Moderate to Severe Plaque Psoriasis MedDRA version: 20.0 Level: SOC Classification code 10021428 Term: Immune system disorders System Organ Class: 10021428 - Immune system disorders
Conditions
Interventions
Product Name: Recombinant human monoclonal IgG1 antibody
Product Code: BAT2306
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: Recombinant human monoclonal IgG
Sponsors
Bio-Thera Solutions, Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female aged = 18 years with a diagnosis of plaque-type psoriasis at least 24 weeks before screening. 2. Have moderate to severe plaque-type psoriasis as defined at screening and baseline by: a. PASI = 12, b. IGA = 3 (based on a scale of 0-4), and c. BSA affected by chronic plaque-type psoriasis = 10% 3. Candidates for systemic therapy, defined as having chronic plaque-type psoriasis considered inadequately controlled by: a. topical treatment and/or b. phototherapy and/or c. previous systemic therapy. 4. Female patients of childbearing potential and male patients with a female partner of childbearing potential must be willing to use highly effective contraceptive precautions throughout the study period and continuing for at least 20 weeks after the last dose of study drug. 5. If female of childbearing potential, patient should have a negative pregnancy test result at screening and baseline visits. 6. Must be willing to provide written consent and to comply with the requirements of the study protocol. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 400 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 100
Exclusion criteria
Exclusion criteria: 1. Have any forms of psoriasis at the time of the screening visit other than plaque-type, such as erythrodermic psoriasis, pustular psoriasis, guttate psoriasis, medication-induced psoriasis, or other skin conditions (e.g., eczema) that would interfere with evaluations of the effect of investigational product on psoriasis. 2. Have previously received secukinumab, a biosimilar of secukinumab, or any drug that targets interleukin-17 or the IL-17 receptor. 3. Weight > 120 kg. 4. Have received any monoclonal antibody-based biologic drugs for treatment of autoimmune disease or with a potential effect on the study condition other than those prohibited within 5 half-lives or 6 months, whichever is longer, before the screening visit. 5. Have received non-monoclonal antibody biological drugs for the treatment of PSO or PsA within 12 weeks or 5 half-lives (whichever is longer) before the screening visit. 6. Have received topical therapies for the treatment of psoriasis (such as but not limited to corticosteroids, vitamin D analogs, or retinoids) within 2 weeks before baseline visit. 7. Have received phototherapy such as ultraviolet (UV) A phototherapy (with or without oral psoralen), UVB phototherapy, or any systemic steroids, or nonbiological drugs for treatment of autoimmune disease or with a potential effect on the study condition (such as but not limited to methotrexate, apremilast, acitretin, tofacitinib, sulfasalazine, or cyclosporine) within 4 weeks before baseline visit. 8. Have received any investigational drug within 8 weeks or 5 half-lives (whichever is longer) before the screening visit. 9. Have received any herbal remedies or traditional medicines used to treat psoriasis within 4 weeks before baseline visit. 10. Have current or chronic inflammatory or autoimmune disease other than plaque psoriasis that may affect patient’s safety or efficacy assessment. 11. History of allergy to the active substance or any of the excipients of study drugs, or of hypersensitivity to latex. 12. Plan to receive any live vaccination after screening and during the study period (Patient must agree not to receive a live vaccination during the study), or with any Covid-19 vaccination within 2 weeks prior to baseline visit. 13. Have clinical signs or symptoms consistent with coronavirus disease 2019 (COVID-19) infection, e.g., fever, dry cough, dyspnea, sore throat, fatigue, or confirmed infection by appropriate laboratory test (done at the discretion of investigator or per local regulation) within the last 4 weeks before screening or during screening. Resolution of confirmed infection is defined as a negative appropriate COVID-19 laboratory test (as per local regulation) or at least 4 weeks since recovery from symptoms in those symptomatic or at least 4 weeks without any symptom after a positive COVID-19 test in those asymptomatic. 14. History of invasive infection (e.g., histoplasmosis, coccidioidomycosis, blastomycosis). 15. Presence of active infection at screening, history of infection requiring intravenous antibiotics and/or hospitalization = 8 weeks before baseline visit, or oral antibiotics = 2 weeks before baseline visit. 16. Any recurrent bacterial, fungal, or viral infection that (based on the investigator’s clinical assessment) makes the patient unsuitable for the study, including recurrent/disseminated herpes zoster. 17. Meet any of the criteria relative to latent or active TB infection listed in the protocol. 18. Presence of any
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate equivalent efficacy of BAT2306 and Cosentyx® in patients with moderate to severe plaque psoriasis. ;Secondary Objective: - To evaluate the efficacy of BAT2306 compared with Cosentyx over the study period based on secondary efficacy endpoints. - To evaluate the safety and tolerability of BAT2306 compared with Cosentyx over the study period. - To evaluate the immunogenicity of BAT2306 compared with Cosentyx over the study period. - To evaluate the steady-state pharmacokinetics (PK) of BAT2306 compared with Cosentyx. - To assess safety and immunogenicity after transition from Cosentyx to BAT2306.;Primary end point(s): Percent change from baseline in Psoriasis Area and Severity Index (PASI) score to Week 8 . ;Timepoint(s) of evaluation of this end point: per protocol | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Percentage change from baseline in PASI score at Weeks 2, 4, 12, 16, 20, 24, 28, 32, 36, 40, and 44 Proportion of patients who achieve at least 50/75/90/100% improvement from baseline in PASI (PASI-50/75/90/100) at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44 Change from baseline in PASI score at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44 Area under the effect curve (AUEC) for PASI from baseline to Weeks 8, 12, and 24 Change from baseline in Investigator’s Global Assessment (IGA mod 2011) at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44 Proportion of patients with IGA score of cleared (0) or minimal (1) at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44 Change from baseline in affected body surface area at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44 Change from baseline in Dermatology Life Quality Index (DLQI) score to Weeks 2, 4, 8, 12, 24, 32 and 44;Timepoint(s) of evaluation of this end point: per protocol | — |
Countries
China, Hungary, Japan, Poland
Contacts
Public ContactXiaolei Yang
Bio-Thera Solutions, Ltd.
Outcome results
None listed