Comparative Clinical Trial of Efficacy and Safety of BCD-057 and Humira® in Patients With Moderate to Severe Plaque Psoriasis

NCT02762955 | Completed Phase 3

• 1 other identifier: BCD-057-2
• Study Type: interventional
• Target: 344
• Locations: 1 country
• Sites: 1

Brief Summary

CALYPSO clinical study is a phase 3 study which is carried out to establish the efficacy, safety and pharmacokinetic equivalence of BCD-055 (adalimumab, manufactured by JSC BIOCAD, Russia) and Humira® when used in patients with moderate to severe plaque psoriasis.

Conditions

Psoriasis

Keywords

adalimumab; biosimilar; BCD-057; psoriasis; tumor necrosis factor; monoclonal antibody

Outcome Measures

Primary Outcomes (1)

• Ratio of patients with PASI75 response after 16 weeks of therapy

  Ratio of patients who developed a decrease in Psoriasis Area Severity Index score by 75% or more (PASI75) after 16 weeks of therapy with adalimumab vs. baseline.

  16 weeks of therapy

Secondary Outcomes (16)

• PASI Improvement (%) after 16, 24, 33 and 55 weeks of therapy with adalimumab.

  16, 24, 33 and 55 weeks of therapy

• Ratio of patients with PASI75 response after 24, 33, 55 weeks of therapy

  24, 33 and 55 weeks of therapy

• Ratio of patients with PASI50 and PASI90 response after 16, 33, 55 weeks of therapy.

  16, 24, 33 and 55 weeks of therapy

• Ratio of patients with sPGA response after 16, 33, 55 weeks of therapy

  16, 24, 33 and 55 weeks of therapy

• BSA Improvement (%) after 16, 24, 33, 55 weeks of therapy

  16, 24, 33 and 55 weeks of therapy

Study Arms (2)

BCD-057 group

EXPERIMENTAL

BCD-057 group includes patients with moderate to severe plaque psoriasis, who will receive BCD-057 subcutaneously at a dose 80 mg on week 0, then at a dose 40 mg on weeks 1, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21 and 23. Patients will be invited for randomization at week 24 (in order to keep the double-blind design of the study), but it will have a formal character (assignment of a new randomization number and lot). From week 25 patients of this group will continue to receive BCD-057 at a dose 40 mg on weeks 25, 27, 29, 31, 33, 35, 37, 39, 41, 43, 45, 47, 49 and 51. BCD-057 is adalimumab biosimilar, monoclonal antibody to tumor necrosis factor alfa.

Biological: BCD-057

Humira® group

ACTIVE COMPARATOR

Humira® group includes patients with moderate to severe plaque psoriasis, who will receive Humira® subcutaneously at a dose 80 mg on week 0, then at a dose 40 mg on weeks 1, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23. At week 24 participants will re-randomized (1:1) to treatment with Humira® or will transitioned to BCD-057. Patients will receive BCD-057 or Humira® at a dose 40 mg on weeks 25, 27, 29, 31, 33, 35, 37, 39, 41, 43, 45, 47, 49 and 51. BCD-057 is adalimumab biosimilar, monoclonal antibody to tumor necrosis factor alfa. Humira® is original drug of adalimumab, monoclonal antibody to tumor necrosis factor alfa.

Biological: Humira®

Interventions

BCD-057 BIOLOGICAL

BCD-057 is biosimilar of adalimumab (produced by BIOCAD).

Also known as: adalimumab

BCD-057 group

Humira® BIOLOGICAL

Humira is the original adalimumab (produced by F. Hoffman-La Roche)

Also known as: adalimumab

Humira® group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient had written informed consent.
• Age between 18 and 75 years.
• Patient has moderate to severe plaque psoriasis with stable course of the disease for 6 months
• Patient has had at least 1 course of phototherapy or systemic treatment for psoriasis or are candidates for such treatment in opinion of Investigator.
• BSA affected by psoriasis ≥ 10%, PASI score ≥ 12, sPGA score ≥ 3.
• Patient has hemoglobin ≥ 10 g/dl, leucocytes count ≥ 3 000/mcl, thrombocytes count ≥ 100 000/mcl, neutrophil count ≥ 2 000/mcl, aspartate aminotransferase, alanine aminotransferase and alkaline phosphatase exceed 2,5 or less times the upper limit of the normal range creatinine less than 176,8 µmol/l, no serologic or virologic markers of hepatitis B virus and hepatitis C virus, negative urine pregnancy test, no signs of tuberculosis (negative tuberculosis skin test or negative quantiferon test. Patients can be included in they have positive tuberculin test, have had Bacteria Calmette-Guerin (BCG) vaccination and have negative Diaskintest or negative quantiferon test. Patients can be included if they have positive tuberculin test, have not been vaccinated with BCG and also patients with positive or uncertain quantiferon test/Diaskintest if they have documented adequate prophylaxis of tuberculosis finished before first adalimumab injection AND have documented absence of contacts with patients who have active tuberculosis AND have no signs of tuberculosis on chest X-Ray that was performed during 3 months before randomization)
• Patients are able to perform all procedures planed by protocol.
• Patients are ready for contraception with reliable methods starting 2 weeks before entering the study, and up to 4 weeks after the last dose of study drug.

