A Phase 2a Study to Investigate the Effects of Repeated Administration of AeroDerm in Subjects With Atopic Eczema

May 9, 2008 updated by: Aerovance, Inc.
The primary objective of this study is to investigate the effect of AERODERM (also known as pitrakinra, AER 001, BAY 16-9996) on Eczema Area and Severity Index (EASI) score in subjects with moderate to severe atopic eczema

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The primary objective of this study is to investigate the effect of AERODERM (also known as pitrakinra, AER 001, BAY 16-9996) on Eczema Area and Severity Index (EASI) score in subjects with moderate to severe atopic eczema in a randomised, placebo controlled, parallel-group study with bid sc. dosing of AERODERM for 28 days

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • London, United Kingdom, SE1 1YR
        • Guy's Drug Research Unit, Quintiles Limited

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adult males and females > 18 years.
  • Subjects who currently have allergic eczema with an EASI score in the range of 10-50.
  • Subjects who have been on a stable dose of topical medications for eczema for ≥ 1 month from screening but whose eczema is not adequately responsive to, or controlled by, conventional topical treatments (eg: topical steroids, Tracrolimus, Pimecrolimus).
  • Subjects who have not had systemic immunosuppressive therapy (eg systemic steroids) within 1 month of screening.
  • Subjects who if female, are not currently pregnant or breast feeding and are using medically acceptable methods of contraception.
  • Subjects who have a pre-study medical history, physical examination and vital signs acceptable to the investigator.
  • Subjects who have clinical laboratory tests within the reference ranges or clinically acceptable to the investigator.
  • Subjects who are negative for HbsAg, hepatitis C antibody and HIV II and I test at screening.
  • Subjects who are negative for drugs of abuse tests at screening and admission.
  • Subjects with stable, adequately treated medical conditions other than eczema may be enrolled provided the Investigator does not consider their study participation to place them at increased risk of adverse events. Subjects should continue their concomitant treatments for medical conditions (other than eczema).
  • Subjects who are able and willing to give written informed consent.

Exclusion Criteria:

  • Subjects who do not conform to the above inclusion criteria.
  • Subjects who have the following medical conditions: Diabetes mellitus, Thyroiditis, Rheumatiod arthritis, Multiple sclerosis, Uveitis, Sarcoidosis, Glomerulonephritis, Helminthic infection.
  • Subjects who have a history of relevant drug hypersensitivity.
  • Subjects who have a history of alcoholism.
  • Subjects who have a history of drug abuse.
  • Subjects who have a significant infection at the time of screening and/or admission.
  • Subjects who are having acute gastrointestinal symptoms at the time of screening and/or admission (e.g. nausea, vomiting, diarrhoea, heartburn), may be asked to reschedule their screening and/or admission to when they are not longer having acute symptoms.
  • Subjects who have an acute infection such as influenza at the time of screening and/or admission.
  • Female subjects who are not using an acceptable method of contraception.
  • Subjects who have used any investigational drug and /or participated in any clinical trial within 3 months of their first dosing.
  • Subjects who have previously received AeroDerm.
  • Subjects using medication, which in the opinion of the Investigator will affect the outcome of the study.
  • Subjects who have donated and/or received any blood or blood products within the previous 3 months prior to first dosing (to review on a case by case basis).
  • Subjects who cannot communicate reliably with the investigator.
  • Subjects who are unlikely to co-operate with the requirements of the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Aeroderm (also known as pitrakinra, AER 001, BAY 16-9996)
Drug: Aeroderm (also known as pitrakinra, AER 001, BAY 16-9996)
30 mgs s.c. b.i.d.
Other Names:
  • AER 001, BAY16-9996, pitrakinra
Placebo Comparator: 2
placebo control
Drug: placebo
1.5 mL s.c. b.i.d.
Other Names:
  • pbs

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Eczema Area and Severity index (EASI) score
Time Frame: weekly for 28 days of treatment
weekly for 28 days of treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Investigator Global Assessment (IGA)
Time Frame: daily for 28 days of treatment
daily for 28 days of treatment
levels of Tcell subsets
Time Frame: after 28 days of treatment
after 28 days of treatment
total IgE
Time Frame: after 28 days of treatment
after 28 days of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aerovance, Inc.

Investigators

  • Principal Investigator: Darren Wilbraham, MBBS, Guy's Drug Research Unit, Quintiles Limited
  • Principal Investigator: Richard Groves, FRCP, St. Johns Institute of Dermatology St. Thomas' Hospital London

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2006

Primary Completion (Actual)

July 1, 2006

Study Completion (Actual)

August 1, 2006

Study Registration Dates

First Submitted

May 9, 2008

First Submitted That Met QC Criteria

May 9, 2008

First Posted (Estimate)

May 13, 2008

Study Record Updates

Last Update Posted (Estimate)

May 13, 2008

Last Update Submitted That Met QC Criteria

May 9, 2008

Last Verified

May 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • QGUY/2005/AER 001/-02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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