A study to determine the effects of 8 week treatment with an oral drug called ZPL-3893787 in adult subjects with moderate to severe atopic dermatitis.

• Conditions: Atopic Dermatitis (AD); MedDRA version: 18.1Level: LLTClassification code 10003639Term: Atopic dermatitisSystem Organ Class: 100000004858; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: EUCTR2014-005057-39-PL
• Lead Sponsor: Ziarco Pharma Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-04-01
• Last Update Posted: 25 April 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 90

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 or must agree to use highly effective methods of contraception. Males with partners who are WOCBP must also use contraception
* Eczema Area and Severity Index (EASI) of =12 and <48.
* An Investigator’s Global Assessment (IGA) score = 3 at both Screening and Day 0.
* A mean pruritus score of = 5 on a 0-10 scale over the 7 day Run In (Days -7 to -1)
* Atopic dermatitis affecting =10% BSA
* Patients must be willing to apply stable amounts of an additive-free, basic, bland emollient, twice daily for at least 7 days before the baseline visit.
*Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, eDiary completion and other study procedures.
* Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study.
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 81
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 9

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 (BP<140/90 mmHg) thyroid disease, well-controlled Type 1 or Type 2 diabetes (HbA1c< 8%), hypercholesterolemia, gastroesophageal reflux, or depression under control with medication (other than tricyclic antidepressants), are acceptable provided the symptoms and medications would not be predicted to compromise safety or interfere with the tests and interpretations of this study).
11 Clinically significant cardiac disease or ECG abnormalities, including:
? Predominant heart rhythm other than normal sinus rhythm
? AV block greater than first degree
? Resting heart rate >100 or <50 bpm
? Electrocardiographic evidence or a history of myocardial infarction
? Electrocardiographic evidence of conduction system abnormality
? Subjects with pre-randomization evidence of QTc prolongation (defined as >450 msec).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

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

Name	Time	Method
Secondary end point(s): Secondary Endpoints: Efficacy<br>Change from baseline in the daytime NRS for Pruritus (Worst Itch)<br>Change from baseline in the night time NRS for Pruritus (Worst Itch)<br>Change from baseline in the NRS for Sleep Disturbance<br>Change from baseline in Duration of Itching<br>Change from baseline in Verbal Rating Score (VRS) for Pruritus<br>Change from baseline in the Eczema Area and Severity Index (EASI) score<br>Change from baseline in the SCORing Atopic Dermatitis (SCORAD) score<br>Investigators Global Assessment (IGA) Score<br>Amount of rescue medication use<br>Patient Global Impression of Change (PGIC)<br><br>Secondary Endpoints: Safety<br>Adverse events, vital signs, temperature, 12-lead ECG, laboratory safety tests (clinical chemistry, hematology, urinalysis).;Timepoint(s) of evaluation of this end point: Week 8