Atopic Dermatitis (AD) MedDRA version: 18.0 Level: LLT Classification code 10003639 Term: Atopic dermatitis System Organ Class: 100000004858
Conditions
Interventions
Product Name: ZPL-3893787
Product Code: ZPL-3893787
Pharmaceutical Form: Capsule
INN or Proposed INN: ZPL-3893787
Current Sponsor code:
Sponsors
Ziarco Pharma Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: * Males and females aged 18-65 years inclusive with physician documented history or diagnosis of atopic dermatitis for at least 12 months prior to screening. Chronic AD should be diagnosed by the Eichenfield revised criteria of Hanifin and Rajka (Eichenfield, 2004). *Females should be either of non child-bearing potential (as specified in Section 5.7) or must agree to use both a highly effective methods of contraception, and a barrier method of contraception (e.g. male condom, female condom or diaphragm with spermicide) (as specified in Section 5.7). Males with partners who are WOCBP must also use contraception (as specified in Section 5.7). [UK specific] * Eczema Area and Severity Index (EASI) of =12 and =65 years) yes F.1.3.1 Number of subjects for this age range 5
Exclusion criteria
Exclusion criteria: Subjects presenting with any of the following will not be included in the study: 1 AD of such severity (EASI >48) that the subject could not comply with the demands of the study and/or the subject is not a suitable candidate for a placebo-controlled study 2 Have concurrent skin disease (e.g. acne) of such severity in the study area that it could interfere with the study evaluation or presence of skin comorbidities that may interfere with study assessments. 3 Have an active skin infection or any other clinically apparent infections. 4 Hypersensitivity to mometasone or to any other ingredients contained by the topical corticosteroid product used as rescue medication in the study. 5 Have received phototherapy (e.g. UVA, UVB), or systemic therapy (e.g. immunosuppressants, cytostatics) known or suspected to have an effect on AD, within 4 weeks of the start of the Run In. 6 Have received systemic corticosteroids ([CS] e.g. oral, intravenous, intraarticular, rectal) within 4 weeks of the start of the Run in. Subjects on a stable maintenance dose (over the preceding 3 months) of inhaled or intranasal CS may participate. 7 Were treated with oral antihistamines or topical calcineurin inhibitors or topical steroids within 7 days of starting Run In; intranasal antihistamines for the treatment of allergic rhinitis are acceptable. 8Use of a tanning booth/parlour within 4 weeks before start of the Run In. 9 Have used antiseptic treatments (e.g. bleach baths, potassium permanganate etc.) within 4 weeks before the start of the Run In. (Patients who have recently used antiseptic treatment may be rescreened at a later date if they wish to participate in the study and agree to stop antiseptic treatment.) 10 Evidence of significant concomitant clinical disease that may need a change in management during the study or could interfere with the conduct or safety of this study (Stable well-controlled chronic conditions such as controlled hypertension (BP100 or 450 msec).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of 8 weeks treatment of 30 mg od ZPL-3893787 on pruritus in adult subjects with moderate to severe atopic dermatitis.;Primary end point(s): Change from baseline in the Numerical Rating Score (NRS) for Pruritus (Worst Itch) over 24 hours;Timepoint(s) of evaluation of this end point: 24 hours; Secondary Objective: To assess the safety and tolerability of 8 weeks treatment of 30 mg od ZPL-3893787 in adult subjects with moderate to severe atopic dermatitis. To evaluate the efficacy of 8 weeks treatment of 30 mg od ZPL-3893787 on severity of AD skin lesions in adult subjects with moderate to severe atopic dermatitis. | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: Week 8; Secondary end point(s): Secondary Endpoints: Efficacy Change from baseline in the daytime NRS for Pruritus (Worst Itch) Change from baseline in the night time NRS for Pruritus (Worst Itch) Change from baseline in the NRS for Sleep Disturbance Change from baseline in Duration of Itching Change from baseline in Verbal Rating Score (VRS) for Pruritus Change from baseline in the Eczema Area and Severity Index (EASI) score Change from baseline in the SCORing Atopic Dermatitis (SCORAD) score Investigators Global Assessment (IGA) Score Amount of rescue medication use Patient Global Impression of Change (PGIC) Secondary Endpoints: Safety Adverse events, vital signs, temperature, 12-lead ECG, laboratory safety tests (clinical chemistry, hematology, urinalysis). | — |
Countries
Belgium, Germany, Poland, United Kingdom
Contacts
Public ContactLynn Purkins
Ziarco Pharma Ltd
Outcome results
None listed