SB17 versus to Stelara® in Subjects with Moderate to Severe Plaque Psoriasis
- Conditions
- Moderate to severe plaque psoriasisMedDRA version: 20.0Level: LLTClassification code 10071117Term: Plaque psoriasisSystem Organ Class: 100000004858Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
- Registration Number
- EUCTR2020-006115-19-CZ
- Lead Sponsor
- Samsung Bioepis Co., Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 464
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.
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 441
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 23
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method