Kesimpta for Multiple Sclerosis During Pregnancy

Recruiting at 1 trial location

Overseen By Diana Johnson

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Novartis Pharmaceuticals

Must be taking: Kesimpta

Must not be taking: Anti-CD20, S1P modulators

Disqualifiers: Previous Kesimpta pregnancy, Autoimmune, others

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

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

725 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how the medication Kesimpta (ofatumumab) affects pregnancy and infant outcomes in women with multiple sclerosis (MS). It compares three groups: women with MS who took Kesimpta during pregnancy, women with MS who did not take Kesimpta, and healthy women without MS. Pregnant women with MS, particularly those taking Kesimpta, may be suitable candidates for this trial. The researchers aim to better understand the effects of Kesimpta on both mothers and their babies. As an unphased trial, this study provides a unique opportunity to contribute to valuable research that could improve health outcomes for mothers and infants.

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 women who have taken certain medications like anti-CD20 monoclonal antibodies, S1P modulators, Cladribine, and Teriflunomide within a specific time before conception. It's best to discuss your current medications with the trial team to see if they affect your eligibility.

What prior data suggests that Kesimpta is safe for pregnant women with MS?

Research has shown that ofatumumab, also known as Kesimpta, is generally safe during pregnancy. One study found that pregnancy outcomes for women taking ofatumumab were similar to those in the general population, with about 70.9% resulting in live births, which is typical. Additionally, no birth defects were reported in over 20 pregnancies where ofatumumab was used. Studies in monkeys also did not show an increased risk of birth defects. This evidence suggests that the treatment does not significantly increase the risk of negative pregnancy outcomes. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Kesimpta (Ofatumumab) for treating multiple sclerosis (MS) because it offers a unique approach compared to existing options. Most MS treatments focus on modulating the immune system broadly, but Kesimpta targets a specific type of immune cell called B cells, thanks to its action as a monoclonal antibody. This targeted approach can lead to fewer side effects while maintaining effectiveness. Additionally, Kesimpta is administered via a convenient once-monthly injection, which can be done at home, offering more flexibility and ease for patients compared to some other therapies that require more frequent dosing or clinic visits.

What evidence suggests that this trial's treatments could be effective for MS?

Research has shown that ofatumumab (Kesimpta) effectively treats multiple sclerosis (MS). In studies, over 80% of patients taking ofatumumab did not experience worsening disability over six months. The treatment also significantly reduced disease activity, with about 70% of patients showing no signs of disease activity after one year, resulting in fewer relapses and slower disease progression. Ofatumumab has proven more effective than some other MS treatments, such as teriflunomide, in reducing symptoms. Overall, these findings suggest that ofatumumab is a strong option for managing relapsing forms of MS.

In this trial, one group of participants will include women and infants exposed to Kesimpta during pregnancy to treat MS. Comparison groups will consist of women with MS who have not used Kesimpta during pregnancy and healthy women without MS or autoimmune diseases. ^{6 7 8 9 10}

Who Is on the Research Team?

Novartis Pharmaceuticals

Principal Investigator

Novartis Pharmaceuticals

Are You a Good Fit for This Trial?

Inclusion Criteria

Agree to the conditions and requirements of the study including the interview schedule, release of medical records, the dysmorphology examination of live born infants (OTIS specific), and validated developmental performance questionnaire in live born children

Cohort 2: Disease-Matched Comparison Cohort (Comparison Group 1)

Agree to the conditions and requirements of the study including the interview schedule, release of medical records, the dysmorphology examination of live born infants, and validated developmental performance questionnaire in live born children

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Enrollment and Data Collection

Pregnant women and their infants are enrolled and data is collected on pregnancy and infant outcomes

Up to 21 months

Follow-up

Participants are monitored for safety and effectiveness after data collection

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Ofatumumab

How Is the Trial Designed?

Group I: Kesimpta-exposed cohort Experimental Treatment 1 Intervention

women and infants who are exposed to Kesimpta during pregnancy to treat MS.

