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AzTrials

Axial SpondyloarthritisPhase 3NCT06333210

Study of the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of BCD-180 in Patients With Axial Spondyloarthritis (LEVENTA)

A Phase 3 study testing anti-TRBV9 monoclonal antibody infusions and Adalimumab subcutaneous injection in people with Axial Spondyloarthritis, run by Biocad at 32 sites in 2 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

The aim of the study is to evaluate the efficacy, safety, immunogenicity, pharmacokinetics and pharmacodynamics of a fixed dose of study drug (BCD-180) in comparison with placebo in patients with active axial spondyloarthritis (axSpA). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Axial Spondyloarthritis
What is being tested?
anti-TRBV9 monoclonal antibody infusions and Adalimumab subcutaneous injection
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
421 participants
Where
32 sitesin 2 countries
Study dates
25 Dec 2023to Feb 2028
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Signed Informed Consent Form for participation in the study.
  • Men and women aged >18 years of age at the time of signing the Informed Consent Form for participation.
  • Positive test result for HLA-B27.
  • 4. Presence of r-axSpA OR nr-axSpA according to the criteria provided below:
  • r-axSpA: axSpA diagnosis meets the ASAS 2009 criteria subject to the presence of radiographic signs of sacroiliitis according to the modified New York criteria (van der Linden et al. 1984) according to the central review. Subjects with an established diagnosis of ankylosing spondylitis according to the modified New York criteria may also be included in the study (van der Linden et al. 1984).
  • nr-axSpA: axSpA diagnosis meets ASAS 2009 criteria in the absence of radiographic signs of sacroiliitis according to the modified New York criteria (van der Linden et al. 1984) according to the central review.
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  • Active disease at the screening and the randomization visit diagnosed based on both criteria:
  • ASDAS-CRP ≥2.1
  • assessment of the severity of back pain ≥4 on the NRS (BASDAI, question No. 2).
  • For subjects with nr-axSpA: presence of objective MRI signs of sacroiliitis (according to ASAS/OMERACT) as assessed by the central review AND/OR based on hsCRP level >1.5 ULN at screening.
  • For subjects with r-axSpA: hsCRP level ˃1.5 ULN at screening.
  • Duration of back pain ≥3 months, age <45 years at the onset of the axSpA-associated back pain.
  • Meeting at least one of the following criteria based on the Investigator's assessment:
  • Inadequate response to therapy with NSAIDs defined as insufficient response to therapy with NSAIDs at therapeutic doses for at least 4 weeks, or insufficient response to therapy with two NSAIDs at the maximum permitted dose with the total duration of therapy of at least 4 weeks;
  • Contraindications for therapy with NSAIDs;
  • Intolerance of therapy with more than one NSAID.
  • For bDMARDs-experienced and/or targeted synthetic DMARD-experienced subjects (tsDMARD): meeting at least one of the following criteria based on the Investigator's assessment:
  • lack and/or loss of efficacy, according to the European Alliance of Associations for Rheumatology 2022 (EULAR 2022) recommendations, while on therapy with adequate doses of bDMARDs or tsDMARDs for ≥12 weeks;
  • intolerance of bDMARDs and/or tsDMARDs used for the treatment of axSpA (regardless of treatment duration).
  • For subjects continuing to receive NSAIDs or COX-2 inhibitors: the drug dose shall be steady for at least 14 days prior to Visit 1/Week 0.
  • For women: negative pregnancy test result at screening (the test is not performed in women who have been postmenopausal for at least 2 years or are surgically sterile) .
  • The ability of the subject to follow the Protocol procedures, according to the Investigator.
  • Willingness of subjects and their sexual partners of childbearing potential to use reliable methods of contraception from the date of signing the ICF, throughout the study, and for 8 weeks after the last administration of BCD-180/placebo (infusions)/adalimumab/placebo (subcutaneously). This requirement does not apply to subjects who have had operative sterilization and women who have been postmenopausal for more than 2 years.
  • For participants of childbearing potential, from signing the informed consent form, throughout the study, and for 8 weeks after the last dose of BCD-180/placebo (intravenously)/adalimumab/placebo (subcutaneous):
  • no egg donation for female subjects;
  • no sperm donation for male subjects.

