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

Phase 2

Completed

• Conditions: Atopic Eczema
• Interventions: Drug: placebo; Drug: Aeroderm (also known as pitrakinra, AER 001, BAY 16-9996)

• Registration Number: NCT00676884
• Lead Sponsor: Aerovance, Inc.

Brief Summary

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

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 Timeline

• Study Start: 2006-02
• Primary Completion: 2006-07
• Study Completion: 2006-08
• Status Verified: 2008-05
• Study First Submitted: 2008-05-09
• Study First Submitted QC: 2008-05-09
• Last Update Submitted: 2008-05-09
• Study First Posted: 2008-05-13
• Last Update Posted: 2008-05-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	placebo	placebo control
1	Aeroderm (also known as pitrakinra, AER 001, BAY 16-9996)	Aeroderm (also known as pitrakinra, AER 001, BAY 16-9996)

Primary Outcome Measures

Name	Time	Method
Eczema Area and Severity index (EASI) score	weekly for 28 days of treatment

Secondary Outcome Measures

Name	Time	Method
Investigator Global Assessment (IGA)	daily for 28 days of treatment
levels of Tcell subsets	after 28 days of treatment
total IgE	after 28 days of treatment

Trial Locations

Locations (1)

Guy's Drug Research unit, Quintiles Limited; 🇬🇧 London, United Kingdom