NCT03927352Unknown3 期
A Phase 3, Randomized, Double-blind Study Evaluating the Efficacy and Safety of SCT630 Compared With Adalimumab in Subjects With Moderate to Severe Plaque Psoriasis
适应症
干预措施
试验速览
- 阶段
- 3 期
- 入组人数
- 330
- 试验地点
- 1
- 主要终点
- Percent Improvement From Baseline in Psoriasis Area and Severity Index (PASI) at Week 16
研究概览
简要总结
The purpose of this research study is to compare the efficacy and safety of SCT630 and adalimumab (HUMIRA®) in adults with plaque psoriasis.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men or women ≥ 18 and ≤ 70 years of age at time of screening.
- •History of psoriasis for at least 6 months ,and stable moderate to severe plaque psoriasis within 2 months prior to randomized.
- •Moderate to severe psoriasis defined at screening and baseline by：Body surface area (BSA) affected by plaque psoriasis of 10% or greater, and PASI score of 12 or greater, and static physician's global assessment score of 3 or greater.
- •Negative test for Interferon-gamma-release assay an chest X-ray at time of screening.
- •Subject is a candidate for systemic therapy or phototherapy procedures.
- •Female participants must have a negative pregnancy test; are not planning to become pregnant; and must not be lactating.
- •From the screening period to the end (Six months after the last administration),female participants must agree to employ a highly effective contraceptive measure.
排除标准
- •Other forms of psoriasis,skin conditions(eg, eczema) or systemic autoimmune diseases which affected the evaluation of treatment outcomes .
- •Received local anti-psoriasis drugs within 2weeks prior to baseline;
- •Received PUVA ,UVB or non-biologics within 4weeks prior to baseline,including methotrexate,Cyclosporine,tretinoins,traditional Chinese medicine,and so on.
- •Received etanercept or its biosimilars within 4weeks prior to baseline.
- •Received other anti-TNF ,IL-12/23inhibitors or IL-17inhibitors within12months prior to baseline.
- •Be receiving or had received any biologics ≤ five half-lives.
- •Patients who previously used adalimumab or a biosimilar of adalimumab ineffectively or intolerantly.
- •History of tuberculosis, active tuberculosis or latent tuberculosis infection.
- •Suffering from active infection or history of infection :Systemic anti-infective therapy was performed 4 weeks before screening, severe infections with hospitalization or intravenous anti-infective treatment within 8 weeks before screening or recurrent, chronic or other active infections which were assessed by researchers to increase the risk of subjects.
- •Subjects were known to have malignant tumors or a history of malignant tumors (except for skin squamous cell carcinoma in situ, basal cell carcinoma, cervical cancer in situ, or skin squamous cell carcinoma with no evidence of recurrence after thorough treatment, or five years prior to investigational product administration)
- •Moderate to severe congestive heart failure (New York Heart Association Classes III or IV）.
- •Subjects with a significant disease other than psoriasis and/or a significant uncontrolled disease (such as, but not limited to, nervous system, renal, hepatic, endocrine, hematological, autoimmune or gastrointestinal disorders)，and which were assessed by researchers to increase the risk of subjects.
- •Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 2.5 times upper limit of normal (ULN) ,Hemoglobin < 90 g/L ,Leukocyte count < 3.5×109/L,Platelets < 100×109/L ,Serum creatinine > 2.5 times upper limit of normal (ULN) at Screening.
- •Received any live vaccines ≤4 weeks prior to investigational product administration,or patients who are expecting to receive any live vaccines during the trial.
- •Subjects had hypersensitivity to test drugs and their excipients, or drugs with the same pharmacological and biological classification as test drugs, and had a history of allergy to active substances or excipients of adalimumab or SCT
- •Positive test for anti-nuclear antibody(ANA) or anti-double-stranded DNA antibody at screening.
- •Subjects were accompanied by active neuropathy, including but not limited to multiple sclerosis, Guillain-Barre syndrome, optic neuritis, transverse myelitis, or neurological symptoms suggesting demyelinating lesions of the central nervous system.
- •Positive test for HIV antibodies, hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibodies ,or Treponema pallidum antibody at screening.
- •The results of five tests for hepatitis B virus infection should be further tested for hepatitis B virus DNA, if it is greater than or equal to the upper limit of the reference value of each hospital.
- •Women who are pregnant or nursing.
研究组 & 干预措施
SCT630
Experimental
Participants received 80 mg SCT630 subcutaneously on week 1/day 1 (initial loading dose) and 40 mg at week 2 and every 2 weeks thereafter until week 16.
Participants with a PASI 50 response at week 16 continued to receive 40 mg SCT630 until week 48.
干预措施: SCT630 (Biological)
adalimumab-EU source
Active Comparator
Participants received 80 mg adalimumab subcutaneously on week 1/day 1 (initial loading dose) and 40 mg at week 2 and every 2 weeks thereafter until week 16.
At week 16 participants with a PASI 50 response were re-randomized to treatment with adalimumab or were transitioned to SCT630 until week 48
干预措施: Adalimumab (Biological)
结局指标
主要结局
Percent Improvement From Baseline in Psoriasis Area and Severity Index (PASI) at Week 16
时间窗: Baseline and Week 16
The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0.0 to 72.0, with higher scores indicating greater severity and/or more extensive psoriasis. Percent improvement from baseline was calculated as (value at baseline - value at post-baseline visit) × 100 / (value at baseline).
次要结局
- Minimum Concentration of SCT630 and EU-licensed Humira(Week1、4、16、32、48、50)
- Percent Improvement From Baseline in PASI at Week 4、8、12、24、32、48、50(Baseline and week 4、8、12、24、32、48、50)
- Change From Baseline in the Percentage of Body Surface Area (BSA) Involved With Psoriasis at Week 4、8、12、16、24、32、48、50(Baseline and Week 4、8、12、16、24、32、48、50)
- Change From Baseline of dermatology life quality index (DLQI)at Week 4、8、12、16、24、32、48、50(Baseline and Week 4、8、12、16、24、32、48、50)
- Percentage of Participants With a PASI 90 Response at Week 4、8、12、16、24、32、48、50(Baseline and Week 4、8、12、16、24、32、48、50)
- Percentage of Participants With a PASI 50 Response at Week 4、8、12、16、24、32、48、50(Baseline and Week 4、8、12、16、24、32、48、50)
- Percentage of Participants With a PASI 75 Response at Week 4、8、12、16、24、32、48、50(Baseline and Week 4、8、12、16、24、32、48、50)
- Positive rate of ADA and NAb(Week1、4、16、32、48、50、52)
- Percentage of Participants With a PASI 100 Response at Week 4、8、12、16、24、32、48、50(Baseline and Week 4、8、12、16、24、32、48、50)
- Percentage of Participants With a Static Physician's Global Assessment (sPGA) Response at Week 4、8、12、16、24、32、48、50(Week 4、8、12、16、24、32、48、50)
- Number of Participants With Adverse Events(Week2、4、8、12、16、24、32、40、48、52)
研究者
研究点 (1)
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