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A Study to Assess Efficacy and Safety of Efgartigimod in Adults With Sjogren's Disease-associated Sensorimotor Polyneuropathy or Sensory Polyneuropathy (SERENITY)
Sponsor: argenx
Summary
This study aims to assess the efficacy and safety of efgartigimod PH20 in adults with Sjogren's Disease (SjD) associated with nerve damage. The study will assess how efgartigimod PH20 affects symptoms of SjD specifically linked to the peripheral nervous system; the safety and tolerability of efgartigimod PH20; and whether receiving efgartigimod PH20 affects the participant's quality of life.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
75
Start Date
2026-08-14
Completion Date
2029-07-28
Last Updated
2026-08-12
Healthy Volunteers
No
Interventions
efgartigimod PH20 SC
subcutaneous efgartigimod PH20 SC given by prefilled syringe
Placebo PH20 SC
subcutaneous placebo PH20 SC given by prefilled syringe