CD40L Antagonism in Rheumatoid Arthritis (RA) — CONTROL-RA  

Rheumatoid Arthritis Clinical Trial

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

Status Active, not recruiting

Clinical Trial 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.

Clinical Trial 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, defined for this study as etanercept or adalimumab or their respective biosimilars, for at least 12 weeks.

Study participation is divided into two phases: the study drug administration period (from week 0 to week 12) and the post-administration observation period (from week 12 to week 40).

Participants will be randomized into one of the three study arms to assess safety and efficacy; VIB4920 plus TNFI (double-blinded); VIB4920 plus placebo (double-blinded); and continued TNFi treatment (evaluator-blinded). ;

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

• NCT number: NCT05306353
• Study type: Interventional
• Source: National Institute of Allergy and Infectious Diseases (NIAID)
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: July 25, 2023
• Completion date: March 2025