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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00676884
First Posted: May 13, 2008
Last Update Posted: May 13, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Aerovance, Inc.
  Purpose
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

Condition Intervention Phase
Atopic Eczema Drug: Aeroderm (also known as pitrakinra, AER 001, BAY 16-9996) Drug: placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2a Study to Investigate the Effects of Repeated Administration of AeroDerm in Subjects With Atopic Eczema

Resource links provided by NLM:


Further study details as provided by Aerovance, Inc.:

Primary Outcome Measures:
  • Eczema Area and Severity index (EASI) score [ Time Frame: weekly for 28 days of treatment ]

Secondary Outcome Measures:
  • Investigator Global Assessment (IGA) [ Time Frame: daily for 28 days of treatment ]
  • levels of Tcell subsets [ Time Frame: after 28 days of treatment ]
  • total IgE [ Time Frame: after 28 days of treatment ]

Enrollment: 25
Study Start Date: February 2006
Study Completion Date: August 2006
Primary Completion Date: July 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: AER 001, BAY16-9996, pitrakinra
Placebo Comparator: 2
placebo control
Drug: placebo
1.5 mL s.c. b.i.d.
Other Name: pbs

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
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00676884


Locations
United Kingdom
Guy's Drug Research unit, Quintiles Limited
London, United Kingdom, SE1 1YR
Sponsors and Collaborators
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
  More Information

Responsible Party: Rick Fuller, FRCP, Aerovance, Inc.
ClinicalTrials.gov Identifier: NCT00676884     History of Changes
Other Study ID Numbers: QGUY/2005/AER 001/-02
First Submitted: May 9, 2008
First Posted: May 13, 2008
Last Update Posted: May 13, 2008
Last Verified: May 2008

Keywords provided by Aerovance, Inc.:
atopic eczema
atopic dermatitis
allergy

Additional relevant MeSH terms:
Eczema
Dermatitis, Atopic
Dermatitis
Skin Diseases
Skin Diseases, Eczematous
Skin Diseases, Genetic
Genetic Diseases, Inborn
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases