NCT07757568Active, not recruiting
Prospective Evaluation of De-Escalation From antiCD-20 Therapies to Dimethyl Fumarate (Tecfidera) or Diroximel Fumarate (Vumerity)
Source: ClinicalTrials.gov · Last updated 11 Aug 2026
Brief summary (registry, in English)
The investigators propose a multi-center pilot study, which aims to evaluate safety and efficacy of fumarates as de-escalation therapy in clinically stable MS patients previously treated with anti-CD20 therapy.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 11 (actual)
- First submitted
- 12 Sept 2025
- Start date
- 7 Mar 2023
- Primary completion date
- 1 Sept 2026
- Lead sponsor
- University of Colorado, Denver
- Diseases
- Multiple sclerosis
- NCT number
- NCT07757568
What you commit to
- Study type: Observational
- Participants enrolled: 11
- From 7 Mar 2023 to the primary completion date, 1 Sept 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Any progression of neurological symptoms in the year prior to the screening visit that would be consistent with progressive MS.
- Prior use of alemtuzumab, mitoxantrone, cyclophosphamide, methotrexate, cyclosporine or any experimental MS treatment in the last 5 years.
- Prior allergy to Vumerity
Other illness
- 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).
- 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
- History of other chronic neurological illnesses that might mimic MS with chronic or intermittent symptoms (i.e. ALS, myasthenia gravis, chronic neuropathy, etc.)
Lab values
- IgG levels \<300 mg/dL
- lymphocytes \<800 cells/mm3
Other
- EDSS \>6.5
- Is considering pregnancy at the screening visit
- Unable to give informed consent or follow the protocol.
- Unable to undergo brain MRI.
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Colorado Denver Coordinator of this site? Confirm its status | Aurora | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.