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

• Register: ClinicalTrials.gov
• Last refreshed on: 8 November 2021
• Main ID: NCT02763111
• Date of registration: 03/04/2016
• Prospective Registration: Yes
• Primary sponsor: Biocad
• Public title: Clinical Trial to Evaluate Efficacy and Safety of Multiple Subcutaneous Injections of Various Doses of BCD-085 in Patients With Active Ankylosing Spondylitis
• Scientific 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
• Date of first enrolment: September 2016
• Target sample size: 88
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02763111
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator).
• Phase: Phase 2

Contacts

• Name: Roman Ivanov, PhD
• Affiliation: JCS BIOCAD

Key inclusion & exclusion criteria

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.



Age minimum: 18 Years
Age maximum: 65 Years
Gender: All

Health Condition(s) or Problem(s) studied

Ankylosing Spondylitis

Intervention(s)

Drug: BCD-085

Other: Placebo

Primary Outcome(s)

Ratio of patients with ASAS20 response after 16 weeks of therapy [Time Frame: Week 16]

Secondary Outcome(s)

?el [Time Frame: 0 to 168 hours post-dose]

Cl [Time Frame: 0 to 168 hours post-dose]

Frequency of AE/SAE 3-4 grade CTCAE 4.03 [Time Frame: 16 weeks]

Proportion of patients who developed binding and neutralizing antibodies to BCD-085 [Time Frame: 16 weeks]

Cmin [Time Frame: 0 to 168 hours post-dose]

Proportion of patients with deterioration of roentgenologic signs of sacroileitis after 16 weeks of treatment [Time Frame: Week 16]

Ratio of patients with ASAS40 response after 4, 8, 12, 16 weeks of therapy [Time Frame: Week 4, Week 8, Week 12, Week 16]

Mean BASDAI score at screening and after 4, 8, 12, 16 weeks of therapy [Time Frame: Screening, Week 4, Week 8, Week 12, Week 16]

Cmax [Time Frame: 0 to 168 hours post-dose]

Mean ASDAS-CRP score at screening and after 4, 8, 12, 16 weeks of therapy [Time Frame: Screening, Week 4, Week 8, Week 12, Week 16]

Mean C-reactive protein concentration at screening and after 4, 8, 12 and 16 weeks of treatment. [Time Frame: Screening, Week 4, Week 8, Week 12, Week 16]

Ratio of patients with ASAS5/6 response after 4, 8, 12, 16 weeks of therapy [Time Frame: Week 4, Week 8, Week 12, Week 16]

?max [Time Frame: 0 to 168 hours post-dose]

AUC0-8 [Time Frame: 0 to 168 hours post-dose]

Frequency of AE/SAE [Time Frame: 16 weeks]

Mean SF-36 score at screening and after 8 and 16 weeks of therapy [Time Frame: Screening, Week 8, Week 16]

Ratio of patients with ASAS20 response after 4, 8, 12 weeks of therapy [Time Frame: Week 4, Week 8, Week 12]

?½ [Time Frame: 0 to 168 hours post-dose]

Mean BASFI score at screening and after 4, 8, 12, 16 weeks of therapy [Time Frame: Screening, Week 4, Week 8, Week 12, Week 16]

Mean MASES score at screening and after 4, 8, 12, 16 weeks of therapy [Time Frame: Screening, Week 4, Week 8, Week 12, Week 16]

Mean pain score during a day at screening and after 1, 2, 4, 8, 12, 16 weeks of therapy [Time Frame: Screening, Week 1, Week 2, Week 4, Week 8, Week 12, Week 16]

AUC (0-168h) [Time Frame: 0 to 168 hours post-dose]

Frequency of local reactions [Time Frame: 16 weeks]

Frequency of withdrawals due to AE/SAE [Time Frame: 16 weeks]

Mean BASMI score at screening and after 4, 8, 12, 16 weeks of therapy [Time Frame: Screening, Week 4, Week 8, Week 12, Week 16]

Mean chest excursion at screening and after 4, 8, 12, 16 weeks of therapy [Time Frame: Screening, Week 4, Week 8, Week 12, Week 16]

Secondary ID(s)

BCD-085-3

Source(s) of Monetary Support

Please refer to primary and secondary sponsors