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NCT07225504 · ClinicalTrials.gov registry record · Phase 3

A Study to Evaluate the Efficacy and Safety of Remibrutinib in Secondary Progressive Multiple Sclerosis

A Phase 3 study of Secondary Progressive Multiple Sclerosis (SPMS), sponsored by Novartis Pharmaceuticals.

Recruiting
Registry status
Phase 3
Development phase
1,275
Enrollment target
20
Study locations

NCT07225504: Recruiting Phase 3 study of Secondary Progressive Multiple Sclerosis (SPMS), sponsored by Novartis Pharmaceuticals.

NCT07225504 is a Phase 3 study of Secondary Progressive Multiple Sclerosis (SPMS) that is actively recruiting participants, run by Novartis Pharmaceuticals. The registered enrollment target is 1,275 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (65% higher). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT07225504, a Phase 3 study of Secondary Progressive Multiple Sclerosis (SPMS), is actively recruiting participants, sponsored by Novartis Pharmaceuticals.

RECRUITING
Registry status
Phase 3
Development phase
1,275 participants
Enrollment target
20
Study locations

Study Summary

The purpose of this study is to provide efficacy and safety data for remibrutinib in patients with secondary progressive multiple sclerosis (SPMS)

Primary Outcome

The EDSS is an ordinal scale used for assessing neurologic impairment in MS based on a neurological examination. It consists of scores in each of seven functional systems and an ambulation score that are then combined to determine the EDSS steps (ranging from 0 (normal) to 10 (death due to MS)). 6mCDP is defined as an increase from baseline in EDSS sustained for at least 6 months.

Interventions

  • DRUG Placebo
  • DRUG Remibrutinib (blinded)
  • DRUG Remibrutinib (Open label)

Study Locations (20)

Florida

  • Neurology of Central FL Res Ctr - Altamonte Springs
  • Aqualane Clinical Research - Naples
  • Orlando Health Clinical Trials - Orlando
  • Neurology Associates of Ormond Beach - Ormond Beach
  • Axiom Brain Health - Tampa

California

  • Fullerton Neuro and Headache Ctr - Fullerton
  • Regina Berkovich MD PhD Inc - West Hollywood

New South Wales

  • Novartis Investigative Site - Kogarah
  • Novartis Investigative Site - Westmead

Victoria

  • Novartis Investigative Site - Clayton
  • Novartis Investigative Site - Heidelberg

Alabama

  • Alabama Neurology Associates PC - Birmingham

Arizona

  • AZ Integrated Neuro and Spine - Phoenix

Hawaii

  • Hawaii Pacific Neuroscience LLC - Honolulu

Kansas

  • University of Kansas Hospital - Kansas City

Trial Details

FieldValue
Enrollment Target 1,275 participants
Start Date 2025-11-11
Est. Completion 2034-01-02
Phase Phase 3
Novartis Pharmaceuticals

1,375 total trials

What NCT07225504 shows while recruiting

NCT07225504 is an interventional study that assigns participants to a tested intervention. Its 1,275 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (65% higher).

The record links to 1 condition, with Secondary Progressive Multiple Sclerosis (SPMS) appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.

NCT07225504 names 20 study sites across 13 states, led by Florida, California, New South Wales.

Frequently Asked Questions

What is clinical trial NCT07225504 about?

NCT07225504 is a clinical study titled "A Study to Evaluate the Efficacy and Safety of Remibrutinib in Secondary Progressive Multiple Sclerosis". The purpose of this study is to provide efficacy and safety data for remibrutinib in patients with secondary progressive multiple sclerosis (SPMS)

What is the current status of trial NCT07225504?

This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 1,275 participants. The study started on 2025-11-11. Estimated completion is 2034-01-02.

What conditions does trial NCT07225504 study?

This clinical trial studies the following conditions: Secondary Progressive Multiple Sclerosis (SPMS).

What interventions are being tested in trial NCT07225504?

The interventions under investigation include: Placebo (DRUG), Remibrutinib (blinded) (DRUG), Remibrutinib (Open label) (DRUG).

Who is sponsoring clinical trial NCT07225504?

This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT07225504 being conducted?

This trial has 20 study locations across Alabama, Arizona, California, Florida, Hawaii. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Secondary Progressive Multiple Sclerosis (SPMS)

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT07225504's enrollment target sits among peer trials

1,275 200th of 2000 higher than 1,801 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.

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Source: ClinicalTrials.gov NCT07225504, the US trial registry maintained by the National Library of Medicine. NCT07225504 (large enrollment · wide site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.