Atopic dermatitis MedDRA version: 20.0 Level: LLT Classification code 10003639 Term: Atopic dermatitis System Organ Class: 100000004858
Conditions
Sponsors
Novartis Pharma AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Signed informed consent must be obtained before any assessment is performed. 2. Female and male subjects with atopic dermatitis who have participated in and completed 16 weeks of treatment in CZPL389A2203 study. 3. Willing and able to comply with scheduled visits, treatment plan, laboratory tests, diary completion and other study procedures. 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 286 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
Exclusion criteria: 1. Inability to use TCS and/or TCI concomitantly or intermittently due to history of important side effects of topical medication (e.g., intolerance to treatment, hypersensitivity reactions, significant skin atrophy, systemic effects), as assessed by the investigator or subject’s treating physician. 2. Subjects who met any study and/or treatment discontinuation criteria during the CZPL389A2203 study (Section 9.1). 3. Any skin disease that, in the opinion of the investigator, would confound the diagnosis or evaluation of AD disease activity (e.g., Netherton Syndrome, Cutaneous T-Cell Lymphoma, extensive contact dermatitis, chronic actinic dermatitis) 4. Subjects taking medications prohibited by the protocol (see Section 6.2.2) 5. Pregnant or nursing (lactating) women 6. Women of child-bearing potential (WOCBP), defined as all women physiologically capable of becoming pregnant, unless they use required methods of contraception during dosing and for 4 weeks after stopping of investigational medication. 7. Sexually active males unless they use a condom during intercourse while taking drug and for 4 weeks after stopping investigational medication and should not father a child in this period. A condom is required to be used also by vasectomized men in order to prevent delivery of the drug via seminal fluid.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the short-term and long-term safety of 30 mg o.d and 50 mg o.d ZPL389 with concomitant or intermittent use of TCS and/or TCI up to total of 32 weeks and 116 weeks of treatment.;Secondary Objective: To evaluate the efficacy of 30 mg o.d and 50 mg o.d ZPL389 with concomitant or intermittent use of TCS and/or TCI as assessed by IGA response over time. To evaluate the efficacy of 30 mg o.d and 50 mg o.d ZPL389 with concomitant or intermittent use of TCS and/or TCI as assessed by EASI over time.;Primary end point(s): • Frequency of AEs at Week 32 (short-term) and Week 116 (long-term).;Timepoint(s) of evaluation of this end point: at week 32 and week 116 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): IGA score over time (absolute and relative frequencies from core study baseline). IGA response is defined as achievement of an IGA score of 0 or 1 with a 2-point reduction from core study baseline without use of confounding therapy (e.g. rescue medication) up to the assessment time point. EASI score over time (absolute and percent change from core study baseline). EASI-50/EASI-75 response over time: EASI-50/EASI-75 response is defined as achieving =50%/= 75% improvement (reduction) in EASI score compared to baseline without use of confounding therapy (e.g. rescue medication) up to the assessment time point.;Timepoint(s) of evaluation of this end point: Over time | — |
Countries
Canada, Czech Republic, Estonia, Finland, France, Germany, Iceland, Japan, Netherlands, Poland, Slovakia, United Kingdom, United States
Contacts
Public ContactMedical Information
Novartis Healthcare A/S
Outcome results
None listed