A study to assess the safety and efficacy of ZPL389 with concomitant or intermittent use of TCS and/or TCI in atopic dermatitis patients

Phase 1

Conditions: Atopic dermatitis
MedDRA version: 20.0Level: PTClassification code 10012438Term: Dermatitis atopicSystem Organ Class: 10040785 - Skin and subcutaneous tissue disorders
Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

Registration Number: EUCTR2018-000595-15-GB

Lead Sponsor: ovartis Pharma AG

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 230

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 215
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 15

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 active 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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.<br>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.;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.;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 Outcome Measures

Name	Time	Method
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<br>core study baseline without use of confounding therapy (e.g. rescue medication) up to the<br>assessment time point.<br>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

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