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Prospective Evaluation of De-Escalation From antiCD-20 Therapies to Dimethyl Fumarate (Tecfidera) or Diroximel Fumarate (Vumerity)

NCT07757568 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 11

Last updated 2026-08-11

No results posted yet for this study

Summary

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.

Conditions

  • Multiple Sclerosis (MS) Relapsing Remitting

Interventions

DRUG

Vumerity

Titration starting with 231 mg twice a day, orally, for 7 days (per United States Product information). Then continue with 462 mg orally (administered as two 231 mg capsules) twice a day.

DRUG

Tecfidera

Titration will start with 120mg twice a day, orally, for 7 days (per United States product information) and then continue with 240mg twice a day orally.

Sponsors & Collaborators

  • University of Colorado, Denver

    lead OTHER

Principal Investigators

  • Enrique Alvarez, MD/PhD · University of Colorado, Denver

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-07
Primary Completion
2026-09-01
Completion
2026-11-07
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07757568 on ClinicalTrials.gov