NCT02379910

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Nov 2014

Shorter than P25 for phase_1

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2014

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 19, 2015

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 5, 2015

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

December 11, 2015

Status Verified

December 1, 2015

Enrollment Period

7 months

First QC Date

February 19, 2015

Last Update Submit

December 10, 2015

Conditions

Atopic Dermatitis

Outcome Measures

Primary Outcomes (10)

  • 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 Outcomes (4)

  • Pharmacokinetics: Cmax, AUC, tmax, t1/2, Vss/F, CL/F

    Profil Day 1-15

  • Pruritus on a Visual Analog Scale

    Day 1-15

  • Erythema on a Likert scale

    Day 1-15

  • Modified Eczema Area and Severity Index (mEASI)

    Day 1-15

Study Arms (5)

SAD 1

EXPERIMENTAL

AM1030-CREAM

Drug: AM1030-CREAM or placebo

SAD 2

EXPERIMENTAL

AM1030-CREAM

Drug: AM1030-CREAM or placebo

SAD 3

EXPERIMENTAL

AM1030-CREAM

Drug: AM1030-CREAM or placebo

MAD 1

EXPERIMENTAL

AM1030-CREAM

Drug: AM1030-CREAM or placebo

MAD 2

EXPERIMENTAL

AM1030-CREAM

Drug: AM1030-CREAM or placebo

Interventions

AM1030-CREAM or placeboDRUG
MAD 1MAD 2SAD 1SAD 2SAD 3

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Covance CRU

Leeds, LS2 9LH, United Kingdom

Location

CRLCRU Royal Liverpool University Hospital

Liverpool, L7 8XP, United Kingdom

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, GeneticGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDermatitisSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, EczematousHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Jim Bush

    Covance CRU

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 19, 2015

First Posted

March 5, 2015

Study Start

November 1, 2014

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

December 11, 2015

Record last verified: 2015-12

Locations

GB(2)