Phase 2
Completed N=183
A Study to Evaluate the Efficacy and Safety of VIB4920 in Participants With Sjögren's Syndrome
Source: ClinicalTrials.gov NCT04129164 ↗Enrolled (actual)
183
Serious AEs
3.4%
Results posted
Apr 2025
Primary outcomePrimary: Population 1: Change From Baseline in ESSDAI at Day 169 — -4.1; -6.3 Score on scale
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Population 1: Change From Baseline in ESSDAI at Day 169 |
-4.1; -6.3 | — |
| PRIMARY Population 2: Change From Baseline in ESSPRI at Day 169 |
-0.53; -1.80 | — |
| SECONDARY Population 1: Change From Baseline in ESSPRI at Day 169 |
-1.12; -1.80 | — |
| SECONDARY Population 1: Number of Participants Who Achieved ESSDAI[3] and ESSDAI[4] Response at Day 169 |
22; 26; 18; 24 | — |
| SECONDARY Change From Baseline in The Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score at Day 169 |
5.8; 8.1; 2.8; 8.1 | — |
| SECONDARY Change From Baseline in Ocular Surface Disease Index (OSDI) at Day 169 |
-14.02; -16.00; -8.52; -13.95 | — |
| SECONDARY Patient Global Impression of Severity (PGIS) Score at Day 169 |
-0.5; -0.6; -0.4; -0.6 | — |
| SECONDARY Population 2: Number of Participants Who Achieved ESSPRI Response at Day 169 |
18; 36 | — |
| SECONDARY Number of Participants Who Experience Treatment-emergent Adverse Events (TEAEs) |
23; 28; 38; 37; 0; 1 | — |
| SECONDARY Serum Concentration of VIB4920 |
0.002; 0.002; 470.370; 496.984; 97.058; 111.636 | — |
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 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.
Data sourced from ClinicalTrials.gov (NCT04129164). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.