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NOT YET RECRUITING
NCT07760818
PHASE2

A Study to Assess Efficacy and Safety of Efgartigimod in Adults With Sjogren's Disease-associated Sensorimotor Polyneuropathy or Sensory Polyneuropathy (SERENITY)

Sponsor: argenx

View on ClinicalTrials.gov

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

BIOLOGICAL

efgartigimod PH20 SC

subcutaneous efgartigimod PH20 SC given by prefilled syringe

OTHER

Placebo PH20 SC

subcutaneous placebo PH20 SC given by prefilled syringe