Who cannot join

  • Refusal to take NSAIDs for the treatment of axSpA for any subjective reasons that do not have a clinical justification.
  • Use of the following medicines/procedures:
  • at any time before signing the ICF: total lymphoid irradiation;
  • at any time before signing the ICF: bone marrow transplantation, including stem and hematopoietic cell transplantation for any indications;
  • at any time before signing the ICF: splenectomy;
  • within 8 weeks before signing the ICF: treatment with immunoglobulins;
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  • within 12 months before signing the ICF: use of immunosuppressants. Exception: glucocorticoids. A subject receiving glucocorticoids may be included in the study provided that the daily dose of glucocorticoids is ≤10 mg/day (calculated with reference to prednisolone) and was stable for at least 4 weeks prior to the Randomization Visit.
  • within 4 weeks before signing the ICF and during the screening period: use of synthetic DMARDs and thiopurines, including, but not limited to: 6-mercaptopurine, azathioprine, and others.
  • Exception: the medicinal products listed below if their dose was stable for 4 weeks before signing the ICF and during the screening period:
  • oral or parenteral methotrexate at a dose ≤25 mg/week, therapy shall be started at least 8 weeks before signing the ICF;
  • 5-aminosalicylic acid and its derivatives, including sulfasalazine, at a dose not exceeding 3 g/day, provided that therapy was started at least 8 weeks before signing the ICF. Subjects with inflammatory bowel disease (IBD) may be treated with topical 5-aminosalicylic acid at therapeutic doses;
  • intra-articular and paraspinal glucocorticoids within 4 weeks prior to the Randomization Visit, intramuscular glucocorticoids within 2 weeks prior to the Randomization Visit;
  • use of alkylating agents at any time within 12 months prior to signing the ICF;
  • BCD-180 administration at any time before signing the ICF.
  • Vaccination with any vaccines within 12 weeks prior to signing the ICF.
  • Documented presence of one or more of the listed conditions:
  • within 8 weeks before signing the ICF and during the screening period: exacerbated IBD (attack of Crohn's disease or exacerbation (relapse, attack) of ulcerative colitis), severe, generalized, pustular, exudative, psoriasis of the hands and feet;
  • acute uveitis within less than 2 weeks prior to signing the ICF and during the screening period.
  • Clarification: for subjects with IBD: IBD therapy must be stable for 8 weeks prior to signing the ICF. For subjects with psoriasis: topical products may be used.
  • A current diagnosis or a history of a severe immunodeficiency of any origin.
  • A diagnosis of HIV infection, hepatitis B, hepatitis C.
  • The following laboratory test results at screening:
  • Transaminase (ALT and/or AST) activity >1.5×ULN;
  • ALP activity >1.5×ULN;
  • WBC count <3.0 cells×109/L;
  • Neutrophil count <1.5 cells×109/L;
  • Lymphocyte count <0.8 cells×109/L;
  • Platelet count <100 cells × 109/L;
  • Hemoglobin level <100 g/L;
  • Serum blood creatinine >ULN.
  • Clinically significant thyroid disease and/or clinically significant deviation of the TSH level from the reference values at screening.
  • Diagnosis of active or latent tuberculosis, including a history of tuberculosis .
  • Major surgery within 4 weeks prior to signing the ICF or major surgery planned for the period of participation in the study.
  • Documented diagnosis of infectious mononucleosis within 8 weeks prior to signing the ICF and during the screening period, any active infection or recurrent infection within 4 weeks prior to signing the ICF and during the screening period, including fever ≥38°C at the Randomization Visit.
