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An International Multicenter, Randomized, Double-blind, Placebo-Controlled Clinical Study of Efficacy and Safety of Two Dosing Regimens of BCD-085 (JSC BIOCAD, Russia) in Patients With Moderate to Severe Plaque Psoriasis

Study Purpose

BCD-085 is an innovative drug, monoclonal antibody against interleukin-17. The toxicity, safety, and pharmacokinetics of BCD-085 was investigated in animals, in phase I clinical study in healthy volunteers, and in phase III clinical study in patients with moderate to severe plaque psoriasis. This clinical study aims at investigating the efficacy and safety of BCD-085 every other week regimen (after induction for first 3 weeks) versus BCD-085 one per month regimen (after induction for first 3 weeks) versus placebo in patients with moderate to severe plaque psoriasis. Study purpose: To investigate the efficacy and safety of BCD-085 versus placebo and Cosentyx® in patients with moderate to severe plaque psoriasis (psoriasis vulgaris) Study objectives: 1. To compare the efficacy of BCD-085 every 2 weeks versus BCD-085 every 4 weeks versus placebo, based on the proportion of patients who achieved a PASI75, target sPGA score, and on other secondary efficacy measures. 2. To evaluate the proportion of patients in each study arm who develop adverse events with multiple injections of BCD-085 and placebo. Compare the safety profiles of BCD-085 when used every 4 weeks and when used every 2 weeks. 3. 4. To assess the immunogenicity of BCD-085 defined as the proportion of patients who develop anti-drug antibodies (binding or neutralizing).

Recruitment Criteria

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Accepts Healthy Volunteers
No

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


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Study Type
Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Subjects must give a written and signed informed consent. 2. Men or women at least 18 years old at the time of signing the ICF 3. Moderate to severe plaque psoriasis diagnosed at least 6 months before signing the informed consent form. 4. Patients received at least one course of phototherapy or systemic therapy for psoriasis or are candidates for such treatment according to the investigator. 5. Body surface area (BSA) affected by psoriasis of 10% or greater, the PASI score of 10 or greater, and the sPGA score of 3 or greater at screening. 6. Negative pregnancy urine test in female subjects (no test is required in women who are post-menopausal for at least 2 years and in surgically sterile women). 7. The patient must be able to follow the Protocol procedures (in the investigator's opinion). 8. Patients of childbearing potential and their partners with preserved reproductive function must implement reliable contraceptive methods starting from signing informed consent to 20 weeks after the last dose of the study therapy. This requirement does not apply to the patients after surgical sterilization and to females who are post-menopausal for 2 years or longer. Reliable contraception methods suggest using one barrier method in combination with one of the following: spermicides, intrauterine device/oral contraceptives

Exclusion Criteria:

