NCT06470048

A Clinical Study to Evaluate Ianalumab in Participants With Diffuse Cutaneous Systemic Sclerosis

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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

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.

Conditions

• Diffuse Cutaneous Systemic Sclerosis

Interventions

Type	Name	Description
DRUG	Placebo	Ianalumab matching placebo subcutaneous (s.c.) injection as defined in the protocol
DRUG	Ianalumab	subcutaneous (s.c.) injection as defined in the protocol

Timeline

• Start date: 2024-10-09
• Primary completion: 2027-07-06
• Completion: 2030-07-15
• First posted: 2024-06-24
• Last updated: 2026-03-11

Locations

127 sites across 25 countries: United States, Argentina, Austria, Belgium, Brazil, China, Colombia, France, Germany, Greece, Hungary, India, Italy, Japan, Malaysia, Mexico, Poland, Portugal, South Korea, Spain, Taiwan, Thailand, Turkey (Türkiye), United Kingdom, Vietnam

Regulatory

• FDA-regulated drug study