Clinical Study of Efficacy and Safety of BCD-085 (Monoclonal Anti-IL-17 Antibody) in Psoriatic Arthritis

NCT03598751 | Completed Phase 3

• 1 other identifier: BCD-085-8
• Study Type: interventional
• Target: 194
• Locations: 2 countries
• Sites: 3

Brief Summary

Study BCD-085-8/PATERA is a multicentre double-blind placebo-controlled Phase 3 study in patients with psoriatic arthritis (PsA). The objective of the study is to evaluate the efficacy and safety of BCD-085 comparing to placebo in patients with PsA.

Conditions

Psoriatic Arthritis

Outcome Measures

Primary Outcomes (1)

• ACR 20

  The percentage of patients achieved 20% improvement according to American College of Rheumatology response criteria. The ACR Criteria is a dichotomous variable with a positive (=responder) or negative (=non-responder) outcome. The ACR Criteria measures improvement in tender / swollen joint counts and improvement in at least three of the following parameters: 1) patient assessment 2) physician assessment 3) pain scale 4) disability/functional questionnaire 5) acute phase reactant (ESR or CRP). ACR 20 / 50 / 70 has a positive outcome if 20% / 50% / 70% improvement in tender and swollen joint counts was achieved as well as a 20% / 50% / 70% improvement in at least three of the other five criteria.

  week 24

Secondary Outcomes (6)

• ACR 20

  Week 1, 2, 4, 8, 12, 16, 20, 24, 30, 38, 46, 54

• ACR 50

  Week 1, 2, 4, 8, 12, 16, 20, 24, 30, 38, 46, 54

• ACR 70

  Week 1, 2, 4, 8, 12, 16, 20, 24, 30, 38, 46, 54

• Proportion of patients achieved PsARC (Psoriatic Arthritis Response Criteria)

  Week 1, 2, 4, 8, 12, 16, 20, 24, 30, 38, 46, 54

• Change in radiological signs of arthritis (mTSS)

  Week 24 and 54

Study Arms (2)

BCD-085

EXPERIMENTAL

Blinded period: BCD-085 120 mg at weeks 0, 1, 2, 4, 6, 8, 10, 14, 18, 22 Open-label period: BCD-085 120 mg at weeks 26, 30, 34, 38, 42, 46, 50, 54

Drug: BCD-085

Placebo

PLACEBO COMPARATOR

Blinded period: Placebo at weeks 0, 1, 2, 4, 6, 8, 10, 14 * patients who don't achieve ACR 20 at week 16 will receive BCD-085 at weeks 18 and 22 * patients who achieve ACR 20 at week 16 will continue placebo at weeks 18 and 22 Open-label period: BCD-085 120 mg at weeks 26, 30, 34, 38, 42, 46, 50, 54

Drug: Placebo

Interventions

BCD-085 DRUG

120 mg / 2 mL subcutaneously

Also known as: Anti-interleukin-17 Monoclonal Antibody

BCD-085

Placebo DRUG

2 mL

Placebo

Eligibility Criteria

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

You may qualify if:

• Signed informed consent (IC)
• History of psoriatic arthritis (According to CASPAR, 2006) for 6 months
• /68 TJC and 3/66 SJC
• RF / ACCP negative
• At least 1 psoriatic plaque ≥ 2 cm and/or psoriatic nails and/or history of confirmed plaque psoriasis
• History of inadequate response to NSAID
• Stable dose of NSAID for 2 weeks
• If on steroids: inadequate response to steroids (at least 3 months of treatment) and stable dose of steroids (10 mg or less) for at least 2 weeks.
• If on MTX: inadequate response to MTX (stable dose 15 - 25 mg / week for at least 2 months)
• In case of history of etanercept therapy: at least 4 weeks after last administration
• In case of history of infliximab therapy: at least 8 weeks after last administration
• In case of history of adalimumab / golimumab / certolizumab pegol therapy: at least 10 weeks after last administration
• In case of history of other mabs / fragments / small molecules : at least 5 half life after last administration
• Negative pregnancy test for women with childbearing potential
• Ability to follow procedures of the study

You may not qualify if:

• Therapy with anti-IL17 / IL17R or anti-IL12/23 or history of therapy with 2 or more monoclonal antibodies or therapy with topical / oral retinoids or phototherapy or other topical medication for psoriasis history or parenteral steroids administration or any intraarticular injections within 4 weeks prior IC sign or any DMARD therapy (excl. methotrexate) on the dated of IC
• Vaccination with live vaccines within 8 weeks prior to IC sign
• Diagnosis of any other chronic infection which may increase the risk of infectious adverse events.
• HIV, HCV, HBV, Syphilis.
• Clinically significant deviations in blood chemistry and blood count
• History of Herpes Zoster
• History of depression, suicidal ideation/behavior.
• Known history of alcohol or drug abuse
• Diagnosis or history of tuberculosis
• Any acute infection or chronic infection flare within 30 days prior to informed consent sign, which may increase (according to the PI opinion) the risk of infectious adverse events.
• Any other documented conditions which increase the risk of AEs development or may interfere with symptoms the disease (masking, increasing or changing) or induce clinical symptoms or laboratory abnormalities similar to PsA:
• Uncontrolled diabetes mellitus;
• Severe, uncontrolled hypertension;
• Presence or history of inflammatory joint disease other than PsA (or any other systemic autoimmune disease (including lupus, Crohn's disease, ulcerative colitis, scleroderma, inflammatory myopathy, mixed connective tissue disease, autoimmune overlap syndrome, fibromyalgia etc.);
• History of malignancy, excluding cured basal cell carcinoma / cervical cancer in situ (complete remission for 5 years); cured basal cell skin carcinoma (5 years complete remission), cured ductal breast cancer (5 years complete remission);

Sponsors & Collaborators

• Biocad: lead

Study Sites (3)

1st City Clinical Hospital

Minsk, Belarus

Location

Chelyabinsk Regional Clinical hospital

Chelyabinsk, Russia

Location

North-Western State Medical University n.a. I.I.Mechnikov

Saint Petersburg, Russia

Location

MeSH Terms

Conditions

Arthritis, Psoriatic

Condition Hierarchy (Ancestors)

Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases; Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Roman Ivanov, PhD

  Biocad

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2018
• First Posted: July 26, 2018
• Study Start: July 25, 2018
• Primary Completion: June 26, 2019
• Study Completion: August 31, 2022
• Last Updated: July 8, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

RU (2); BE (1)