A Study to Assess the Safety, Tolerability, PK and PD of AM1030-CREAM in Patients With Atopic Dermatitis

AM1030: A Phase I/II, Double-Blind, Placebo-Controlled, Single and Multiple Ascending (Topical) Dose, Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study in Patients (Male and Female) With Atopic Dermatitis

This is a study of safety, tolerability, pharmacokinetics and pharmacodynamics of AM1030-CREAM in patients with Atopic Dermatitis.

Study Overview

• Status: Completed
• Conditions: Atopic Dermatitis
• Intervention / Treatment: Drug: AM1030-CREAM or placebo

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United Kingdom
  • Leeds, United Kingdom, LS2 9LH
    • Covance CRU
  • Liverpool, United Kingdom, L7 8XP
    • CRLCRU Royal Liverpool University Hospital

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:

• Males and/or females of any ethnic origin between 18 and 65 years of age
• Body mass index between 18.0 and 35.0 kg/m2
• Subjects with AD as defined by the Hanifen and Rajka criteria and with mild to severe disease activity (IGA 2-4)
• AD lesions amenable to cutaneous treatment located on the trunk and/or limbs

Exclusion Criteria:

• Subjects with scars, moles, tattoos, sunburn or other blemishes in test areas
• Systemic treatment with immunosuppressants, immunomodulators or corticosteroids within 2 weeks prior to dosing
• Topical treatment with corticosteroids, antibiotics and/or immunomodulators within 4 days prior to dosing
• Treatment with systemic antihistamines within 24 hours of the first dose administration
• Treatment with SSRIs within 2 weeks of the first dose administration
• Subjects who have received phototherapy within 4 weeks prior to dosing

Study Plan

How is the study designed?

Design Details

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

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SAD 1; AM1030-CREAM	Drug: AM1030-CREAM or placebo
Experimental: SAD 2; AM1030-CREAM	Drug: AM1030-CREAM or placebo
Experimental: SAD 3; AM1030-CREAM	Drug: AM1030-CREAM or placebo
Experimental: MAD 1; AM1030-CREAM	Drug: AM1030-CREAM or placebo
Experimental: MAD 2; AM1030-CREAM	Drug: AM1030-CREAM or placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse Events	Number of adverse events as a measure of Safety	Day 1-15
Local Tolerability: Change in Erythema (Likert scale 0-4)	Change in Erythema (Likert scale 0-4) as a measure of Local Tolerability	Day 1-15
Local Tolerability: Change in Oedema (Likert scale 0-3)	Change in Oedema (Likert scale 0-3) as a measure of Local Tolerability	Day 1-15
Local Tolerability: Change in Burning (Likert scale 0-3)	Change in Burning (Likert scale 0-3) as a measure of Local Tolerability	Day 1-15
Local Tolerability: Change in Prutitus (VAS)	Change in Prutitus (VAS) as a measure of Local Tolerability	Day 1-15
Vital Signs	Change in blood pressure as a measure of Safety	Day 1-15
Vital Signs	Change in pulse rate as a measure of Safety	Day 1-15
Vital Signs	Change in body temperature as a measure of Safety	Day 1-15
ECG	Change in ECG as a measure of Safety	Day 1-15
Physical Examination	Any abnormal observations from Physical Examination as a measure of Safety	Day 1-15

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetics: Cmax, AUC, tmax, t1/2, Vss/F, CL/F	Pharmacokinetics as measured by Cmax, AUC, tmax, t1/2, Vss/F, CL/F	Profil Day 1-15
Pruritus on a Visual Analog Scale	Pruritus (Visual Analog Scale 10 cm) as a measure of Efficacy	Day 1-15
Erythema on a Likert scale	Erythema (Likert Scale 0-4) as a measure of Efficacy	Day 1-15
Modified Eczema Area and Severity Index (mEASI)	mEASI (Composite score 0-64.8) as a measure of Efficay	Day 1-15

Collaborators and Investigators

• Sponsor: AnaMar AB
• Collaborators: Covance
• Investigators: Principal Investigator: Jim Bush, Covance CRU

Study record dates

Study Major Dates

• Study Start: November 1, 2014
• Primary Completion (Actual): June 1, 2015
• Study Completion (Actual): June 1, 2015

Study Registration Dates

• First Submitted: February 19, 2015
• First Submitted That Met QC Criteria: March 4, 2015
• First Posted (Estimate): March 5, 2015

Study Record Updates

• Last Update Posted (Estimate): December 11, 2015
• Last Update Submitted That Met QC Criteria: December 10, 2015
• Last Verified: December 1, 2015

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
• Other Study ID Numbers: 1030-260-01; 2014-003684-38 (EudraCT Number)