About the Study
Multiple sclerosis (MS) is a chronic disease of the central nervous system that may affect movement, sensation, energy levels, and daily functioning. According to the National Institutes of Health (NIH), symptoms and disease activity can vary widely from person to person, and many individuals require long-term treatment and ongoing monitoring throughout the course of the disease.
For some people living with relapsing multiple sclerosis (RMS) or secondary progressive multiple sclerosis (SPMS), treatment may become part of everyday life over many years. Although doctors have some options in treating different forms of MS, researchers continue to study investigational therapies that may help support long-term disease management and the overall treatment experience.
This clinical research study is evaluating an investigational drug in adults living with RMS or nonrelapsing SPMS (nrSPMS). This study is “open-label,” meaning that all study participants will receive the active investigational drug. It will compare subcutaneous (under the skin) administration with intravenous (IV) administration to better understand safety, tolerability, efficacy, and participant experience.
Participants enrolled in the study will undergo regular study visits, MRI assessments, laboratory testing, questionnaires, and other study-related evaluations throughout participation.
All study-related care will be provided at no charge. Participation is voluntary, and participants may choose to leave the study at any time.
If you are unsure whether you may meet these preliminary eligibility criteria, please share your contact information and a member of the study team will be happy to talk with you about eligibility.
Eligible participants must meet these minimum requirements*:
- 18 to 55 years of age diagnosed with relapsing MS, OR
- 18 to 60 years of age diagnosed with non-relapsing secondary progressive MS
*This is not a complete list of requirements for participation. If you provide us with your contact information, we will promptly reach out to provide you with more information about our research study.
What to Expect
Screening & Enrollment
If you choose to move forward, you will review and sign an informed consent form. The study team will confirm eligibility and collect information such as your medical history, current medications, and multiple sclerosis diagnosis and treatment history.
Screening may include physical examinations, MRI assessments, laboratory testing, questionnaires, and other study-related evaluations to help determine whether this study may be a good fit for you.
Study Participation
If you qualify and choose to participate, you will attend scheduled study visits during the study period.
Participants will be randomly assigned to receive the investigational medication either subcutaneously (under the skin) or intravenously (IV). Participation includes study-related assessments throughout the study, which may include MRI scans, laboratory testing, questionnaires, and evaluations related to treatment experience and disease activity.
Some participants may also have the opportunity for at-home self-administration during parts of the study.
Follow-Up & Monitoring Period
Throughout the study, the study team will regularly monitor your health and study participation.
This may include clinic visits, MRI assessments, laboratory tests, physical examinations, and questionnaires about your health and treatment experience.
Participants may continue to be followed after the treatment period, which may include additional visits and study-related assessments.
Study Completion
Your participation will be complete once all required study visits and follow-up activities are finished.
Participation in this study is voluntary, and you may choose to withdraw at any time without affecting your regular medical care.
Compensation may be available for those who qualify and complete applicable study-related requirements.
Screening & Enrollment
If you choose to move forward, you will review and sign an informed consent form. The study team will confirm eligibility and collect information such as your medical history, current medications, and multiple sclerosis diagnosis and treatment history. Screening may include physical examinations, MRI assessments, laboratory testing, questionnaires, and other study-related evaluations to help determine whether this study may be a good fit for you.
Study Participation
If you qualify and choose to participate, you will attend scheduled study visits during the study period. Participants will be randomly assigned to receive the investigational medication either subcutaneously (under the skin) or intravenously (IV). Participation includes study-related assessments throughout the study, which may include MRI scans, laboratory testing, questionnaires, and evaluations related to treatment experience and disease activity. Some participants may also have the opportunity for at-home self-administration during parts of the study.
Follow-Up & Monitoring Period
Throughout the study, the study team will regularly monitor your health and study participation. This may include clinic visits, MRI assessments, laboratory tests, physical examinations, and questionnaires about your health and treatment experience. Participants may continue to be followed after the treatment period, which may include additional visits and study-related assessments.
Study Completion
Your participation will be complete once all required study visits and follow-up activities are finished. Participation in this study is voluntary, and you may choose to withdraw at any time without affecting your regular medical care. Compensation may be available for those who qualify and complete applicable study-related requirements.
