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

NCT05445076 | Active Not Recruiting Phase 2 DMC

• 1 other identifier: BCD-180-2
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 2

Brief 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). 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).

Conditions

Axial Spondyloarthritis

Keywords

biologics; axial spondyloarthritis; monoclonal antibodies; TRBV9

Outcome Measures

Primary Outcomes (1)

• Proportion of subjects who achieved ASAS40

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

  week 24

Secondary Outcomes (30)

• Proportion of subjects with the ASDAS-CRP <1.3

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

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

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

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

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

• Proportion of subjects with the ASDAS-CRP >3.5

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

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

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

Study Arms (3)

BCD-180, low dose

EXPERIMENTAL

Subjects in this arm will receive BCD-180 low dose infusions

Biological: anti-TRBV9 monoclonal antibody, low dose

BCD-180, high dose

EXPERIMENTAL

Subjects in this arm will receive BCD-180 high dose infusions

Biological: anti-TRBV9 monoclonal antibody, high dose

Placebo

PLACEBO COMPARATOR

Subjects in this arm will receive placebo till the assessment of the primary endpoint and then will be switched to BCD-180 low dose

Biological: anti-TRBV9 monoclonal antibody, low dose; Other: placebo

Interventions

anti-TRBV9 monoclonal antibody, low dose BIOLOGICAL

infusion

BCD-180, low dose; Placebo

anti-TRBV9 monoclonal antibody, high dose BIOLOGICAL

infusion

BCD-180, high dose

placebo OTHER

infusion

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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;
• 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;
• 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;

Sponsors & Collaborators

• Biocad: lead

Study Sites (2)

Clinical Rheumatology Hospital №25

Saint Petersburg, Russia

Location

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

Saint Petersburg, Russia

Location

MeSH Terms

Conditions

Axial Spondyloarthritis

Condition Hierarchy (Ancestors)

Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Ankylosis; Joint Diseases; Arthritis

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2022
• First Posted: July 6, 2022
• Study Start: April 19, 2022
• Primary Completion: December 1, 2025
• Study Completion (Estimated): June 1, 2027
• Last Updated: April 18, 2023

Record last verified: 2022-06

Locations

RU (2)