NCT01428297已完成1 期
A First-In-human Study to Evaluate Safety and Tolerability of Topical BPR277 in Healthy Volunteers, and Proof of Concept (PoC) Studies to Evaluate the Safety, Tolerability, and Efficacy of Topical BPR277 in Patients With Atopic Dermatitis and Netherton Syndrome
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Systemic and local tolerability of BPR277 ointment, as measured by change in local tolerability score, number of adverse events and clinically significant changes in standard hematology, blood chemistry.
研究概览
简要总结
The study is divided in 3 parts, starting with the safety assessment of BPR277 ointment in Healthy volunteers (Part 1). If found to be well tolerated in Part 1, BPR277 ointment will be assessed in two different patients groups to evaluate safety and efficacy in atopic dermatitis (Part 2) and in Netherton syndrome (Part 3).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- 是
入选标准
- •Part 1 Healthy volunteers
- •Healthy male and female subjects of non childbearing potential, 18 to 65 years of age inclusive and in good health
- •Part 2 Patients with atopic dermatitis:
- •Male and female subjects, 18 to 65 years of age inclusive and having passed screening examinations
- •Presence of atopic dermatitis confirmed by Itchy skin condition in the past 12 months (must have) Plus three or more of the following:
- •History of involvement of the skin creases
- •Personal history of asthma or hay fever
- •History of generally dry skin in the past year
- •Onset before age of 2 years
- •Visible flexural dermatitis
- •Diagnosis of at least moderate atopic dermatitis by the IGA and a minimum target area (right or left) situated on the forearm including the antecubital fossa with a corresponding baseline total lesional sign score (TLSS)
- •Part 3 Patients with Netherton Syndrome:
- •Patients with Netherton syndrome, male and female subjects, 18 to 65 years of age inclusive and having passed screening examinations
- •Confirmed diagnosis of Netherton syndrome (SPINK5 mutation or LEKTI deficiency in the skin).
- •Minimum total lesional sign score NS (TLSS-NS) of 5-9 for two selected target areas at baseline. The TLSS-NS values need to be similar between the two areas at baseline.
排除标准
- •Part 1 Healthy volunteers :
- •History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes or history of serious allergic reaction.
- •Use of any prescription drugs, herbal supplements, within four (4) weeks prior to initial dosing, and/or over-the-counter (OTC) medication, dietary supplements (vitamins included) within two (2) weeks prior to initial dosing.
- •Part 2 Patients with atopic dermatitis:
- •History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes or history of serious allergic reaction.
- •History of abnormal skin reactivity to UV light. Unusual exposure to UV light in the previous 3 weeks to study start (screening), including tanning and sun beds.
- •Pregnant or nursing (lactating) women.
- •Women of child-bearing potential must use highly effective contraception (as further defined in study protocol)
- •Use of topical prescription treatment for eczema within 1 week prior to initial dosing of topical corticosteroids (TCS).
- •Recent previous treatment with systemic treatment including phototherapy. A washout period will be required for such patients to be eligible to participate in the trial.
- •Part 3 Patients with Netherton Syndrome:
- •History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes or history of serious allergic reaction.
- •History of abnormal skin reactivity to UV light. Unusual exposure to UV light in the previous 3 weeks to study start (screening), including tanning and sun beds.
- •Pregnant or nursing (lactating) women.
- •Women of child-bearing potential must use highly effective contraception (as further defined in study protocol)
- •Use of topical prescription treatment within 2 week prior to initial dosing of study drug.
- •Recent previous treatment with systemic treatment. A washout period will be required for such patients to be eligible to participate in the trial.
研究组 & 干预措施
Cohort A and B, BPR277 and Placebo (vehicle)
Experimental
干预措施: BPR277 ointment (controlled application) (Drug)
Cohort A and B, BPR277 and Placebo (vehicle)
Experimental
干预措施: Placebo (Vehicle) (Drug)
Part 2 BPR277
Experimental
干预措施: BPR277 ointment (Drug)
Part 2 Placebo (vehicle)
Placebo Comparator
干预措施: Placebo (Vehicle) (Drug)
Part 3 BPR277 and Placebo (vehicle)
Experimental
干预措施: BPR277 (Drug)
Part 3 BPR277 and Placebo (vehicle)
Experimental
干预措施: Placebo (Vehicle) (Drug)
结局指标
主要结局
Systemic and local tolerability of BPR277 ointment, as measured by change in local tolerability score, number of adverse events and clinically significant changes in standard hematology, blood chemistry.
时间窗: 2-4 weeks
Part 2 and 3: Patients with Atopic Dermatitis / Netherton syndrome: Change in Total Lesional Signs Score at the treated skin area
时间窗: 4 weeks
次要结局
- Part 2 and 3: Patients with Atopic Dermatitis / Netherton syndrome: Change for each sign comprising the total lesional signs score at the treated skin area(4 weeks)
研究者
研究点 (1)
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