search
Back to results

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

Primary Purpose

Atopic Dermatitis

Status
Completed
Phase
Phase 1
Locations
United Kingdom
Study Type
Interventional
Intervention
AM1030-CREAM or placebo
Sponsored by
AnaMar AB
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atopic Dermatitis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Covance CRU
  • CRLCRU Royal Liverpool University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

SAD 1

SAD 2

SAD 3

MAD 1

MAD 2

Arm Description

AM1030-CREAM

AM1030-CREAM

AM1030-CREAM

AM1030-CREAM

AM1030-CREAM

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
February 19, 2015
Last Updated
December 10, 2015
Sponsor
AnaMar AB
Collaborators
Covance
search

1. Study Identification

Unique Protocol Identification Number
NCT02379910
Brief Title
A Study to Assess the Safety, Tolerability, PK and PD of AM1030-CREAM in Patients With Atopic Dermatitis
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
November 2014 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
June 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AnaMar AB
Collaborators
Covance

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SAD 1
Arm Type
Experimental
Arm Description
AM1030-CREAM
Arm Title
SAD 2
Arm Type
Experimental
Arm Description
AM1030-CREAM
Arm Title
SAD 3
Arm Type
Experimental
Arm Description
AM1030-CREAM
Arm Title
MAD 1
Arm Type
Experimental
Arm Description
AM1030-CREAM
Arm Title
MAD 2
Arm Type
Experimental
Arm Description
AM1030-CREAM
Intervention Type
Drug
Intervention Name(s)
AM1030-CREAM or placebo
Primary Outcome Measure Information:
Title
Adverse Events
Description
Number of adverse events as a measure of Safety
Time Frame
Day 1-15
Title
Local Tolerability: Change in Erythema (Likert scale 0-4)
Description
Change in Erythema (Likert scale 0-4) as a measure of Local Tolerability
Time Frame
Day 1-15
Title
Local Tolerability: Change in Oedema (Likert scale 0-3)
Description
Change in Oedema (Likert scale 0-3) as a measure of Local Tolerability
Time Frame
Day 1-15
Title
Local Tolerability: Change in Burning (Likert scale 0-3)
Description
Change in Burning (Likert scale 0-3) as a measure of Local Tolerability
Time Frame
Day 1-15
Title
Local Tolerability: Change in Prutitus (VAS)
Description
Change in Prutitus (VAS) as a measure of Local Tolerability
Time Frame
Day 1-15
Title
Vital Signs
Description
Change in blood pressure as a measure of Safety
Time Frame
Day 1-15
Title
Vital Signs
Description
Change in pulse rate as a measure of Safety
Time Frame
Day 1-15
Title
Vital Signs
Description
Change in body temperature as a measure of Safety
Time Frame
Day 1-15
Title
ECG
Description
Change in ECG as a measure of Safety
Time Frame
Day 1-15
Title
Physical Examination
Description
Any abnormal observations from Physical Examination as a measure of Safety
Time Frame
Day 1-15
Secondary Outcome Measure Information:
Title
Pharmacokinetics: Cmax, AUC, tmax, t1/2, Vss/F, CL/F
Description
Pharmacokinetics as measured by Cmax, AUC, tmax, t1/2, Vss/F, CL/F
Time Frame
Profil Day 1-15
Title
Pruritus on a Visual Analog Scale
Description
Pruritus (Visual Analog Scale 10 cm) as a measure of Efficacy
Time Frame
Day 1-15
Title
Erythema on a Likert scale
Description
Erythema (Likert Scale 0-4) as a measure of Efficacy
Time Frame
Day 1-15
Title
Modified Eczema Area and Severity Index (mEASI)
Description
mEASI (Composite score 0-64.8) as a measure of Efficay
Time Frame
Day 1-15

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jim Bush
Organizational Affiliation
Covance CRU
Official's Role
Principal Investigator
Facility Information:
Facility Name
Covance CRU
City
Leeds
ZIP/Postal Code
LS2 9LH
Country
United Kingdom
Facility Name
CRLCRU Royal Liverpool University Hospital
City
Liverpool
ZIP/Postal Code
L7 8XP
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs