EUCTR2022-000695-19-LT进行中（未招募）1 期
A Phase IV, Randomised, Double-blind, Parallel-group, Multiple-dose, Active Comparator, Multicentre Clinical Study to Evaluate the Pharmacokonetics, Efficacy, Safety, and Immunogenicity of SB5 Versus Humira® in Subjects with Moderate to Severe Chronic Plaque Psoriasis
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 366
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •For lead-in period:
- •1. Age of 18 to 80 years at Screening (defined as the time of signing the informed consent form [ICF]).
- •2. Have a) no history of adalimumab (including biosimilars) or cell-depleting biologics (such as rituximab, etc) use, and b) no history of any other biologic (defined as any therapeutic monoclonal antibody or fusion receptor protein) use within 6 months prior to Week 0.
- •3. Have plaque psoriasis diagnosed at least 6 months prior to Screening, with or without psoriatic arthritis.
- •4. Have plaque psoriasis at Screening and Week 0 with the involvement and severity defined as the following:
- •a. Total affected body surface area (BSA) = 10%.
- •b. Psoriasis Area and Severity Index (PASI) score of = 12.
- •c. Physician’s Global Assessment (PGA) score of = 3 (moderate).
- •5. Considered to be a candidate for phototherapy or systemic therapy for psoriasis at Screening.
- •6. Adequate haematological function at Screening
- •7. Adequate renal and hepatic function at Screening
- •8. Non-childbearing potential female (e.g., permanently sterilised, postmenopausal, OR
- •Childbearing potential female subjects or male subjects with their (respectively male or childbearing female) partners who agree to use at least two forms of appropriate contraception method from Screening until 5 months after the last dose of IP.
- •9. Have provided informed consent and must be able to, in the opinion of the Investigator, understand the implications of taking part in the study and be willing to follow the study requirements.
- •For Switching Period:
- •1. Have achieved at least an PASI50 response on Week 13 visit assessment.
- •2. Are willing to participate in the rest of study and able to follow the study procedure with the opinion of the Investigator.
- •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 256
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 110
排除标准
- •For lead-in period:
- •1. Have nonplaque forms of psoriasis, including erythrodermic, pustular, guttate, or drug-induced psoriasis at Screening.
- •2. Have other skin disease than psoriasis that requires topical, phototherapy or systemic therapy, or may confound the efficacy evaluation per Investigator discretion at Screening.
- •3. Known allergic reactions or hypersensitivity to adalimumab or to any ingredients of Humira® or SB5, or any history of Stevens-Johnson syndrome or erythema multiforme at Screening.
- •4. Have received any treatment or therapy of the following, within 4 weeks prior to Week 0:
- •a. Phototherapy
- •b. Conventional systemic therapy
- •Vitamin D (cholecalciferol or ergocalciferol) will be permitted only for non-psoriasis purposes, up to 2000 IU/day. Other vitamin D analogues such as calcitriol, etc. are prohibited.
- •c. Other immunosuppressants or immunomodulators
- •5. Have received topical therapy for psoriasis within 2 weeks prior to Week 0.
- •US class 6/7 topical corticosteroids limited on face and groins will be permitted.
- •Bland emollients that do not contain excluded ingredients will be permitted.
- •6. Have received an IP from another study within 5 half-lives of that product prior to Week 0 or use of an investigational device at Week 0.
- •7. Women who are pregnant or nursing at Screening, or men and women planning pregnancy during the study period and until 5 months after the last dose of IP.
- •8. Have received a live or live attenuated vaccine within 8 weeks prior to Week 0. Non-live or live attenuated Coronavirus Disease 2019 (COVID-19) vaccines are permitted at any time.
- •9. Have active or latent tuberculosis (TB) at Screening
- •10. Have an 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.
- •11. History of sepsis, chronic or recurrent infection, conditions that require regular antibiotic prophylaxis, opportunistic, granulomatous, or invasive fungal infection at Screening.
- •12. History of other bacterial, fungal, viral, parasitic, or helminthic infection requiring oral antimicrobial within 2 weeks prior to Week 0 or a serious infection within 8 weeks prior to Week 0. Other mild infections should be resolved before Week 0. For COVID-19, please see below.
- •13. History of lymphoproliferative disease or leukaemia at Screening.
- •14. History of malignancy (except for squamous or basal cell carcinoma of the skin that has been treated and not recurred within 3 months prior to Screening, or surgically treated cervical carcinoma in situ) within the last 5 years prior to Screening.
- •15. History of demyelinating disease (including multiple sclerosis, optic neuritis or Guillain-Barré syndrome) at Screening.
- •16. History of systemic or cutaneous lupus erythematosus at Screening.
- •17. History of myocardial infarction, unstable angina, or stroke within 12 months prior to Week 0, or any history of New York Heart Association (NYHA) III/IV congestive heart failure (CHF) at Week 0.
- •18. History of interstitial lung disease or pulmonary fibrosis at Screening.
- •19. Have uncontrolled hypertension at Screening.
- •20. Have uncontrolled diabetes mellitus (defined as having history of diabetic peripheral neuropathy or diabetic foot, or otherwise considered uncontrolled in the opinion of the Investigator) at Screening.
- •21. History of organ transplantation at Screening.
- •22. Evidence of alcohol or drug abuse within the last 12 months prior to Scree
研究者
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