BCD-089-5/LUNAR – A Two-Stage Study of the Efficacy, Safety, Pharmacokinetics, Pharmacodynamics and Immunogenicity of Various Doses of Levilimab when Administered Intravenously and Subcutaneously to Healthy Subjects and Subjects with Active Rheumatoid Arthritis.
The second stage of the clinical study BCD-089-5/LUNAR will evaluate the efficacy and safety of levilimab at a dose of 648 mg intravenously once every 4 weeks in combination with methotrexate and at a dose of 324 mg subcutaneously once every 2 weeks in combination with methotrexate in subjects with active rheumatoid arthritis resistant to methotrexate monotherapy who:
Have reached the age of 18 years.
Have a documented diagnosis of rheumatoid arthritis that meets the ACR 2010 criteria and was made at least 24 weeks before the date of signing the Informed Consent Form.
Have received methotrexate at a stable dose during the last 12 weeks before the date of signing the Informed Consent Form.
Meet at least two of the following three criteria:
This study has exclusion criteria (precluding participation in this clinical study), which will all be explained to the potential participant by the study doctor. In particular, the exclusion criteria are:
Use of tocilizumab or anti-interleukin-6 receptor/anti-interleukin-6 monoclonal antibodies.
The study BCD-089-5/LUNAR is taking place in study centers of the Russian Federation and the Republic of Belarus, such as Kazan, Ulyanovsk, St. Petersburg, Novosibirsk, Rostov-on-Don, Smolensk, Omsk, Moscow, Chelyabinsk, Nizhny Novgorod, Saratov, Kemerovo, Ufa, Barnaul, Nalchik, Perm, Minsk and others.
You can ask questions about participation in the clinical study and clarify the contact information of study centers through the “Any questions?” form.
The study doctor will tell the potential participant about other eligibility criteria and contraindications for participation in this clinical study. The potential participant should read the full information about the study and consult the study doctor and/or attending physician.
Clinical Study Authorization No. 634 of the Ministry of Health of the Russian Federation dated November 01, 2022, and the list of approved study centers have been published in the State Register of Medicines.
Clinical Study Authorization No. 75/471/2023 of the Ministry of Health of the Republic of Belarus dated April 05, 2023, and the list of approved study centers in the Republic of Belarus have been published in the State Register of Clinical Studies of the Republic of Belarus.