Pharmacodynamics of Omiganan BID in Patients With Atopic Dermatitis

A Randomized, Double-blind, Placebo-controlled Study to Assess the Pharmacodynamics, Safety, Tolerability and Efficacy of Omiganan BID in Patients With Mild to Moderate Atopic Dermatitis

This study has a randomized, double-blind, placebo-controlled design to assess the efficacy, pharmacodynamics and safety/tolerability of omiganan in patients with mild to moderate atopic dermatitis when applied BID to all atopic dermatitis lesions.

Study Overview

• Status: Completed
• Conditions: Atopic Dermatitis
• Intervention / Treatment: Drug: Placebo; Drug: Omiganan; Drug: Omiganan; Drug: Omiganan

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Phase 2

Contacts and Locations

Study Locations

• Netherlands
  • Leiden, Netherlands
    • LUMC/Centre for Human Drug Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Male and female subjects with mild to moderate AD (IGA 2 or 3) 18 to 65 years of age,inclusive. The health status is verified by absence of evidence of any clinical significant active or uncontrolled chronic disease other than AD following a detailed medical history, a complete physical examination including vital signs, 12-lead ECG, hematology, blood chemistry, virology and urinalysis;
• Confirmed AD diagnosis;
• Symptoms present for at least 1 year;
• EASI between 7.1 - 50.0, inclusive at screening;
• 2-20% body surface area (BSA) affected at screening;
• Body mass index (BMI) between 18 and 35 kg/m2, inclusive, and with a minimum weight of 50 kg;
• Able to participate and willing to give written informed consent and to comply with the study restrictions;
• Subjects and their partners of childbearing potential must use effective contraception, for the duration of the study and for 3 months after the last dose.

Exclusion Criteria:

• Any current and / or recurrent clinical significant skin condition other than AD;
• Pregnant, a positive pregnancy test, intending to become pregnant, or breastfeeding;
• Ongoing use of prohibited atopic dermatitis treatments. Requires washout period prior to baseline (first dose of the study drug);
• Use of topical medication (prescription or over-the-counter [OTC]) within 14 days of study drug administration, or less than 5 half-lives (whichever is longer) in local treatment area;
• Tanning due to sunbathing, excessive sun exposure or a tanning booth within 3 weeks of enrollment;
• Known hypersensitivity to the compound or excipients of the compound or known hypersensitivity to one or more different emollients;
• Participation in an investigational drug or device study within 3 months prior to screening or more than 4 times a year;
• Loss or donation of blood over 500 mL within three months (males) or four months (females) prior to screening.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Vehicle	Drug: Placebo; Vehicle
Experimental: Omiganan 1%	Drug: Omiganan; Omiganan 1%; Drug: Omiganan; Omiganan 1.75%; Drug: Omiganan; Omiganan 2.5%
Experimental: Omiganan 1.75%	Drug: Omiganan; Omiganan 1%; Drug: Omiganan; Omiganan 1.75%; Drug: Omiganan; Omiganan 2.5%
Experimental: Omiganan 2.5%	Drug: Omiganan; Omiganan 1%; Drug: Omiganan; Omiganan 1.75%; Drug: Omiganan; Omiganan 2.5%

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Evaluation (oSCORAD)	oSCORAD Assessment	Within 7 Weeks
Clinical Evaluation (EASI)	EASI Assessment	Within 7 Weeks
Clinical Evaluation (IGA)	IGA Assessment	Within 7 Weeks
Patient-Orientated Outcome Measure (POEM)	Patient Assessment by collecting POEM	Within 7 Weeks
Dermatology Life Quality Index (DLQI)	Assessment of health-related quality of life by measuring DLQI	Within 7 Weeks
eDiary	Singe-Question assessment of pruritus and sleeplessness	Within 4 Weeks
Clinical Photography	Whole body photograph for qualitative and observational record	Within 7 Weeks
Pharmacodynamics (Biomarkers)	Local biomarkers sequencing	Within 7 Weeks
Pharmacodynamics (Microbiome)	Microbiome analysis	Within 7 Weeks
Pharmacodynamics (Microbiology)	Microbiology analysis	Within 7 Weeks
Pharmacodynamics (TEWL)	Transepidermal water-loss assessment	Within 7 Weeks
Pharmacodynamics (Thermography)	Skin temperature measurements will be taken	Within 7 Weeks
Pharmacodynamics (TAP)	Analysis of biomarkers captured by Transdermal Analysis Patch	Within 7 Weeks
Pharmacodynamics (Cytokines)	Cytokine assessment via blood evaluation	Within 7 Weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety (AE)	Adverse Events will be collected throughout the study	Within 7 Weeks
Safety (Vital Signs)	Vital Signs will be collected throughout the study	Within 7 Weeks
Safety (Clinical Laboratory Tests)	Lab samples collected in various timepoints within the study	Within 7 Weeks
Safety (ECG)	ECGs collected before beginning and end of study	Within 7 Weeks

Collaborators and Investigators

• Sponsor: Maruho Co., Ltd.
• Investigators: Principal Investigator: J. (Koos) Burggraaf, MD, PhD, Centre for Human Drug Research

Study record dates

Study Major Dates

• Study Start (Actual): March 8, 2017
• Primary Completion (Actual): December 20, 2017
• Study Completion (Actual): December 20, 2017

Study Registration Dates

• First Submitted: March 21, 2017
• First Submitted That Met QC Criteria: March 21, 2017
• First Posted (Actual): March 27, 2017

Study Record Updates

• Last Update Posted (Actual): December 27, 2017
• Last Update Submitted That Met QC Criteria: December 22, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Hypersensitivity, Immediate; Genetic Diseases, Inborn; Skin Diseases, Genetic; Hypersensitivity; Skin Diseases, Eczematous; Dermatitis; Eczema; Dermatitis, Atopic; Anti-Infective Agents; Antimicrobial Cationic Peptides
• Other Study ID Numbers: CLS001-CO-PR-014; 2016-003849-28 (EudraCT Number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No