A Phase 2, Randomized, Double-Blinded, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Efgartigimod PH20 Subcutaneous Administered by Prefilled Syringe in Adult Participants with Sjogren’s Disease-Associated Sensorimotor or Sensory Polyneuropathy

Sjogren’s Disease-Associated Sensorimotor Polyneuropathy (SMPN) or Sensory Polyneuropathy (SPN)

Change from baseline in mTCNS total score at the end of Part A

Change from baseline in mTCNS total score over time, Change from baseline in Norfolk QoL-DN total score at the end of part A and over time, Change from baseline in clinESSDAI score at the end of part A and over time, Change from baseline in ESSDAI score at the end of part A and over time, Proportion of participants with low disease activity (clinESSDAI < 5) at the end of part A and over time, Incidence, severity, and relatedness of AEs, Clinically significant changes in vital signs, physical examination, ECG, and clinical laboratory safety evaluations., Change from baseline in NPQ at the end of part A and over time, Change from baseline in difficulty thinking NRS at the end of part A and over time, Change from baseline in PGIS, PGIC, CGIS, and CGI scores at the end of part A and over time, Change from baseline in FACIT-Fatigue scores at the end of part A and over time

No related papers found yet.