  • Documented diagnosis of any other chronic infection that, in the opinion of the investigator, can increase the risk of infectious complications.
  • Severe infectious diseases (requiring hospitalization, parenteral use of antibacterial, antimycotic or antiprotozoal drugs) within 8 weeks prior to signing the ICF and during the screening period.
  • Systemic antibacterial, antimycotic or antiprotozoal therapy within 8 weeks prior to signing the ICF and during the screening period.
  • Epileptic seizures, a history of seizures.
  • A history of or current (at the time of signing the ICF and during the screening period) significant uncontrolled neuropsychiatric disorders, severe depression and/or suicide attempts, a risk of suicide and/or any psychiatric illness that, in the opinion of the investigator, may pose an excessive risk to the subject or have an impact on the subject's ability to follow the protocol.
  • Known (including from historical data) alcohol or drug dependence, psychoactive substance or drug abuse, evidence of alcohol/drug dependence or current abuse that, in the investigator's opinion, is a contraindication to AS therapy or limits treatment adherence.
  • The following diseases:
  • at screening and/or in the past and at the Randomization Visit: non-axSpA inflammatory joint disease (including rheumatoid arthritis, gout, psoriatic arthritis, Lyme disease, etc.),
  • at screening and/or at the Randomization Visit: reactive arthritis,
  • at screening and/or in the past and at the Randomization Visit: systemic autoimmune diseases (including systemic lupus erythematosus, systemic scleroderma, inflammatory myopathy, mixed forms of inflammatory connective tissue diseases, overlap syndrome, etc.).
  • Exception: the following subjects may be included in the study:
  • eligible patients with psoriasis;
  • diagnosed with IBD, at the stage of remission without the need for systemic therapy;
  • with uveitis associated with axSpA, except for subjects with severe visual impairment or with sight in one eye, subjects with corneal opacity, significant cataract, posterior capsule opacity, or posterior synechia in the studied eye of such severity that makes assessment of uveitis severity insufficient or impossible. Clarification: the study may include subjects with prior acute uveitis 2 weeks after the resolution, including those receiving topical therapy, including intra-bulbar administration of glucocorticoids.
  • Comorbidities (including, but not limited to, metabolic, hematological, renal, hepatic, pulmonary, neurological, endocrine, cardiac, infectious, gastrointestinal disorders), including disorders ongoing at the time of screening, which, in the opinion of the investigator, may affect the course of radiographic axSpA, the results of assessment of its symptoms, or create an unacceptable risk to the subject from study therapy.
  • Known allergy or intolerance to any component of the test drug, premedication drugs used in this clinical study. For bDMARDs and/or tsDMARD-naive subjects: known allergy or intolerance of any components of adalimumab.
  • For bDMARDs and/or tsDMARD-naive subjects: contraindications for the use of adalimumab.
  • A history of angioedema.
  • Fibromyalgia, or other conditions associated with chronic pain .
  • Lymphoproliferative diseases or malignancies with a remission duration of less than 5 years, with the exception of cured basal cell carcinoma and cervical cancer in situ.
  • Pregnancy, pregnancy planning (including pregnancy of female sexual partners of male study subjects) less than 8 weeks after the last administration of BCD-180/placebo (intravenously)/adalimumab/placebo (subcutaneous), 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 ICF, prior participation in this study.
  • Exception: subjects who dropped out of this study at screening.

