Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02763111
Other study ID # BCD-085-3
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date September 2016
Est. completion date June 2017

Study information

Verified date October 2021
Source Biocad
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

BCD-085-3 is a next step in clinical investigation of BCD-085. BCD-085 is a monoclonal antibody to interleukin 17. During the trial patients with active ankylosing spondylitis will receive 40, 80 or 120 mg of BCD-085 subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10, 12. Efficacy and safety parameters will be evaluated.


Recruitment information / eligibility

Status Completed
Enrollment 88
Est. completion date June 2017
Est. primary completion date June 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - Written informed consent - Age between 18 and 65 years - Active ankylosing spondylitis according to modified criteria of New York classification (1984), that was diagnosed at least 3 months prior to screening. - Active disease according to BASDAI (score 4 or more) if nonsteroidal antiinflammatory drugs were used in the last 3 month prior to screening. - Mean backache intensity equals 4 points or more. - If patient have had biologic therapy to treat ankylosing spondylitis for at least 3 months, there was no positive results of such treatment or patient revealed intolerance to the drug. This therapy must be discontinued at least 12 weeks before enrollment in the study. - Female patients have negative urine pregnancy test. - Patient has no history of tuberculosis. - Patients have negative results of Diaskintest. - Patient has no history of alcohol or drug abuse. Exclusion Criteria: - Total spinal ankylosis. - Allergy or intolerance of monoclonal antibodies or any excipients of study drugs. - Previous receipt of anti-interleukin 17 drugs or anti-interleukin 17 receptor drugs. - Prior use of two or more biologics to tumor necrosis factor alfa. - Prior use of two or more biologics to other targets. Previous receipt of monoclonal antibodies if they were cancelled less that in 12 weeks before signing informed consent. - Patient is taking corticosteroids for up to 4 weeks in a dose more than 10 mg (recalculated to prednisolone) before signing informed consent and during screening, or in a dose less than 10 mg (recalculated to prednisolone) if it was not stable. - Prior use of disease-modifying antirheumatic drugs including methotrexate, sulfasalazin, chloroquine or hydroxychloroquine for up to 4 weeks before randomization, if their dose was not stable for up to 4 weeks before signing informed consent and during screening. - Prior use of live or attenuated vaccines for up to 8 weeks before signing informed consent. - Prior use of alkylating agents for up to 12 months prior to signing informed consent. - Intraarticular use of corticosteroids for up to 4 weeks before randomization.

Study Design


Intervention

Drug:
BCD-085

Other:
Placebo


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Biocad

References & Publications (1)

