Status:
COMPLETED
A Study to Evaluate the Efficacy and Safety of VIB4920 in Participants With Sjögren's Syndrome
Lead Sponsor:
Amgen
Conditions:
Sjögren's Syndrome
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief 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).
Detailed Description
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 D...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 9 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 10 2023
Estimated Enrollment :
183 Patients enrolled
Trial Details
Trial ID
NCT04129164
Start Date
December 9 2019
End Date
March 10 2023
Last Update
April 30 2025
Active Locations (62)
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1
Research Site
Fullerton, California, United States, 92835
2
Research site
Upland, California, United States, 91786
3
Research Site
Lawrenceville, Georgia, United States, 30046
4
Research Site
Kansas City, Kansas, United States, 66160