Comparative Double-blind Study of the Efficacy and Safety of BCD-057 and Humira® in Patients with Moderate to Severe Plaque Psoriasis.
- Conditions
- Health Condition 1: null- Patients with Moderate to Severe Plaque Psoriasis
- Registration Number
- CTRI/2018/03/012598
- Lead Sponsor
- BIOCAD INDIA PVT LTD
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 0
1. A signed informed consent form.
2. Age at screening of 18 to 75 years inclusive.
3. Stable moderate to severe plaque psoriasis diagnosed at least 6 months before signing the informed consent form.
4. Patients who received at least 1 course of phototherapy or systemic therapy for psoriasis and had, in the opinion of the Investigator, inadequate response for it, or candidates for these therapies, in the opinion of the Investigator.
5. At baseline, body surface area (BSA) affected by psoriasis is >= 10%, PASI score (showing the extent and severity of psoriasis) is >= 12, sPGA (static Physicianâ??s Global Assessment) score is >= 3.
6. The following laboratory parameters at screening:
a. Hb level >= 10 g/dL (100 g/L),
b. WBC count >= 3000/μL (3.0�109/L),
c. Platelet count >= 100,000/μL (100�109/L),
d. Neutrophil count >= 1500/μL (1.5�109/L),
e. AST, ALT, or AP level should be within the upper limit of normal,
f. Serum creatinine level should be within the upper limit of the normal,
g. Negative results for serum and virologic markers of active and latent hepatitis B (HBV)2 and hepatitis C (HCV)3.
7. Negative urine test for pregnancy at screening (the test is not performed for women in menopause for at least 2 years or those who underwent surgical sterilization).
8. Negative test for tuberculosis:
a. Negative Quantiferon assay,
9. Patients with doubtful/positive results of Quantiferon may be included in the study only if all of these three criteria are met:
a. Negative result of an additional single Quantiferon assay
b. No signs of active tuberculosis according to chest X-ray/CT/MRI that was taken at the screening or within 1 month before signing the informed consent form.
c. TB specialistâ??s/Pulmonologist report that the patient does not have tuberculosis; the report should be given during the screening period.
10. The patient is able to carry out all procedures per Protocol, in the Investigatorâ??s opinion.
11. Study subjects and their sexual partners with retained childbearing potential are ready to implement reliable contraceptive measures throughout the screening period (from signing informed consent), during the treatment period, and for 4 weeks after the last dose of BCD-057/Humira®. This requirement does not apply to subjects who underwent surgical sterilization. Reliable contraception methods include one barrier method in combination with one of the following: spermicides, intrauterine device/oral contraceptives in the sexual partner.
1. Baseline psoriatic erythroderma, pustular psoriasis, or other skin diseases (for example, eczema) that can confound/complicate the assessment of psoriasis response to BCD-057/Humira®.
2. The patient has already used any monoclonal antibodies inhibiting TNFα.
3. The patient has already used two or more monoclonal antibodies (or their fragments) against other targets.
4. The patient received monoclonal antibodies within 12 weeks before signing the informed consent form.
5. Use of the following concurrent medications:
a. Systemic (oral or parenteral) glucocorticoids or systemic retinoids (acitretin) within 4 weeks before the date of randomization into the study.
b. Systemic non-biological medications including (but not limited to) methotrexate, sulphasalazine, or cyclosporin within 4 weeks before the date of randomization into the study.
c. Phototherapy [including selective phototherapy (UVB) and photochemotherapy (PUVA)] within 4 weeks before the date of randomization into the study.
d. Vaccination with live or attenuated vaccines within 8 weeks before signing the informed consent form.
6. A major surgery4 within 30 days before signing the informed consent form or a major surgery planned during the study.
7. At screening, the patient has an active infection or a history of any infection meeting the criteria below:
a. Any active infection required systemic anti-infectious agents within 28 days before signing the informed consent form.
b. Any infection required hospitalization or intravenous/intramuscular administration of anti-infectious agents within 8 weeks before signing the informed consent form.
c. Relapsing, chronic, or any other active infection in which BCD-057/Humira® can inflict damage to the patient, in the Investigatorâ??s opinion.
8. Diagnosed HIV infection or a history of severe immune deficiency of any other origin.
9. Diagnosed hepatitis B or hepatitis C5 virus revealed at screening.
10. Tuberculosis, including that in the past.
11. Diagnosed syphilis. In case of positive results of T. pallidum hemagglutination assay (TPHA)6 at the screening, the patient should undergo a further examination. The further examination includes:
a. In case of a known history of syphilis â?? medical records confirming the adequate therapy for syphilis,
b. ELISA [ELISAtotal or ELISA(IgG)+ELISA(IgM)], or immunofluorescence reaction with absorption, or T. pallidum immobilization test
c. Dermatology/Venerology Specialistâ??s report about the absence/presence of syphilis in the patient.
Having considered the Dermatologist/Venerologistâ??s report and the results of the further examination, the Sponsor will decide whether to include this patient in the study.
12. Baseline concomitant medical conditions that can increase a risk of AEs during the study therapy, affect the assessment of the main disease severity, mask, aggravate, affect symptoms of the main disease, or result in the same clinical and laboratory instrumental symptoms as those of psoriasis:
a. Acute inflammatory diseases or relapses of chronic inflammatory diseases except for psoriasis;
b. Stable effort angina of functional class III-IV, unstable angina, or a history of myocardial infarction within one year before signing the informed consent form;
c. Moderate to severe cardiac insufficiency (NYHA classes III and
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The proportion of patients with a 75% reduction in psoriasis area and severity from baseline (a PASI 75 response) at Week 16.Timepoint: The primary endpoints included Cmax and AUC(0-â??) after a single subcutaneous administration of BCD-057 or Humira®
- Secondary Outcome Measures
Name Time Method Changes in PASI score (50% & 90%) in patients of each group at Weeks 16, 33, and 55 vs. baseline. Proportion of patients with PASI 75 reduction at Weeks 33,55. Changes in sPGA, VAS, NAPSI, BSA of psoriasis at Weeks 16, 33, 55.Timepoint: Secondary endpoints included other standard PK parameters AUC(0-inf), Тmax, T half, Vd, Ð?el, CL), safety parameters (AE, SAE) & immunogenicity parameters