NCT04967508已完成3 期
A Phase III, Randomised, Double-blind, Multicentre Clinical Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics, and Immunogenicity of SB17 (Proposed Ustekinumab Biosimilar) Compared to Stelara® in Subjects With Moderate to Severe Plaque Psoriasis
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 503
- 试验地点
- 2
- 主要终点
- Percent Change From Baseline in PASI at Week 12
研究概览
简要总结
This is a randomised, double-blind, multicentre clinical study to evaluate the efficacy, safety, tolerability, PK, and immunogenicity of SB17 compared to Stelara® in subjects with moderate to severe plaque psoriasis.
详细描述
Subjects will be randomised in a 1:1 ratio to receive either SB17 or Stelara® via subcutaneous injection. At Week 28, subjects receiving Stelara® will be randomised again in a 1:1 ratio to either continue on Stelara® or be transitioned to SB17. Investigational products (IPs) (SB17 or Stelara®) will be administered at Week 0, 4, and then every 12 weeks up to Week 40, and the last assessment will be done at Week 52.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18 years or older at Screening.
- •Have plaque psoriasis diagnosed at least 6 months, with or without psoriatic arthritis.
- •Have plaque psoriasis with the involvement and severity of total affected BSA ≥ 10%, PASI score of ≥ 12 and PGA score of ≥ 3 (moderate).
- •Considered to be a candidate for phototherapy or systemic therapy for psoriasis
- •Less than 95 kg of body weight.
- •Adequate hematological, renal and hepatic function by central lab.
- •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.
排除标准
- •Have nonplaque forms of psoriasis, including erythrodermic, pustular, guttate, or drug-induced psoriasis.
- •Have other skin disease than psoriasis that requires topical or systemic corticosteroids.
- •Prior biologic use as any TNF inhibitors within the previous 6 months; any IL-12 or IL-23 inhibitor biologics, IL-17 inhibitor, rituximab, or integrin inhibitor biologics at any time; or other biologics within the longer of either 5 half-lives or 3 months prior to randomisation.
- •Known allergic reactions or hypersensitivity to ustekinumab or to any ingredients of Stelara® or SB17
- •History of exfoliative dermatitis, reversible posterior leukoencephalopathy syndrome, facial palsy, allergic alveolitis, or non-infectious pneumonia.
- •Have received phototherapy or conventional systemic therapy for psoriasis within 4 weeks prior to Randomisation.
- •Have received topical therapy for psoriasis within 2 weeks prior to Randomisation.
- •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.
- •Have received a live or live attenuated viral vaccine or a live bacterial vaccine within 4 weeks (for BCG, 12 months) prior to Randomisation.
- •Have active or latent tuberculosis.
- •History of ongoing infection or a positive test of HBV, HCV, or HIV infection
- •History of sepsis, chronic or recurrent infection
- •History of malignancy within the last 5 years
- •History of lymphoproliferative disease or leukemia
- •History of myocardial infarction, NYHA III/IV congestive heart failure, or stroke within 12 months
- •Have uncontrolled hypertension or diabetes
- •History of uncontrolled psychiatric disorders or risk of suicide
研究组 & 干预措施
SB17 (Proposed Ustekinumab Biosimilar)
Experimental
干预措施: SB17 (Proposed Ustekinumab Biosimilar) (Drug)
Stelara® (Ustekinumab)
Active Comparator
干预措施: Stelara® (Ustekinumab) (Drug)
Stelara® (Ustekinumab)
Active Comparator
干预措施: SB17 (Proposed Ustekinumab Biosimilar) (Drug)
结局指标
主要结局
Percent Change From Baseline in PASI at Week 12
时间窗: Baseline and Week 12
Psoriasis area severity index (PASI) measures the activity of psoriasis through erythema, induration and scaling and can range from 0 to 72. The degree of PASI improvement in terms of percent change from baseline at Week 12 is measured.
次要结局
未报告次要终点
研究者
研究点 (2)
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