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NCT07138833Not yet recruitingPhase 4

A Phase IV Study of Dimethyl Fumarate Enteric-coated Capsules for Relapsing Multiple Sclerosis (RMS)

A Multicenter, Open-label, Single Group, Phase 4 Study to Evaluate Dimethyl Fumarate Enteric-coated Capsules in Relapsing Multiple Sclerosis (RMS)

Source: ClinicalTrials.gov · Last updated 24 Aug 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

The goal of this clinical trial is to evaluate the efficacy and safety\] in \[subjects diagnosed with RMS according to the 2017 McDonald criteria, including clinically isolated syndrome (CIS), relapsing-remitting multiple sclerosis (RRMS), and active secondary progressive multiple sclerosis (SPMS). The main questions it aims to answer are: \[Question 1\] The efficacy of dimethyl fumarate enteric-coated capsules in the treatment of RMS. \[Question 2\] The safety of dimethyl fumarate enteric-coated capsules in the treatment of RMS. Participants will: Eligible 50 RMS patients will orally take dimethyl fumarate enteric-coated capsules during treatment, with an initial dose of 120 mg twice daily for 7 days, followed by a maintenance dose of 240 mg twice daily for 48 weeks. The annualized relapse rate (ARR) at Week 48 will be observed.

Status (registry)
Not yet recruiting
Phase (registry)
Phase 4
Study type
Interventional
Enrollment
50 (estimated)
First submitted
17 Aug 2025
Start date
Sept 2025
Primary completion date
Apr 2028
Lead sponsor
Qilu Pharmaceutical (Hainan) Co., Ltd.
NCT number
NCT07138833

What you commit to

  • Study type: Interventional · Phase 4
  • Planned participants: 50
  • From Sept 2025 to the primary completion date, Apr 2028
  • No sites listed in no 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

  • Protocol-defined multiple sclerosis (MS) relapse within 30 days prior to screening, or failure to achieve clinical stability from a prior relapse.
  • History of suicidal behavior within 5 years prior to screening. Suicidal ideation (indicated by a "Yes" response to Item 4 or 5 on the C-SSRS) within 6 months prior to screening.Subjects with a history of suicidal behavior occurring \>5 years prior to screening require investigator assessment of eligibility.

Other illness

  • History or current diagnosis of malignancy (except fully resected basal cell carcinoma), or uncontrolled severe diseases of major organ systems (e.g., cardiac, renal, hepatic, neurological \[excluding multiple sclerosis\]) that, in the investigator's assessment, pose a significant risk to the subject or could confound study results.

Who the study is looking for

  • Confirmed RMS per the 2017 McDonald criteria, including clinically isolated syndrome (CIS), relapsing-remitting MS (RRMS), or active secondary progressive MS (SPMS)
  • At least one documented relapse within 12 months prior to screening; plus evidence of MS-consistent lesions on prior brain MRI or gadolinium-enhancing (GdE) lesions on an MRI performed within 6 weeks before screening
  • Expanded Disability Status Scale (EDSS) score between 0.0 and 5.0 (inclusive) at screening

Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.