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Ravagalimab is an investigational protein-based antibody. It is also known by the development code USP/Ph. Eur.ABBV-323.[1] The product records show no marketing authorisation, meaning it is not yet an approved medicine.[1] The company supplying the product is AbbVie Deutschland GmbH & Co. KG.[1]
Ravagalimab is an antibody that targets the CD40 pathway. CD40 is a protein involved in immune system activation, and antibodies against CD40 can act as antagonists, blocking the pathway, or as agonists, stimulating it. Research on CD40/anti-CD40 antibody complexes illustrates these two structural switches.[3] In rheumatoid arthritis, blocking CD40 signalling may reduce the immune-driven inflammation that damages joints.
Ravagalimab is prepared as a solution for injection or infusion and is given by subcutaneous injection.[1] The European Medicines Agency record also lists intravenous use as a possible route of administration.[2]
One trial of ravagalimab is registered in the EU Clinical Trials Information System. It is a Phase 2, interventional study in rheumatoid arthritis with a planned enrolment of 204 participants.[1] The trial has the status Authorised, meaning it has received regulatory approval to begin but is not yet recruiting.[1]
The trial compares ravagalimab with lutikizumab and with a placebo, given as subcutaneous injections. The main outcome measure is the percentage of participants with an American College of Rheumatology 50% (ACR50) response at week 12. An ACR50 response means at least a 50% improvement in tender and swollen joint counts and in at least three of five other measures of disease activity.[1]
The study aims to evaluate the safety and efficacy of monotherapy and combination therapy for moderately to severely active rheumatoid arthritis.[1]
The available sources do not report specific side effects for ravagalimab. As the Phase 2 trial is designed to evaluate safety, side effect information is expected to come from that study.[1]
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