Siponimod for MS

Overseen By Diana Johnson

Age: Any Age

Sex: Female

Trial Phase: Academic

Sponsor: Novartis Pharmaceuticals

Must be taking: Siponimod

Must not be taking: Cladribine, S1P modulators, Teriflunomide, Anti-CD20 antibodies

Disqualifiers: Previous pregnancy, Major structural defect, Autoimmune disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

867 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the effects of siponimod (Mayzent) on pregnancy and infant outcomes in women with multiple sclerosis (MS). Researchers aim to determine how siponimod taken during pregnancy might impact both mother and baby. The trial includes three groups: women with MS taking siponimod, women with MS not taking siponimod, and healthy women without MS or other autoimmune diseases. Pregnant women with MS, whether or not they have siponimod exposure, and pregnant healthy women without autoimmune diseases, may be eligible to join.

As a Phase 4 trial, siponimod has already received FDA approval and proven effective. This research seeks to understand its benefits for a broader range of patients.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but it does exclude participants who have taken certain medications like Cladribine, S1P modulators, and Teriflunomide within a specific time frame before conception. It's best to discuss your current medications with the trial team.

Is there any evidence suggesting that siponimod is likely to be safe for pregnant women with MS?

Research has shown that siponimod is already approved by the FDA to treat certain types of multiple sclerosis (MS), indicating it has passed several safety checks for that condition. In studies with non-pregnant patients, siponimod is generally well-tolerated, though some reported side effects like headaches and high blood pressure.

However, limited information exists on siponimod's safety during pregnancy. Some animal studies showed risks of birth defects, so caution is needed. This trial is part of ongoing research to determine if siponimod is safe for pregnant women and their babies.

Prospective participants should discuss any concerns with their doctor. A doctor can help understand the potential risks and benefits based on personal health needs. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Siponimod is unique because it targets the sphingosine-1-phosphate (S1P) receptor, which is different from other multiple sclerosis (MS) treatments that often focus on modulating the immune system more broadly. This targeted approach can potentially reduce the number of relapses and slow down the progression of disability in MS patients, with possibly fewer side effects. Researchers are excited about siponimod because it offers a more precise way to manage MS, especially in patients who are pregnant, where treatment options are limited due to safety concerns.

What evidence suggests that siponimod is effective for treating MS during pregnancy?

Research has shown that siponimod effectively treats multiple sclerosis (MS). It reduces the number of relapses and slows the progression of physical disability in people with MS. While researchers continue to study the safety of siponimod during pregnancy, this trial will compare pregnant women with MS who are exposed to siponimod with those who are not, as well as with healthy pregnant women. The aim is to balance the mother's health needs with any potential risks during pregnancy. This study seeks to provide more information on how siponimod affects pregnancy outcomes. ^{2 3 6 7 8}

Who Is on the Research Team?

Novartis Pharmaceuticals

Principal Investigator

Novartis Pharmaceuticals

Are You a Good Fit for This Trial?

Inclusion Criteria

Cohort 1: Siponimod-Exposed Cohort

Pregnant women

Diagnosed with MS, with the indication validated by medical records when possible

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

Observation

Prospective, observational cohort design to examine pregnancy and infant outcomes in women and infants exposed to siponimod during pregnancy

Up to 10.5 years

Follow-up

Participants are monitored for safety and effectiveness after exposure, including developmental milestones and health outcomes of infants

Up to 10.5 years

What Are the Treatments Tested in This Trial?

Interventions

• Siponimod

How Is the Trial Designed?

Group I: Siponimod-Exposed Experimental Treatment 1 Intervention

Pregnant women with MS exposed to siponimod during pregnancy

Group II: Healthy Comparison Experimental Treatment 0 Interventions

Pregnant women who are neither diagnosed with MS nor with any other autoimmune disease, and not exposed to siponimod or any known teratogenic agent during pregnancy

Group III: Disease-Matched Comparison Experimental Treatment 0 Interventions

Pregnant women with MS not exposed to siponimod during pregnancy

Siponimod is already approved in United States, Canada, European Union for the following indications:

Approved in United States as Mayzent for:

• Relapsing forms of multiple sclerosis in adults

Approved in Canada as Mayzent for:

• Relapsing forms of multiple sclerosis in adults

Approved in European Union as Mayzent for:

• Active secondary progressive multiple sclerosis

Who Is Running the Clinical Trial?

Novartis Pharmaceuticals

Lead Sponsor

Trials

2,963

Recruited

4,275,000+

Founded

1996

Headquarters

Basel, Switzerland

Known For

Precision medicine

Top Products

Gleevec, Cosentyx, Entresto, Kisqali

Dr. Vas Narasimhan

Novartis Pharmaceuticals

Chief Executive Officer since 2018

MD from Harvard Medical School

Dr. Shreeram Aradhye

Novartis Pharmaceuticals

Chief Medical Officer since 2021

MD

Citations

1. novartis.com novartis.com/clinicaltrials/study/nct04933552

Post-Authorization Safety Study for Assessment of ... The prevalence of each outcome in women exposed to siponimod and their infants will be compared to those observed in two unexposed comparator ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04933552

Post-Authorization Safety Study for Assessment of ... The prevalence of each outcome in women exposed to siponimod and their infants will be compared to those observed in two unexposed comparator groups: a disease ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8280312/

Influence of Pregnancy in Multiple Sclerosis and Impact of ... No effect on fertility. Population-based studies showed that among MS patients who became pregnant, more than 40% were not taking DMTs in the 12 months before ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0165572823001649

Disease modifying therapy and pregnancy outcomes in ... Existing research suggests that DMT use in MS patients during pregnancy is generally considered safe. This study supports their utilization on a case-by-case ...

5. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/nda/2019/209884Orig1s000OtherR.pdf

209884Orig1s000 OTHER REVIEW(S) - accessdata.fda.gov United States that compare the maternal, fetal, and infant outcomes of women with multiple sclerosis exposed to Mayzent during pregnancy.

6. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK582956/

Siponimod (Mayzent®) - MotherToBaby | Fact Sheets - NCBI Siponimod (Mayzent®) is a medication approved to treat relapsing forms of multiple sclerosis (MS), including clinically isolated syndrome, relapsing-remitting ...

7. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/nda/2019/209884Orig1s000Approv.pdf

CENTER FOR DRUG EVALUATION AND RESEARCH This new drug application provides for the use of Mayzent (siponimod) tablets for the treatment of relapsing forms of multiple sclerosis (MS), ...

8. my.clevelandclinic.org my.clevelandclinic.org/departments/neurological/depts/multiple-sclerosis/ms-approaches/siponimod

Siponimod | MS Approaches Is siponimod safe during pregnancy? Although there are no data on the safety of siponimod in pregnant woman, siponimod has been shown to cause teratogenicity in ...