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An Open-label Study to Assess the Safety, Efficacy, and Cellular Kinetics of YTB323 in Relapsing Multiple Sclerosis

Name: An Open-label Study to Assess the Safety, Efficacy, and Cellular Kinetics of YTB323 in Relapsing Multiple Sclerosis — clinical trial record (NCT06617793)
Creator: DataLookout
License: https://creativecommons.org/licenses/by/4.0/

StatusActive, Not Recruiting

PhasePhase 1/2

SponsorNovartis Pharmaceuticals

Started2025-02-24

View on ClinicalTrials.gov ↗

This is an open-label, multi-center, non-confirmatory study to assess the safety, efficacy, and cellular kinetics of YTB323 in approximately 28 participants with Relapsing Multiple Sclerosis (RMS) with breakthrough disease activity during previous treatment with a highly efficacious therapy (BD-HET). The study design utilizes an ascending single dose design consisting of 3 sentinel cohorts followed by an expansion cohort.

Amendment history 3 changes detected by DataLookout

2026-09-03

Enrollment closed, study ongoing

2026-08-05

Primary completion moved earlier: 2030-10-01 → 2030-08-07

2026-08-05

Completion moved earlier: 2030-10-01 → 2030-08-07

Trial Details

NCT Number	NCT06617793
Lead Sponsor	Novartis Pharmaceuticals
Conditions	Relapsing Multiple Sclerosis
Enrollment	28 participants
Start Date	2025-02-24
Primary Completion	2030-08-07 (estimated)
Study Completion	2030-08-07 (estimated)
Updated on ClinicalTrials.gov	2026-09-02