Trial locations and contacts

32 sites in 2 countries.

32 sites in 2 countries

Russia30 sites

  • KGBU "City Hospital No. 4 named after N.P. Gull, Barnaul"

    Barnaul

  • Chelyabinsk Regional Clinical hospital

    Chelyabinsk

  • Regional State Budgetary Healthcare Institution "Irkutsk City Clinical Hospital 1"

    Irkutsk

  • Republican Clinical Diagnostic Center of the Ministry of Health of the Udmurt Republic

    Izhevsk

  • Republican Clinical Hospital of the Ministry of Health of the Republic of Tatarstan

    Kazan'

  • State Autonomous Healthcare Institution "Kuzbass Clinical Emergency Hospital named after M. A. Podgorbunsky"

    Kemerovo

  • Federal State Budgetary Institution "Pirogov National Medical Surgical Center" of the Ministry of Health of the Russian Federation

    Moscow

  • Federal State Budgetary Scientific Institution "Research Institute of Rheumatology named after V.A. Nasonova"

    Moscow

  • State Budgetary Healthcare Institution of Moscow City "City Clinical Hospital 15 named after O.M. Filatov of the Moscow City Health Department"

    Moscow

  • State Budgetary Healthcare Institution of Moscow City Clinical Hospital 1 named after N.I. Pirogov of the Moscow City Health Department

    Moscow

  • State Budgetary Higher Vocational Education Institution I.M. Sechenov First Moscow State Medical University

    Moscow

  • State Budgetary Healthcare Institution "Center of Allergology and Immunology" of Kabardino-Balkarian Republic

    Nal'chik

  • State Budgetary Healthcare Institution of the Nizhny Novgorod Region "Nizhny Novgorod Regional Clinical Hospital named after N. A. Semashko"

    Nizhny Novgorod

  • Federal State Budgetary Scientific Institution "Institute of Cytology and Genetics of the Siberian Branch of the Russian Academy of Sciences"

    Novosibirsk

  • Budgetary healthcare institution of the Omsk region "Regional clinical hospital"

    Omsk

  • State Budgetary Healthcare Institution of Perm Krai "Order of Honour" Perm Regional Clinical Hospital "

    Perm

  • Federal State Budgetary Educational Institution of Higher Education "Rostov State Medical University" of the Ministry of Health of the Russian Federation

    Rostov-on-Don

  • Clinical Rheumatology Hospital №25

    Saint Petersburg

  • Federal State Budgetary Educational Institution of Higher Education "St. Petersburg State University"

    Saint Petersburg

  • Federal State Budgetary Institution "Almazov National Medical Research Center" of the Ministry of Health of the Russian Federation

    Saint Petersburg

  • North-Western State Medical University n.a. I.I.Mechnikov

    Saint Petersburg

  • State Budgetary Healthcare Institution "Samara Regional Clinical Hospital named after V.D. Seredavin"

    Samara

  • Private Healthcare Institution "Clinical Hospital" RD-Medicine "of the city of Saratov

    Saratov

  • Private Healthcare Institution "Clinical Hospital" RD-Medicine "of Smolensk

    Smolensk

  • Federal State Budgetary Educational Institution of Higher Education "Siberian State Medical University"

    Tomsk

  • Republican Clinical Hospital named after G. G. Kuvatov

    Ufa

  • State Healthcare Institution Ulyanovsk Regional Clinical Hospital

    Ulyanovsk

  • State Healthcare Institution "City Clinical Emergency Hospital 25"

    Volgograd

  • State Budgetary Healthcare Institution of the Yaroslavl Region "Clinical Hospital named after N.A. Semashko"

    Yaroslavl

  • State Autonomous Healthcare Institution of the Sverdlovsk Region "City Clinical Hospital 14 Ekaterinburg"

    Yekaterinburg

Other trials in Russia

Belarus2 sites

  • 1St City Clinical Hospital, Minsk

    Minsk

  • State Institution "Minsk Scientific and Practical Center for Surgery, Transplantology and Hematology"

    Minsk

Other trials in Belarus

About this study

Official title: A Randomized, Double-Blind, Placebo-Controlled Clinical Study of the Efficacy and Safety of BCD-180 in Patients With Active Axial Spondyloarthritis

The aim of the study is to evaluate the efficacy, safety, immunogenicity, pharmacokinetics and pharmacodynamics of a fixed dose of study drug (BCD-180) in comparison with placebo in patients with active axial spondyloarthritis (axSpA). The study will include HLA-B27+ patients with radiographic (r-axSpA) and non-radiographic (nr-axSpA) who had no response to prior therapy with non-steroidal anti-rheumatic drugs (NSAIDs), have not received biologic disease-modifying anti-rheumatic drugs (bDMARDs) or targeted synthetic disease-modifying antirheumatic drugs (tsDMARDs), and subjects with insufficient efficacy and/or loss of efficacy on bDMARDs and/or tsDMARDs.

