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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)

NCT07760818 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2026-08-12

No results posted yet for this study

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.

Conditions

  • Sjogrens Disease
  • Primary Sjögren's Syndrome Painful Sensory Neuropathies

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

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-14
Primary Completion
2028-07-28
Completion
2029-07-28
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07760818 on ClinicalTrials.gov