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Bruton's Tyrosine Kinase (BTK) Inhibitor

Remibrutinib vs Teriflunomide for Multiple Sclerosis (REMODEL-2 Trial)

Phase 3
Recruiting
Research Sponsored by Novartis Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
EDSS score of 0 to 5.5 (inclusive)
Neurologically stable within 1 month
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline up to 30 months
Awards & highlights

REMODEL-2 Trial Summary

This trial compares the effectiveness and safety of two different drugs for people with relapsing multiple sclerosis.

Who is the study for?
Adults aged 18-55 with Relapsing Multiple Sclerosis (RMS) who've had at least one relapse in the past year or a new lesion. They must be neurologically stable, not have primary progressive MS, no severe CNS diseases other than MS, and no history of certain cancers or infections like PML. Women must use effective contraception; men agree to use condoms.Check my eligibility
What is being tested?
The trial is testing the effectiveness and safety of Remibrutinib compared to Teriflunomide in treating RMS. Participants will receive either drug and their health outcomes will be monitored to see which treatment works better for controlling the disease.See study design
What are the potential side effects?
Potential side effects may include liver problems, infection risks due to immune system effects, digestive issues, allergic reactions to medication components, blood disorders such as low platelet counts or anemia, and possibly others depending on individual health conditions.

REMODEL-2 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My disability level allows me to walk without aid or rest for 200 meters.
Select...
My neurological condition has been stable for the last month.
Select...
My condition meets the 2017 criteria for RMS diagnosis.
Select...
My condition has worsened at least once in the past year or I have had an active lesion recently.
Select...
I am between 18 and 55 years old.

REMODEL-2 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline up to 30 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline up to 30 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Annualized relapse rate (ARR) of confirmed relapses [Core Part]
Secondary outcome measures
Annualized rate of new or enlarging T2 lesion [Core Part]
Annualized rate of new or enlarging T2 lesion [Extension Part]
Annualized relapse rate (ARR) of confirmed relapses [Extension Part]
+21 more

REMODEL-2 Trial Design

4Treatment groups
Experimental Treatment
Active Control
Group I: Remibrutinib - Extension (on teriflunomide in Core)Experimental Treatment1 Intervention
Participants on teriflunomide in Core will switch to remibrutinib tablet
Group II: Remibrutinib - ExtensionExperimental Treatment1 Intervention
Participants on remibrutinib in Core will continue on remibrutinib tablet
Group III: Remibrutinib - CoreExperimental Treatment1 Intervention
Remibrutinib tablet and matching placebo of teriflunomide capsule
Group IV: Teriflunomide - CoreActive Control1 Intervention
Teriflunomide capsule and matching placebo remibrutinib tablet

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor
2,859 Previous Clinical Trials
4,197,444 Total Patients Enrolled
100 Trials studying Multiple Sclerosis
51,327 Patients Enrolled for Multiple Sclerosis

Media Library

Remibrutinib (Bruton's Tyrosine Kinase (BTK) Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05156281 — Phase 3
Multiple Sclerosis Research Study Groups: Remibrutinib - Core, Teriflunomide - Core, Remibrutinib - Extension, Remibrutinib - Extension (on teriflunomide in Core)
Multiple Sclerosis Clinical Trial 2023: Remibrutinib Highlights & Side Effects. Trial Name: NCT05156281 — Phase 3
Remibrutinib (Bruton's Tyrosine Kinase (BTK) Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05156281 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the total number of people who have signed up for this experiment?

"Yes, this is an active trial that was originally posted on December 13th 2021 and updated as recently as November 16th. The study is looking for 800 individuals total at 21 different sites."

Answered by AI

Are there any other existing research projects that focus on Remibrutinib?

"Remibrutinib was first studied in 2014 at site 056001. To date, there have been 27 completed trials and 13 active ones. A large majority of the ongoing research is based in Merrillville, Indiana."

Answered by AI

What is the FDA's official stance on Remibrutinib?

"Remibrutinib falls into Phase 3 of clinical trials, meaning that while there is evidence supporting its efficacy, multiple rounds of data are required to support its safety. Our team has given it a score of 3."

Answered by AI

What is the novelty of this research?

"Remibrutinib has had a considerable amount of clinical research since its inception in 2014. Genzyme, a subsidiary of Sanofi, sponsored the first 166-person study. After this initial Phase 3 drug approval trial, there have been 13 more active trials for Remibrutinib around the world."

Answered by AI

Could you please tell me who would make a good candidate for this clinical trial?

"To participate in this study, potential patients must suffer from multiple sclerosis and be between 18-55 years old. In total, the study is trying to enroll 800 individuals."

Answered by AI

In how many different places is this trial being run today?

"To make participating in this clinical trial as convenient as possible for patients, it is being offered at 21 different locations. While a full list of sites is available, some notable examples include Merrillville, Greenfield Park and Pembroke Pines."

Answered by AI

Does this experiment test the effects of a new medication on elderly patients?

"According to the prerequisites for joining this study, potential participants must be between 18 and 55 years old."

Answered by AI

Is this research study looking for new participants?

"Yes. The clinical trial is recruiting participants and was first posted on December 13th, 2021. The last update to the posting was on November 16th, 2022. There are 21 sites enrolling a total of 800 patients."

Answered by AI

Who else is applying?

What state do they live in?
Illinois
Georgia
What site did they apply to?
Novartis Investigative Site
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
1
3+

Why did patients apply to this trial?

Help find a cure.
PatientReceived no prior treatments

How responsive is this trial?

Typically responds via
Email
Most responsive sites:
  1. Novartis Investigative Site: < 48 hours
Average response time
  • < 2 Days
Recent research and studies
clinicaltrials.govStudy
Efficacy and Safety of Remibrutinib Compared to Teriflunomide in Participants With Relapsing Multiple Sclerosis (RMS)
2021. "Efficacy and Safety of Remibrutinib Compared to Teriflunomide in Participants With Relapsing Multiple Sclerosis (RMS)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05156281.
~369 spots leftby Apr 2026
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