In short
Ravagalimab is an investigational protein-based antibody with no marketing authorisation. It is being studied in a Phase 2 trial for rheumatoid arthritis, with 204 participants planned. The trial compares ravagalimab with another targeted therapy, lutikizumab, and a placebo, given as subcutaneous injections.
Key points
- Ravagalimab is an investigational antibody without marketing authorisation.
- It is being tested in a Phase 2 trial for rheumatoid arthritis.
- The trial plans to enrol 204 participants.
- The main measure is the ACR50 response at week 12.
- The trial status is Authorised, meaning it has been approved but not yet started.
- Ravagalimab is given by subcutaneous injection.
What is ravagalimab?
Ravagalimab is an investigational protein-based antibody. It is also known by the development code USP/Ph. Eur.ABBV-323. The product records show no marketing authorisation, meaning it is not yet an approved medicine. The company supplying the product is AbbVie Deutschland GmbH & Co. KG.
How does ravagalimab work?
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. In rheumatoid arthritis, blocking CD40 signalling may reduce the immune-driven inflammation that damages joints.
Which conditions is ravagalimab studied for?
- Rheumatoid arthritis — the Phase 2 trial is testing ravagalimab in people with moderately to severely active rheumatoid arthritis.
- Ulcerative colitis — a paediatric investigation plan at the European Medicines Agency listed ravagalimab for the treatment of ulcerative colitis, although the plan was later discontinued.
How is ravagalimab given?
Ravagalimab is prepared as a solution for injection or infusion and is given by subcutaneous injection. The European Medicines Agency record also lists intravenous use as a possible route of administration.
What do the clinical trials show?
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. The trial has the status Authorised, meaning it has received regulatory approval to begin but is not yet recruiting.
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.
The study aims to evaluate the safety and efficacy of monotherapy and combination therapy for moderately to severely active rheumatoid arthritis.
What side effects are known?
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.