Ianalumab for Diffuse Cutaneous Systemic Sclerosis
This study is testing a drug called ianalumab in people with diffuse cutaneous systemic sclerosis (dcSSc), a condition that causes skin hardening and other issues. Researchers want to see how well ianalumab works, if it's safe, and if your body can tolerate it compared to a placebo (an inactive substance). You might be able to join if you are between 18 and 70 years old and have a confirmed diagnosis of dcSSc. The main goal is to see if participants show a 3/5 rCRISS25 response (a measure of improvement in symptoms) after 52 weeks of treatment. The current status of this study is unclear.
- Study design
- This interventional study plans to enroll 200 participants. It compares ianalumab to a placebo.
- What's involved
- The study involves a screening period of up to 6 weeks, followed by a 52-week treatment period, another 52-week open-label treatment period, and a follow-up period of at least 20 weeks.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for at least 20 weeks after their last dose, and up to 2 years.
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NCT06470048
A Clinical Study to Evaluate Ianalumab in Participants With Diffuse Cutaneous Systemic Sclerosis
Recruiting
PHASE2Ages 18–70InterventionalTreatmentNovartis Pharmaceuticals
~200 participants
Updated 2026-08-19 on ClinicalTrials.gov
What's tested:PlaceboIanalumab
At a glance
Recruiting sites
99 of 128 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
3/5 rCRISS25 response
Measured over Week 52
Conditions
Where it's being run
128 sites across 80 statesFrance8
Florida4
Tokyo4
Japan4
Taiwan4
Michigan3
Texas3
Argentina3
Study leadership
- Novartis Pharmaceuticals · STUDY_DIRECTOR · Novartis Pharmaceuticals
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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 of \>= 2 units compared with the most recent assessment performed within the previous 6 months
Involvement of two new body areas within the previous 6 months
Elevated acute phase reactants (ESR) \>= 30 mm/hr or high-sensitivity C-reactive protein (hsCRP) \>= 6 mg/L)
Presence of SSc-interstitial lung disease (ILD) and ATA autoantibody positivity
Modified EUSTAR disease activity index (mDAI) ≥ 2.5
Participant must be positive for at least one of the following autoantibodies:
anti-topoisomerase I (ATA) (also known as anti-SCL-70)
anti-RNA polymerase III (anti-RNAP3)
anti-nuclear antibody (ANA) (≥ 1:80) Participants who are positive only for ANA (while being negative for both ATA /anti-RNAP3) will be limited to 30% of the overall randomized study population.
Treatment with any investigational agent within ≤ 4 weeks (or 5 half-lives of the investigational drug, whichever is longer) of the baseline visit.
Use of anti-fibrotic agents including colchicine, D-penicillamine, pirfenidone, or tyrosine kinase inhibitors (e.g., nintedanib, nilotinib, imatinib, dasatinib) in the 4 weeks prior to baseline visit. Patients with SSc-ILD requiring antifibrotics for management of ILD during the study, as per investigator judgement, should be excluded.
Previous treatment with chlorambucil, bone marrow transplantation or total lymphoid irradiation.
Women of childbearing potential, defined as all women physiologically capable of becoming pregnant from menarche until becoming post-menopausal, unless they are using highly effective methods of contraception (failure rate \< 1% per year) while taking study treatment and for 6 months after stopping study treatment.
Exclusion
Rheumatic disease other than dcSSc, including limited cutaneous disease (lcSSc) or sine scleroderma at the screening visit. Secondary Sjogren's disease and scleroderma myopathy are not exclusionary.
Positive anti-centromere antibody (ACA+) without positive ATA or anti-RNAP3 autoantibody result at the screening visit
Previous improvement (decrease) in mRSS \> 10 units
Pulmonary disease with FVC ≤ 50% of predicted or diffusing capacity of the lung for carbon monoxide (DLCO, corrected for hemoglobin) ≤ 40% of predicted at the screening visit
WHO Functional Class 3 or higher assessment for pulmonary arterial hypertension (PAH, as defined on right heart catheterization), receiving IV therapy for PAH or evidence of other moderately severe pulmonary disease
Participants treated with cyclophosphamide within 12 weeks prior to Baseline.
Prior use of a B-cell depleting therapy other than ianalumab (e.g., rituximab, other anti-CD20 mAb, anti-CD22 mAb, or anti-CD52 mAb) administered within 36 weeks prior to randomization, or as long as B cell count is less than the lower limit of normal or baseline value prior to receipt of B cell-depleting therapy (whichever is lower).
What this trial measures
- 3/5 rCRISS25 responseWeek 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