Efgartigimod Tested for Nerve Damage in Sjögren's Disease
Tests efgartigimod against placebo in adults with Sjögren's disease and nerve damage.
Plain-language title generated from the registry record
Registry title: A Study to Assess Efficacy and Safety of Efgartigimod in Adults With Sjogren's Disease-associated Sensorimotor Polyneuropathy or Sensory Polyneuropathy (SERENITY)
Key facts
- Where
- Barcelona, Bilbao, Madrid, Málaga, and Santiago de Compostela, SpainSee the 7 sites
- Phase
- Phase 2
Where in Spain
- Hospital Universitari Vall d'HebronBarcelona, SpainTaking people
- Sanitas S.A. De HospitalesBarcelona, SpainTaking people
- Hospital Universitario BasurtoBilbao, SpainTaking people
- Hospital Universitario 12 de OctubreMadrid, SpainTaking people
- Hospital Universitario Ramón y CajalMadrid, SpainTaking people
- Hospital Quironsalud MalagaMálaga, SpainTaking people
- Clínica Gaias - SantiagoSantiago de Compostela, SpainTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- argenx
- Trial code
- NCT07760818EU 2026-526218-10-00
- Record updated
- 12 August 2026
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: 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).
Exclusion: 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; 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; 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); 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; History of malignancy unless considered cured by adequate treatment with no evidence of recurrence for ≥ 3 years; before first IMP administration; An alternative etiology for SMPN/SPN/sensory ganglionopathy or insufficient evidence of the diagnosis.