NCT06470048 · Novartis Pharmaceuticals
A Clinical Study to Evaluate Ianalumab in Participants With Diffuse Cutaneous Systemic Sclerosis
What this study is about
The purpose of this study is to evaluate effectiveness, safety and how well patients handle the treatment of s.c.
View original scientific description
The purpose of this study is to evaluate efficacy, safety and tolerability of s.c.
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
Primary outcome measures
3/5 rCRISS25 response
Time frame: Week 52
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
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Male and female participants \>= 18 and =\< 70 years (at the time of the screening visit).
- Diagnosis of systemic sclerosis, as defined by the 2013 American College of Rheumatology/ European League Against Rheumatism (ACR/EULAR) classification criteria for SSc (van den Hoogen et al 2013) and meet the dcSSc subset classification according to LeRoy (LeRoy 1988)
- Disease duration of =\< 60 months (defined as time from the first non-Raynaud phenomenon manifestation, e.g., puffy hands, scleroderma, digital ulcers, arthralgia, dyspnea)
- mRSS units of \>= 15 and =\< 45 at the time of the screening visit
- Active disease that meets at least one of the following criteria at screening:
- Disease duration of =\< 18 months defined as time from the first non-Raynaud phenomenon manifestation
- Increase in mRSS of \>= 3 units compared with the most recent assessment performed within the previous 6 months
- Involvement of one new body area and an increase in mRSS o
Where
- Mesa, Arizona
- Los Angeles, California
- Newport Beach, California
- Clearwater, Florida
- Cooper City, Florida
- Plantation, Florida
- Sarasota, Florida
- Chicago, Illinois
- New Orleans, Louisiana
- Ann Arbor, Michigan
- Detroit, Michigan
- Saint Clair Shores, Michigan
And 5 more locations — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 10, 2026 · Source of record for eligibility and locations