Read the detailed description

Subjects meeting the eligibility criteria will be randomized in 2 groups:bDMARDs and/or tsDMARD naive subjects and bDMARDs and/or tsDMARD experienced subjects will be randomized independently of each other.

bDMARDs and tsDMARD-naive subjects (naïve) will be randomized into 3 groups:

  • BCD-180 (naïve);
  • Placebo (naïve);
  • Adalimumab. bDMARDs and/or tsDMARD experienced subjects (exp) will be randomized into 2 groups:
  • BCD-180 (exp);
  • Placebo (exp).

After the primary endpoint assessment all subjects will be switched to BCD-180.

Being tested
anti-TRBV9 monoclonal antibody infusions, Placebo infusions, Adalimumab subcutaneous injection, Placebo subcutaneous injection
Keywords
biologics, axial spondyloarthritis, monoclonal antibodies, TRBV9
Medical subject headings
Axial Spondyloarthritis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • anti-TRBV9 monoclonal antibody infusionsBiological

    Also called BCD-180 infusions

    infusions

  • Placebo infusionsOther

    infusions

  • Adalimumab subcutaneous injectionDrug

    subcutaneous injection

  • Placebo subcutaneous injectionOther

    subcutaneous injection

Study groups in NCT06333210
Study groupRoleWhat they receive
bDMARDs and/or tsDMARD experienced subjects, BCD-180 groupExperimentalSubjects in this arm will receive a fixed dose of BCD-180 infusions
Receives: Biological: anti-TRBV9 monoclonal antibody infusions
bDMARDs and/or tsDMARD experienced subjects, Placebo groupPlacebo comparatorSubjects in this arm will receive Placebo infusions till the assessment of the primary endpoint and then will be switched to BCD-180 infusions
Receives: Other: Placebo infusions
bDMARDs and tsDMARD-naive subjects, BCD-180 groupExperimentalSubjects in this arm will receive a fixed dose of BCD-180 infusions and subcutaneous injections of placebo to maintain blindness of adalimumab therapy till the assessment of the primary endpoint, thereafter subjects will receive only BCD-180 infusions
Receives: Biological: anti-TRBV9 monoclonal antibody infusions; Other: Placebo subcutaneous injection
bDMARDs and tsDMARD-naive subjects, Placebo groupPlacebo comparatorSubjects in this arm will receive Placebo infusions and subcutaneous injections of placebo to maintain blindness of adalimumab therapy till the assessment of the primary endpoint, thereafter subjects will be switched to BCD-180 infusions
Receives: Other: Placebo infusions; Other: Placebo subcutaneous injection
bDMARDs and tsDMARD-naive subjects, Adalimumab groupActive comparatorSubjects in this arm will receive subcutaneous injections of adalimumab and infusions of placebo till the assessment of the primary endpoint, thereafter subjects will be switched to BCD-180 infusions
Receives: Other: Placebo infusions; Drug: Adalimumab subcutaneous injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of subjects who achieved ASAS40 among bDMARDs and tsDMARD-naive subjects

    Ratio of patients who developed a decrease in ankylosing spondylitis assessment score (ASAS) by 40% or more

    Measured: [Time Frame: week 24]

  2. Proportion of subjects who achieved ASAS40 among bDMARDs and/or tsDMARD-experienced subjects

    Ratio of patients who developed a decrease in ankylosing spondylitis assessment score (ASAS) by 40% or more

    Measured: [Time Frame: week 24]

Secondary outcomes (35)

  1. Proportion of subjects who achieved ASAS40 among subjects with r-axSpA

    Ratio of patients who developed a decrease in ankylosing spondylitis assessment score (ASAS) by 40% or more

    Measured: [Time Frame: week 24]

