A Randomized, Single-Center, Observer-Blind, Vehicle- and ActiveComparator-Controlled Phase 1b Study to Assess the Effect and Local Safety and Tolerability Of Roflumilast and BYK321084 – Phosphodiesterase Type 4 Inhibitors (PDE4i) Dermal Formulations in Patients with Chronic Plaque Psoriasis using a Psoriasis Plaque Test

Takeda Pharma A/S0 个研究点开始时间: 2012年8月9日最近更新: 2014年8月5日

适应症

试验速览

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•Subjects with mild to moderate chronic stable phase plaque psoriasis, providing written informed consent and capable
•of understanding and complying with protocol requirements and scheduled clinic procedures.
•Non-sterilized and sexually active subjects agree to use adequate contraception from providing informed consent to 12 weeks after the last study dose.
•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 14
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 1

•Subjects who have hypersensitivity to roflumilast, BYK321084, or any components or controls used in the study and who have received any investigational compound within 30 days prior to the screening visit.
•Subjects who have pustular, erythrodermic, exfoliative, inverse or guttate psoriasis or psoriatic arthritis.
•Subjects who have rapidly improving or rapidly deteriorating psoriasis or psoriasis that is unresponsive or poorly responsive to topical treatments.
•Subjects who have a significant history of depression associated with suicidal ideation or behavior, or have any significant results from physical examinations or clinical laboratory tests as deemed by the investigator.
•Subjects who are cytochrome P450 (CYP) 2D6 poor metabolizers.

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