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

NCT06470048 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2026-03-11

No results posted yet for this study

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

Conditions

  • Diffuse Cutaneous Systemic Sclerosis

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-09
Primary Completion
2027-07-06
Completion
2030-07-15
FDA Drug
Yes

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

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06470048 on ClinicalTrials.gov