In short
ELV001 is an investigational chemical substance being studied as an add-on treatment for active rheumatoid arthritis in people who have not responded well enough to methotrexate and tumour necrosis factor (TNF) inhibitors. One Phase 2 trial, authorised in the EU, is comparing different doses of ELV001 with placebo in 180 participants. The main measure is the change in the DAS28-CRP score from baseline to week 12.
Key points
- ELV001 is an investigational chemical substance with no marketing authorisation in the product records.
- The single registered trial is a Phase 2 study in active rheumatoid arthritis.
- It plans to enrol 180 participants with an inadequate response to methotrexate and TNF inhibitors.
- The main outcome is the change in DAS28-CRP between baseline and week 12.
- The trial is currently authorised and compares different doses of ELV001 with placebo.
What is ELV001?
ELV001 is an investigational chemical substance developed by ELEVARA MEDICINES LTD. It has no marketing authorisation in the product records, which means it is not yet approved as a medicine. The substance is being studied in the therapeutic area of immune system diseases. ELV001 is a chemically synthesised substance, rather than a protein-based one.
How does ELV001 work?
The registry records do not describe the molecular target or mechanism of action of ELV001. The trial is designed to evaluate whether adding ELV001 to standard-of-care treatment improves disease activity in people with active rheumatoid arthritis. The primary comparison is between placebo and the highest dose group, which suggests the study aims to establish whether a higher dose produces a greater reduction in disease activity.
Which conditions is it studied for?
- Rheumatoid arthritis — a long-term autoimmune condition that causes pain, swelling and stiffness in the joints. The trial focuses on people whose disease remains active despite treatment with methotrexate and TNF inhibitors.
How is ELV001 given?
ELV001 is given by mouth as a capsule. The trial records list a 125 mg dose in the oral form. The study is comparing different doses of ELV001 against placebo tablets, with the primary comparison focusing on the highest dose group.
What do the clinical trials show?
There is one registered trial of ELV001. It is a Phase 2 study titled START SYNERGY, currently authorised in the EU. The trial plans to enrol 180 participants with active rheumatoid arthritis who have had an inadequate response to methotrexate and TNF inhibition.
The main outcome measured is the change in DAS28-CRP between baseline and week 12. DAS28-CRP is a score that combines tender and swollen joint counts, a blood marker of inflammation (C-reactive protein, or CRP) and the patient's own assessment of disease activity. The primary comparison will be between placebo and the highest dose group.
The trial is interventional, meaning participants receive a specific treatment and are followed over time. It is designed to assess both safety and efficacy of different doses of ELV001 as an add-on to standard-of-care treatment.
What side effects are known?
The registry records for this trial do not list side effects of ELV001. Because the substance is still in Phase 2 testing, its safety profile is being evaluated in the current study.