Primary Sjögren's Syndrome Clinical Trial
— rhoOfficial title:
A Phase 2, Randomized, Placebo-controlled, Parallel-group, Double-blinded, proof-of Concept Study to Evaluate the Safety and Efficacy of Intravenous Efgartigimod in Adult Participants With Primary Sjögren's Syndrome
Verified date | May 2024 |
Source | argenx |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to assess the efficacy and safety of human FcRn blocking therapy with efgartigimod compared to placebo, in participants with pSS.
Status | Completed |
Enrollment | 34 |
Est. completion date | February 12, 2024 |
Est. primary completion date | January 29, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - 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 at screening: ACR/EULAR 2016 pSS who met criteria =7 years before screening; ESSDAI =5; Anti-Ro/SS-A positive; Residual salivary flow (UWSF rate >0 and/or SWSF rate >0.10) Exclusion Criteria: - 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 that are associated with an AIDS-defining condition, 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 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 |
Country | Name | City | State |
---|---|---|---|
Belgium | Universitair Ziekenhuis Gent | Gent | |
Hungary | Debreceni Egyetem | Debrecen | |
Hungary | Vita Verum Medical Egeszsegugyi Szolgaltato Bt. | Szekesfehervar | |
Netherlands | Universitair Medisch Centrum Groningen , Dept of Rheumatology and Clinical Immunology | Groningen | |
Poland | Ambulatorium Barbara Bazela | Elblag | |
Poland | MCBK Iwona Czajkowska Anna Podrazka- Szczepaniak S.C. | Grodzisk Mazowiecki | |
Poland | FutureMeds Krakow | Krakow | |
Poland | Centrum Medyczne Plejady | Kraków | |
Poland | ETG Lublin | Lublin | |
Poland | Reumed Spolka z o.o. | Lublin | |
Poland | Clinical Research Center Spólka z ograniczona odpowiedzialnoscia Medic-R Sp.k. | Poznan | |
Poland | Centrum Medyczne Pratia Poznan | Skórzewo | |
Poland | Centrum Medyczne Reuma Park | Warsaw | |
Poland | FutureMeds Targowek | Warsaw | |
Poland | KO-Med - Centrum Badan Medycznych NIGRiR | Warszawa | |
Poland | MICS Centrum Medyczne Warszawa | Warszawa | |
Poland | FutureMeds Wroclaw | Wroclaw |
Lead Sponsor | Collaborator |
---|---|
argenx | Iqvia Pty Ltd |
Belgium, Hungary, Netherlands, Poland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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) | up to week 24 | |
Secondary | Change in the relative counts of lymphocytic infiltrate (stained for CD45) at week24 | up to 24 weeks | ||
Secondary | Change in B/B+T cell ratio at week 24 | up to 24 weeks | ||
Secondary | Incidence and severity of TEAEs, AESIs, and SAEs by SOC and PT | To evaluate the safety of efgartigimod IV compared to placebo in participants with pSS | up to 35 weeks | |
Secondary | Clinically significant changes in vital sign measurements | weight in kg, Systolic Blood Pressure in mmHg, Diastolic Blood Pressure in mmHg, pulse in bpm | Up to 35 weeks | |
Secondary | Clinically significant changes in ECG results | Heart Rate in bpm, QRS in ms, PR in ms, QTc in ms | Up to 35 weeks | |
Secondary | Clinically significant changes in clinical laboratory safety evaluations | Chemistry, Haematology, HbA1C in %, Urinalysis, beta-hCG mUI/mL | Up to 35 weeks | |
Secondary | Proportion of participants with minimal clinically important improvement in ESSDAI: improvement of =3 points in ESSDAI score at week 24 | up to 24 weeks | ||
Secondary | Proportion of participants with low disease activity: ESSDAI score of <5 at week 24 | up to 24 weeks | ||
Secondary | Proportion of participants with minimal clinically important improvement in clinESSDAI: improvement of =3 points in clinESSDAI score at week 24 | up to 24 weeks | ||
Secondary | Proportion of participants with low disease activity: clinESSDAI score of <5 at week 24 | up to 24 weeks | ||
Secondary | Proportion of participants with minimal clinically important improvement in ESSPRI: decrease of 1 point or =15% at week 24 | up to 24 weeks | ||
Secondary | Change in ESSDAI score at week 24 | up to 24 weeks | ||
Secondary | Change in clinESSDAI score at week 24 | up to 24 weeks | ||
Secondary | Change in ESSPRI score at week 24 | up to 24 weeks | ||
Secondary | Proportion of participants with STAR score of =5 at week 24 | up to 24 weeks |
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