NCT01072383已完成2 期
A Randomized, Placebo-controlled, Double-blind, Multicentre, Multiple Dose, Cohort Study With Escalating Doses to Evaluate the Safety and Efficacy of the Humanized Monoclonal Antibody BT061 Administered to Patients With Moderate to Severe Chronic Plaque Psoriasis
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Biotest
- 入组人数
- 49
- 试验地点
- 4
- 主要终点
- Improvement in PASI score (Psoriasis Area and Severity Index) , as compared to PASI at baseline visit,
研究概览
简要总结
This Phase II clinical study is to test safety and efficacy of BT061 against psoriasis given as repeated doses.
详细描述
Patients are enrolled into escalating dose levels. Improvement of PASI, physician's global assessment and itching score is evaluated after administration of BT061 or placebo. Safety data are assessed by an independent data and safety monitoring board (DSMB).
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female patients with moderate, moderate to severe or severe chronic plaque psoriasis diagnosed ≥ 12 months prior to Screening.
- •BSA (Body surface area) involvement > 10% for more than 6 months.
- •Age ≥ 18 to ≤ 75 years.
- •Body mass index (BMI) of 18-30 kg/m2 with a body weight between 50 and 130 kg.
排除标准
- •Erythrodermic, guttate or palmar pustular psoriasis (mixed forms may be admissible if chronic plaque psoriasis clearly remains the predominant diagnosis
- •Treatment with a biological within less than 30 days or within less than 5 half-lives of the respective compound prior to administration of BT061/placebo.
- •Serious local (e.g. abscess) or systemic infection (e.g. pneumonia, septicaemia) within 3 months prior to the administration of BT061 or placebo.
- •Presence or history of clinically significant immune deficiency or autoimmune disease (except psoriasis).
- •Positive diagnosis for acute or chronic infections (i.e. Hepatitis C Virus [HCV], Hepatitis B Virus [HBV], Human Immunodeficiency Virus [HIV]) at Screening visit.
研究组 & 干预措施
BT061
Experimental
receiving BT061 (active compound)
干预措施: BT061 (Drug)
Placebo
Placebo Comparator
receiving a placebo
干预措施: placebo treatment (Drug)
结局指标
主要结局
Improvement in PASI score (Psoriasis Area and Severity Index) , as compared to PASI at baseline visit,
时间窗: weekly during treatment, then 1 week, 1 month and 3 months after last dosing
次要结局
- Dose group with the highest number of responders (PASI score improvement)(weekly during treatment, then 1 week, 1 month and 3 months after last dosing)
- PGA (Physician's global assessment)(weekly during treatment, then 1 week, 1 month and 3 months after last dosing)
- Itching score(weekly during treatment, then 1 week, 1 month and 3 months after last dosing)
- DLQI (dermatology life quality index)(weekly during treatment, then 1 week, 1 month and 3 months after last dosing)
- Physical examination(weekly during treatment, then 1 week, 1 month and 3 months after last dosing)
- Differential white blood cell count(weekly during treatment, then 1 week, 1 month and 3 months after last dosing)
- Cytokine profile(weekly during treatment, then 1 week after last dosing)
研究者
研究点 (4)
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