The BCD-180-2/ELEFTA clinical study will evaluate the efficacy of two doses of BCD-180 compared with placebo in patients who:
Have an established diagnosis of radiographic axSpA (ankylosing spondylitis, AS).
Have failed treatment with non-steroidal anti-inflammatory drugs (NSAIDs), have contraindications to the use of drugs of this group, or have intolerance to more than one NSAID.
Have received no biological therapy or targeted disease-modifying anti-rheumatic drugs (DMARDs).
Have a documented HLA-B27+ test result.
Have high disease activity.
Have a CRP level1 ≥ 5 mg/mL at screening.
For women: have a negative pregnancy test at screening2.
Are ready to use reliable methods of contraception3, starting from the date of signing of the informed consent form, throughout the study and for 8 weeks after the last administration of the study drug or placebo.
Are ready to abstain from egg donation (for women), sperm donation (for men), provided that fertility is preserved, starting from the signing of the informed consent form, throughout the study, and for 8 weeks after the last infusion of the study drug or placebo4, 5.
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, exclusion criteria include:
Specific radiological changes of the spine assessed by an independent expert at screening.
Age of onset of the disease less than 18 years.
Use of certain drugs or procedures, including at any time prior to the signing of the informed consent form:
Use of any monoclonal antibody products or their fragments for any indications.
Total lymphoid irradiation.
Bone marrow transplantation, including stem and hematopoietic cell transplantation for any indications.
Splenectomy (removal of the spleen).
Use, for a certain period of time and at certain doses, of immunoglobulin products, immunosuppressive drugs, synthetic disease-modifying anti-rheumatic drugs, alkylating agents, vaccines, etc.
Presence of one or more of the listed conditions within 8 weeks prior to the signing of the informed consent form and during the screening period: acute anterior uveitis, exacerbated IBD (Crohn’s disease attack or exacerbation (relapse, attack) of ulcerative colitis), exacerbated psoriasis.
Other concomitant diseases or conditions that may affect the safety of BCD-180 or preclude any of the necessary study procedures.
Pregnancy, pregnancy planning (including pregnancy of female sexual partners of a male subject included in the study) less than 8 weeks after the last administration of the study drug or placebo, breastfeeding.
Contraindications to MRI.
Simultaneous participation in other clinical studies, as well as previous participation in other clinical studies less than 3 months before signing the informed consent form, prior participation in this study, with the exception of participants who dropped out of this study at screening.
The study will be conducted in study centers of different Russian and Belarusian cities, including Moscow, Saint Petersburg, Saratov, Nizhny Novgorod, Kazan, Smolensk, Ulyanovsk, Yekaterinburg, Rostov-on-Don, Volgograd, Omsk, Chelyabinsk, Irkutsk, Novosibirsk, Kemerovo, Minsk, Brest, and other cities.
You can ask questions about participation in the clinical study and request contact information about study centers using a special form «Do you have any questions?».
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.
Authorization of the Ministry of Health of the Russian Federation for this clinical study, No. 160 dated March 14, 2022, and the list of approved study centers have been published in the State Register of Medicines.
Authorization of the Ministry of Health of the Republic of Belarus for this clinical study, No. 58/1514/2022 dated November 03, 2022, and the list of approved study centers have been published in the State Register of Clinical Studies of the Republic of Belarus.
CRP, C-reactive protein
The pregnancy test is not performed in women who have been postmenopausal for at least 2 years or are surgically sterile).
Reliable methods of contraception include any barrier method in combination with one of the following: spermicides, intrauterine device, oral contraceptives for the sexual partner.
Sexual partners of study participants should also be prepared to use reliable methods of contraception for the specified period of time.
This requirement does not apply to subjects who have undergone surgical sterilization, as well as to women who have been postmenopausal for more than 2 years.