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.
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)
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.
Parallel
efgartigimod PH20 SC
Biological/Vaccinesubcutaneous efgartigimod PH20 SC given by prefilled syringe
Placebo PH20 SC
Other interventionsubcutaneous placebo PH20 SC given by prefilled syringe
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.
Change from baseline in modified Toronto Clinical Neuropathy Score (mTCNS) total score over time
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.
Change from baseline in Norfolk Quality of Life-Diabetic Neuropathy (Norfolk QoL-DN) total score at the end of part A and over time
The Norfolk QoL-DN is a patient-reported outcome (PRO) instrument designed to assess neuropathy symptom severity and the impact of peripheral neuropathy on participants' ability to complete activities of daily living (ADLs). The Norfolk QoL-DN consists of 35 items that assess the presence and severity of sensory symptoms (eg, numbness, tingling, pain), motor and balance difficulties, and the extent to which neuropathy interferes with daily activities, sleep, work, and social functioning.
Change from baseline in clinical EULAR Sjögren's Syndrome Disease Activity Index (clinESSDAI) score at the end of part A and over time
The EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) was designed to measure systemic disease activity in patients with SjD. The ESSDAI consists of 12 domains, and the final score falls between 0 (no disease activity) and, theoretically, 123 (maximum disease activity). Clinical EULAR Sjögren's Syndrome Disease Activity Index (clinESSDAI) includes all ESSDAI domains except the biological domain. The clinical domains in clinESSDAI have different weights than in ESSDAI.
Change from baseline in EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) score at the end of part A and over time
The ESSDAI was designed to measure systemic disease activity in patients with SjD. The ESSDAI consists of 12 domains, and the final score falls between 0 (no disease activity) and, theoretically, 123 (maximum disease activity).
This trial is not recruiting at the moment. You can still explore other options:
