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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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

Other trials in United Kingdom

About this study

Read the detailed description

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 groups in NCT00676884
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.

Feb 2006Aug 2006

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)

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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
Studies of Skin Microbes in Healthy People and in People With Skin Conditions
Eczema, Atopic Dermatitis
RecruitingPhase 2
Effects of Treatments on Atopic Dermatitis
Eczema, Dermatitis
RecruitingPhase 3
A Long-term Study of the Medicine Called Abrocitinib in Children Aged 2 Years and Older With Moderate to Severe Eczema
Atopic Dermatitis
RecruitingPhase 2
A Study to Learn About Study Medicine Called PF-08049820 in People With Eczema
Atopic Dermatitis, Eczema, Atopic
Not yet recruitingPhase 3
Roflumilast Cream 0.3% for Moderate to Severe Atopic Dermatitis
Atopic Dermatitis, Atopic Dermatitis (AD)

All Atopic Eczema trials

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.

Detailed description

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.

Related trials for Atopic Eczema

RecruitingObservational study
Studies of Skin Microbes in Healthy People and in People With Skin Conditions
Eczema, Atopic Dermatitis
RecruitingPhase 2
Effects of Treatments on Atopic Dermatitis
Eczema, Dermatitis
RecruitingPhase 3
A Long-term Study of the Medicine Called Abrocitinib in Children Aged 2 Years and Older With Moderate to Severe Eczema
Atopic Dermatitis
RecruitingPhase 2
A Study to Learn About Study Medicine Called PF-08049820 in People With Eczema
Atopic Dermatitis, Eczema, Atopic
Not yet recruitingPhase 3
Roflumilast Cream 0.3% for Moderate to Severe Atopic Dermatitis
Atopic Dermatitis, Atopic Dermatitis (AD)

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?

On the ClinicalTrials.gov record for NCT00676884.

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; AzTrials last refreshed its copy on 6 Nov 2026.