This phase 1b/2a trial will investigate the safety and effectiveness of AMG 592 in rheumatoid arthritis (RA).
The main outcome will be a 20% improvement in symptoms at week 12.
The details
Rheumatoid arthritis (RA) is a condition caused by long-term inflammation. This leads to painful swelling in the joints. To treat RA, drugs that reduce inflammation are prescribed. It can be difficult to reduce inflammation in RA. This is because there are many different inflammatory processes. Drugs used to treat RA can cause side effects. Some newer drugs are being developed to to target cells that cause inflammation. This may improve RA symptoms and have fewer side effects. One such drug is AMG 592. This drug targets a type of immune cell called T regulatory cells or Tregs. Tregs are cells that balance the level of inflammation. AMG 592 causes Tregs to multiply. This reduces the level of inflammatory chemicals.
This trial will investigate the safety and effectiveness of AMG 592 in patients with rheumatoid arthritis (RA). The main outcome will be an improvement in disease activity at week 12.
Who are they looking for?
This study will recruit 105 patients with moderate-severe RA. Patients must be receiving treatment with methotrexate (MTX) and folic/folinic acid. Patients may also be taking prednisone or other corticosteroid drugs. Patients must have a normal electrocardiogram (ECG; records the electrical activity of the heart). Patients must have received all vaccination as per standard of care.
Patients with severe RA or active infections (including tuberculosis) cannot take part in the trial. Patients with cancer, a history of alcohol/substance abuse, uncontrolled diabetes, heart failure, and hypertension will not be included. Treatment with medications other than methotrexate, unwillingness to use contraceptive methods during the study and an additional 6 weeks are other exclusion criteria.
How will it work
Patients will be assigned to receive either AMG 592 or placebo. There are 2 phases in this trial. In the phase 1b study, patients will receive AMG 592 or placebo. The recommended dose will be determined by this phase 1b. Patients will then enter the phase 2a trial. During this phase, patients will take either AMG 592 or placebo.
The main outcome will be disease activity at week 12.
