Phase 2
Completed N=78
A Study to Evaluate the Safety and Efficacy of VIB4920 in Participants With Rheumatoid Arthritis
Source: ClinicalTrials.gov NCT04163991 ↗Enrolled (actual)
78
Serious AEs
3.9%
Results posted
Feb 2023
Primary outcomePrimary: Change From Baseline to Day 113 in DAS28-CRP — -1.06; -1.90; -1.87; -1.87 score on a scale — p=0.0296
Summary
The purpose of the study is to evaluate the efficacy, safety, and pharmacokinetics (PK) of VIB4920 (formerly MEDI4920) in adult participants with rheumatoid arthritis (RA).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline to Day 113 in DAS28-CRP |
-1.06; -1.90; -1.87; -1.87; -1.83 | 0.0296 sig |
| PRIMARY Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (TESAEs), and Treatment-emergent Adverse Events of Special Interest (TEAESIs) |
10; 10; 14; 11; 11; 4 | — |
| SECONDARY Pharmacokinetics (PK) of VIB4920: Maximum Observed Concentration (Cmax) |
877; 476; 860; 421; 504; 1050 | — |
| SECONDARY PK of VIB4920: Time to Cmax (Tmax) |
0.0899; 0.0875; 0.0875; 0.0903; 0.0681; 0.0667 | — |
| SECONDARY PK of VIB4920: Area Under the Concentration-Time Curve From Time 0 to the Last Quantifiable Concentration (AUClast) |
7350; 3980; 7870; 2960; 5280; 10000 | — |
| SECONDARY PK of VIB4920: Area Under the Concentration-Time Curve From Time 0 to Day 56 (AUC0-56D) |
7280; 4280; 7870; 5310; 9910 | — |
| SECONDARY PK of VIB4920: Total Body Clearance (CL) for Dose 1 and Total Body Clearance at Steady State (CLss) for Doses 2 to 4 |
430; 371; 417; 314; 340; 294 | — |
| SECONDARY PK of VIB4920: Terminal Elimination Half-Life (t1/2) |
9.27; 9.06; 9.02; 9.55; 9.88; 10.5 | — |
| SECONDARY PK of VIB4920: Volume of Distribution at Steady State (Vss) |
4350; 3750; 4540; 3490; 3600; 3210 | — |
| SECONDARY Total Soluble Cluster of Differentiation 40 Ligand (sCD40L) Plasma Concentration Over Time |
4.6759; 30.7744; 36.0088; 28.2492; 33.9007; 4.8431 | — |
| SECONDARY Percentage of Participants With Positive Anti-Drug Antibodies (ADA) to VIB4920 |
44.4; 11.8; 38.5; 28.6; 0; 0 | — |
| SECONDARY Change From Baseline to Day 113 in Anti-Citrullinated Protein Antibodies (ACPAs) |
1.08; 0.69; 0.82; 0.84; 0.62 | 0.0584 |
| SECONDARY Change From Baseline to Day 113 in Rheumatoid Factor (RF) |
1.20; 0.77; 0.74; 0.72; 0.57 | 0.0007 sig |
| SECONDARY Percentage of Participants With Clinical Remission at Day 113 |
18.8; 18.8; 6.3; 13.3; 13.3 | 0.7750 |
| SECONDARY Time to Start of New Treatment for Rheumatoid Arthritis (Rescue Medication) |
NA; NA; NA; NA; NA | 0.9805 |
Eligibility Criteria
Principal Inclusion Criteria:
- Male or female adults, >= 18 years of age at time of informed consent.
- Diagnosed with RA according to the European League Against Rheumatism/American College of Rheumatology (EULAR/ACR) 2010 criteria >= 6 months prior to screening.
- Disease Activity Score in 28 Joints (DAS 28) using C-reactive Protein (DAS28-CRP) > 3.2 at screening with >= 4 tender joint count (TJC) and >= 4 swollen joint count (SJC) out of the 28 joints assessed for DAS28 present at screening and confirmed present at visit 2 prior to randomization.
- Positive for rheumatoid factor (RF) and/or anti-citrullinated protein antibodies (ACPA) at screening, in accordance with criteria at the central laboratory.
- Treated with methotrexate (MTX), with or without a concomitant conventional disease-modifying anti-rheumatic drug (cDMARD).
- Agreeing to use of protocol defined contraception methods.
Principal Exclusion Criteria:
- Prior or current inflammatory joint disease other than RA.
- Severe interstitial lung disease.
- Prior receipt of any biologic B-cell-depleting therapy.
- Receipt of any anti - tumor necrosis factor alpha (TNF-α) biologic agent 10 mg/day dose of oral prednisolone or equivalent within 4 weeks prior to screening.
- Previous treatment with anti-cluster of differentiation 40 ligand (CD40L) compounds at any time before randomization.
- Hepatitis B, hepatitis C, or human immunodeficiency virus infection.
- Pregnant or lactating or planning to get pregnant during the duration of the study.
- Evidence of active tuberculosis (TB) or being at high risk for TB.
- History of more than one episode of herpes zoster in the 12 months prior to screening or any opportunistic infection in the 12 months prior to screening, excluding localized mucocutaneous candidiasis.
- Receipt of live vaccine or live therapeutic infectious agent within the 4 weeks prior to screening.
Data sourced from ClinicalTrials.gov (NCT04163991). 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.