  2. Proportion of subjects who achieved ASAS40 among subjects with nr-axSpA

    Ratio of patients who developed a decrease in ankylosing spondylitis assessment score (ASAS) by 40% or more

    Measured: [Time Frame: week 24]

  3. Proportion of subjects with the ASDAS-CRP <1.3

    Proportion of subjects with the Ankylosing Spondylitis Disease Activity Score-C-reactive protein (ASDAS-CRP) score <1.3

    Measured: [Time Frame: weeks 1, 2, 3, 4, 8, 12, 16, 20, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156]

  4. Proportion of subjects with the ASDAS-CRP ≥1.3 - <2.1

    Proportion of subjects with the Ankylosing Spondylitis Disease Activity Score-C-reactive protein (ASDAS-CRP) score ≥1.3 - <2.1

    Measured: [Time Frame: weeks 1, 2, 3, 4, 8, 12, 16, 20, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156]

  5. Proportion of subjects with the ASDAS-CRP ≥2.1 - ≤3.5

    Proportion of subjects with the Ankylosing Spondylitis Disease Activity Score-C-reactive protein (ASDAS-CRP) score ≥2.1 - ≤3.5

    Measured: [Time Frame: weeks 1, 2, 3, 4, 8, 12, 16, 20, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156]

  6. Proportion of subjects with the ASDAS-CRP >3.5

    Proportion of subjects with the Ankylosing Spondylitis Disease Activity Score-C-reactive protein (ASDAS-CRP) score >3.5

    Measured: [Time Frame: weeks 1, 2, 3, 4, 8, 12, 16, 20, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156]

  7. Proportion of subjects who achieved ASDAS-CII (clinically important improvement)

    Clinically important improvement defined as a decrease from baseline in ASDAS ≥1.1

    Measured: [Time Frame: weeks 1, 2, 3, 4, 8, 12, 16, 20, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156]

  8. Proportion of subjects who achieved ASDAS-MI (Major improvement)

    Major improvement (MI) defined as a decrease from baseline in ASDAS ≥2.0

    Measured: [Time Frame: weeks 1, 2, 3, 4, 8, 12, 16, 20, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156]

  9. ASDAS-CRP change from baseline

    Measured: [Time Frame: weeks 1, 2, 3, 4, 8, 12, 16, 20, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156]

  10. Proportion of patients who achieved clinical response defined as an improvement of BASDAI by at least 50% compared to baseline

    Measured: [Time Frame: weeks 1, 2, 3, 4, 8, 12, 16, 20, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156]

  11. Change from baseline in BASDAI

    Change from baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)

    Measured: [Time Frame: weeks 1, 2, 3, 4, 8, 12, 16, 20, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156]

  12. Proportion of subjects who achieved ASAS40

    Ratio of patients who developed a decrease in ankylosing spondylitis assessment score (ASAS) by 40% or more

    Measured: [Time Frame: weeks 1, 2, 3, 4, 8, 12, 16, 20, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156]

  13. Proportion of subjects who achieved ASAS20

    Ratio of patients who developed a decrease in ankylosing spondylitis assessment score (ASAS) by 20% or more

    Measured: [Time Frame: weeks 1, 2, 3, 4, 8, 12, 16, 20, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156]

  14. Proportion of subjects who achieved ASAS5/6

    Ratio of patients who developed a response in at least 5 of 6 criteria of ankylosing spondylitis assessment score (ASAS)

    Measured: [Time Frame: weeks 8, 12, 16, 20, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156]

  15. Proportion of subjects who achieved ASAS partial remission

    Measured: [Time Frame: weeks 1, 2, 3, 4, 8, 12, 16, 20, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156]

  16. Change from baseline in BASMI

    Change from baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) score

    Measured: [Time Frame: weeks 8, 12, 16, 20, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156]

  17. Change from baseline in BASFI

    Change from baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) score

    Measured: [Time Frame: weeks 1, 2, 3, 4, 8, 12, 16, 20, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156]

  18. Change from baseline in the swollen joint count (44 joints)

    Measured: [Time Frame: weeks 4, 8, 12, 16, 20, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156]

