Clinical Trial to Evaluate Efficacy and Safety of Multiple Subcutaneous Injections of Various Doses of BCD-085 in Patients With Active Ankylosing Spondylitis

Ankylosing Spondylitis Clinical Trial

Official title:

International Multi-center Comparative Randomized Double-blind Placebo-controlled Clinical Trial to Evaluate Efficacy and Safety of Multiple Subcutaneous Injections of BCD-085 in Various Doses in Patients With Active Ankylosing Spondylitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02763111
• Other study ID #: BCD-085-3
• Status: Completed
• Phase: Phase 2
• Start date: September 2016
• Est. completion date: June 2017

Study information

• Verified date: October 2021
• Source: Biocad
• Contact: n/a
• Is FDA regulated: No
• 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.

Related Conditions & MeSH terms

• Ankylosing Spondylitis
• Spondylitis
• Spondylitis, Ankylosing

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	?½	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