Group II: Healthy cohort (only applicable in the Kesimpta-OTIS sub-study) (Comparison Group 2) Experimental Treatment 0 Interventions

healthy women who are not diagnosed with MS or any other autoimmune disease, have not had exposure to a known human teratogen, and have not taken Kesimpta in pregnancy (healthy comparison group). Since the DMSKW register is an MS population specific register that does not collect data on non-MS population, this cohort is only applicable in the Kesimpta-OTIS sub-study.

Group III: Disease-matched cohort (Comparison Group 1) Experimental Treatment 0 Interventions

comparison group consisting of women diagnosed with MS who have not used Kesimpta during pregnancy (unexposed disease-matched comparison group).

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. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40652442/

Five-Year Safety and Efficacy Outcomes with Ofatumumab ... With ofatumumab treatment up to 5 years, > 80% of patients remained free of 6-month confirmed disability worsening (6mCDW). Annualised relapse ...

2. novartis.com novartis.com/us-en/news/media-releases/new-novartis-data-further-support-benefits-kesimpta-relapsing-ms-following-switch-from-oral-disease-modifying-therapies

New Novartis data further support benefits of Kesimpta® in ... ARTIOS Phase IIIb, open-label, single-arm, prospective study showed a substantial reduction in disease activity in people with relapsing ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S1878747925002028

Real-world effectiveness and safety of ofatumumab in ... Additionally, in our cohort, 79.8 ​% of patients achieved NEDA-3 at 6 months post- OFA initiation, 69.5 ​% at 12 months. These findings are ...

4. link.springer.com link.springer.com/article/10.1007/s40120-025-00784-0

Five-Year Safety and Efficacy Outcomes with Ofatumumab ... Ofatumumab demonstrated superior efficacy and similar safety versus teriflunomide in ASCLEPIOS I/II in people with relapsing multiple sclerosis.

5. practicalneurology.com practicalneurology.com/news/kesimpta-shows-sustained-long-term-efficacy-and-safety-in-relapsing-multiple-sclerosis/2483559/

Kesimpta Shows Sustained Long-Term Efficacy and Safety in ... Across both studies, Kesimpta demonstrated high rates of no evidence of disease activity (NEDA-3), sustained suppression of MRI activity, and ...

6. novartis.com novartis.com/clinicaltrials/study/nct06156683

Kesimpta Pregnancy and Infant Safety Study Using Real ... The main research question is to determine whether the exposure during pregnancy to Kesimpta increases the risk of adverse pregnancy and infant outcomes in ...

7. neurology.org neurology.org/doi/10.1212/WNL.0000000000202940

Pregnancy Outcomes in Patients With MS Following ... As per ofatumumab's label, women of childbearing potential should use effective contraception during treatment and for at least 6 months after discontinuation ...

8. neurologylive.com neurologylive.com/view/pregnancy-outcomes-ofatumumab-treated-women-appear-consistent-general-population-rates

Pregnancy Outcomes in Ofatumumab-Treated Women ... Ofatumumab exposure during pregnancy showed outcomes consistent with general population rates, with 70.9% live births and 12.6% each for induced ...

9. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK617900/

Ofatumumab (Kesimpta®, Arzerra®) - MotherToBaby - NCBI No birth defects were reported in over 20 pregnancies exposed to ofatumumab. Animal studies done in monkeys have not reported an increased chance of birth ...

10. clinicaltrials.gov clinicaltrials.gov/study/NCT06156683?term=AREA%5BBasicSearch%5D(multiple%20sclerosis)%20AND%20AREA%5BLastUpdatePostDate%5D%20RANGE%5B2020-10-29,MAX%5D&rank=10

Kesimpta Pregnancy and Infant Safety Study Using Real ... The main research question is to determine whether the exposure during pregnancy to Kesimpta increases the risk of adverse pregnancy and infant outcomes in ...