Primary Sjögren’s Syndrome MedDRA version: 21.0 Level: LLT Classification code 10042846 Term: Syndrome Sjogren's System Organ Class: 100000004859
Conditions
Sponsors
argenx BV
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Participants are eligible to be included in the study only if all of the following criteria apply: - Is at least the legal age of consent for clinical trials when signing the informed consent form - Is capable of providing signed informed consent and complying with protocol requirements - Agrees to use contraceptive measures consistent with local regulations and measures described in the protocol - Meets the following criteria: ACR/EULAR 2016 pSS who met criteria =7 years before screening; ESSDAI =5; Ro/SS-A positive; Residual salivary flow (UWSF rate >0 and/or SWSF rate >0.10) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 27 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 3
Exclusion criteria
Exclusion criteria: Participants will be excluded from the study if any of the following criteria apply: - Known autoimmune disease or any medical condition that, in the investigator’s judgment, would interfere with an accurate assessment of clinical symptoms of pSS or puts the participant at undue risk - History of malignancy unless considered cured by adequate treatment with no evidence of recurrence for =3 years before the first administration of IMP. Adequately treated participants with the following cancers may be included at any time: Basal cell or squamous cell skin cancer; Carcinoma in situ of the cervix; Carcinoma in situ of the breast; Incidental histological finding of prostate cancer (TNM stage T1a or T1b) - Clinically significant uncontrolled active acute or chronic bacterial, viral, or fungal infection - Positive serum test at screening for an active infection with any of the following: HBV that is indicative of an acute or chronic infection, unless associated with a negative HBsAg or negative HBV DNA test; HCV based on HCV antibody assay unless a negative RNA test is available; HIV based on test results of a CD4 count of 200 cells/mm3 not adequately treated with antiviral therapy - Clinically significant disease, recent major surgery (within 3 months of screening), or intention to have surgery during the study; or any other medical condition that, in the investigator’s opinion, would confound the results of the study or put the participant at undue risk - Immunoglobulin G (IgG) levels cannot be below a certain threshold ( 4g/L) - Positive covid test at study start - Some of the medications such as vaccines with live components or medicines that may be prescribed for Sjogren’s syndrome cannot be taken either shortly before or during this study - Current participation in another interventional clinical study or previously participation in an efgartigimod clinical study and treatment with =1 dose of IMP - Known hypersensitivity to IMP or 1 of its excipients - History (within 12 months of screening) of current alcohol, drug, or medication abuse as assessed by the investigator - Pregnant or lactating state or intention to become pregnant during the study - Secondary Sjögren’s syndrome overlap syndromes where another confirmed autoimmune rheumatic or systemic inflammatory condition is the primary diagnosis - Chinese traditional medicine with known immunomodulatory action A detailed list is provided in the protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the effect of efgartigimod IV compared to placebo on CRESS;Secondary Objective: • To evaluate the effect of efgartigimod IV compared to placebo on the histology of the parotid gland (selected sites only) • To evaluate the safety of efgartigimod IV compared to placebo in participants with pSS • To evaluate the effect of efgartigimod IV compared to placebo on clinical efficacy parameters • To evaluate the effect of efgartigimod IV compared to placebo on STAR • To evaluate the PK of efgartigimod IV • To evaluate the PD of efgartigimod IV • To evaluate the immunogenicity of efgartigimod IV;Primary end point(s): Proportion of CRESS responders on =3 of 5 items at week 24. The 5 items are: - Systemic disease activity: clinESSDAI - Patient-reported symptoms: ESSPRI - Tear gland function: Schirmer’s test and OSS - Salivary gland function: UWSF rate and SGUS - Serology (serum IgG and/or RF);Timepoint(s) of evaluation of this end point: At week 24. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Change in the relative counts of lymphocytic infiltrate (stained for CD45) at week 24 • Change in B/B+T cell ratio at week 24 • Incidence and severity of TEAEs, AESIs, and SAEs by SOC and PT up to 35 weeks • Changes in vital sign measurements, ECG results, and clinical laboratory safety evaluations up to 35 weeks • Proportion of participants with minimal clinically important improvement in ESSDAI: improvement of =3 points in ESSDAI score at week 24 up to 24 weeks • Proportion of participants with low disease activity: ESSDAI score of <5 at week 24 up to 24 weeks • Proportion of participants with minimal clinically important improvement in clinESSDAI: improvement of =3 points in clinESSDAI score at week 24 up to 24 weeks • Proportion of participants with low disease activity: clinESSDAI score of <5 at week 24 up to 24 weeks • Proportion of participants with minimal clinically important improvement in ESSPRI: decrease of 1 point or =15% at week 24 up to 24 weeks • Change in ESSDAI score at week 24 • Change in clinESSDAI score at week 24 • Change in ESSPRI score at week 24 • Proportion of participants with STAR score of =5 at week 24 • Efgartigimod serum concentration-time profile • Values, changes from baseline, and percent reduction from baseline in total IgG levels in serum • Values, changes from baseline, and percent reduction from baseline in autoantibodies - Anti-Ro/ SS-A - Anti-La/ SS-B in serum • Incidence and prevalence of ADA against efgartigimod in serum;Timepoint(s) of evaluation of this end point: At week 24 | — |
Countries
Belgium, Czechia, Germany, Hungary, Netherlands, Poland, Spain
Contacts
Public ContactRegulatory
argenx BV
Outcome results
None listed