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(352) 733-0111

SANOFI 16035 PERSEUS

  • Status
    Accepting Candidates
  • Age
    18 Years - 55 Years
  • Sexes
    All
  • Healthy Volunteers
    No
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Objective

Primary Objective:

To determine the efficacy of SAR442168 compared to placebo in delaying disability progression in primary progressive multiple sclerosis (PPMS)

Secondary Objectives:

To evaluate efficacy of SAR442168 compared to placebo on clinical endpoints, magnetic resonance imaging (MRI) lesions, cognitive performance, physical function, and quality of life To evaluate safety and tolerability of SAR442168 To evaluate population pharmacokinetics (PK) of SAR442168 in PPMS and its relationship to efficacy and safety To evaluate pharmacodynamics of SAR442168

Description

Study duration will vary per participant in this event driven trial with a treatment duration of approximately 12 to 60 months.

Details

Full study title A Phase 3, randomized, double-blind, efficacy and safety study comparing SAR442168 to placebo in participants with primary progressive multiple sclerosis (PERSEUS)
Protocol number OCR41726
ClinicalTrials.gov ID NCT04458051
Phase Phase 3

Eligibility

Inclusion Criteria: * 18 to 55 years of age inclusive

  • Diagnosis of PPMS according to the 2017 McDonald criteria

  • Expanded disability status scale (EDSS) score between 2.0 to 6.5 points, at screening inclusive

  • Positive cerebrospinal fluid oligoclonal bands and/or elevated Immunoglobulin G (IgG) index either during screening or documented previous history.

  • Contraceptive use consistent with local regulations for individuals participating in clinical studies

  • Participant is eligible to participate if she is not pregnant or breastfeeding, and at

Least one of the following conditions applies:

  • Is not a woman of childbearing potential (WOCBP) or is a WOCBP and agrees to use an acceptable contraceptive method

  • the participant must not have access to ocrelizumab (eg, ocrelizumab not available on the national market or not reimbursed for the approved indication).

  • the participant must have access to and be eligible to be treated with ocrelizumab

But: 1) does not tolerate it due to side effects or safety reasons; and/or 2) has

Failed ocrelizumab treatment due to perceived lack of efficacy Exclusion Criteria:

Participants are excluded from the study if any of the following criteria apply:

  • Participant has conditions that would adversely affect study participation such as short life expectancy.

  • Evidence of infection with human immunodeficiency virus (HIV), transplantation, progressive multifocal leukoencephalopathy (PML), active hepatitis B or C, active or latent tuberculosis or other active infection that would adversely affect study participation.

  • Persistent chronic or active or recurring system infection that may adversely affect participation or IMP administration in this study as judged by the investigator

  • History of malignancy within 5 years prior to screening.

  • History of alcohol or drug abuse within 1 year prior to Screening.

  • Hospitalized for psychiatric disease within 2 years prior to Screening.

  • Clinically significant laboratory abnormalities (including evidence of liver injury) or electrocardiogram abnormalities at Screening.

  • A bleeding disorder or known platelet dysfunction at any time prior to the screening visit.

  • A platelet count

Lead researcher

  • Torge Rempe, MD, PhD
    Neurologist
    Languages: Spanish, German
    Torge Rempe

Participate in a study

Here are some general steps to consider when participating in a research study:

  1. Step
    1

    Contact the research team

    Call or email the research team listed within the specific clinical trial or study to let them know that you're interested. A member of the research team, such as the researcher or study coordinator, will be available to tell you more about the study and to answer any questions or concerns you may have.

    Primary contact

  2. Step
    2

    Get screened to confirm eligibility

    You may be asked to take part in prescreening to make sure you are eligible for a study. The prescreening process ensures it is safe for you to participate. During the prescreening process, you will be asked some questions and you may also be asked to schedule tests or procedures to confirm your eligibility.

  3. Step
    3

    Provide your consent to participate

    If you are eligible and want to join the clinical trial or study, a member of the research team will ask for your consent to participate. To give consent, you will be asked to read and sign a consent form for the study. This consent form explains the study's purpose, procedures, risks, benefits and provides other important information, such as the study team's contact information.

  4. Step
    4

    Participate

    If you decide to participate in a clinical trial or study, the research team will keep you informed of the study requirements and what you will need to do to throughout the study. For some trials or studies, your health care provider may work with the research team to ensure there are no conflicts with other medications or treatments.