NCT05306353

CD40L Antagonism in Rheumatoid Arthritis (RA)

Combining a CD40L-Binding Protein (VIB4920) With a TNF-alpha Inhibitor for the Treatment of Inadequately Controlled Rheumatoid Arthritis (ITN092AI)

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary objective is to determine if the addition of a 12-week course of treatment with VIB4920 to TNFi treatment will result in improved clinical disease control in patients with RA who have had an inadequate response to a TNFi.

Detailed description

This study is a phase 2, multi-site, prospective, randomized, placebo-controlled, three-arm \[two arms double-blinded, one arm evaluator-blinded (participant is aware of his/her treatment status, but evaluator is not)\] trial of VIB4920 in 104 adults with seropositive Rheumatoid arthritis (RA) in the United States. Individuals will be eligible if they have moderate or high disease activity (Simplified Disease Activity Index \[SDAI\] ≥ 17) despite treatment with a TNFi for at least 12 weeks. All FDA-approved TNFi (including biosimilars) administered subcutaneously utilizing FDA-approved dosing regimens are permitted.

Conditions

• Rheumatoid Arthritis

Interventions

Type	Name	Description
DRUG	Placebo for VIB4920	26 participants will receive VIB4920 placebo administered intravenously at weeks 0, 2, 4, 8, and 12 while continuing background rheumatoid arthritis (RA) therapy including tumor necrosis factor alpha inhibitor (TNFi) (double-blinded)
DRUG	VIB4920 with TNFi	52 participants will receive 1500 mg administered intravenously at weeks 0, 2, 4, 8, and 12 while continuing background rheumatoid arthritis (RA) therapy including Tumor necrosis factor alpha inhibitor (TNFi) (double blinded)
DRUG	VIB4920 without TNFi	Participants will receive 1500 mg administered intravenously at weeks 0, 2, 4, 8, and 12 but discontinue necrosis factor alpha inhibitor (TNFi) while continuing all other background rheumatoid arthritis (RA) therapy (evaluator-blinded)

Timeline

• Start date: 2023-07-25
• Primary completion: 2025-07-28
• Completion: 2025-07-28
• First posted: 2022-04-01
• Last updated: 2026-01-29

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study