A Study to Evaluate the Safety and Effectiveness of SAR442168 Compared to Placebo in Primary Progressive Multiple Sclerosis (PPMS) Patients

Overview

About this study

The primary objectgive of this study is to determine the effectiveness of SAR442168 compared to placebo in delaying disability progression in primary progressive multiple sclerosis (PPMS).

The secondare objectives are to evaluate the effectiveness 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 effectivness and safety; and to evaluate pharmacodynamics of SAR442168.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Patients 18 to 55 years of age, inclusive.
  • Diagnosis of PPMS according to the 2017 McDonald criteria.
  • Expanded disability status scale (EDSS) between 2.0 to 6.5 points, inclusive at screening.
  • Disease duration from the onset of MS symptoms of < 15 years if screening EDSS score of > 5.0 OR < 10 years if screening EDSS score of ≤ 5.0.
  • 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

Exclusion Criteria:

  • Participant has conditions that would adversely affect study participation such as short life expectancy.
  • History of organ transplant.
  • Evidence of infection with human immunodeficiency virus (HIV), progressive multifocal leukoencephalopathy (PML), active hepatitis B or C, active or latent tuberculosis or other active infection that would adversely affect study participation.
  • 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.
  • Bleeding disorder, known platelet dysfunction or platelet count <150 000/μL at Screening.
  • Lymphocyte count below the lower limit of normal at Screening.
  • Recent live (attenuated) vaccine within 2 months before the first treatment visit.
  • Recent major surgery (within 4 weeks of Screening) or planned major surgery during the study.
  • The participant has received medications/treatments for MS within a specified time frame.
  • Receiving strong inducers or inhibitors of cytochrome P450 3A (CYP3A) or CYP2C8 hepatic enzymes.
  • Receiving anticoagulant or antiplatelet therapy (such as aspirin, clopidogrel, warfarin).
  • Contraindications to magnetic resonance imaging (MRI). The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

B Mark Keegan, M.D.

Closed-enrolling by invitation

What is this? (?)
"Close"
Not open to everyone who meets the eligibility criteria, but only those invited to participate by the study team.

Contact information:

Christina McCarthy

McCarthy.Christina@mayo.edu

More information

Publications

Publications are currently not available
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CLS-20507923

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