clinical trial · NCT06470048
A Clinical Study to Evaluate Ianalumab in Participants With Diffuse Cutaneous Systemic Sclerosis
Diffuse Cutaneous Systemic SclerosisPlaceboIanalumab
brief summary
The purpose of this study is to evaluate efficacy, safety and tolerability of s.c. ianalumab administered in participants with diffuse cutaneous systemic sclerosis relative to placebo
started
Oct 9, 2024
primary completion
Jul 30, 2027
completion
Jul 31, 2034
last updated
Jul 10, 2026
detailed description
The study consists of the following periods:
* Screening Period, with a duration of up to 6 weeks; * Treatment Period 1, with a duration of 52 weeks; * Treatment Period 2 (Open-label treatment), with a duration of 52 weeks; * Post-treatment Follow-up Period, with a duration of at least 20 weeks post last dose and up to 2 years.
official title
A Randomized, Double-blind, Parallel Group, Placebo-controlled Multicenter Study to Evaluate Efficacy, Safety and Tolerability of Ianalumab in Participants With Diffuse Cutaneous Systemic Sclerosis
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol