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
Novartis Pharmaceuticals
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
Description
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.
Eligibility
- Age range
- 18–70 years
- Sex
- All
- Healthy volunteers
- No
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 a…
Interventions
- DrugPlacebo
Ianalumab matching placebo subcutaneous (s.c.) injection as defined in the protocol
- DrugIanalumab
subcutaneous (s.c.) injection as defined in the protocol
Locations (127)
- Arizona Arthritis and Rheumatology Research PLLCMesa, Arizona
- UCLALos Angeles, California
- Hoag HospitalNewport Beach, California
- Clinical Res Of W FloridaClearwater, Florida
- GNP ResearchCooper City, Florida
- IRIS Research and DevelopmentPlantation, Florida