[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"primary-sjgrens-syndrome-painful-sensory-neuropathies\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:primary-sjgrens-syndrome-painful-sensory-neuropathies":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":4},"100651513","phase-2-a-study-to-assess-efficacy-and-safety-of-efgartigimod-in-adults-with-sjogrens-disease-associated-sensorimotor-polyneuropathy-or-sensory-polyneuropathy-serenity-100651513",false,"NCT07760818","A Study to Assess Efficacy and Safety of Efgartigimod in Adults With Sjogren's Disease-associated Sensorimotor Polyneuropathy or Sensory Polyneuropathy (SERENITY)","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","SERENITY","Inclusion Criteria:\n\n* Is at least 18 years of age and the local legal age of consent for clinical studies when signing the ICF\n* 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\u002FSS-A positive at a central laboratory at screening\n* 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 \\\u003Clevel 3 at screening (does not apply to sensory ganglionopathy cohort where any severity is acceptable)\n\nExclusion Criteria:\n\n* 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.\n* 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).\n* 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.\n* An alternative etiology for SMPN\u002FSPN\u002Fsensory ganglionopathy or insufficient evidence of the diagnosis.\n* 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.\n* 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.\n* History of malignancy unless considered cured by adequate treatment with no evidence of recurrence for ≥ 3 years; before first IMP administration.","ALL","18 Years",{"count":20,"type":21},75,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","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.",[27,28],"Sjogrens Disease","Primary Sjögren's Syndrome Painful Sensory Neuropathies","NOT_YET_RECRUITING","2026-08-07",{"date":32,"type":33},"2026-08-12","ACTUAL",{"date":35,"type":21},"2026-08-14",{"date":37,"type":21},"2029-07-28",{"name":39,"class":40},"argenx","INDUSTRY"]