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Evaluating Ianalumab for Patients 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

Phase 2 Interventional Novartis · NCT06470048

This study is testing if a new medication called ianalumab can help people with diffuse cutaneous systemic sclerosis feel better compared to a placebo.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment200 (estimated)
Ages18 Years to 70 Years
SexAll
SponsorNovartis Industry-sponsored
Drugs / interventionsianalumab, rituximab, nilotinib, imatinib, dasatinib, cyclophosphamide
Locations127 sites (Mesa, Arizona and 126 other locations)
Trial IDNCT06470048 on ClinicalTrials.gov

What this trial studies

This clinical study aims to assess the efficacy, safety, and tolerability of ianalumab, a medication administered subcutaneously, in participants diagnosed with diffuse cutaneous systemic sclerosis compared to a placebo. The study includes a screening period of up to 6 weeks, followed by a 52-week treatment period and an additional 52-week open-label treatment phase. Participants will be monitored for at least 20 weeks after the last dose, with a total follow-up period extending up to 2 years. The study is designed to provide insights into the potential benefits of ianalumab for this condition.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 to 70 with a diagnosis of diffuse cutaneous systemic sclerosis and active disease.

Not a fit: Patients with a disease duration exceeding 60 months or those with a modified Rodnan skin score (mRSS) outside the specified range may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could improve the management and outcomes for patients suffering from diffuse cutaneous systemic sclerosis.

How similar studies have performed: Previous studies have explored treatments for systemic sclerosis, but the specific use of ianalumab in this context is novel.

Eligibility criteria

Show full inclusion / exclusion criteria 
Key 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 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.

Key Exclusion Criteria:

* 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).
* Treatment with biologic agents, such as intravenous immunoglobulin or monoclonal antibodies, including marketed drugs, within 12 weeks or 5 half-lives (whichever is longer) prior to baseline visit, unless explicitly allowed in inclusion criteria.
* 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.

Other protocol-defined inclusion/exclusion criteria may apply.

Where this trial is running

Mesa, Arizona and 126 other locations

+77 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Diffuse Cutaneous Systemic SclerosisDiffuse SclerodermaDiffuse Systemic SclerosisScleroderma, DiffuseScleroderma, ProgressiveSclerosis, Progressive SystemicSudden Onset SclerodermaB cell depletion
Last reviewed 2026-06-09 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.