Moderate to severe plaque psoriasis MedDRA version: 20.0 Level: LLT Classification code 10071117 Term: Plaque psoriasis System Organ Class: 100000004858
Conditions
Sponsors
Samsung Bioepis Co., Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Aged 18 years or older at Screening. 2.Have plaque psoriasis diagnosed at least 6 months prior to Screening, with or without psoriatic arthritis. 3.Have plaque psoriasis at Screening and Randomisation with the involvement and severity defined as the following: a.Total affected body surface area (BSA) = 10%. b.PASI score of = 12. c.PGA score of = 3 (moderate). 4.Considered to be a candidate for phototherapy or systemic therapy for psoriasis at Screening. 5.Be less than 95 kg of body weight at Screening and at Randomisation. 6.Adequate haematological function at Screening defined as the following by central lab: a.White blood cell count = 3.5 × 10^3 cells/µL (= 3.5 × 10^9 cells/L). b.Neutrophil count = 1.5 × 10^3 cells/µL (= 1.5 × 10^9 cells/L). c.Haemoglobin = 10 g/dL. d.Platelet count = 125,000/mm^3 (= 125 × 10^9/L). 7.Adequate renal and hepatic function at Screening defined as the following by central lab: a.Serum creatinine =65 years) yes F.1.3.1 Number of subjects for this age range 23
Exclusion criteria
Exclusion criteria: 1.Have nonplaque forms of psoriasis, including erythrodermic, pustular, guttate, or drug-induced psoriasis at Screening. 2.Have other skin disease than psoriasis that: a.Requires topical or systemic corticosteroid or other immunosuppressive therapy at Screening. b.May confound the efficacy evaluation per Investigator discretion at Screening. 3.Have used biologics such as; a.Any tumour necrosis factor (TNF) inhibitors within the previous 6 months prior to Randomisation. b.Any interleukin (IL)-12 or IL-23 inhibitor biologics, IL-17 inhibitor, rituximab, or integrin inhibitor biologics at any time prior to Randomisation. c.Other biologics within the longer of either 5 half-lives or 3 months prior to Randomisation. 4.Known allergic reactions or hypersensitivity to ustekinumab or to any ingredients of Stelara® or SB17 at Screening. 5.History of a systemic allergic reaction or hypersensitivity to prior biologic therapies at Screening. 6.History of life-threatening or corticosteroid-dependent asthma 7.History of exfoliative dermatitis, Reversible Posterior Leukoencephalopathy Syndrome (RPLS), facial palsy, allergic alveolitis, or non-infectious pneumonia including interstitial pneumonia, cryptogenic organizing pneumonia, or eosinophilic pneumonia, etc. at Screening. 8.Have received phototherapy or conventional systemic therapy for psoriasis within 4 weeks prior to Randomisation. 9.Have received topical therapy for psoriasis within 2 weeks prior to Randomisation. 10.Have received any disease-modifying anti-rheumatic drugs (DMARDs), any systemic immunosuppressants or any other injectable or enema corticosteroids, within 4 weeks prior to Randomisation (except for leflunomide: within 12 weeks from Randomisation). 11.Have received non-biologic IP from another study within 5 half-lives of that product prior to Randomisation or use of an investigational device at Randomisation. 12.Women who are pregnant or nursing at Screening, or men and women planning pregnancy during the study period and until 15 weeks after the last dose of IP. 13.Have received a live or live attenuated viral vaccine or a live bacterial vaccine (except Bacille Calmette-Guerin [BCG] vaccination) within 4 weeks prior to Randomisation or plan to do so within 15 weeks after the last dose of IP. For BCG vaccination, subjects who have received BCG within 12 months prior to Randomisation or plan to do so within 12 months after the last dose of IP. 14.Have active or latent tuberculosis (TB) at Screening, by known history or any of the following: 15.History of ongoing infection or a positive test of hepatitis B virus, hepatitis C virus, or human immunodeficiency virus (HIV) infection, or any history of primary immunodeficiency at Screening. 16.History of sepsis, chronic or recurrent infection, conditions that require regular antibiotic prophylaxis, opportunistic, granulomatous, or invasive fungal infection at Screening. 17.History of other bacterial, fungal, viral, parasitic, or helminthic infection requiring oral antimicrobial within 2 weeks prior to Randomisation or a serious infection within 8 weeks prior to Randomisation. Other mild infections should be resolved before Randomisation. 18.History of lymphoproliferative disease or leukaemia at Screening. 19.History of malignancy within the last 5 years prior to Screening. 20.History of myocardial infarction, New York Heart Association (NYHA) III/IV congestive heart failure, or stroke within 12 months prior to Randomisation. 21.Have unco
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Demonstrate the equivalence of SB17 to Stelara®, in terms of the percent change from baseline in Psoriasis Area and Severity Index (PASI) at Week 12 in subjects with moderate to severe plaque psoriasis;Secondary Objective: • To evaluate the efficacy of SB17 compared to Stelara® ? Percent change from baseline in PASI other than Week 12 ? Physician’s Global Assessment (PGA) ? PASI50, PASI75, and PASI90 response rate ? Change from baseline in Dermatology Life Quality Index (DLQI) • To evaluate safety and tolerability of SB17 compared to Stelara® • To evaluate the pharmacokinetics (PK) of SB17 compared to Stelara® in subjects participating in PK evaluation • To evaluate the immunogenicity of SB17 compared to Stelara® • To evaluate safety and immunogenicity in subjects who transitioned to SB17 and who maintained Stelara® at Week 28 for the transition period;Primary end point(s): Percent change from baseline in PASI at Week 12;Timepoint(s) of evaluation of this end point: Week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary efficacy endpoints are: • PGA at Week 2, 4, 8, 12, 16, 20, 24, 28, 40, and 52 • PASI50, PASI75, and PASI90 response rate at Week 2, 4, 8, 12, 16, 20, 24, 28, 40, and 52 • Percent change from baseline in PASI at Week 2, 4, 8, 16, 20, 24, 28, 40, and 52 • Change from baseline in DLQI at Week 4, 12, 16, 28, 40, and 52 The safety endpoints are: • Incidence of adverse events (AEs) • Incidence of serious AEs (SAEs) • Changes in vital signs and clinical laboratory parameters The PK endpoints are: • Serum ustekinumab concentration at Week 0, 2, 4, 8, 12, 16, and 28 The immunogenicity endpoints are: • Incidence of anti-drug antibodies (ADAs) at Week 0, 4, 8, 12, 16, 28, 40, and 52 • Incidence of neutralising antibodies (NAbs) at Week 0, 4, 8, 12, 16, 28, 40, and 52;Timepoint(s) of evaluation of this end point: As described in E.5.2 | — |
Countries
Czechia, Czech Republic, Estonia, Hungary, Korea, Republic of, Latvia, Lithuania, Poland, Ukraine
Contacts
Public ContactInformation Desk
Samsung Bioepis Co., Ltd
Outcome results
None listed