Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT06470048 · ClinicalTrials.gov registry record · Phase 2
A Clinical Study to Evaluate Ianalumab in Participants With Diffuse Cutaneous Systemic Sclerosis
A Phase 2 study of Diffuse Cutaneous Systemic Sclerosis, sponsored by Novartis Pharmaceuticals.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 200
- Enrollment target
- 20
- Study locations
NCT06470048: Recruiting Phase 2 study of Diffuse Cutaneous Systemic Sclerosis, sponsored by Novartis Pharmaceuticals.
NCT06470048 is a Phase 2 study of Diffuse Cutaneous Systemic Sclerosis that is actively recruiting participants, run by Novartis Pharmaceuticals. The registered enrollment target is 200 participants, above the 71-participant average among 6 other Diffuse Cutaneous Systemic Sclerosis trials with a reported enrollment target (182% higher). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06470048, a Phase 2 study of Diffuse Cutaneous Systemic Sclerosis, is actively recruiting participants, sponsored by Novartis Pharmaceuticals.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 200 participants
- Enrollment target
- 20
- Study locations
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
Primary Outcome
To demonstrate the superiority of ianalumab, compared to placebo, in achieving 3/5 Revised Composite Response Index in Systemic Sclerosis 25 (rCRISS25) response at Week 52
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Ianalumab
Study Locations (20)
Florida
- Clinical Res Of W Florida - Clearwater
- GNP Research - Cooper City
- IRIS Research and Development - Plantation
- Sarasota Arthritis Res Ctr - Sarasota
Michigan
- Uni Of Michigan Health System - Ann Arbor
- Wayne State University - Detroit
- Clinical Research Inst of MI - Saint Clair Shores
Texas
- Arthritis and Rheumatology Ins - Allen
- Novel Research LLC - Bellaire
- Prolato Clinical Research Center - Houston
California
- UCLA - Los Angeles
- Hoag Hospital - Newport Beach
Buenos Aires
- Novartis Investigative Site - CABA
- Novartis Investigative Site - CABA
Arizona
- Arizona Arthritis and Rheumatology Research PLLC - Mesa
Illinois
- University of Chicago Hospitals - Chicago
Louisiana
- UMC New Orleans - New Orleans
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Start Date | 2024-10-09 |
| Est. Completion | 2030-07-15 |
| Phase | Phase 2 |
What NCT06470048 shows while recruiting
NCT06470048 is an interventional study that assigns participants to a tested intervention. The registered 200 participants enrollment target is mid-sized for trials with a published cap, above the 71-participant average among 6 other Diffuse Cutaneous Systemic Sclerosis trials with a reported enrollment target (182% higher).
The record links to 1 condition, with Diffuse Cutaneous Systemic Sclerosis appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT06470048 names 20 study sites across 11 states, led by Florida, Michigan, Texas.
Frequently Asked Questions
What is clinical trial NCT06470048 about?
NCT06470048 is a clinical study titled "A Clinical Study to Evaluate Ianalumab in Participants With Diffuse Cutaneous Systemic Sclerosis". 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
What is the current status of trial NCT06470048?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 200 participants. The study started on 2024-10-09. Estimated completion is 2030-07-15.
What conditions does trial NCT06470048 study?
This clinical trial studies the following conditions: Diffuse Cutaneous Systemic Sclerosis.
What interventions are being tested in trial NCT06470048?
The interventions under investigation include: Placebo (DRUG), Ianalumab (DRUG).
Who is sponsoring clinical trial NCT06470048?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06470048 being conducted?
This trial has 20 study locations across Arizona, California, Florida, Illinois, Louisiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Diffuse Cutaneous Systemic Sclerosis
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.
-
Phase 2 Safety and Efficacy Study of Tulisokibart (MK-7240/PRA023) in Subjects With Systemic Sclerosis Associated With Interstitial Lung Disease (SSc-ILD) (MK-7240-007)
ACTIVE NOT RECRUITING · Phase 2
-
A Study of Subcutaneous Abatacept to Treat Diffuse Cutaneous Systemic Sclerosis
COMPLETED · Phase 2
-
Study to Evaluate Efficacy, Safety, and Tolerability of MT-7117 in Subjects With Diffuse Cutaneous Systemic Sclerosis
COMPLETED · Phase 2
-
A Safety and Efficacy Study Evaluating CTX112 in Adult Subjects With Refractory Autoimmune Disease
RECRUITING · Phase 1
-
A Study of CNTY-101 in Participants With Refractory B Cell-mediated Autoimmune Diseases
ACTIVE NOT RECRUITING · Phase 1
-
CARTIMMUNE: Study of Patients With Autoimmune Diseases Receiving KYV-101
ACTIVE NOT RECRUITING · Phase 1
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT00107289 · 200 participants · Phase 2
Iodine I 131 Metaiodobenzylguanidine in Treating Patients With Recurrent, Progressive, or Refractory Neuroblastoma or Malignant Pheochromocytoma or Paraganglioma
- NCT00109174 · 200 participants · NA
MRS Measurement of Glutamate and GABA Metabolism in Brain
- NCT00177268 · 200 participants
Blood, Urine, and Tissue Collection for Cutaneous Lymphoma, Eczema, and Atopic Dermatitis Research
- NCT00493688 · 200 participants
A Study to Determine Whether Perioperative Energy Dynamics Correlates With Postoperative Outcomes
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI