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
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
200
3/5 rCRISS25 response
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
Time frame: Week 52
Change from baseline in FVC% predicted at Week 52
To demonstrate the superiority of ianalumab, compared to placebo, on change from baseline in percent-predicted forced vital capacity (FVC%) at Week 52
Time frame: Week 52
Change from baseline in mRSS at Week 52
To demonstrate the superiority of ianalumab, compared to placebo, on change from baseline in modified Rodnan Skin Score (mRSS) at Week 52
Time frame: Week 52
Change from baseline in HAQ-DI at Week 52
To demonstrate the superiority of ianalumab, compared to placebo, on change from baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 52
Time frame: Week 52
Ianalumab concentrations in serum during treatment and Follow-up Period
To assess the pharmacokinetics of ianalumab
Time frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 52, Week 64, Week 76, Week 88, Week 104, Week 108, Week 112, Week 116, Week 120, Week 124 and Week 208
Incidence and titer of anti-drug (ianalumab) antibodies (ADAs) in serum over time
To evaluate the immunogenicity of ianalumab
Time frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 52, Week 64, Week 76, Week 88, Week 104, Week 124, Week 208
Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)
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Arizona Arthritis and Rheumatology Research PLLC
Mesa, Arizona, United States
RECRUITINGUCLA
Los Angeles, California, United States
RECRUITINGHoag Hospital
Newport Beach, California, United States
RECRUITINGClinical Res Of W Florida
Clearwater, Florida, United States
RECRUITINGGNP Research
Cooper City, Florida, United States
RECRUITINGIRIS Research and Development
Plantation, Florida, United States
RECRUITINGSarasota Arthritis Res Ctr
Sarasota, Florida, United States
RECRUITINGUniversity of Chicago Hospitals
Chicago, Illinois, United States
RECRUITINGUMC New Orleans
New Orleans, Louisiana, United States
RECRUITINGUni Of Michigan Health System
Ann Arbor, Michigan, United States
RECRUITING...and 110 more locations
The distribution of adverse events for ianalumab will be done via the analysis of frequencies for Adverse Event (AEs) and Serious Adverse Event (SAEs) through the monitoring of relevant clinical and laboratory safety parameters.
Time frame: Up to Week 208