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Can MS drug vumerity be safe during pregnancy? a global registry seeks answers

NCT ID NCT05658497

Knowledge-focused Sponsor: Biogen Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 11, 2026 · Last updated Aug 12, 2026 · Updated 1 time

Summary

This registry study follows women with multiple sclerosis (MS) who become pregnant, comparing those who took the medication Vumerity (diroximel fumarate) with those who took other MS treatments or no treatment at all. The main goal is to estimate the risk of major birth defects in babies born to women exposed to Vumerity early in pregnancy. By tracking pregnancy outcomes, the study aims to provide better safety information for women with MS who are planning a family.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Diroximel fumarate (Vumerity), an oral medication for multiple sclerosis
What this could lead to
If successful, this registry could provide clearer safety data on using Vumerity during pregnancy, helping women with MS and their doctors make more informed treatment decisions.
What could go wrong
As an observational registry, it cannot prove cause and effect. Results may be influenced by underlying disease severity or other factors, and the study relies on voluntary reporting, which may introduce bias.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 908 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2023

Expected to finish

Jul 2032

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

The study population will include pregnant female participants with MS who were exposed to DRF at any time from 2 weeks after the first day of their LMP up through any time during pregnancy and compared with pregnancies among women with MS who were exposed to DMF, women with MS who were exposed to other DMTs (e.g., Avonex and Tysabri Pregnancy Registries), women with MS who were unexposed to DMTs, and women without MS. Participants will be classified into 2 enrolment types, Prospective and Retrospective. Prospective registration:a report of a pregnancy enrolled prior to knowledge of the pregnancy outcome, including prior to the detection of a congenital malformation at prenatal testing. Women who enrol after any knowledge of the pregnancy outcome will be enrolled as retrospective cases but will not be included in the primary analysis, i.e.,pregnancies with a prenatal testing result indicative of any congenital malformation/pregnancies with known outcomes at time of initial report.

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Key Inclusion Criteria: * Participant must have a diagnosis of MS * Documentation that the participant was one of the following: 1. exposed to DRF at any time from 2 weeks after the first day of their LMP (i.e., conception date) up through any time during pregnancy. (If exact exposure dates are unknown, the reporter must be able to specify or estimate trimester of exposure). 2. unexposed to any DMT during pregnancy, defined as having never received DMT therapy; discontinued treatment with DRF at least 1 day before 2 weeks after the first day of their LMP (i.e., conception date); or discontinued a non Registry-specified MS DMT more than 5 times its half-life prior to 2 weeks after the first day of their LMP (i.e., conception date) * Participants with knowledge of the outcome of the pregnancy (e.g., pregnancy loss or live birth) Key Exclusion Criteria: \- None NOTE: Other protocol defined Inclusion criteria may apply

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Conditions

The condition(s) this trial relates to.

multiple sclerosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Multiple sclerosis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    8 sites in 7 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Austin Hospital

    RECRUITING

    Heidelberg, 3084, Australia

  • Hospital Universitario Ramon y Cajal

    RECRUITING

    Madrid, 28034, Spain

  • IQVIA US Office

    RECRUITING

    Durham, North Carolina, 27703, United States

  • Inselspital

    RECRUITING

    Bern, 3010, Switzerland

  • Katholisches Klinikum Bochum

    RECRUITING

    Bochum, North Rhine-Westphalia, 44791, Germany

  • Salford Care Organization

    RECRUITING

    Salford, Greater Manchester, M68HD, United Kingdom

  • St Vincent's University Hospital

    RECRUITING

    Dublin, DO4 T6F4, Ireland

  • University of Colorado Anschutz Medical Campus

    RECRUITING

    Aurora, Colorado, 80045, United States

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