A Study to Evaluate the Efficacy and Safety of VIB4920 in Participants With Sjögren's Syndrome

Launched by AMGEN · Oct 14, 2019

Keywords

ClinConnect Summary

The study will enrol 2 SS populations: Population 1 will include participants with moderate to high systemic disease activity defined by European League Against Rheumatism (EULAR) Sjögren's Syndrome Disease Activity Index (ESSDAI) \>= 5; Population 2 will include participants with moderate to severe subjective symptoms defined by EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI) score \>= 5 and residual stimulated salivary flow but with mild systemic disease activity defined by ESSDAI score \< 5. This study will include 3 periods: screening (4 weeks), treatment period (40 Weeks) and ...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Diagnosed with SS by meeting the 2016 American College of Rheumatology (ACR)/EULAR Classification Criteria.
• • Residual salivary gland function as defined by whole stimulated salivary flow \> 0.1 mL/min (only for Population 2).
• • Have an ESSDAI score of \>= 5 at screening; (not including the peripheral nervous system, central nervous system, and pulmonary domains) (only for Population 1).
• • Have an ESSPRI score of \>= 5 at screening (only for Population 2).
• • Have an ESSDAI score of \< 5 at screening (only for Population 2).
• • Positive for either anti-Ro autoantibodies or rheumatoid factor, or both at screening.
• • Male and female participants who agree to follow protocol defined contraceptive methods.
• • No active or untreated latent tuberculosis (TB).
• Exclusion Criteria:
• • Medical history of confirmed deep venous thrombosis or arterial thromboembolism within 2 years of signing the informed consent form (ICF).
• • Risk factors for venous thromboembolism or arterial thrombosis, prothrombotic status.
• • Concomitant polymyositis or dermatomyositis or systemic sclerosis.
• • Active malignancy or history of malignancy, except in situ carcinoma of the cervix and cutaneous basal cell carcinoma.
• • Hepatitis B, hepatitis C, or human immunodeficiency virus infection.
• • More than one episode of herpes zoster and/or an opportunistic infection in the last 12 months.
• • Active viral, bacterial, or other infections or history of more than 2 infections requiring intravenous antibiotics within 12 months prior to signing the ICF.
• • Participants with corona virus disease 2019 (COVID-19) infection or who, in the judgment of the investigator, are at unacceptable risk of COVID-19 or its complications.
• • A documented positive severe acute respiratory syndrome-coronavirus-2 (SARS-CoV-2) test within 2 weeks prior to randomization.
• • Received live (attenuated) vaccine within the 4 weeks prior to ICF signature.
• • Treated with any biologic B-cell-depleting therapy within 12 months or other B-cell targeting therapy \< 3 months before randomization.
• • Injectable corticosteroids (including intraarticular) or treatment with \> 10 mg/day dose oral prednisone or equivalent within 6 weeks prior to randomization (only for Population 1).
• • Treated with systemic corticosteroids for indications other than SS, rheumatoid arthritis (RA), and systemic lupus erythematosus (SLE) for more than a total of 2 weeks within 24 weeks prior to screening visit (only for Population 1).
• • Received previous treatment with anti-CD40L compounds at any time before screening.
• • Pregnant or lactating or planning to get pregnant during the duration of the study.