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BCD-180-3/LEVENTA

More about the molecule

Axial Spondyloarthritis, Bechterew’s disease

BCD-180-3/LEVENTA: A Randomized, Double-Blind, Placebo-Controlled Clinical Study of the Efficacy and Safety of BCD-180 in Patients with Active Axial Spondyloarthritis

This clinical study investigates the efficacy, safety, immunogenicity, pharmacokinetics, and pharmacodynamics of a fixed dose of BCD-180 in subjects with axial spondyloarthritis who meet the following criteria:

  • 18 years of age or older;
  • A documented diagnosis of radiologically active axial spondyloarthritis (p-axSpA) or non-radiologically active axial spondyloarthritis (nr-axSpA);
  • High disease activity;
  • A documented HLA-B27+ test result1;
  • Failure of prior treatment with non-steroidal anti-inflammatory drugs (NSAIDs), contraindications to NSAIDs, or intolerance to more than one NSAID;
  • Failure and/or loss of response or intolerance to biologic drugs and/or targeted synthetic disease-modifying anti-rheumatic drugs2; or no prior exposure to biologic drugs and/or targeted synthetic disease-modifying anti-rheumatic drugs2;

This study uses exclusion criteria (criteria of ineligibility for the particular clinical study) a potential participant will be fully informed of by the study doctor. In particular, exclusion criteria include:

  • Refusal to receive NSAIDs for the treatment of axial spondyloarthritis for any subjective reasons without clinical rationale;
  • The following treatments:
    • Total lymphoid irradiation;
    • Bone marrow transplantation, including stem and hematopoietic cell transplantation for any indications;
    • Splenectomy;
    • Immunoglobulin products within 8 weeks before signing the informed consent;
    • Immunosuppressive drugs within 12 months before signing the informed consent (except for glucocorticoids at doses ≤ 10 mg/day);
    • Synthetic disease-modifying anti-rheumatic drugs and thiopurines, including 6-mercaptopurine and azathioprine, within 4 weeks before signing the informed consent and during the screening period3;

    Patients receiving stable doses of the following drugs within 4 weeks before signing the informed consent and during screening are eligible3:

    • oral or parenteral methotrexate at a weekly dose ≤ 25 mg for at least 8 weeks before signing the informed consent;
    • 5-aminosalicylic acid products or derivatives, including sulfasalazine, at daily doses ≤ 3 g for at least 8 weeks before signing the informed consent. Subjects with inflammatory bowel disease (IBD) who receive therapeutic doses of topical 5-aminosalicylic acid products are eligible;
    • Intrathecal and intra-articular injections of glucocorticoids within 4 weeks before the randomization visit4; intramuscular injections of glucocorticoids within 2 weeks before the randomization visit4;
    • Alkylating agents5 within 12 months before signing the informed consent;
    • The investigational product BCD-180 at any time before signing the informed consent;
  • Any vaccines within 12 weeks before signing the informed consent;
  • An exacerbation of IBD within 8 weeks before signing the informed consent;
  • Acute uveitis within 2 weeks before signing the informed consent and during the screening period3;
  • A current diagnosis or a prior history of severe immunodeficiency6;
  • A diagnosis of HIV infection, hepatitis B or C;
  • Active or latent tuberculosis, or a prior history thereof;
  • Clinically significant thyroid diseases;
  • A documented diagnosis of infectious mononucleosis within 8 weeks before signing the informed consent and during the screening period3, any active or recurrent infection within 4 weeks before signing the informed consent and during the screening period3;
  • Severe infectious diseases (requiring hospitalization, parenteral antibacterial, antimycotic or antiprotozoal drugs) within 8 weeks before signing the informed consent and during the screening period3;
  • Systemic use of antibacterial, antimycotic or antiprotozoal drugs within 8 weeks before signing the informed consent and during the screening period3;
  • Epileptic seizures, a history of seizures;
  • Significant uncontrolled neuropsychiatric disorders, severe depression, and/or suicide attempts, or a prior history thereof at the time of signing the informed consent and during the screening period3;
  • Known alcohol or drug addiction, substance or medication abuse, or a prior history thereof;
  • A prior history of inflammatory joint disease other than axial spondyloarthritis (including rheumatoid arthritis, gout, psoriatic arthritis, and Lyme disease), systemic autoimmune diseases;
  • A prior history of angioedema7;
  • Fibromyalgia8 or other conditions associated with chronic pain;
  • Less than 5-year-long remission of a lymphoproliferative disease or a malignant neoplasm, except for cured basal cell carcinoma and cervical carcinoma in situ9;
  • Pregnancy, breastfeeding, or planned pregnancy at any time during the participation in the study and 8 weeks after the scheduled last administration of the study drug in this study.

The centers of the BCD-180-3/LEVENTA study are located in Kazan, Irkutsk, Ulyanovsk, St. Petersburg, Nalchik, Tomsk, Yaroslavl, Izhevsk, Rostov-on-Don, Moscow, Novosibirsk, Smolensk, Omsk, Chelyabinsk, Nizhny Novgorod, Saratov, Perm, Kemerovo, Ufa, Barnaul, Voronezh, Volgograd, and Yekaterinburg.

You can ask questions about participating in the clinical study and clarify contact information of study centers through the “Any questions?” form.


The study doctor will tell the potential participant about the 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. 601 dated October 19, 2023, and the list of approved study centers have been published in the State Register of Medicines.

  1. Human leukocyte antigen (HLA) B27 is a specific protein found on the surface of cells and an immunogenetic marker of a high risk of axial spondyloarthritis (Bekhterev’s disease).
  2. Targeted synthetic disease-modifying antirheumatic drugs (tsDMARDs) are synthetic anti-inflammatory drugs.
  3. Screening is a specific time interval intended to determine whether a subject meets the eligibility criteria to be able to participate in a clinical study based on the results of diagnostic tests and consultations with specialists.
  4. Randomization is the procedure of allocating patients to the groups of investigational products.
  5. Alkylating antineoplastic agents are chemotherapeutic antitumor cytostatic drugs that disrupt the DNA structure and halt the division of malignant cells by attaching an alkyl group to DNA.
  6. Immunodeficiencies are a group of immune system disorders characterized by a compromised ability of the immune system to resist infections.
  7. Angioedema (Quincke’s edema) is an acute and transient edema of the skin and subcutaneous tissues or mucous membranes.
  8. Fibromyalgia is a disorder characterized by a combination of chronic widespread musculoskeletal pain and a wide range of associated psychosomatic manifestations, such as fatigue, sleep disorders, general stiffness, depression, anxiety, and cognitive impairment.
  9. In situ, literally “in place,” is a Latin term denoting the early stage of a tumor.