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Could a lighter MS treatment keep the disease at bay?

NCT ID NCT07757568

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 study tests whether people with relapsing-remitting multiple sclerosis (MS) who have been stable on anti-CD20 therapies can safely switch to a fumarate drug like Tecfidera or Vumerity. The goal is to see if the switch keeps the disease inactive—meaning no relapses, no new brain lesions, and no worsening disability—over two years. Participants must have had no new disease activity for at least two years and be on anti-CD20 therapy for at least one year. The study will also measure a blood biomarker of nerve damage to check for subtle changes.

What this could mean

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

Active substance
dimethyl fumarate (Tecfidera) or diroximel fumarate (Vumerity)
What this could lead to
If successful, this could offer a safer, more convenient long-term option for people with stable MS, reducing the need for stronger immunosuppressive therapy.
What could go wrong
This is a small pilot study with only 11 participants, so results may not apply broadly. There is a risk that switching could allow disease activity to return.

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

11 people

The number who actually took part.

Started

Mar 2023

Expected to finish

Nov 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Who is studied

Patients between the ages of \>18 with a minimum of 2 years of MS disease stability and at least one year of experience on an anti-CD20 agent prior to initiating de-escalation with Vumerity will be followed for 24 months post de-escalation.

Ages

18 years and older

Sex

Anyone

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.

Inclusion Criteria: * Diagnosed with relapsing forms of MS * \> 18 years of age at the time of initiation of de-escalation * No evidence of new inflammatory disease activity (no new T2/contrast enhancing lesions, absence of relapses) for at least two years prior to de-escalation * Have had multiple sclerosis related symptoms at least 3 years prior to baseline visit. * Taking an anti-CD20 therapy most recently as a DMT continuously for at least one year (have received at least 2 courses) prior to de-escalation. * Are 6-12 months from their last anti-CD20 infusion * Willing to follow the protocol * Able to undergo a brain MRI without anesthesia Exclusion Criteria: * Any progression of neurological symptoms in the year prior to the screening visit that would be consistent with progressive MS. * Use of any non-FDA-approved DMT or systemic corticosteroids in the last 2 years. (Note: Use of inhaled or topical steroids are not an exclusion criteria. Also, use of oral steroids for no greater than 14 days given for a non-MS condition is not exclusionary). * IgG levels \<300 mg/dL * lymphocytes \<800 cells/mm3 * EDSS \>6.5 * Is considering pregnancy at the screening visit * Prior use of alemtuzumab, mitoxantrone, cyclophosphamide, methotrexate, cyclosporine or any experimental MS treatment in the last 5 years. * Prior allergy to Vumerity * Other significant medical or psychiatric illness, if uncontrolled. Examples: uncontrolled hypertension, uncontrolled diabetes, uncontrolled asthma, uncontrolled depression * Cancers other than basal cell skin cancers within the last 5 years * Unable to give informed consent or follow the protocol. * Unable to undergo brain MRI. * History of other chronic neurological illnesses that might mimic MS with chronic or intermittent symptoms (i.e. ALS, myasthenia gravis, chronic neuropathy, etc.)

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • University of Colorado, Denver

    Aurora, Colorado, 80045, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.