A Randomized, Placebo-controlled, Double-blind, Multicenter Phase 3 Protocol to Assess the Efficacy and Safety of Nipocalimab in Adults With Moderate to Severe Sjogren's Disease (SjD)
A Randomized, Placebo-controlled, Double-blind, Multicenter Phase 3 Protocol to Assess the Efficacy and Safety of Nipocalimab in Adults With Moderate to Severe Sjogren's Disease (SjD)
The purpose of this study is to evaluate the clinical efficacy and safety of nipocalimab in participants with moderate to severe Sjogren's disease (SjD).
This clinical development program for nipocalimab in SjD includes 2 identical double blind, placebo-controlled studies to evaluate the efficacy, safety, and tolerability of nipocalimab in participants greater than or equal to (>=) 18 years of age with moderate to severe SjD.
Inclusion Criteria:-
Exclusion Criteria:
New York, New York 10016, United States
CABA, C1128AAF, Argentina
Cdad Autonoma de Buenos Aires, C1123AAO, Argentina
Ciudad de Buenos Aires, C1055, Argentina
Ciudad de Buenos Aires, C1414, Argentina
Ciudad de Buenos Aires, C1428, Argentina
São José do Rio Preto, 15090 000, Brazil
Karvina Frystat, 73301, Czechia
Budapest, 1097, Hungary
Har Poriyya, 1528001, Israel
Shimotsuga Gun, 321 0293, Japan
Sumida Ku, 130 8575, Japan
Mexico D F, 14080, Mexico
México, 06700, Mexico
San Luis Potosí City, 78213, Mexico
Warsaw, 02 637, Poland
Greater London, E1 4DG, United Kingdom