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

• Status: Recruiting
• Trial end date: 2023-06-03
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Viela Bio

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.