Moderate to Severe Plaque Psoriasis MedDRA version: 20.0 Level: SOC Classification code 10040785 Term: Skin and subcutaneous tissue disorders System Organ Class: 10040785 - Skin and subcutaneous tissue disorders
Conditions
Interventions
Product Name: Recombinant Human Anti-IL12 Monoclonal Antibody
Product Code: BAT2206
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: Recombinant Human Anti-IL12 M
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. sPGA = 3, and c. BSA affected by chronic plaque-type psoriasis = 10% 3. Failed to respond to, have a contraindication to, or is intolerant to other systemic therapies including cyclosporine, methotrexate, or PUVA 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 15 weeks after the last dose of study drug. Abstinence from heterosexual intercourse is accepted when this is the usual lifestyle of the patient and must be continued for at least 15 weeks after the last dose of study drug. A female patient is considered not of childbearing potential when postmenopausal (at least 12 consecutive months without menses without an alternative medical cause) or surgically sterilized (hysterectomy, bilateral salpingectomy, and bilateral oophorectomy). 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 445 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 111
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(eg, eczema)that would interfere with evaluations of the effect of investigational product on psoriasis 2.Have previously received ustekinumab,a biosimilar of ustekinumab,or any drug that targets interleukin-12, interleukin-17 or interleukin-23 3.Weight >120 kg 4.Have received any monoclonal antibody-based biologic drugs for the treatment of Psoriasis(PsO)or Psoriatic arthritis(PsA)other than those prohibited (see exclusion #2)within 5 half-lives of the drugs before the screening visit 5.Have received non-monoclonal antibody biological drugs(eg, etanercept)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 corticosteroids,vitamin D analogs,or retinoids)within 2 weeks before baseline visit. 7.Have received ultraviolet (UV) A phototherapy(with or without oral psoralen),UVB phototherapy,any systemic steroids,or nonbiological drugs(such as methotrexate, apremilast,sulfasalazine, azathioprine,JAK inhibitors,or other immunosuppressive agents)for the treatment of PsO or PsA 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(in case of monoclonal antibody-based investigational drugs exclusion #4 applies) 9.Have received any herbal remedies or traditional medicines used to treat psoriasis or PsA within 4 weeks before baseline visit 10.Have current or chronic inflammatory or autoimmune disease other than plaque psoriasis that may confound the evaluation of the effect of the study treatment.Patients with concurrent PsA will be allowed to participate 11.History of allergy to the active substance or any of the excipients of study drugs,or of hypersensitivity to latex 12.Have received a live vaccination within 4 weeks before the baseline visit(1 year before initiating treatment for Bacillus Calmette–Guerin vaccines). (Patient must agree not to receive a live vaccination during the study and up to 15 weeks [1 year for Bacillus Calmette–Guerin vaccines] after the last dose of the study drug).COVID-19 vaccination will not be allowed for 4 weeks before randomization or for 2 weeks before each dosing (Week 4,Week 16, Week 28,and Week 40)during the study 13.Have clinical signs or symptoms consistent with coronavirus disease 2019 (COVID-19)infection within the last 4 weeks before screening or during screening. In case of confirmed COVID-19 infection before screening, documentation of resolution of infection by appropriate laboratory test is required. 14.History of invasive infection 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.Minor fungal infections may be allowed 16.Any recurrent bacterial, fungal,or viral infection that makes the patient unsuitable for the study,including recurrent/disseminated herpes zoster 17.Meet criteria relative to latent or active tuberculosis infection as described in the protocol 18.Presence of any of the abnormal laboratory test results at screening as described in the protocol 19.Positive HIV
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the study is to demonstrate equivalent efficacy of BAT2206 and Stelara in patients with moderate to severe psoriasis.;Secondary Objective: The secondary objectives of the study are as follows: • To evaluate the efficacy of BAT2206 compared with Stelara over time based on secondary efficacy endpoints. • To evaluate the safety and tolerability of BAT2206 compared with Stelara over the entire study period. • To evaluate the immunogenicity of BAT2206 compared with Stelara. • To evaluate the steady-state PK of BAT2206 compared with Stelara. • To assess safety and immunogenicity after transition from Stelara to BAT2206.;Primary end point(s): The primary endpoint of this study is percent change from baseline (CfB) in Psoriasis Area and Severity Index (PASI) score to Week 8 (EMA) or Week 12 (all other agencies).;Timepoint(s) of evaluation of this end point: Two timepoints (Week 8 or Week 12) will be analyzed independently as primary for this measure, depending on the regulatory agency for submission. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary efficacy endpoints are as follows: • Percent CfB in PASI score to Weeks 4, 16, 20, 28, 32, 40, 44 and 52 • Proportion of patients who achieve at least 50/75/90/100% improvement from baseline in PASI (PASI-50/75/90/100) at Weeks 4, 8, 12, 16, 20, 28, 32, 40, 44 and 52 • Area under the effect curve (AUEC) for PASI from baseline to Weeks 8, 12, and 28. • CfB in static Physician’s Global Assessment (sPGA) score to Weeks 4, 8, 12, 16, 20, 28, 32, 40, 44 and 52 • Proportion of patients with sPGA score on a 6-item scale of cleared (0) or minimal (1) at Week 4, 8, 12, 16, 20, 28, 32, 40, 44 and 52 • CfB in affected body surface area (BSA) at Weeks 4, 8, 12, 16, 20, 28, 32, 40, 44 and 52 • CfB in Dermatology Life Quality Index (DLQI) score to Weeks 8, 12, 28, 40, and 52 ;Timepoint(s) of evaluation of this end point: Timepoints already included in end points | — |
Countries
Bulgaria, China, Georgia, Poland, Russian Federation
Contacts
Public ContactXiaoGe Jia
Bio-Thera Solutions, Ltd.
Outcome results
None listed