Atopic EczemaPhase 2NCT00676884
A Phase 2a Study to Investigate the Effects of Repeated Administration of AeroDerm in Subjects With Atopic Eczema
A Phase 2 study testing Aeroderm (also known as pitrakinra, AER 001, BAY 16-9996) in people with Atopic Eczema, run by Aerovance, Inc. at 1 site in United Kingdom.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atopic Eczema
- What is being tested?
- Aeroderm (also known as pitrakinra, AER 001, BAY 16-9996)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Feb 2006to Aug 2006
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Guy's Drug Research unit, Quintiles Limited
London, SE1 1YR
About this study
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
Read the 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
- Being tested
- Aeroderm (also known as pitrakinra, AER 001, BAY 16-9996), placebo
- Keywords
- atopic eczema, atopic dermatitis, allergy
- Medical subject headings
- Dermatitis, Atopic, Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aeroderm (also known as pitrakinra, AER 001, BAY 16-9996)Drug
Also called AER 001, BAY16-9996, pitrakinra
30 mgs s.c. b.i.d.
placeboDrug
Also called pbs
1.5 mL s.c. b.i.d.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Aeroderm (also known as pitrakinra, AER 001, BAY 16-9996) Receives: Drug: Aeroderm (also known as pitrakinra, AER 001, BAY 16-9996) |
| 2 | Placebo comparator | placebo control Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eczema Area and Severity index (EASI) score
Measured: weekly for 28 days of treatment
Secondary outcomes (3)
Investigator Global Assessment (IGA)
Measured: daily for 28 days of treatment
levels of Tcell subsets
Measured: after 28 days of treatment
total IgE
Measured: after 28 days of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2008 (estimated)
- Study startFeb 2006
- Primary completionJul 2006
- Study completionAug 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic EczemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aerovance, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Darren Wilbraham, MBBS, Principal investigator, Guy's Drug Research Unit, Quintiles LimitedRichard Groves, FRCP, Principal investigator, St. Johns Institute of Dermatology St. Thomas' Hospital London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00676884
- Sponsor's protocol ID
- QGUY/2005/AER 001/-02
- Status last verified
- May 2008
- First submitted
- 9 May 2008
- Last updated
- 13 May 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2a Study to Investigate the Effects of Repeated Administration of AeroDerm in Subjects With Atopic Eczema
- ClinicalTrials.gov ID
- NCT00676884
- Acronym / sponsor ID
- QGUY/2005/AER 001/-02
- Conditions
- Atopic Eczema
- Keywords
- atopic eczema, atopic dermatitis, allergy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Aerovance, Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2006
- Primary completion
- Jul 2006 (actual)
- Study completion
- Aug 2006 (actual)
- First posted
- 13 May 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Aeroderm (also known as pitrakinra, AER 001, BAY 16-9996)Aeroderm (also known as pitrakinra, AER 001, BAY 16-9996) |
| 2 | Placebo comparator | Drug: placeboplacebo control |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aeroderm (also known as pitrakinra, AER 001, BAY 16-9996)Also: AER 001, BAY16-9996, pitrakinra30 mgs s.c. b.i.d. | Drug | 1 |
| placeboAlso: pbs1.5 mL s.c. b.i.d. | Drug | 2 |
Primary outcome
Eczema Area and Severity index (EASI) score
Time frame: weekly for 28 days of treatment
3 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Darren Wilbraham, MBBS principal investigator
Guy's Drug Research Unit, Quintiles Limited
Richard Groves, FRCP principal investigator
St. Johns Institute of Dermatology St. Thomas' Hospital London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Aeroderm (also known as pitrakinra, AER 001, BAY 16-9996) in people with Atopic Eczema, run by Aerovance, Inc. at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 May 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Eczema Area and Severity index (EASI) score (time frame: weekly for 28 days of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2008.