AsthmaPhase 1NCT00725582
Study Evaluating the Effect of IMA-026 on Allergen-Induced Late Asthma Response in Mild Asthma
A Phase 1 study testing IMA-026 in people with Asthma, run by Wyeth is now a wholly owned subsidiary of Pfizer.
Trial summary
The purpose of this study is to evaluate the effect of IMA-026, an antibody to IL-13, on airway hyperresponsiveness and airway inflammation in mild asthmatics. IMA-026 will be given as 2 injections under the skin 1 week apart at 2 mg/kg each dose. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Asthma
- What is being tested?
- IMA-026
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- Sep 2008to Jun 2009
- Phase
- Phase 1
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Healthy men and women 18 to 60 yrs with mild allergic asthma
- only asthma med is short-acting bronchodilator used not more than twice weekly
- FEV1 greater than 70% predicted and a demonstrated baseline late response to allergen induction
Who cannot join
- Upper respiratory infection or asthma exacerbation with 4 weeks of screening
- Serious infection requiring parenteral antibiotics or hospitalization with 4 weeks of test article administration
- Positive radiographic findings indicative of respiratory disease other than asthma
About this study
Official title: The Effects of IMA-026 on Allergen-Induced Airway Responses and Airway Inflammation in Subjects With Mild Atopic Asthma
The purpose of this study is to evaluate the effect of IMA-026, an antibody to IL-13, on airway hyperresponsiveness and airway inflammation in mild asthmatics. IMA-026 will be given as 2 injections under the skin 1 week apart at 2 mg/kg each dose. The study will include a screening period and a treatment period which includes doses on day 1 and day 8.
- Conditions
- Asthma
- Being tested
- IMA-026, Placebo
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IMA-026Drug
PlaceboOther
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Not described Receives: Drug: IMA-026 |
| B | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of the maximum change in FEV1 from baseline for the LAR between IMA-026 and placebo
Measured: 11 weeks
Secondary outcomes (1)
Treatment comparison of the hour 3 and hour 7 FEV1 AUC for the LAR; various comparisons of the methacholine PC20
Measured: 11 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2008 (estimated)
- Study startSep 2008
- Primary completionJun 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Medical Monitor, Study director, Wyeth is now a wholly owned subsidiary of Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00725582
- Sponsor's protocol ID
- 3192K1-1002
- Status last verified
- Jun 2009
- First submitted
- 25 Jul 2008
- Last updated
- 2 Jun 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Gauvreau GM, Boulet LP, Cockcroft DW, Fitzgerald JM, Carlsten C, Davis BE, Deschesnes F, Duong M, Durn BL, Howie KJ, Hui L, Kasaian MT, Killian KJ, Strinich TX, Watson RM, Y N, Zhou S, Raible D, O'Byrne PM. Effects of interleukin-13 blockade on allergen-induced airway responses in mild atopic asthma. Am J Respir Crit Care Med. 2011 Apr 15;183(8):1007-14. doi: 10.1164/rccm.201008-1210OC. Epub 2010 Nov 5.
PubMed 21057005
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of IMA-026 on Allergen-Induced Airway Responses and Airway Inflammation in Subjects With Mild Atopic Asthma
- ClinicalTrials.gov ID
- NCT00725582
- Acronym / sponsor ID
- 3192K1-1002
- Conditions
- Asthma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of PfizerIndustry (pharma, biotech, devices)
- Study start
- Sep 2008
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 30 Jul 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 purpose of this study is to evaluate the effect of IMA-026, an antibody to IL-13, on airway hyperresponsiveness and airway inflammation in mild asthmatics. IMA-026 will be given as 2 injections under the skin 1 week apart at 2 mg/kg each dose. The study will include a screening period and a treatment period which includes doses on day 1 and day 8.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: IMA-026 |
| B | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy men and women 18 to 60 yrs with mild allergic asthma
- only asthma med is short-acting bronchodilator used not more than twice weekly
- FEV1 greater than 70% predicted and a demonstrated baseline late response to allergen induction
Key exclusion criteria (3 listed)
- Upper respiratory infection or asthma exacerbation with 4 weeks of screening
- Serious infection requiring parenteral antibiotics or hospitalization with 4 weeks of test article administration
- Positive radiographic findings indicative of respiratory disease other than asthma
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 |
|---|---|---|
| IMA-026 | Drug | A |
| Placebo | Other | B |
Primary outcome
Comparison of the maximum change in FEV1 from baseline for the LAR between IMA-026 and placebo
Time frame: 11 weeks
1 secondary outcome
Treatment comparison of the hour 3 and hour 7 FEV1 AUC for the LAR; various comparisons of the methacholine PC20
Time frame: 11 weeks
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 2 Jun 2009.
- Derived from this study: PubMed 21057005Gauvreau GM, Boulet LP, Cockcroft DW, Fitzgerald JM, Carlsten C, Davis BE, Deschesnes F, Duong M, Durn BL, Howie KJ, Hui L, Kasaian MT, Killian KJ, Strinich TX, Watson RM, Y N, Zhou S, Raible D, O'Byrne PM. Effects of interleukin-13 blockade on allergen-induced airway responses in mild atopic asthma. Am J Respir Crit Care Med. 2011 Apr 15;183(8):1007-14. doi: 10.1164/rccm.201008-1210OC. Epub 2010 Nov 5.
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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.
Medical Monitor study director
Wyeth is now a wholly owned subsidiary of Pfizer
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing IMA-026 in people with Asthma, run by Wyeth is now a wholly owned subsidiary of Pfizer.
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 3 inclusion and 3 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 2 Jun 2009. Status can change between updates, so confirm with the study contact before making plans.
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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Comparison of the maximum change in FEV1 from baseline for the LAR between IMA-026 and placebo (time frame: 11 weeks). 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 NCT00725582, which also lists 1 linked publication.
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 2 Jun 2009.