E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Moderate to severe plaque psoriasis |
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E.1.1.1 | Medical condition in easily understood language |
Moderate to severe plaque psoriasis |
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E.1.1.2 | Therapeutic area | Diseases [C] - Skin and Connective Tissue Diseases [C17] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10071117 |
E.1.2 | Term | Plaque psoriasis |
E.1.2 | System Organ Class | 100000004858 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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 |
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E.2.2 | Secondary objectives of the trial |
• 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 |
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E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
Pharmacokinetic Assessment: PK will be performed in approximately 140 subjects (70 subjects per treatment group in initial randomisation at Week 0 [Day 1]) participating in PK evaluation. Only subjects who consent to the PK blood sampling will be enrolled in PK sub-study. |
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E.3 | Principal 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 < 1.5 × upper limit of normal (ULN). b.Serum alanine transaminase (ALT) and aspartate transaminase (AST) < 2 × ULN. 8.Non-childbearing potential female, OR childbearing potential female subjects or male subjects with their partners who agree to use at least two forms of appropriate contraception method from Screening until 15 weeks after the last dose of IP. |
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E.4 | Principal 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 uncontrolled hypertension at Screening. 22.Have uncontrolled diabetes mellitus at Screening. 23.History of organ transplantation at Screening. 24.Evidence of alcohol or substance abuse within the last 12 months prior to Screening. 25.History of a major surgery in the opinion of the Investigator within 12 weeks prior to Randomisation or have a plan to do so during the study period. 26.History of uncontrolled psychiatric disorders or risk of suicide at Screening 27.Have other major organ dysfunction or failure such as liver cirrhosis, dialysis-dependent renal failure, any cardiopulmonary disease with functional disability of NYHA III/IV equivalent, aplastic anaemia or any other transfusion-dependent/stimulating factor dependent haematological disorders, or dementia at Screening. 28.Considered to be at risk of progressive weight gain or widely fluctuating body weight, in the opinion of the Investigator, at Screening. 29.History of COVID-19 as: a.History of asymptomatic, mild or moderate COVID-19 within 8 weeks prior to Randomisation. b.Any history of severe or critical COVID-19, or hospitalisation due to COVID-19 at Randomisation. c.Any history of COVID-19 complications or sequalae including lung fibrosis, thromboembolism, cardiac, gastrointestinal, neuropsychiatric, ‘long COVID’, or dermatologic manifestations, etc. at Randomisation. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Percent change from baseline in PASI at Week 12 |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | 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 |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
Tolerability and Immunogenicity |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
Transition period at Week 28 for subjects PASI50 response |
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E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 3 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 46 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
Korea, Republic of |
Ukraine |
Estonia |
Hungary |
Latvia |
Lithuania |
Poland |
Czechia |
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E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 8 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 8 |