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

NCT00676884 | Completed Phase 2

• 1 other identifier: QGUY/2005/AER 001/-02
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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

Conditions

Atopic Eczema

Keywords

atopic eczema; atopic dermatitis; allergy

Outcome Measures

Primary Outcomes (1)

• Eczema Area and Severity index (EASI) score

  weekly for 28 days of treatment

Secondary Outcomes (3)

• 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

Study Arms (2)

1

EXPERIMENTAL

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

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

2

PLACEBO COMPARATOR

placebo control

Drug: placebo

Interventions

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

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

Also known as: AER 001, BAY16-9996, pitrakinra

1

placebo DRUG

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

Also known as: pbs

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Aerovance, Inc.: lead

Study Sites (1)

Guy's Drug Research unit, Quintiles Limited

London, SE1 1YR, United Kingdom

Location

MeSH Terms

Conditions

Dermatitis, Atopic; Hypersensitivity

Interventions

pitrakinra; 5-methoxy-methylindoleacetic acid

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Immune System Diseases

Study Officials

• Darren Wilbraham, MBBS

  Guy's Drug Research Unit, Quintiles Limited

  PRINCIPAL INVESTIGATOR

• Richard Groves, FRCP

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: May 9, 2008
• First Posted: May 13, 2008
• Study Start: February 1, 2006
• Primary Completion: July 1, 2006
• Study Completion: August 1, 2006
• Last Updated: May 13, 2008

Record last verified: 2008-05

Locations

GB (1)