BCD-180-4 A Randomized, Open-Label, Exploratory Pharmacodynamic Study of Seniprutug in Patients with Ankylosing Spondylitis.
Over the course of the BCD-180-4 clinical trial, the pharmacodynamics, safety, immunogenicity, pharmacokinetics and efficacy of Seniprutug will be assessed in subjects with ankylosing spondylitis (radiologic axial spondyloarthritis), both in pretreated with interleukin-17 inhibitors and not previously treated with genetically engineered biological medicinal products/targeted synthetic baseline anti-inflammatory drugs, who:
Are between 18 and 65 years of age at the time of signing the Informed Consent Form;
Have documentary evidence of a diagnosis of ankylosing spondylitis established according to the modified New York Classification criteria1;
Have documentary evidence of being a carrier of Human Leucocyte Antigen-B272;
Have a high level of disease activity;
Have been previously treated with genetically engineered biological medicinal products (GEBPs) and/or targeted synthetic baseline anti-inflammatory drugs (tsDMARDs) and have inadequate efficacy and/or loss of effect, or intolerance to GIBPs and/or tsDMARDs.3.
This clinical trial has exclusion criteria (criteria for non-eligibility for participation in a specific clinical trial), the full list of which will be communicated to the potential participant by the Investigator. In particular, the exclusion criteria are:
Previous treatment with GEBPs/tsDMARDs and no treatment with IL-17 inhibitors4;
Refusal of treatment with NSAIDs5/iCOX-26 for the treatment of ankylosing spondylitis for any subjective reasons without clinical justification;
Total spinal ankylosis;
History of extraskeletal manifestations of ankylosing spondylitis (inflammatory bowel disease; severe, generalized, and other forms of psoriasis other than psoriasis vulgaris (e.g., pustular, exudative, palm and plantar psoriasis); uveitis) at the time of signing the informed consent (IC). Subjects with relapsed uveitis outside the exacerbation period (not less than 2 weeks after the exacerbation has resolved) may be included;
Use of products related to immunoglobulins, immunosuppressive products, synthetic baseline anti-inflammatory products, alkylating agents, vaccination, etc., at definite doses over a definite period of time;
Immunization with any vaccines within 12 weeks prior to signing the IC;
Diagnosis of HIV infection, hepatitis B, including history hereof; acute or chronic hepatitis C;
Active or latent tuberculosis, including history of tuberculosis;
Severe infectious diseases (requiring hospitalization and parenteral antibacterial, antimycotic or antiprotozoal agents) in the subject within the 8 weeks prior to signing the IC and during the Screening period8;
Fibromyalgia9 or other conditions followed by chronic pain syndrome;
Lymphoproliferative diseases or malignancy with a remission duration of less than 5 years, except cured basal cell carcinoma or in situ cervical cancer10;
Pregnancy, planning pregnancy (including pregnancy of female sex partners when a male subject is included in the study) within less than 8 weeks after the last administration of Seniprutug or 12 weeks after the last administration of Netakimab, or breastfeeding period;
MRI contraindications. Concurrent participation in other clinical trials, prior participation in other clinical trials within less than 3 months prior to signing the IC, and prior participation in this trial.
Use of the drug Seniprutug at any time before signing the Informed Consent (IC).
The BCD-180-4 clinical trial is being conducted at study sites in numerous cities of the Russian Federation, including Moscow, St. Petersburg, Gatchina, Nizhny Novgorod, Yekaterinburg, Tomsk, Novosibirsk, Chelyabinsk, and Ufa.
To ask questions about potential participation in a clinical trial, including contact details of study sites, please use a special form at ct.biocad.ru.
The Investigator will inform the potential participant about other eligibility criteria and contraindications for participation in this clinical trial. The potential participant should read the complete study information and consult with the Clinical Investigator and/or their attending physician.
Clinical Study Authorization No. 31 dated February 2, 2026 of the Ministry of Health of the Russian Federation and the list of authorized study sites are published in the State Register of Medicines.
New York classification is a scale according to which ankylosing spondylitis (AS) is diagnosed based on a combination of clinical signs and radiological data (sacroileitis).
HLA-B27 antigen is a specific protein found on the surface of cells which is an immunogenetic marker of high predisposition to axial spondyloarthritis (Bechterew's disease).
Targeted synthetic DMARDs (tsDMARDs) are a group of synthetic anti-inflammatory drugs of chemical origin.
IL-17 (interleukin-17) inhibitors are a group of genetically engineered biological products (GEBPs) that block the pro-inflammatory protein of the same name.
NSAIDs (non-steroidal anti-inflammatory drugs) are a class of products that have a non-selective effect on cyclooxygenase (COX) enzymes.
Selective COX-2 inhibitors selectively inhibit cyclooxygenase-2 (COX-2), the COX enzyme isoform responsible for inflammation and pain.
TSH (thyroid stimulating hormone) is the main regulator of thyroid function, produced by the pituitary gland.
Screening is a specific period for the assessment of the possibility of a subject’s participation in the clinical trial according to the eligibility criteria based on the results of diagnostic procedures and specialists’ consultations.
Fibromyalgia is a condition characterized by a combination of chronic spread muscle pain and a wide range of associated psychosomatic manifestations such as fatigue, sleep disturbances, general stiffness, depression, anxiety, and cognitive impairment.
In situ is the Latin term used in oncology to refer to a tumor in its initial stages of development.