Pharmacodynamics of Omiganan BID in Patients With Atopic Dermatitis

NCT03091426 | Completed Phase 2

• 2 other identifiers: CLS001-CO-PR-0142016-003849-28
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Atopic Dermatitis

Outcome Measures

Primary Outcomes (14)

• 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 Outcomes (4)

• Safety (AE)

  Within 7 Weeks

• Safety (Vital Signs)

  Within 7 Weeks

• Safety (Clinical Laboratory Tests)

  Within 7 Weeks

• Safety (ECG)

  Within 7 Weeks

Study Arms (4)

Omiganan 1%

EXPERIMENTAL

Drug: Omiganan

Omiganan 1.75%

EXPERIMENTAL

Drug: Omiganan

Omiganan 2.5%

EXPERIMENTAL

Drug: Omiganan

Vehicle

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Omiganan DRUG

Omiganan 1%

Omiganan 1%

Placebo DRUG

Vehicle

Vehicle

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• % 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Maruho Co., Ltd.: lead

Study Sites (1)

LUMC/Centre for Human Drug Research

Leiden, Netherlands

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

Omiganan

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• J. (Koos) Burggraaf, MD, PhD

  Centre for Human Drug Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2017
• First Posted: March 27, 2017
• Study Start: March 8, 2017
• Primary Completion: December 20, 2017
• Study Completion: December 20, 2017
• Last Updated: December 27, 2017

Record last verified: 2017-12

Locations

NL (1)