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

NCT07760818 | Not Yet Recruiting Phase 2 FDA Drug

• 2 other identifiers: argx-113-15-SJD-20032026-526218-10-00
• Study Type: interventional
• Target: 75
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (1)

• Change from baseline in modified Toronto Clinical Neuropathy Score (mTCNS) total score at the end of Part A

  The mTCNS (modified Toronto Clinical Neuropathy Score) is a clinician-reported outcome measure derived from the original TCNS to improve sensitivity to early and mild neuropathy and to enhance feasibility and consistency inclinical research settings. The total mTCNS score is calculated as the sum of the symptom and sensory subscores, yielding a total possible score range of 0 to 33, with higher scores indicating greater neuropathy severity.

  Up to 48 weeks

Secondary Outcomes (13)

• Change from baseline in modified Toronto Clinical Neuropathy Score (mTCNS) total score over time

  up to 96 weeks

• Change from baseline in Norfolk Quality of Life-Diabetic Neuropathy (Norfolk QoL-DN) total score at the end of part A and over time

  up to 96 weeks

• Change from baseline in clinical EULAR Sjögren's Syndrome Disease Activity Index (clinESSDAI) score at the end of part A and over time

  up to 96 weeks

• Change from baseline in EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) score at the end of part A and over time

  up to 96 weeks

• Proportion of participants with low disease activity (clinESSDAI < 5) at the end of part A and over time

  up to 96 weeks

Study Arms (3)

Double-blinded treatment period (DBTP): Efgartigimod PH20 SC

EXPERIMENTAL

Participants receiving efgartigimod PH20 SC during the double-blinded treatment period

Biological: efgartigimod PH20 SC

Double-blinded treatment period (DBTP): Placebo PH20 SC

PLACEBO COMPARATOR

Participants receiving placebo PH20 SC during the double-blinded treatment period

Other: Placebo PH20 SC

Open-label treatment period (OLTP)

EXPERIMENTAL

Participants receiving efgartigimod PH20 SC during the open-label treatment period

Biological: efgartigimod PH20 SC

Interventions

efgartigimod PH20 SC BIOLOGICAL

subcutaneous efgartigimod PH20 SC given by prefilled syringe

Double-blinded treatment period (DBTP): Efgartigimod PH20 SC; Open-label treatment period (OLTP)

Placebo PH20 SC OTHER

subcutaneous placebo PH20 SC given by prefilled syringe

Double-blinded treatment period (DBTP): Placebo PH20 SC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Is at least 18 years of age and the local legal age of consent for clinical studies when signing the ICF
• Meets the following SjD criteria: Fulfilled American College of Rheumatology and the European Alliance of Associations for Rheumatology classification 2016 SjD criteria before screening; Moderate-to-severe disease defined as a ESSDAI ≥ 5 or clinESSDAI ≥ 6 with PNS domain score of ≥ 5 (ie, a score of at least low activity) at screening; Anti-Ro/SS-A positive at a central laboratory at screening
• Meets the following SjD-associated polyneuropathy criteria: Diagnosis of SjD-associated SMPN, SPN or sensory ganglionopathy, with neuropathy duration ≤ 5 years at screening and signs of active neuropathic disease development within the last 12 months; patients with co-existing SjD-associated small fiber neuropathy are eligible; No alternative diagnosis of neuropathy etiology; Total mTCNS ≥ 6 at screening; mTCNS sensory test score \<level 3 at screening (does not apply to sensory ganglionopathy cohort where any severity is acceptable)

You may not qualify if:

• Besides the indication under study, known medical conditions that would interfere with an accurate assessment of clinical symptoms of SjD-associated SMPN or SPN or gangliopathy, confound the study results, or puts the participant at undue risk.
• Associated (also known as secondary) SjD, defined as overlap with another autoimmune rheumatic or systemic inflammatory condition (eg, rheumatoid arthritis, systemic lupus erythematosus, scleroderma, or idiopathic inflammatory myopathy).
• Active fibromyalgia which is not adequately controlled in the judgment of the investigator, or participant is receiving fibromyalgia treatment that has not been stable treatment for at least 12 weeks before screening.
• An alternative etiology for SMPN/SPN/sensory ganglionopathy or insufficient evidence of the diagnosis.
• Any severe SjD manifestation or other health condition not adequately controlled at screening or baseline that may put the participant at undue risk based on the investigator's opinion.
• Comorbidities (eg, asthma, chronic obstructive pulmonary disease) which have required 3 or more courses of systemic (oral, IV, or IM) glucocorticoids within the previous 12 months.
• History of malignancy unless considered cured by adequate treatment with no evidence of recurrence for ≥ 3 years; before first IMP administration.

Sponsors & Collaborators

• argenx: lead

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2026
• First Posted: August 12, 2026
• Study Start (Estimated): August 14, 2026
• Primary Completion (Estimated): July 28, 2028
• Study Completion (Estimated): July 28, 2029
• Last Updated: August 12, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share