Mild to moderate, chronical, stable Psoriasis vulgaris MedDRA version: 15.1 Level: PT Classification code 10037153 Term: Psoriasis System Organ Class: 10040785 - Skin and subcutaneous tissue disorders
Conditions
Interventions
Product Name: roflumilast 0.5% cream
Pharmaceutical Form: Cream
INN or Proposed INN: ROFLUMILAST
CAS Number: 162401-32-3
Current Sponsor code: BY217
Concentration unit: % percent
Concentration type: e
Sponsors
Takeda Pharma A/S
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate whether a dermal formulation of roflumilast is superior compared with vehicle on the reduction of psoriatic infiltrate thickness during 21 days of treatment in subjects with chronic plaque psoriasis. To evaluate whether a dermal formulation of BYK321084 (at 2 concentrations) is superior compared with vehicle (to roflumilast) on the reduction of psoriatic infiltrate thickness during 21 days of treatment in subjects with chronic plaque psoriasis.;Secondary Objective: To evaluate the safety and tolerability of a dermal formulation of roflumilast. To evaluate the safety and tolerability of a dermal formulation of BYK321084 (at 2 concentrations). To compare the efficacy (thickness of psoriatic skin infiltrate and clinical severity) of dermal roflumilast with active comparators. To compare the efficacy (thickness of psoriatic skin infiltrate and clinical severity) of dermal BYK321084 with active comparators.;Primary end point(s): The primary endpoint for this study is the change from Baseline in thickness of the psoriatic skin infiltrate on Day 22 (assessed using 20 MHz sonographic measurement).;Timepoint(s) of evaluation of this end point: Day 22 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Change from Baseline in thickness of the psoriatic skin infiltrate on Days 8 and 15 (assessed using 20 MHz sonographic measurement). AUC of the baseline-corrected thickness of the psoriatic skin infiltrate on Days 1, 8, 15 and 22 (assessed using 20 MHz sonographic measurement). Change in clinical severity of the psoriatic lesions within each test field area on Days 8, 15 and 22 compared with Baseline and with untreated plaque(s) beneath the hydrocolloid dressing.;Timepoint(s) of evaluation of this end point: Days 1, 8, 15, 22 | — |
Countries
Germany
Contacts
Public ContactClinical Trial Manager
Takeda Pharma A/S
Outcome results
None listed