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

• Register: ClinicalTrials.gov
• Last refreshed on: 15 April 2024
• Main ID: NCT04129164
• Date of registration: 02/10/2019
• Prospective Registration: Yes
• Primary sponsor: Amgen
• Public title: A Study to Evaluate the Efficacy and Safety of VIB4920 in Participants With Sjögren's Syndrome SS
• Scientific title: A Phase 2 Randomized, Double-blind, Placebo-controlled, Proof of Concept Study to Evaluate the Efficacy and Safety of VIB4920 in Subjects With Sjögren's Syndrome (SS)
• Date of first enrolment: October 16, 2019
• Target sample size: 183
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/ct2/show/NCT04129164
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 2

Countries of recruitment

Argentina, France, Hungary, India, Italy, Korea, Republic of, Mexico, Peru, Poland, Taiwan, United Kingdom, United States

Contacts

• Name: MD
• Affiliation: Amgen

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Sjögren's Syndrome

Intervention(s)

Drug: VIB4920

Drug: Placebo

Primary Outcome(s)

Change From Baseline in European League Against Rheumatism (EULAR) Sjögren's Syndrome Disease Activity Index (ESSDAI) at Day 169 in Population 1 [Time Frame: Baseline (Day 1) and Day 169]

Change From Baseline in EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI) at Day 169 in Population 2 [Time Frame: Baseline (Day 1) and Day 169]

Secondary Outcome(s)

Change From Baseline in ESSPRI at Day 169 in Population 1 [Time Frame: Baseline (Day 1) and Day 169]

Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue Score at Day 169 in Populations 1 and 2 [Time Frame: Baseline (Day 1) and Day 169]

Change From Baseline in Ocular Surface Disease Index (OSDI) at Day 169 in Populations 1 and 2 [Time Frame: Baseline (Day 1) and Day 169]

Number of participants With Adverse Events of Special Interest (AESIs) in Populations 1 and 2 [Time Frame: From Baseline (Day 1) up to Day 365]

Percentage of Participants achieving ESSDAI [3] and ESSDAI [4] response in Population 1 [Time Frame: Baseline (Day 1) to Day 169]

Number of participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) in Populations 1 and 2 [Time Frame: From Baseline (Day 1) up to Day 365]

Patient's Global Impression of Severity at Day 169 in Populations 1 and 2 [Time Frame: Day 169]

Percentage of Participants With Positive Antibody Titer to VIB4920 in Populations 1 and 2 [Time Frame: Day 1 to Day 365]

Number of Participants With Abnormal Laboratory Parameters, Vital Signs, and Electrocardiograms (ECGs) Reported as TEAEs in Populations 1 and 2 [Time Frame: From Baseline (Day 1) up to Day 365]

Plasma Concentration of VIB4920 [Time Frame: Day 1 to Day 365]

Percentage of Participants achieving ESSPRI response in Population 2 [Time Frame: Baseline (Day 1) to Day 169]

Secondary ID(s)

2019-002713-19

VIB4920.P2.S2

Source(s) of Monetary Support

Please refer to primary and secondary sponsors