Last updated 5 months ago
A Clinical Study to Evaluate Ianalumab in Participants With Diffuse Cutaneous Systemic Sclerosis
200 patients around the world
Available in United States, Argentina
The study consists of the following periods:
- Screening Period, with a duration of up to 6 weeks;
- Treatment Period 1, with a duration of 52 weeks;
- Treatment Period 2 (Open-label treatment), with a duration of 52 weeks;
- Post-treatment Follow-up Period, with a duration of at least 20 weeks post last dose
and up to 2 years.
Novartis Pharmaceuticals
1Research sites
200Patients around the world
This study is for people with
Systemic Sclerosis
Diffuse Cutaneous Systemic Sclerosis
Requirements for the patient
To 70 Years
All Gender
Medical requirements
- 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 classification criteria for SSc and meet the dcSSc subset classification according to LeRoy.Disease duration of <= 60 months defined as time from the first non-Raynaud phenomenon manifestation.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 >= 6 mg/dL.Presence of interstitial lung disease and ATA autoantibody positivity.Modified EUSTAR disease activity index > 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-nuclear antibody (ANA) (≥ 1:80) Participants who are positive only for ANA while being negative for both ATA and anti-RNAP3 will be limited to 30% of the overall randomized study population.
- Rheumatic disease other than dcSSc, including limited cutaneous disease or sine scleroderma at the screening visit.Positive anti-centromere antibody (ACA+) without positive ATA or anti-RNAP3 autoantibody result at the screening visit.Previous improvement 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 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 administered within 36 weeks prior to randomization.Treatment with biologic agents, such as intravenous immunoglobulin or monoclonal antibodies, including marketed drugs, within 12 weeks or 5 half-lives prior to baseline visit unless explicitly allowed in inclusion criteria.Treatment with any investigational agent within <= 4 weeks of the baseline visit.Use of anti-fibrotic agents including colchicine, D-penicillamine, pirfenidone, or tyrosine kinase inhibitors in the 4 weeks prior to baseline visit.Previous treatment with chlorambucil, bone marrow transplantation or total lymphoid irradiation.
Sites
Centro Médico Arsema
Recruiting
SponsorNovartis Pharmaceuticals
Study typeInterventional
Conditions
Diffuse Cutaneous Systemic Sclerosis
Requirements
To 70 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT06470048
