Randomized Double Blind Phase III Trial Comparative Clinical Safety, Efficacy and Immunogenicity of Adalimumab (Manufactured by Mabscale, LLC) to Humira®.
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 494
- 试验地点
- 9
- 主要终点
- Proportion of patients with positive antibody titer to Adalimumab
研究概览
简要总结
MABPS-3/2020 is a double-blind randomized multicenter clinical trial comparing efficacy, immunogenicity and safety profiles of Adalimumab (manufactured by Mabscale, LLC) compared to Humira®.
The purpose of the study is to demonstrate efficacy, immunogenicity and safety of Adalimumab (manufactured by Mabscale, LLC) to Humira ® in adult patients with chronic plaque psoriasis of moderate and severe degree.
详细描述
Adalimumab is a recombinant humanized monoclonal antibody currently being developed by Mabscale LLC, as a proposed biosimilar to Humira®, which is approved as treatment in patients with chronic plaque psoriasis.
This randomized equivalence study is designed to meet the regulatory requirement for approval of a biosimilar product.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent.
- •Male and female patients aged 18-65 years, body weight ≥ 50 kg and ≤ 120 kg.
- •Established clinical diagnosis plaque psoriasis, lasting at least 6 months before the screening.
- •Plaque psoriasis of moderate or severe severity of stable course with:
- •PASI ≥ 12 points;
- •BSA ≥ 10 %;
- •sPGA ≥ 3 points.
- •Patients who have been shown to undergo systemic therapy and/or patients who have had insufficient therapeutic efficacy of at least 1 previous standard systemic therapy for psoriasis, including phototherapy, therapy with cytostatic and immunosuppressive drugs, or who have had intolerance to standard systemic therapy.
排除标准
- •Data on intolerance or hypersensitivity to any components of the drugs, or to any other human proteins, immunoglobulin preparations.
- •A history of severe hypersensitivity reactions of any etiology.
- •Other (other than plaque) forms of psoriasis.
- •Drug-induced psoriasis.
- •Data on the use of the Adalimumab or any preparations of monoclonal antibodies inhibiting TNF-α at any time during life.
- •The presence of Adalimumab antibodies.
- •Extensive surgical intervention performed less than 30 days before the screening period, or planned extensive surgical intervention during the study period.
- •Active or latent tuberculosis
- •Lymphoproliferative diseases, lymphoma, leukemia, myeloproliferative diseases or a history of multiple myeloma.
- •Any other malignant neoplasms currently or in anamnesis within the last 5 years, with the exception of completely removed and/or cured.
- •Confirmed coronavirus infection caused by COVID-19 within 8 weeks prior to the screening period.
- •Anamnestic data on the presence of syphilis, viral hepatitis B, viral hepatitis C, HIV.
- •Vaccination with live or attenuated vaccines within 8 weeks before the screening period.
- •Hepatic and/or renal insufficiency.
- •Pregnancy or lactation.
研究组 & 干预措施
Adalimumab (manufactured by Mabscale, LLC)
In the main period, patients will begin Visit 1 receiving Adalimumab therapy at an initial dose (80 /0, 16 ml) on Visit 1, from Visit 2 Adalimumab therapy at a maintenance dose (40 /0, 8 ml) for up to Visit 9 of therapy. Each visit is conducted every two weeks ± 2 days. In additional period (from Visit 11 until Visit 28), eligible patients will continue to receive treatment after additional randomization (Adalimumab or Humira® (40 /0, 8 ml)) every 2 weeks until the end of a trial.
干预措施: Adalimumab (Drug)
Humira®
In the main period, patients will begin Visit 1 receiving Humira® therapy at an initial dose (80 /0, 8 ml) on Visit 1, from Visit 2 Humira® therapy at a maintenance dose (40 /0, 4 ml) for up to Visit 9 of therapy. Each visit is conducted every two weeks ± 2 days.
In additional period (from Visit 11 until Visit 28), eligible patients will continue to receive treatment after additional randomization (Adalimumab or Humira® (40 /0, 4 ml)) every 2 weeks until the end of a trial.
干预措施: Humira (Drug)
结局指标
主要结局
Proportion of patients with positive antibody titer to Adalimumab
时间窗: 51 weeks of therapy
The proportion of patients who achieved a response according to the PASI criterion of 75 (a decrease in the severity and prevalence of psoriasis by ≥75% from the baseline level assessed by the PASI index)
时间窗: after 16 weeks of therapy (assessment at Visit 10)
Percentage of patients who have neutralizing antibodies to Adalimumab
时间窗: 51 weeks of therapy
次要结局
未报告次要终点