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Axial SpondyloarthritisPhase 2ELEFTANCT05445076

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

A Phase 2 study testing anti-TRBV9 monoclonal antibody, low dose and anti-TRBV9 monoclonal antibody, high dose in people with Axial Spondyloarthritis, run by Biocad at 2 sites in Russia.

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 two doses of study drug (BCD-180) in comparison with placebo in patients with active radiographic axial spondyloarthritis (axSpA). Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Axial Spondyloarthritis
What is being tested?
anti-TRBV9 monoclonal antibody, low dose and anti-TRBV9 monoclonal antibody, high dose
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
250 participants
Where
2 sitesRussia
Study dates
19 Apr 2022to Jun 2027
Phase
Phase 2
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 to 65 years
  • 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 to 65 years inclusive at the time of signing the Informed Consent Form.
  • An established diagnosis of ankylosing spondylitis according to the modified New York classification criteria (van der Linden et al. 1984).
  • Sacroiliitis (bilateral ≥ grade 2 or unilateral grade 3-4) based on central review of radiographs.
  • Positive ASAS criteria for axial spondyloarthritis (Rudwaleit et al. 2009).
  • Duration of back pain ≥3 months and age of onset of back pain <45 years.
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  • Positive HLA-B27 test.
  • Active disease at screening and at the Randomization Visit, based on both of the following criteria:
  • BASDAI ≥4,
  • back pain NRS score ≥4 (BASDAI question 2).
  • CRP level ≥5 mg/mL at screening.
  • At least one of the following criteria, as assessed by the investigator:
  • Inadequate response to NSAID therapy defined as an insufficient response to NSAID therapy at a therapeutic dose for at least 4 weeks, or an insufficient response to therapy with two NSAIDs at the maximum allowed dose with a total duration of therapy of at least 4 weeks;
  • Contraindications for NSAID therapy;
  • Intolerance to more than one NSAID.
  • For subjects continuing to receive NSAIDs or COX-2 inhibitors: the dose of the drug should be stable for at least 14 days prior to Visit 1/Week 0.
  • For women: a negative pregnancy test 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, in the opinion of the investigator, to follow the protocol procedures.
  • 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 the test drug/placebo. This requirement does not apply to subjects who have had operative sterilization and women who have been postmenopausal for more than 2 years. Reliable methods of contraception include the use of one barrier method in combination with one of the following in the female partner: spermicides, intrauterine device, oral contraceptives.
  • For subjects of childbearing potential (from the ICF signing, throughout the study, and for 8 weeks after the last infusion of the test drug/placebo):
  • no egg donation for female subjects;
  • no sperm donation for male subjects.

Who cannot join

  • Total ankylosis of the spine defined by the presence of syndesmophytes in ≥3 adjacent vertebral segments based on central review of radiographs.
  • Age less than 18 years at disease onset.
  • Refusal to take NSAIDs for the treatment of AS for any subjective reasons that do not have a clinical justification.
  • Use of the following medicines/procedures:
  • at any time before signing the ICF: use of any monoclonal antibodies or their fragments for any indication;
  • at any time before signing the ICF: total irradiation of the lymphatic system;
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  • at any time before signing the ICF: bone marrow transplantation, including transplantation of stem and hematopoietic cells for any indication;
  • at any time before signing the ICF: splenectomy;
  • within 8 weeks before signing the ICF: treatment with immunoglobulins;
  • 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:
  • methotrexate orally or parenterally at a dose not exceeding 25 mg/week, provided that therapy was 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;
  • use of targeted synthetic disease-modifying antirheumatic drugs (kinase inhibitors) 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 following conditions within 8 weeks before signing the ICF and during the screening period: acute anterior uveitis, exacerbated IBD (attack of Crohn's disease or exacerbation (relapse, attack) of ulcerative colitis), exacerbated psoriasis.
  • 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, syphilis.
  • 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 cell×109/L;
  • Platelet count <100 cells×109/L;
  • Hemoglobin level <100 g/L;
  • Serum creatinine level >ULN.
  • A history of hypothyroidism/hyperthyroidism/autoimmune thyroiditis and/or abnormal TSH level at screening.
  • Active or latent tuberculosis, including a history thereof .
  • 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; Clarification: if a subject presents with an acute infection during the screening, the screening can be extended if agreed with the Sponsor. In this case, the Sponsor's representative will decide whether the subject can be randomized. Subjects with body temperature ≥38 °C may be rescreened once 4 weeks after resolution of the condition.
  • A history of coronavirus infection (positive PCR test for SARC-CoV2-RNA) less than 14 weeks before signing the ICF.
  • Clarification: including according to the subject.
  • A 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: subjects with psoriasis who have not previously received and do not currently need systemic therapy, as well as patients with IBD regarded as an extraskeletal manifestation of axSpA, may be included in the study if all other eligibility criteria are met.
  • 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.
  • Grade 3 or 4 obesity.
  • Known allergy or intolerance to any component of the test drug, premedication drugs used in this clinical study.
  • 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 the test drug/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 ICF, prior participation in this study.
  • Exception: subjects who dropped out of this study at screening.