  19. Change from baseline in MASES

    Change from baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES)

    Measured: [Time Frame: weeks 8, 12, 16, 20, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156]

  20. Change from baseline in overall back pain severity (BASDAI No. 2)

    Measured: [Time Frame: weeks 1, 2, 3, 4, 8, 12, 16, 20, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156]

  21. Change from baseline in nocturnal back pain severity

    Change from baseline in nocturnal back pain score during measured by Visual Analog Scale for Pain

    Measured: [Time Frame: weeks 1, 2, 3, 4, 8, 12, 16, 20, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156]

  22. Change in the patient global assessment of disease activity from baseline

    Measured: [Time Frame: weeks 1, 2, 3, 4, 8, 12, 16, 20, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156]

  23. Change in the quality of life score assessed with EQ-5D-3L questionnaire from baseline

    Measured: [Time Frame: weeks 12, 24, 48, 72, 84, 96, 108, 132, 156, 160]

  24. Change from baseline in SF-36 Physical Functioning compared to baseline

    Measured: [Time Frame: weeks 4, 8, 12, 16, 20, 24, 48, 72, 84, 96, 108, 120, 132, 144, 156, 160]

  25. Change from baseline in SF-36 Mental Health compared to baseline

    Measured: [Time Frame: weeks 4, 8, 12, 16, 20, 24, 48, 72, 84, 96, 108, 120, 132, 144, 156, 160]

  26. Change in the WPAI score from baseline

    Change from baseline in Work Productivity and Activity Impairment (WPAI)

    Measured: [Time Frame: weeks 12, 24, 48, 72, 84, 96, 120, 132, 144, 156, 160]

  27. Change in the ASAS HI score from baseline

    Change from baseline in ASAS Health Index

    Measured: [Time Frame: weeks 12, 24, 48, 72, 84, 96, 120, 132, 144, 156, 160]

  28. Change in the concentration of hsCRP from baseline

    Measured: [Time Frame: weeks 4, 8, 12, 16, 20, 24, 48, 72, 84, 96, 108, 120, 132, 144, 156, 160]

  29. Change in ESR from baseline

    Measured: [Time Frame: weeks 4, 8, 12, 16, 20, 24, 48, 72, 84, 96, 108, 120, 132, 144, 156, 160]

  30. Changes in the SPARCC score (spine, SIJ) from baseline

    Change from baseline in Spondyloarthritis Research Consortium of Canada Enthesitis (SPARCC)

    Measured: [Time Frame: weeks 24, 48, 108, 144, 156]

  31. Changes in mSASSS scores from baseline

    Change from baseline in Modified stoke ankylosing spondylitis spinal score (mSASSS)

    Measured: [Time Frame: weeks 48, 108, 144,156]

  32. Proportion of subjects with adverse events

    Measured: [Time Frame: weeks 24, 160]

  33. Proportion of subjects with serious adverse events

    Measured: [Time Frame: weeks 24, 160]

  34. Proportion of subjects with grade 3 or higher adverse events according to CTCAE 5.0

    Measured: [Time Frame: weeks 24, 160]

  35. Proportion of subjects prematurely withdrawn from the study due to adverse events

    Measured: [Time Frame: weeks 24, 160]

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Mar 2024
  2. Study start25 Dec 2023
  3. Primary completionDec 2024 (estimated)
  4. Study completionFeb 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
421 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06333210
Sponsor's protocol ID
BCD-180-3
Status last verified
May 2024
First submitted
20 Mar 2024
Last updated
3 Jun 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing anti-TRBV9 monoclonal antibody infusions and Adalimumab subcutaneous injection in people with Axial Spondyloarthritis, run by Biocad at 32 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 26 inclusion and 58 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 3 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 32 sites in Russia, Belarus. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of subjects who achieved ASAS40 among bDMARDs and tsDMARD-naive subjects (time frame: [Time Frame: week 24]). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06333210.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2024.

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