requirements during study intervention and for at least 24 weeks after the last dose of study intervention: Refrain from donating sperm. Plus any of the following: 1) Able to practice abstinence (abstinence from heterosexual intercourse) as their daily and preferred lifestyle (long-term and continuous abstinence) and agree to adhere to abstinence. 2) Must agree to use a contraceptive/barrier method as detailed below. 3) agree to use a male condom and should inform the participant of the benefits of using a highly effective method of contraception (see Section 10.4 Appendix 4 Contraception and Barrier Requirements for a description) as the condom may rupture or leak during sexual intercourse with a woman of childbearing potential (WOCBP) who is not currently pregnant. (2) Female participants: Female participants are eligible for the study if they are not pregnant or lactating and meet at least one of the following criteria: 1) Not a WOCBP, as defined in Appendix 4 Contraceptive and Barrier Guidelines (Section 10.4). 2) Is a WOCBP who agrees to use a highly effective method of contraception (annual failure rate <1%) as described in the Appendix 4 Contraceptive and Barrier Guidelines (Section 10.4) for the duration of study intervention administration (effective prior to initiation of intervention administration) and for at least 24 weeks after the last dose of study intervention (Section 10.4) and agrees not to donate or cryopreserve eggs (oocytes, oocytes) for reproductive purposes during this period. 3) WOCBP must have a negative result of a highly sensitive pregnancy test (urine or serum, as required by loc
Exclusion criteria
Exclusion criteria: 1. Participants must have a diagnosis of primary progressive MS according to the 2017 revised McDonald diagnostic criteria (24). 2. Participant has a history of infection or may be at risk for infection: (1) History of T lymphocyte or T lymphocyte receptor vaccination, transplantation (including solid organ, stem cell, and bone marrow transplantation), and/or anti-rejection therapy. (2) Participants have received any live (attenuated) vaccine (including but not limited to varicella-zoster vaccine, oral polio vaccine, and nasal influenza vaccine) within 3 months prior to the first dose of study intervention. (3) History of diagnosis of progressive multifocal leukoencephalopathy (PML) or screening MRI with findings suggestive of PML. History of active or latent tuberculosis (TB); TB examination should be performed at screening, and if there is a clinical indication during the study, the examination should be performed again, and the examination can be repeated based on clinical judgment, borderline results, or when TB infection is clinically suspected. TB screening tests can be found in Appendix 2 (Section 10.2). (4) Note: The investigator may arrange an infectious disease specialist consultation as needed, for example, if the test result is unclear or suspected to be a false positive. If the infectious disease specialist determines that the test result is false positive and not clinically significant, and confirms that the participant is eligible for enrollment in the trial, the investigator must document this in the source data and then the participant can be randomized. (5) History of human immunodeficiency virus (HIV) infection (e.g., any known positive HIV test or participant interview information). (6) Serious systemic viral, bacterial, or fungal infection (e.g., infectious pneumonia, pyelonephritis), infection requiring hospitalization or IV injection of antibiotics in the 30 days prior to screening and during screening, or significant chronic viral, bacterial, or fungal infection (e.g., osteomyelitis). (7) Participant has a history of invasive opportunistic infections, including but not limited to histoplasmosis, listeriosis, coccidioidomycosis, candidiasis, Pneumocystis jirovecii, and aspergillosis. (8) Fever (=38°C; However, if caused by transient and mild ear, nose, and throat viral infections, the participant may be allowed to enroll at the discretion of the investigator). (9) Any other active infection that, in the judgment of the investigator, may adversely affect participation in this study or IMP administration in this study. 3. Presence of mental disorders or substance abuse, as evidenced by: (1) Any history of mental illness, behavioral symptoms, or depression requiring hospitalization within 2 years prior to the screening visit. Documented suicide attempt within 6 months prior to the screening visit, or category 4 or 5 suicidal ideation according to the Columbia Suicide Severity Rating Scale (C-SSRS) at baseline/screening, or if the participant is at risk of committing suicidal behavior according to the investigator's judgment. (2) Active alcohol use-related illness, history of alcohol abuse, or drug abuse within one year prior to the screening visit. 4. The following findings obtained during the screening visit, judged by the investigator to be clinically significant: Any laboratory test values outside the normal range at screening (unless not clinically significant). Abnormal ECG. Note: If an abnormal lab check value
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area under the curve over the interval W20 to W24 (AUCW20-W24).;Trough concentration at steady state (Ctrough,SS); | — |
Secondary
| Measure | Time frame |
|---|---|
| Total number of GdE T1 lesions at W24; | — |
Countries
China
Contacts
Public ContactHongyu Zhou
West China Hospital of Sichuan University
Outcome results
None listed