Could a lighter MS treatment keep the disease at bay?
NCT ID NCT07757568
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 Hide 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.)
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Multiple sclerosis (MS) - relapsing-remitting are added.
Genom att skicka in godkänner du våra Användarvillkor
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.
- Gut health meets diet: a new angle on managing multiple sclerosis
- Brain scans to reveal if new MS drug quietly calms inflammation
- A motorized hip brace may help MS patients walk better — small study puts it to the test
- Ear stimulation may help repair nerve damage in multiple sclerosis
- Could a gentle zapping of the brain ease MS fatigue and brain fog?
- Gentle exercise with cuffs may boost muscle in MS patients