Trial locations and contacts

2 sites in 1 country.

Russia2 sites

  • Clinical Rheumatology Hospital №25

    Saint Petersburg

  • North-Western state Medical University named after I.I. Mechnikov

    Saint Petersburg

Other trials in Russia

About this study

Official title: An International, Multicenter, Double-Blind, Randomized Placebo-Controlled Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of BCD-180 in Patients With Axial Spondyloarthritis

The aim of the study is to evaluate the efficacy, safety, immunogenicity, pharmacokinetics and pharmacodynamics of two doses of study drug (BCD-180) in comparison with placebo in patients with active radiographic axial spondyloarthritis (axSpA). The study will include HLA-B27+ patients with radiographic axSpA who had no response to prior therapy with Non-steroidal anti-inflammatory drugs (NSAIDs), have not received biologic therapy or targeted Disease-modifying antirheumatic drugs (DMARDs).

Read the detailed description

Subjects meeting the eligibility criteria will be randomized in 3 groups to receive one of two studied doses of BCD-180 or placebo.

After the primary endpoint assessment subjects in placebo group will be switched to BCD-180 in minimal studied dose. After the completion of the main period of the study in each of the BCD-180 groups subjects who meet the criterion of non-active radiographic axSpA (ASDAS-CRP <1.3 at two subsequent visits) will be subjected to repeated randomization in two groups for the use of two different dosing regimens. Subjects of the Placebo group will continue to receive BCD-180 infusions.

Being tested
anti-TRBV9 monoclonal antibody, low dose, anti-TRBV9 monoclonal antibody, high dose, placebo
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, low doseBiological

    infusion

  • anti-TRBV9 monoclonal antibody, high doseBiological

    infusion

  • placeboOther

    infusion

Study groups in NCT05445076
Study groupRoleWhat they receive
BCD-180, low doseExperimentalSubjects in this arm will receive BCD-180 low dose infusions
Receives: Biological: anti-TRBV9 monoclonal antibody, low dose
BCD-180, high doseExperimentalSubjects in this arm will receive BCD-180 high dose infusions
Receives: Biological: anti-TRBV9 monoclonal antibody, high dose
PlaceboPlacebo comparatorSubjects in this arm will receive placebo till the assessment of the primary endpoint and then will be switched to BCD-180 low dose
Receives: Biological: anti-TRBV9 monoclonal antibody, low dose; Other: placebo

What is being measured

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

  1. Proportion of subjects who achieved ASAS40

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

    Measured: week 24

Secondary outcomes (30)

  1. 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: weeks 1, 2, 3, 4, 8, 12, 16, 20, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156

  2. 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: weeks 1, 2, 3, 4, 8, 12, 16, 20, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156

  3. 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: 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 >3.5

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

    Measured: 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 who achieved ASDAS-CII (clinically important improvement)

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

    Measured: 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 who achieved ASDAS-MI (Major improvement)

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

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

  7. ASDAS-CRP change from baseline

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

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

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

  9. Change from baseline in BASDAI

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

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

  10. Proportion of subjects who achieved ASAS40

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

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

  11. Proportion of subjects who achieved ASAS20

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

    Measured: 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 ASAS5/6

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

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

  13. Proportion of subjects who achieved ASAS partial remission

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

  14. Change from baseline in BASMI

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

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

  15. Change from baseline in BASFI

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

    Measured: 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 the swollen joint count (44 joints)

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

  17. Change from baseline in MASES

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

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

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

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

  19. 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: weeks 1, 2, 3, 4, 8, 12, 16, 20, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156

  20. Change from baseline in the quality of life assessed using EQ-5D-3L questionnaire

    Measured: weeks 12, 24, 48, 108, 156

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

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

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

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

  23. Change from baseline in ASAS HI compared to baseline

    ASAS Health Index

    Measured: weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156

  24. Change from baseline in SPARCC

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

    Measured: weeks 24, 48, 108, 156

  25. Change from baseline in mSASSS

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

    Measured: weeks 48, 108, 156

  26. Proportion of subjects with adverse events

    Measured: weeks 36, 160

  27. Proportion of subjects with serious adverse events

    Measured: weeks 36, 160

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

    Measured: weeks 36, 160

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

    Measured: weeks 36, 160

  30. Proportion of subjects with adverse events of special interest

    Measured: weeks 36, 160

Timeline

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

  1. First posted6 Jul 2022
  2. Study start19 Apr 2022
  3. Primary completionDec 2025 (estimated)
  4. Study completionJun 2027 (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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
250 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05445076
Sponsor's protocol ID
BCD-180-2
Acronym
ELEFTA
Status last verified
Jun 2022
First submitted
3 Jun 2022
Last updated
18 Apr 2023
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 2 study testing anti-TRBV9 monoclonal antibody, low dose and anti-TRBV9 monoclonal antibody, high dose in people with Axial Spondyloarthritis, run by Biocad at 2 sites in Russia.

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 22 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 18 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Russia. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 (time frame: week 24). 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 NCT05445076.

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 18 Apr 2023.

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