Erdes S, Nasonov E, Kunder E, Pristrom A, Soroka N, Shesternya P, Dubinina T, Smakotina S, Raskina T, Krechikova D, Povarova T, Plaksina T, Gordeev I, Mazurov V, Reshetko O, Zonova E, Eremeeva A, Chernyaeva E, Makulova T, Ivanov R. Primary efficacy of net — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Ratio of patients with ASAS20 response after 16 weeks of therapy Ratio of patients who developed a decrease in ankylosing spondylitis assessment score (ASAS) by 20% or more after 16 weeks of therapy with BCD-085. Week 16
Secondary Ratio of patients with ASAS20 response after 4, 8, 12 weeks of therapy Ratio of patients who developed a decrease in ankylosing spondylitis assessment score (ASAS) by 20% or more after 4, 8, 12 weeks of therapy with BCD-085. Week 4, Week 8, Week 12
Secondary Ratio of patients with ASAS40 response after 4, 8, 12, 16 weeks of therapy Ratio of patients who developed a decrease in ankylosing spondylitis assessment score (ASAS) by 40% or more after 4, 8, 12, 16 weeks of therapy with BCD-085. Week 4, Week 8, Week 12, Week 16
Secondary Ratio of patients with ASAS5/6 response after 4, 8, 12, 16 weeks of therapy Ratio of patients who developed a response in at least 5 of 6 criteria of ankylosing spondylitis assessment score (ASAS) after 4, 8, 12, 16 weeks of therapy with BCD-085. Week 4, Week 8, Week 12, Week 16
Secondary Mean BASDAI score at screening and after 4, 8, 12, 16 weeks of therapy Mean Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score at screening and after 4, 8, 12, 16 weeks of therapy Screening, Week 4, Week 8, Week 12, Week 16
Secondary Mean BASMI score at screening and after 4, 8, 12, 16 weeks of therapy Mean Bath Ankylosing Spondylitis Metrology Index (BASMI) score at screening and after 4, 8, 12, 16 weeks of therapy Screening, Week 4, Week 8, Week 12, Week 16
Secondary Mean MASES score at screening and after 4, 8, 12, 16 weeks of therapy Mean Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) at screening and after 4, 8, 12, 16 weeks of therapy Screening, Week 4, Week 8, Week 12, Week 16
Secondary Mean chest excursion at screening and after 4, 8, 12, 16 weeks of therapy Mean chest excursion at screening and after 4, 8, 12, 16 weeks of therapy measured by Cloth Tape Measure Technique Screening, Week 4, Week 8, Week 12, Week 16
Secondary Mean BASFI score at screening and after 4, 8, 12, 16 weeks of therapy Mean Bath Ankylosing Spondylitis Functional Index (BASFI) score at screening and after 4, 8, 12, 16 weeks of therapy Screening, Week 4, Week 8, Week 12, Week 16
Secondary Mean ASDAS-CRP score at screening and after 4, 8, 12, 16 weeks of therapy Mean Ankylosing Spondylitis Disease Activity Score-C-reactive protein (ASDAS-CRP) score at screening and after 4, 8, 12, 16 weeks of therapy Screening, Week 4, Week 8, Week 12, Week 16
Secondary Mean SF-36 score at screening and after 8 and 16 weeks of therapy Mean Short Form-36 (SF36) score at screening and after 8, 16 weeks of therapy Screening, Week 8, Week 16
Secondary Mean pain score during a day at screening and after 1, 2, 4, 8, 12, 16 weeks of therapy Mean pain score during a day at screening and after 1, 2, 4, 8, 12, 16 weeks of therapy measured by Visual Analog Scale for Pain Screening, Week 1, Week 2, Week 4, Week 8, Week 12, Week 16
Secondary Proportion of patients with deterioration of roentgenologic signs of sacroileitis after 16 weeks of treatment Week 16
Secondary Mean C-reactive protein concentration at screening and after 4, 8, 12 and 16 weeks of treatment. Screening, Week 4, Week 8, Week 12, Week 16
Secondary Frequency of AE/SAE 16 weeks
Secondary Frequency of local reactions 16 weeks
Secondary Frequency of AE/SAE 3-4 grade CTCAE 4.03 16 weeks
Secondary Frequency of withdrawals due to AE/SAE 16 weeks
Secondary Cmin Minimal concentration of BCD-085 in blood after drug injection 0 to 168 hours post-dose
Secondary AUC (0-168h) Area under curve from 0 to 168 hours of BCD-085 in blood after drug injection 0 to 168 hours post-dose
Secondary AUC0-8 Area under curve from 0 to infinity of BCD-085 in blood after drug injection 0 to 168 hours post-dose
Secondary Cmax Maximal concentration of BCD-085 in blood after drug injection 0 to 168 hours post-dose
Secondary ?max Time before Cmax of BCD-085 is reached in blood after drug injection 0 to 168 hours post-dose
Secondary Half-life of BCD-085 in blood after drug injection 0 to 168 hours post-dose
Secondary ?el Elimination rate constant of BCD-085 in blood after drug injection 0 to 168 hours post-dose
Secondary Cl Clearance of BCD-085 in blood after drug injection 0 to 168 hours post-dose
Secondary Proportion of patients who developed binding and neutralizing antibodies to BCD-085 16 weeks
See also
  Status Clinical Trial Phase
Terminated NCT02685904 - A Multicentre Study to Evaluate the Efficacy and Safety of ENIA11 in Patients With Ankylosing Spondylitis Phase 3
Completed NCT02186873 - A Study of Golimumab in Participants With Active Ankylosing Spondylitis Phase 3
Completed NCT01668004 - The Incidence of Extra-Articular Manifestations in Participants With Ankylosing Spondylitis Treated With Golimumab (MK-8259-012) Phase 4
Completed NCT05051943 - A Study of the Real-world Use of an Adalimumab Biosimilar and Evaluation of Nutritional Status on the Therapeutic Response
Completed NCT01934933 - Etanercept and Celecoxib Alone/Combined Treatment in Effectiveness and Safety of Active Ankylosing Spondylitis Phase 4
Not yet recruiting NCT04875299 - Optimal Adalimumab Plasma Concentrations in Ankylosing Spondylitis Patients
Completed NCT02758782 - NSAIDs Added to Anti-TNF Therapy Versus Anti-TNF Therapy Alone on Progression of Structural Damage in Ankylosing Spondylitis Phase 4
Active, not recruiting NCT02687620 - Does Immunogenicity Have an Influence on the Efficacy of Anti-TNF Therapy in Patients With AS: An Inception Cohort Study
Completed NCT02154425 - A Multicenter, Postmarketing Study Evaluating the Concentration of Cimzia® in Mature Breast Milk of Lactating Mothers Phase 1
Completed NCT01750528 - Prevalence and Progression of Periodontitis in Ankylosing Spondylitis N/A
Completed NCT01463189 - Web-based Support to Manage Arthritis Pain Phase 2
Completed NCT01091675 - Assessment of the Response to Etoricoxib in Patients With Ankylosing Spondylitis and Inadequate Response to ≥2 NSAIDs Phase 3
Completed NCT00844805 - Infliximab for Treatment of Axial Spondyloarthritis (P05336 AM1) Phase 3
Recruiting NCT00747578 - Health-Related Quality of Life and Disease-Related Costs: Comparison Between Ankylosing Spondylitis, Rheumatoid Arthritis and Systemic Lupus Erythematosus in Taiwan N/A
Completed NCT01083693 - Quality of Life Outcomes of HUMIRA in Rheumatoid Arthritis (RA), Psoriatic Arthritis (PsA), Ankylosing Spondylitis (AS) After Unsustainable Response to Biologicals and Disease Modifying Antirheumatic Drugs N/A
Completed NCT00715091 - Effects of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) on RAdiographic Damage in Ankylosing Spondylitis Phase 4
Not yet recruiting NCT00517101 - Presence of IBD Specific Antibodies (ASCA, ALCA, ACCA, AMCA) in the Sera of Patients With Spondyloarthropathy N/A
Completed NCT00367211 - Study to Evaluate the Incidence of Gastric Ulcers Following Administration of Either PN 200 or Naproxen in Subjects Who Are at Risk for Developing NSAID-Associated Ulcers. Phase 3
Completed NCT00133315 - TNFalfa Blocking Treatment of Spondylarthropathies Phase 4
Active, not recruiting NCT00243750 - Methotrexate in Ankylosing Spondylitis (MTX in AS) Phase 2