Allergic AsthmaPhase 2NCT00781443
A Study to Evaluate MILR1444A in the Prevention of Allergen-Induced Airway Obstruction in Adults With Mild Allergic Asthma
A Phase 2 study testing lebrikizumab (MILR1444A) in people with Allergic Asthma, run by Genentech, Inc..
Trial summary
This is a multicenter, randomized, double-blind, placebo-controlled study designed to demonstrate the safety and efficacy of MILR1444A compared with placebo in reducing the airway reaction to an inhaled aeroallergen solution in adult patients with mild allergic asthma. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Allergic Asthma
- What is being tested?
- lebrikizumab (MILR1444A)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 29 participants
- Where
- No sites listed yet
- Study dates
- Dec 2008to Nov 2009
- 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 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Meet criteria for the diagnosis of allergic asthma
- Diagnosis of asthma ≥ 6 months
- Currently treated with only intermittent short-acting inhaled β-adrenergic agonists
- Body weight between 40-120 kg
- Normal chest X-ray within 2 years of screening
Who cannot join
- Require daily controller medication for asthma
- History of hypersensitivity to the study drug or to drugs with similar chemical structures or to any ingredients, including excipients of the study medication or drugs related to MILR1444A (e.g., monoclonal antibodies, polyclonal gamma globulin)
- Documented medical history of anaphylaxis
- Immunotherapy currently or within the past 3 months prior to screening
- Lung disease other than mild allergic asthma
- Previous treatment with other investigational drugs within 30 days or 5 half-lives prior to the screening visit, whichever is longer
Show all 11Show fewer
- Pregnant or lactating
- Significant concurrent medical illness other than asthma
- Clinically significant abnormality on ECG at the screening visit
- Smoked in the previous 6 months or have a history of smoking more than 10 pack-years
- History of helminthic infection
About this study
Official title: A Phase II, Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of MILR1444A in the Prevention of Allergen-Induced Airway Obstruction in Adults With Mild Allergic Asthma
This is a multicenter, randomized, double-blind, placebo-controlled study designed to demonstrate the safety and efficacy of MILR1444A compared with placebo in reducing the airway reaction to an inhaled aeroallergen solution in adult patients with mild allergic asthma. The study will randomize approximately 24 patients at five study centers. In the event of patient discontinuation from the study, additional patients may be enrolled at the discretion of the Sponsor.
- Conditions
- Allergic Asthma
- Being tested
- lebrikizumab (MILR1444A), placebo
- Keywords
- Asthma
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lebrikizumab (MILR1444A)Drug
Repeating subcutaneous injection
placeboDrug
Repeating subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Not described Receives: Drug: lebrikizumab (MILR1444A) |
| B | Placebo comparator | Not described Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Late asthmatic response (LAR)
Measured: Day 92
Secondary outcomes (1)
Early asthmatic response (EAR)
Measured: Day 92
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2008 (estimated)
- Study startDec 2008
- Primary completionNov 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 Allergic AsthmaStudies of the same condition, open and under way.
- More trials run by Genentech, Inc.The sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genentech, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Edward Conner, M.D., Study director, Genentech, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00781443
- Sponsor's protocol ID
- ILR4544g
- Status last verified
- May 2010
- First submitted
- 27 Oct 2008
- Last updated
- 6 May 2010
- Results posted
- No
Publications
Scheerens H, Arron JR, Zheng Y, Putnam WS, Erickson RW, Choy DF, Harris JM, Lee J, Jarjour NN, Matthews JG. The effects of lebrikizumab in patients with mild asthma following whole lung allergen challenge. Clin Exp Allergy. 2014 Jan;44(1):38-46. doi: 10.1111/cea.12220.
PubMed 24131304
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of MILR1444A in the Prevention of Allergen-Induced Airway Obstruction in Adults With Mild Allergic Asthma
- ClinicalTrials.gov ID
- NCT00781443
- Acronym / sponsor ID
- ILR4544g
- Conditions
- Allergic Asthma
- Keywords
- Asthma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Genentech, Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2008
- Primary completion
- Nov 2009 (actual)
- First posted
- 29 Oct 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.
This is a multicenter, randomized, double-blind, placebo-controlled study designed to demonstrate the safety and efficacy of MILR1444A compared with placebo in reducing the airway reaction to an inhaled aeroallergen solution in adult patients with mild allergic asthma. The study will randomize approximately 24 patients at five study centers. In the event of patient discontinuation from the study, additional patients may be enrolled at the discretion of the Sponsor.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: lebrikizumab (MILR1444A) |
| B | Placebo comparator | Drug: placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Meet criteria for the diagnosis of allergic asthma
- Diagnosis of asthma ≥ 6 months
- Currently treated with only intermittent short-acting inhaled β-adrenergic agonists
- Body weight between 40-120 kg
- Normal chest X-ray within 2 years of screening
Key exclusion criteria (11 listed)
- Require daily controller medication for asthma
- History of hypersensitivity to the study drug or to drugs with similar chemical structures or to any ingredients, including excipients of the study medication or drugs related to MILR1444A (e.g., monoclonal antibodies, polyclonal gamma globulin)
- Documented medical history of anaphylaxis
- Immunotherapy currently or within the past 3 months prior to screening
- Lung disease other than mild allergic 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 |
|---|---|---|
| lebrikizumab (MILR1444A)Repeating subcutaneous injection | Drug | A |
| placeboRepeating subcutaneous injection | Drug | B |
Primary outcome
Late asthmatic response (LAR)
Time frame: Day 92
1 secondary outcome
Early asthmatic response (EAR)
Time frame: Day 92
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 6 May 2010.
- Derived from this study: PubMed 24131304Scheerens H, Arron JR, Zheng Y, Putnam WS, Erickson RW, Choy DF, Harris JM, Lee J, Jarjour NN, Matthews JG. The effects of lebrikizumab in patients with mild asthma following whole lung allergen challenge. Clin Exp Allergy. 2014 Jan;44(1):38-46. doi: 10.1111/cea.12220.
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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.
Edward Conner, M.D. study director
Genentech, Inc.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing lebrikizumab (MILR1444A) in people with Allergic Asthma, run by Genentech, Inc..
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 5 inclusion and 11 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 6 May 2010. 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 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?
Late asthmatic response (LAR) (time frame: Day 92). 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 NCT00781443, 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 6 May 2010.