EUCTR2011-000917-38-NL进行中（未招募）不适用
A first–in-human study to evaluate safety and tolerability of repeated topical administrations of BPR277 ointment in healthy volunteers, and safety, tolerability, and preliminary efficacy of multiple topical administrations of BPR277 in patients with atopic dermatitis and Netherton syndrome
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 85
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Subjects eligible for inclusion in this study have to fulfill all of the following criteria:
- •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:
- •a. History of involvement of the skin creases
- •b. Personal history of asthma or hay fever
- •c. History of generally dry skin in the past year
- •d. Onset before age of 2 years
- •e. 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 Cohort A, AA and AB (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.
- •Other protocol-defined inclusion/exclusion criteria may apply. Refer to protocol for details.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 85
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Subjects fulfilling any of the following criteria are not eligible for inclusion in this study. Other protocol-defined exclusion criteria apply in addition to those listed hereafter:
- •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 Cohorts A, AA & AB (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.
- •Other protocol-defined inclusion/exclusion criteria may apply. Refer to protocol for details.
研究者
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CBPR277X2101Part 2: Atopic Dermatitis (AD)Part 3: Netherton Syndrome (NS)MedDRA version: 14.1Level: LLTClassification code 10003639Term: Atopic dermatitisSystem Organ Class: 100000004858MedDRA version: 14.1Level: PTClassification code 10062909Term: Netherton's syndromeSystem Organ Class: 10010331 - Congenital, familial and genetic disordersEUCTR2011-000917-38-DEovartis Pharma Services AG85
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