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

NCT ID: NCT00676884

Last Updated: 2008-05-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-02-28
• Study Completion Date: 2006-08-31

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

Conditions

Atopic Eczema

Keywords

atopic eczema; atopic dermatitis; allergy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

1

Aeroderm (also known as pitrakinra, AER 001, BAY 16-9996)

Group Type: EXPERIMENTAL

Aeroderm (also known as pitrakinra, AER 001, BAY 16-9996)

Intervention Type: DRUG

30 mgs s.c. b.i.d.

2

placebo control

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

1.5 mL s.c. b.i.d.

Interventions

Aeroderm (also known as pitrakinra, AER 001, BAY 16-9996)

30 mgs s.c. b.i.d.

Intervention Type: DRUG

placebo

1.5 mL s.c. b.i.d.

Intervention Type: DRUG

Other Intervention Names

AER 001, BAY16-9996, pitrakinra; pbs

Eligibility 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.

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Aerovance, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Aerovance, Inc.

Principal Investigators

Darren Wilbraham, MBBS

Role: PRINCIPAL_INVESTIGATOR

Guy's Drug Research Unit, Quintiles Limited

Richard Groves, FRCP

Role: PRINCIPAL_INVESTIGATOR

St. Johns Institute of Dermatology St. Thomas' Hospital London

Locations

Guy's Drug Research unit, Quintiles Limited

London, , United Kingdom

Countries

United Kingdom

Other Identifiers

QGUY/2005/AER 001/-02

Identifier Type: -

Identifier Source: org_study_id