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Sponsored by: |
Aerovance, Inc. |
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Information provided by: | Aerovance, Inc. |
ClinicalTrials.gov Identifier: | NCT00676884 |
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 II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase 2a Study to Investigate the Effects of Repeated Administration of AeroDerm in Subjects With Atopic Eczema |
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 |
---|---|
1: Experimental
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.
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2: Placebo Comparator
placebo control
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Drug: placebo
1.5 mL s.c. b.i.d.
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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
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United Kingdom | |
Guy's Drug Research unit, Quintiles Limited | |
London, United Kingdom, SE1 1YR |
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 |
Responsible Party: | Aerovance, Inc. ( Rick Fuller, FRCP ) |
Study ID Numbers: | QGUY/2005/AER 001/-02 |
Study First Received: | May 9, 2008 |
Last Updated: | May 9, 2008 |
ClinicalTrials.gov Identifier: | NCT00676884 |
Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
atopic eczema atopic dermatitis allergy |
Hypersensitivity Dermatitis, Atopic Genetic Diseases, Inborn Skin Diseases Hypersensitivity, Immediate |
Skin Diseases, Eczematous Eczema Skin Diseases, Genetic Dermatitis |
Immune System Diseases |