Moderate to Severe Chronic Plaque Psoriasis MedDRA version: 20.0 Level: LLT Classification code 10071117 Term: Plaque psoriasis System Organ Class: 100000004858
Conditions
Sponsors
Biocon Biologics UK Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patient is willing and able to provide informed consent form (ICF), able to follow study instructions, and comply with the protocol requirements as per the investigator’s opinion; 2. Patient is aged 18 to 80 years, both inclusive, and weighing =65 years) yes F.1.3.1 Number of subjects for this age range 40
Exclusion criteria
Exclusion criteria: 1. Patient has nonplaque psoriasis, such as erythrodermic psoriasis, pustular psoriasis, guttate psoriasis, medication-induced psoriasis, other skin conditions (eg, eczema), other current or chronic systemic autoimmune or inflammatory disease at the time of screening visit that would interfere with the evaluation of the effect of the study treatment of psoriasis. Patients with concurrent psoriatic arthritis will be allowed to participate; 2. Patient who has a current or past history of any of the following infections: a) Current or past history of congenital or acquired immunodeficiency or patient is positive for the human immunodeficiency virus (HIV) antibodies (HIV-1 or HIV-2) at screening; b) Patient has current infection with hepatitis B virus (HBV) or hepatitis C virus (HCV) as per serological tests at screening; c) Presence of active infection at screening or history of infection requiring intravenous antibiotics and/or hospitalization =8 weeks before baseline visit, or oral/intramuscular antibiotics =4 weeks before baseline visit, or topical antibiotics =2 weeks before baseline visit. Minor localized fungal infections or topical antibiotics for facial acne may be allowed; d) Any recurrent bacterial, fungal, opportunistic, or viral infection including recurrent/disseminated herpes zoster that, based on the investigator´s clinical assessment, causes a safety risk and makes the patient unsuitable for the study; e) History of invasive/systemic fungal infection (eg, histoplasmosis) or nontubercular mycobacterial infection. 3. Patient meeting any of the following tuberculosis (TB)-related conditions: a) Patient who has current or history of active TB. b) Patient who has signs or symptoms suggestive of active TB upon medical history or physical examination including chest radiography at screening. c) Patients with current latent TB d) Patient who has had exposure to a person with active TB, such as first-degree family members or coworkers within 16 weeks before the baseline visit. 4. Patient has an underlying condition (including, but not limited to metabolic, hematologic, renal, hepatic, pulmonary, neurologic including central nervous system demyelinating disease, endocrine, cardiac, infection, or gastrointestinal) which, in the opinion of the investigator, significantly immune-compromises the patient and/or places the patient at unacceptable risk for receiving an immunomodulatory therapy. 5. Patient had a major surgical intervention within 12 weeks of the baseline or planned major surgery during the study period. 6. Patient who has prior exposure to more than 1 biologic agent for the treatment of psoriasis or psoriatic arthritis. 7. Patient who has received or plans to receive any of the following prohibited medications or treatment that could affect psoriasis: a) Topical therapies for the treatment of psoriasis within 2 weeks before the baseline visit. b) Ultraviolet A phototherapy (with or without oral psoralen) or ultraviolet B phototherapy for the treatment of psoriasis within 4 weeks before the baseline visit. c) Systemic steroids within 4 weeks before the baseline visit. d) Any nonbiologic systemic therapies for the treatment of psoriasis or psoriatic arthritis within 4 weeks before the baseline visit. e) Any biologic systemic therapy with a mechanism of action that could impact the course of psoriasis/psoriatic arthritis or its evaluations, within 5 half-lives or 90 days, whichever is longer, before the baseline visit. f) Any
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate equivalent efficacy between Bmab 1200 and Stelara® in patients with moderate to severe chronic plaque psoriasis.;Secondary Objective: - To assess the efficacy of Bmab 1200 based on other efficacy parameters and timepoints over the study period as compared with Stelara®; - To assess the safety and tolerability of Bmab 1200 as compared with Stelara® over the study period; - To assess the immunogenicity of Bmab 1200 as compared with Stelara® over the study period; - To assess the PK of Bmab 1200 as compared with Stelara®; - To assess the safety and immunogenicity after switching from Stelara® to Bmab 1200; ;Primary end point(s): Percentage change from baseline in the Psoriasis Area and Severity Index (PASI) score at Week 12 (Time Frame: Baseline [Day 1] to Week 12).;Timepoint(s) of evaluation of this end point: Week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Efficacy Endpoints: • Percentage change from baseline in the PASI score at Weeks 4, 8, 16, 20, and 28 (Time Frame: Baseline [Day 1] through Week 28). • PASI improvement of =50% relative to baseline (PASI 50), PASI improvement of =75% relative to baseline (PASI 75), and PASI improvement of =90% relative to baseline (PASI 90) at Weeks 4, 8, 12, 16, 20, and 28 (Time Frame: Baseline [Day 1] through Week 28). • Static Physician’s Global Assessment (sPGA) response of cleared or almost clear/minimal (PGA of 0 or 1) at Weeks 4, 8, 12, 16, 20, and 28 (Time Frame: Baseline [Day 1] through Week 28). • Area under effect curves (AUECs) of PASI score from baseline to Week 12 (Time Frame: Baseline [Day 1] through Week 12). • Raw PASI scores at Weeks 4, 8, 12, 16, 20, and 28 (Time Frame: Baseline [Day 1] through Week 28). • Change from baseline in affected body surface area (BSA) at Weeks 4, 8, 12, 16, 20, and 28 (Time Frame: Baseline [Day 1] through Week 28). • Change from baseline in quality of life (QoL) as measured by Dermatology Life Quality Index (DLQI) scores at Weeks 4, 8, 12, 16, 20, and 28 (Time Frame: Baseline [Day 1] through Week 28). Safety Endpoints: • Treatment-emergent adverse events (TEAEs) including adverse events of special interest (AESIs) and adverse reactions (ADRs) during the treatment periods (Time Frame: Baseline [Day 1] through Week 28). • Injection-site reactions and hypersensitivity at Day 1, Week 4, Week 16, and throughout the study (Time Frame: Baseline [Day 1] through Week 28) • Other safety endpoints as follows (Time Frame: Baseline [Day 1] through Week 28): - Absolute values and changes from baseline in: • Clinical laboratory assessments (hematology, clinical chemistry, and urinalysis); • Vital sign parameters (systolic and diastolic blood pressure, pulse rate, respiratory rate, and body temperature); • 12-lead electrocardiogram (ECG). - Physical examination Immunogenicity Endpoints: • Proportion of patients developing a | — |
Countries
Estonia, Georgia, Latvia, Poland, United States
Contacts
Public ContactClinical Development
Biocon Biologics Limited
Outcome results
None listed