1. Baseline erythrodermic, pustular, and guttate psoriasis or any other skin diseases (e.g. eczema) that can affect/complicate assessment of psoriasis treatment 2. Use of the following medications:
  • - Prior use of monoclonal antibodies targeting IL17 or its receptor - Prior use of more than one drug containing monoclonal antibodies or their fragments - Prior use of monoclonal antibodies within 12 weeks before signing the informed consent.
  • - Any systemic medications for psoriasis (including glucocorticoids, methotrexate, sulfasalazine, cyclosporine, acitretin, mycophenolate mofetil, аpremilast, calcitriol derivatives, etc.) used within 4 weeks before signing the ICF If prior systemic therapy with non-biologics was stopped due to any reasons, the screening period can be extended up to 8 weeks during which no new non-biologics are allowed.
  • - Use of phototherapy within 4 weeks before signing the ICF - Topical medications for psoriasis used within 2 weeks before signing the ICF - Vaccination with live or attenuated vaccines within 8 weeks before signing the ICF 3.
Any active systemic infection or recurrent infection at screening/randomization 4. HIV, hepatitis B, hepatitis C, or syphilis 5. Blood biochemistry abnormalities appearing as: 1. baseline creatinine > 2 × ULN 2. baseline ALT, AST or alkaline phosphatase > 2.5 × ULN 3. baseline bilirubin > 1.5 × ULN 6. WBC count < 3.0 × 109/L; ANC < <2.0× 109/L; platelet count < 100 × 109/L, or hemoglobin < 90 g/L at baseline 7. Any psychiatric conditions including severe depressive disorders and/or any history of suicidal thoughts or suicidal attempts ; 8. Signs of clinically significant depression (Beck's score of 16 or more at screening) 9. Alcohol or substance abuse 10. Tuberculosis now or in the past 11. Latent TB infection (positive results of the Diaskintest or QuantiFERON test, or T-spot). 12. Concurrent diseases ongoing at screening that may increase the risk of adverse events during the study or affect the evaluation of psoriasis symptoms (mask, enhance or alter the symptoms of psoriasis, or cause clinical or laboratory signs/symptoms similar to those of psoriasis):
  • - active inflammatory diseases or aggravation of chronic inflammatory diseases other than psoriasis - Stable angina class III-IV, unstable angina or a history of myocardial infarction within 1 year before signing the informed consent - Cardiac failure moderate to severe (NYHA class III-IV) - Treatment-resistant hypertension - A history of severe asthma or angioedema - Moderate to severe respiratory failure, COPD grade ¾ - Diabetes mellitus with unsatisfactory glycemic control, when the level of glycated hemoglobin HbA1С ≥8% (results are valid if the test was performed at the screening or within 3 months before signing the ICF) - The patient has thyrotoxicosis, which persists in the presence of thyreostatic medications, or hypothyroidism despite of the thyroid hormone treatment - Systemic autoimmune diseases (including but not limited to SLE, rheumatoid arthritis, ankylosing spondylitis, Crohn's disease, ulcerative colitis, systemic scleroderma, inflammatory myopathy, mixed connective tissue disease , intersection syndrome, etc.) - Any other underlying conditions (including but not limited to metabolic, hematologic, hepatic, renal, pulmonary, neurological, endocrine, cardiac, gastrointestinal conditions and infections) that, in the opinion of the investigator, may affect the course of psoriasis, affect the assessment of signs/symptoms of psoriasis, or put patients using the study treatment at additional risk 13.
Malignancies with less than 5 years of remission 14. Known severe allergies (anaphylaxis or drug allergy to two or more drug products) 15. Known allergy or intolerance to monoclonal antibody drugs (murine, chimeric, humanized, or human) or any other components of the test drug or comparator 16. Major surgery within 30 days before the screening, or a major surgery being scheduled at any time during the study 17. Severe infections (including those that required hospitalization or parenteral antibacterial/antimycotic/antiprotozoal treatment) within 6 months before signing the ICF 18. Systemic antibacterial/antimycotic/antiprotozoal treatment within 2 months before the signing the ICF 19. More than 4 episodes of respiratory infection within 6 months before signing the ICF 20. Episodes of severe mycoses (histoplasmosis, coccidioidomycosis, blastomycosis, etc.) within 6 months before signing the ICF 21. A history of epileptic attacks or seizures 22. Any concurrent diseases during which, in the investigator's opinion, the study treatment can harm the patient 23. Pregnancy, breastfeeding, or planning for pregnancy while participating in the study 24. Participation in any other clinical study within 3 months before signing the ICF or simultaneous participation in other clinical studies 25. Patients will not be re-enrolled in this study if they were randomized to this study and then discontinue the participation

Trial Details

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

Trial ID:
NCT03390101

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase
Phase 3

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Lead Sponsor
Biocad

The person who is responsible for the scientific and technical direction of the entire clinical study.

Principal Investigator
Roman Ivanov, PhD
Principal Investigator Affiliation Vice-president, R&D, International business development BIOCAD

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Agency Class
Industry
Overall Status Recruiting
Countries Russian Federation

The disease, disorder, syndrome, illness, or injury that is being studied.

Conditions
Moderate to Severe Plaque Psoriasis

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

BIOCAD, Saint Petersburg, Strelna, Russian Federation

Status

Recruiting

Address

BIOCAD

Saint Petersburg, Strelna, 198515

Site Contact

Ekaterina Chernyaeva

chernyaeva@biocad.ru

+7 (812) 380 49 33 #403

Nearest Location

Site Contact

Ekaterina Chernyaeva

chernyaeva@biocad.ru

+7 (812) 380 49 33 #403

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