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PsoriasisPhase 3CALYPSONCT02762955

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

A Phase 3 study testing BCD-057 and Humira® in people with Psoriasis, run by Biocad at 1 site in Russia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Psoriasis
What is being tested?
BCD-057 and Humira®
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
344 participants
Where
1 siteRussia
Study dates
Dec 2016to 15 Oct 2018
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 18Show fewer
  • 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.
  • Subject has any mental illness, including severe depressive disorders and / or suicidal thoughts in history, which, in the opinion of the investigator, may create excessive risk to the patient or to influence the patient's ability to follow the protocol.
  • History of drug addiction, alcoholism.
  • Simultaneous participation in any other clinical trial, as well as former participation in other clinical trials within 3 months before this study initiation; previous participation in this study.

Trial locations and contacts

1 site in 1 country.

Russia1 site

  • BIOCAD

    Saint Petersburg, Strelna, 198515

Other trials in Russia

About this study

Official title: International Multi-center Comparative Randomized Double-blind Clinical Trial of Efficacy and Safety of BCD-057 (Adalimumab Produced by BIOCAD, Russia) and Humira® (Adalimumab Produced by Vetter Pharma-Fertigung Gmbh & Co KG, Germany) in Patients With Moderate to Severe Plaque Psoriasis

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.

Read the detailed description

CALYPSO study is the next step of clinical evaluation of adalimumab biosimilar manufactured by joint-stock company (JSC) BIOCAD, Russia.The aim of this study is to establish that BCD-057 is equivalent to Humira® in terms of efficacy, safety and pharmacokinetics when used by the standard regimen in patients with plaque psoriasis.

The study will enroll 344 patients with moderate to severe plaque psoriasis, who will be randomized into 2 groups (1:1 ratio): patients from the first group will receive BCD-057 subcutaneously (SC) 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. Then participants of this group will be invited for randomization at week 25 (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). Patients will continue to receive 40 mg of BCD-057 on weeks 25, 27, 29, 31, 33, 35, 37, 39, 41, 43, 45, 47, 49 and 51.

Patients from the second group will receive Humira® subcutaneously (SC) 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. At week 25 participants will re-randomized (1:1) to treatment with Humira® or will transitioned to BCD-057.They will receive Humira® or BCD-057 at a dose 40 mg on weeks 25, 27, 29, 31, 33, 35, 37, 39, 41, 43, 45, 47, 49 and 51.

Conditions
Psoriasis
Being tested
BCD-057, Humira®
Keywords
adalimumab, biosimilar, BCD-057, psoriasis, tumor necrosis factor, monoclonal antibody
Medical subject headings
Psoriasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BCD-057Biological

    Also called adalimumab

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

  • Humira®Biological

    Also called adalimumab

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

Study groups in NCT02762955
Study groupRoleWhat they receive
BCD-057 groupExperimentalBCD-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.
Receives: Biological: BCD-057
Humira® groupActive comparatorHumira® 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.
Receives: Biological: Humira®

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 16 weeks of therapy

Secondary outcomes (16)

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

    Percent improvement in Psoriasis Area Severity Index (PASI) after 16, 24, 33 and 55 weeks of therapy with adalimumab.

    Measured: 16, 24, 33 and 55 weeks of therapy

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

    Ratio of patients who developed a decrease in Psoriasis Area Severity Index score by 75% or more (PASI75) after 33, 55 weeks of therapy with adalimumab vs. baseline.

    Measured: 24, 33 and 55 weeks of therapy

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

    Ratio of patients who developed a decrease in Psoriasis Area Severity Index score by 50% or more (PASI50) and Psoriasis Area Severity Index score by 90% or more (PASI90) after 16, 24, 33, 55 weeks of therapy with adalimumab vs. baseline.

    Measured: 16, 24, 33 and 55 weeks of therapy

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

    Ratio of patients who have Physicians Global Assessment (sPGA) score 0 or 1 after 16, 33, 55 weeks of therapy with adalimumab.

    Measured: 16, 24, 33 and 55 weeks of therapy

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

    Percent of body surface area (BSA), affected by psoriasis (measured by physician during physical examination of patient), after 16, 33, 55 weeks of therapy with adalimumab vs. baseline.

    Measured: 16, 24, 33 and 55 weeks of therapy

  6. Change in SF-36

    Change in Short Form-36 questionnaire (SF-36) from Week 0 to Week 16 and from Week 16 to Week 55.

    Measured: Week 0 to Week 16; Week 16 to Week 55

  7. Change in DQLI

    Change in Dermatology Quality of Life Index questionnaire (DLQI) from Week 0 to Week 16 and from Week 16 to Week 55.

    Measured: Week 0 to Week 16; Week 16 to Week 55

  8. Adverse events (AE) severity and frequency related to adalimumab

    Measured: 16 and 55 weeks of therapy

  9. Overall adverse events (AE) and serious adverse events (SAE) frequency

    Measured: 16 and 55 weeks of therapy

  10. Frequency of early withdrawal due to AE/SAE

    Measured: 16 and 55 weeks of therapy

  11. Ratio of patients with binding and neutralizing antibodies to adalimumab

    Measured: 55 weeks

  12. AUC(0-tau) of adalimumab after multiple adalimumab injections

    Area under the plasma concentration versus time curve (AUC) 0-tau of adalimumab after multiple adalimumab injections

    Measured: 55 weeks

  13. Cav,ss of adalimumab after multiple adalimumab injections

    Average blood concentration of adalimumab in steady state conditions (Cav,ss)

    Measured: 55 weeks

  14. Т½ of adalimumab after multiple adalimumab injections

    Half-life (Т½) of adalimumab after multiple adalimumab injections

    Measured: 55 weeks

  15. Vd of adalimumab after multiple adalimumab injections

    Volume of distribution (Vd) of adalimumab after multiple adalimumab injections

    Measured: 55 weeks

  16. Cl of adalimumab after multiple adalimumab injections

    Clearance (Cl) of adalimumab after multiple adalimumab injections

    Measured: 55 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 May 2016 (estimated)
  2. Study startDec 2016
  3. Primary completionDec 2017
  4. Study completion15 Oct 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
344 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02762955
Sponsor's protocol ID
BCD-057-2
Acronym
CALYPSO
Status last verified
Sep 2021
First submitted
31 Mar 2016
Last updated
8 Sep 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 35130291

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing BCD-057 and Humira® in people with Psoriasis, run by Biocad at 1 site in Russia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Ratio of patients with PASI75 response after 16 weeks of therapy (time frame: 16 weeks of therapy). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02762955, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2021.

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