You may not qualify if:

• Subject diagnosed with erythrodermic psoriasis, pustular psoriasis, guttate psoriasis, medication-induced psoriasis, or other skin conditions at the time of the screening visit (e.g., eczema) that would interfere with evaluations of the effect of investigational product on psoriasis.
• Previous receipt of adalimumab, history of use of any other biological anti-tumor necrosis factor-alpha therapy. Prior use of two or more biologics for treatment of psoriasis.
• Previous receipt of monoclonal antibodies if they were cancelled less that in 12 weeks before screening
• Patient is taking corticosteroids for up to 4 weeks before signing informed consent and during screening, disease-modifying drugs including methotrexate, sulfasalazin and cyclosporin for up to 4 weeks before signing informed consent, leflunomide, cyclophosphamide for up to 6 months before signing informed consent, phototherapy including selective phototherapy and photochemotherapy for up to 4 weeks before signing informed consent, live or attenuated vaccines for up to 8 weeks before signing informed consent.
• Subject cannot discontinue systemic therapies and/or topical therapies for the treatment of psoriasis and cannot avoid phototherapy.
• Subject has a planned surgical intervention during the study or had surgical intervention less than 30 days prior to study.
• Subject has an active infection or history of infections as follows: any active infection for which systemic anti-infectives were used within 28 days prior to signing informed consent; a serious infection, defined as requiring hospitalization or intravenous anti-infectives within 8 weeks prior to signing informed consent; recurrent or chronic infections or other active infection that, in the opinion of the Investigator, might cause this study to be detrimental to the subject.
• Subject has known history of human immunodeficiency virus or any other severe immunodeficiency.
• Hepatitis B surface antigen or Hepatitis B core antigen or Hepatitis C antibody positivity at screening.
• History of tuberculosis.
• Positive results of rapid plasma reagin-test for T.pallidum at screening.
• Active ongoing diseases other than psoriasis that might confound the evaluation of the benefit of treatment of adalimumab or can increase risk of adverse reactions: acute inflammatory diseases or exacerbation of chronic diseases otherwise than psoriasis; stable ischemic heart disease III-IV functional class, unstable angina or history of myocardial infarction less than 1 year before the signing of informed consent; moderate to severe heart failure (New York Heart Association \[NYHA\] class III/IV; severe resistant arterial hypertension, atopic bronchial asthma, history of angiooedema, moderate to severe respiratory insufficiency, chronic obstructive lung disease 3-4 grade, decompensated diabetes mellitus, systemic autoimmune diseases, active neurologic disorders or their symptoms, other underlying condition (including, but not limited to metabolic, hematologic, renal, hepatic, pulmonary, neurologic, endocrine, cardiac, infectious or gastrointestinal) which in the opinion of the investigator significantly immunocompromises the patient and/or places the patient at unacceptable risk for receiving an immunomodulatory therapy.
• Subject has history of malignancy within 5 years EXCEPT treated and considered cured cutaneous squamous or basal cell carcinoma, in situ cervical cancer, OR in situ breast ductal carcinoma.
• Subject has a history of hypersensitivity to the active substance or to any of the excipients of adalimumab or BCD-057 or other monoclonal antibodies.
• Female subject who is pregnant or breast-feeding or considering becoming pregnant during the study.

Sponsors & Collaborators

• Biocad: lead

Study Sites (1)

BIOCAD

Saint Petersburg, Strelna, 198515, Russia

Location

Related Publications (1)

• Samtsov AV, Bakulev AL, Khairutdinov VR, Kokhan MM, Korotaeva TV, Minullin IK, Vylegzhanina OA, Dubenskiy VV, Khalilov BV, Khotko AA, Zykova OS, Chumachenko IV, Lukyanov AM, Artemeva AV, Pukhtinskaia PP. Long-term data on the proposed adalimumab biosimilar BCD-057 in patients with moderate to severe psoriasis: A randomized controlled trial. PLoS One. 2022 Feb 7;17(2):e0263214. doi: 10.1371/journal.pone.0263214. eCollection 2022.

  PMID: 35130291 DERIVED

MeSH Terms

Conditions

Psoriasis

Interventions

Adalimumab

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Roman Ivanov, PhD

  JCS BIOCAD

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• 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: March 31, 2016
• First Posted: May 5, 2016
• Study Start: December 1, 2016
• Primary Completion: December 1, 2017
• Study Completion: October 15, 2018
• Last Updated: September 8, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)