A Study to Determine the Safety & Efficacy of ZPL-5212372 in Healthy Subjects and in Subjects With Atopic Dermatitis

Last updated: April 1, 2019
Sponsor: Ziarco Pharma Ltd
Overall Status: Completed

Phase

1/2

Condition

Atopic Dermatitis

Allergy

Eczema (Atopic Dermatitis)

Treatment

N/A

Clinical Study ID

NCT02795832
Ziarcopharma
  • Ages 18-65
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

A Randomised, Adaptive Design, Double-Blind (3rd Party Open), Placebo Controlled, Sequential Group Study to Determine the Safety,Tolerability, Pharmacokinetics and Efficacy of Twice Daily Application of a Topical ZPL-5212372 (1.0% w/w) Ointment Administered for up to 2 Weeks in Adult Healthy Volunteers and Patients with Moderate to Severe Atopic Dermatitis

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Healthy males or females, aged between 18 and 55 years, inclusive (healthy is definedas no clinically relevant abnormalities identified by a detailed medical history, fullphysical examination, including blood pressure and pulse rate measurement, 12-lead ECGand clinical laboratory tests). or Males and females aged 18-65 years inclusive with physician documented history or diagnosisof atopic dermatitis for at least 6 months prior to screening. AD should be diagnosed bythe Eichenfield revised criteria of Hanifin and Rajka. For Atopic Dermatitis Patients: Eczema Area and Severity Index (EASI) of ≥9 and <48 at Screening and an EASI of ≥12 and <48at Day 1. An Investigator's Global Assessment (IGA) score ≥ 3 at both Screening and Day 1. Atopic dermatitis affecting between ≥10 to <40% BSA at Screening and ≥10% to <50% BSA onDay 1. All Subjects: Evidence of a personally signed and dated informed consent form, indicating that thesubject has been informed of all pertinent aspects of the study.

Exclusion

Exclusion Criteria: For Healthy Subjects

  • Evidence or history of clinically significant haematological, renal, endocrine,pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, orallergic disease (including drug allergies, but excluding untreated, asymptomatic,seasonal allergies at time of dosing).

  • Have tattoos covering areas of skin to be dosed with study ointment.

  • Subjects who are hirsute in areas of skin to be dosed with study ointment.

  • Subjects who have received treatment with an investigational drug within 3 monthsprior to screening. For Atopic Dermatitis Patients:

  • AD of such severity (EASI >48) that the subject could not comply with the demands ofthe study and/or the subject is not a suitable candidate for a placebo-controlledstudy.

  • Have concomitant skin disease or infection (e.g. acne, impetigo) or presence of skincomorbidities in the study area to be dosed that may interfere with study assessments.

  • Have received phototherapy (e.g. UVA, UVB or PUVA therapy), or systemic therapy (e.g.immunosuppressants [such as cyclosporine, azathioprine, methotrexate], cytostatics)known or suspected to have an effect on AD, within 4 weeks of the start of the study.All other biologics should not have been used within 3 months of the start of study.

  • Have received systemic corticosteroids (e.g. oral, intravenous, intraarticular,rectal) within 4 weeks of the start of the study. Subjects on a stable maintenancedose (over the preceding 3 months) of inhaled or intranasal CS may participate.

  • Patients treated with oral antihistamines or topical calcineurin inhibitors or topicalsteroids within 7 days of starting study; intranasal antihistamines for the treatmentof allergic rhinitis are acceptable.

Study Design

Total Participants: 53
Study Start date:
June 01, 2016
Estimated Completion Date:
March 01, 2017

Study Description

This study was a randomised, adaptive design, double blind (3rd party open), placebo controlled, sequential group study in both healthy volunteers and patients with moderate to severe AD. This study was divided into 3 separate, sequential cohorts:

  • Cohort 1 were to assess safety, toleration and pharmacokinetics (PK) with intensive monitoring as in-patients over 7 days of dosing in healthy volunteers.

  • Cohort 2 were to assess safety, toleration and PK with intensive monitoring as in-patients over 7 days of dosing in moderate to severe AD patients.

  • Cohort 3 were to assess efficacy, safety, toleration and PK as out-patients over 14 days of dosing in moderate to severe AD patients.

Subjects received 1.0% (w/w) ZPL-5212372 or matched placebo ointment topically, twice daily.

Connect with a study center

  • MAC

    Blackpool,
    United Kingdom

    Site Not Available

  • MAC

    Leeds,
    United Kingdom

    Site Not Available

  • MAC

    Manchester,
    United Kingdom

    Site Not Available

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