A Study to Evaluate the Efficacy and Safety of VIB4920 in Participants With Sjögren's Syndrome (NCT04129164) | Clinical Trial Compass
CompletedPhase 2
A Study to Evaluate the Efficacy and Safety of VIB4920 in Participants With Sjögren's Syndrome
United States183 participantsStarted 2019-12-09
Plain-language summary
The purpose of the study is to evaluate the efficacy, safety, and tolerability of VIB4920 (formerly MEDI4920) in adult participants with Sjögren's Syndrome (SS).
Who can participate
Age range18 Years – 75 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 …
What they're measuring
1
Population 1: Change From Baseline in ESSDAI at Day 169
Timeframe: Baseline and Day 169
2
Population 2: Change From Baseline in ESSPRI at Day 169