NCT02435342已完成1 期
A 4 Week Study of the Safety, Tolerability, and Pharmacodynamics of ShK-186 in Active Plaque Psoriasis
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Kineta Inc.
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Subjects with adverse events
研究概览
简要总结
The primary purpose of this study is to examine safety outcomes in active plaque psoriasis patients after systemic administration of dalazatide. Clinical outcome measures will also be assessed.
详细描述
The primary purpose of this study is to examine safety outcomes in active plaque psoriasis patients after systemic administration of dalazatide. Clinical outcome measures will also be assessed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Double (Participant, 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
- •Adult male and female subjects, ages 18-65;
- •Active plaque psoriasis with ≥3% BSA involved;
- •An adequate number of vulgar psoriatic plaques of at least 2 cm X 2 cm with Target Lesion Investigator Global Assessment scores >3, that are not located on the face, scalp, groin, genitals, folds, palms or soles
- •Weight of 50 - 100 kg;
- •Non-child bearing potential or willingness to use adequate contraception in order to prevent pregnancy from the screening visit until 60 days after the follow-up visit.
- •Subject will be evaluated for latent TB infection.
- •Able to communicate and able to provide valid, written informed consent;
排除标准
- •The following will exclude potential subjects from the study:
- •Erythrodermic, predominantly guttate, exclusively palmar/plantar, or generalized pustular psoriasis;
- •Current drug-induced or aggravated psoriasis (e.g., a new onset of psoriasis or an exacerbation of psoriasis from beta-blockers, calcium-channel blockers, or lithium carbonate);
- •Use of the following concurrent systemic medications: corticosteroids, retinoids, cyclosporine, methotrexate, or biologic agents.
- •Use of concurrent topical medications (must be discontinued at least 2 weeks prior to baseline);
- •UVA or UVB therapy within 4 weeks of baseline;
- •The presence of uncontrolled hypertension, uncontrolled diabetes, clinically significant cardiovascular disease, asthma or reduced pulmonary capacity, or a history of seizure or other neurologic disorder;
- •Presence or history of pre-existing paresthesia or neuropathy;
- •Abnormalities on neurological exam at screening or baseline;
- •Clinically significant ECG abnormalities, in the opinion of the Investigator;
- •History of any cancer requiring systemic chemotherapy or radiation;
- •The presence of acute infection or history of acute infection as judged by the Investigator within 7 days of baseline;
- •The presence of clinically significant laboratory abnormalities;
- •A positive hepatitis screen (Hepatitis BsAg or anti-HCV) or positive Human Immunodeficiency Virus (HIV) antibody test ;
- •History of treated or untreated TB
- •Any history of anaphylaxis that is important in the view of the Investigator;
- •Participation in another clinical trial with receipt of an investigational product within 90 days of baseline (or 5 half-lives of the previous drug, whichever is longer);
- •History of alcohol abuse that is important in the view of the Investigator;
- •Positive drug screen for amphetamines, barbituates, benzodiazepines, cocaine, cannabis, methamphetamine, methylenedioxymethanphetamine, opiates or phencyclidine
- •Inadequate venous access that would interfere with obtaining blood samples;
- •Positive pregnancy test at screening or at baseline or current lactation (female subjects only);
- •Inability or unwillingness to comply with study restrictions, return for follow up appointments, or other considerations, in the opinion of the Investigator, which would make the candidate unsuitable for study participation.
研究组 & 干预措施
30ug dalazatide
Experimental
12 subjects, 10 given active agent and 2 given placebo by subcutaneous injection twice weekly for 4 weeks.
干预措施: dalazatide (Drug)
30ug dalazatide
Experimental
12 subjects, 10 given active agent and 2 given placebo by subcutaneous injection twice weekly for 4 weeks.
干预措施: placebo (Drug)
60ug dalazatide
Experimental
12 subjects, 10 given active agent and 2 given placebo by subcutaneous injection twice weekly for 4 weeks.
干预措施: dalazatide (Drug)
60ug dalazatide
Experimental
12 subjects, 10 given active agent and 2 given placebo by subcutaneous injection twice weekly for 4 weeks.
干预措施: placebo (Drug)
结局指标
主要结局
Subjects with adverse events
时间窗: From randomization through Day 57 (12 timepoints)
次要结局
- Target lesion assessment(From randomization to Day 57 (4 timepoints))
- Psoriasis Area Severity Index (PASI) score(From randomization to Day 57 (4 timepoints))
- Patient and Investigator Global Assessment of Psoriasis(From randomization to Day 57 (4 timepoints))
- Skin biomarker assessments(From randomaization to Day 32 (2 timepoints))
- Blood biomarker assessments(From randomizatoin to Day 57 (5 timepoints))
- Dermatology Quality of Life Questionnaire (DLQI)(From randomization to Day 57 (4 timepoints))
- Presence of specific anti-drug antibodies to dalazatide(From randomization to Day 57 (three timepoints))
- Psoriasis Disability Index (PDI)(From randomization to Day 57 (4 timepoints))
- Subjects with changes in vital signs(From randomization to Day 57 (12 timepoints))
- Subjects with changes in symptom-directed physical examinations(From randomization to day 5 (12 timepoints))
研究者
研究点 (1)
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