Clinical trial NCT03091426: Pharmacodynamics of Omiganan BID in Patients With Atopic Dermatitis
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Atopic Dermatitis
Lead sponsor: Maruho Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2017-03-27
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Clinical Evaluation (oSCORAD)
timeFrame: Within 7 Weeks
measure: Clinical Evaluation (EASI)
timeFrame: Within 7 Weeks
measure: Clinical Evaluation (IGA)
timeFrame: Within 7 Weeks
measure: Patient-Orientated Outcome Measure (POEM)
timeFrame: Within 7 Weeks
measure: Dermatology Life Quality Index (DLQI)
timeFrame: Within 7 Weeks
measure: eDiary
timeFrame: Within 4 Weeks
measure: Clinical Photography
timeFrame: Within 7 Weeks
measure: Pharmacodynamics (Biomarkers)
timeFrame: Within 7 Weeks
measure: Pharmacodynamics (Microbiome)
timeFrame: Within 7 Weeks
measure: Pharmacodynamics (Microbiology)
timeFrame: Within 7 Weeks
measure: Pharmacodynamics (TEWL)
timeFrame: Within 7 Weeks
measure: Pharmacodynamics (Thermography)
timeFrame: Within 7 Weeks
measure: Pharmacodynamics (TAP)
timeFrame: Within 7 Weeks
measure: Pharmacodynamics (Cytokines)
timeFrame: Within 7 Weeks
Secondary outcomes:
measure: Safety (AE)
timeFrame: Within 7 Weeks
measure: Safety (Vital Signs)
timeFrame: Within 7 Weeks
measure: Safety (Clinical Laboratory Tests)
timeFrame: Within 7 Weeks
measure: Safety (ECG)
timeFrame: Within 7 Weeks
Other outcomes:
Locations:
city: Leiden
country: Netherlands
facility: LUMC/Centre for Human Drug Research
Study officials:
affiliation: Centre for Human Drug Research
name: J. (Koos) Burggraaf, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: