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

NCT02763111 | Completed Phase 2

• 1 other identifier: BCD-085-3
• Study Type: interventional
• Target: 88
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Ankylosing Spondylitis

Keywords

ankylosing spondylitis; interleukin 17; monoclonal antibody

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (26)

• Ratio of patients with ASAS20 response after 4, 8, 12 weeks of therapy

  Week 4, Week 8, Week 12

• Ratio of patients with ASAS40 response after 4, 8, 12, 16 weeks of therapy

  Week 4, Week 8, Week 12, Week 16

• Ratio of patients with ASAS5/6 response after 4, 8, 12, 16 weeks of therapy

  Week 4, Week 8, Week 12, Week 16

• Mean BASDAI score at screening and after 4, 8, 12, 16 weeks of therapy

  Screening, Week 4, Week 8, Week 12, Week 16

• Mean BASMI score at screening and after 4, 8, 12, 16 weeks of therapy

  Screening, Week 4, Week 8, Week 12, Week 16

Study Arms (4)

BCD-085, 40 mg

EXPERIMENTAL

Patient will receive 40 mg of BCD-085 subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10, 12.

Drug: BCD-085

BCD-085, 80 mg

EXPERIMENTAL

Patient will receive 80 mg of BCD-085 subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10, 12.

Drug: BCD-085

BCD-085, 120 mg

EXPERIMENTAL

Patient will receive 120 mg of BCD-085 subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10, 12.

Drug: BCD-085

Placebo

PLACEBO COMPARATOR

Patient will receive placebo subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10, 12.

Other: Placebo

Interventions

BCD-085 DRUG

BCD-085, 120 mg; BCD-085, 40 mg; BCD-085, 80 mg

Placebo OTHER

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:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Biocad: lead

Related 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 netakimab, a novel interleukin-17 inhibitor, in the treatment of active ankylosing spondylitis in adults. Clin Exp Rheumatol. 2020 Jan-Feb;38(1):27-34. Epub 2019 Apr 16.

  PMID: 31025924 RESULT

MeSH Terms

Conditions

Spondylitis, Ankylosing

Condition Hierarchy (Ancestors)

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

Study Officials

• Roman Ivanov, PhD

  JCS BIOCAD

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: April 3, 2016
• First Posted: May 5, 2016
• Study Start: September 1, 2016
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2017
• Last Updated: November 1, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share