A Phase 3, Randomized, Double-Blind, Efficacy and Safety Study Comparing SAR442168 To Placebo In Participants With Non-Relapsing Secondary Progressive Multiple Sclerosis (HERCULES)
Type of Study/Intervention
Form of MS
Secondary progressive MS
SAR442168 is being developed for the indication of treatment of patients with MS. This study is designed to collect evidence of efficacy and safety of the drug.The goal of this Phase 3 clinical trial is to demonstrate the efficacy and safety of SAR442168 compared to placebo in participants with nonrelapsing secondary progressive multiple sclerosis (nrSPMS). Globally approximately 1700 participants will be screened to achieve 1290 randomly assigned to study intervention (2:1 randomization ratio of SAR442168 to placebo). This study is planned as an event-driven trial based on 6-month confirmed disease progression (CDP) therefore treatment duration ranging from approximately 24 to 48 months in participants with nrSPMS. All participants with 6-month CDP are eligible for open-label active treatment as rescue (SAR442168). In Australia 5 sites will participate to recruit 15 participants.
- 18 to 60 years of age inclusive
- Diagnosis of nonrelapsing secondary progressive multiple sclerosis according to the 2017 McDonald criteria
- Expanded disability status scale (EDSS) between 3.0 to 6.5 points inclusive, at screening
- The participant must have documented evidence of disability progression observed during the 12 months before screening
- Absence of clinical relapses for at least 24 months
- The participant must have, at screening, disease duration from the onset of MS symptoms of:
- <20 years in participants with EDSS scores at screening >5.0; OR
- <10 years in participants with EDSS scores at screening ≤5.0
- Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies
- A female 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 OR
- Is a woman of childbearing potential and agrees to use an acceptable contraceptive method
- The participant has conditions that would adversely affect study participation such as short life expectancy.
- History of organ transplant.
- Evidence of infection with human immuodeficiency virus (HIV), progressive multifocal leukoencephalopathy (PML), active hepatitis B or C, active or latent tuberculosis or other active infections 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.
Anticipated start date
30 June 2020
St Vincent’s Hospital Melbourne, VIC.
Investigator is Dr Neil Shuey; site contact is Judy Chin: [email protected]
Centre for Neuroscience and Specialists on College, SA.
Investigator is Dr Andrew Lee; site contact is Paul Stockle: [email protected]
Princess Alexandra Hospital, QLD.
Investigator is Dr Stefan Blum; site contact is Wendy Smibert: [email protected]
Royal Hobart Hospital, TAS.
Investigator is Dr Michael Dreyer; site contact is Anna Green: [email protected]
The Mater Hospital, QLD.
Investigator is Dr Andrew Swayne, site contact is Matthew Spitzer: [email protected]
Further details of the trial can be found here:
SA, VIC, QLD, TAS