AsthmaPhase 2MILLYNCT00930163
A Study of Lebrikizumab (MILR1444A) in Adult Patients With Asthma Who Are Inadequately Controlled on Inhaled Corticosteroids
A Phase 2 study testing lebrikizumab (MILR1444A) in people with Asthma, run by Genentech, Inc..
Trial summary
This is a randomized, double-blind, placebo-controlled study to evaluate the effects of lebrikizumab in patients with asthma who remain inadequately controlled while on chronic therapy with inhaled corticosteroids (ICS). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- 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
- 218 participants
- Where
- No sites listed yet
- Study dates
- Jul 2009to Sep 2010
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Body weight 40 kg--150 kg
- Chest radiograph with no evidence of clinically significant abnormality
- Uncontrolled asthma
Who cannot join
- Asthma exacerbation during screening
- Known malignancy
- Known immunodeficiency
- Pre-existing lung disease other than asthma
- Uncontrolled clinically significant medical disease
- Current smoker
Show all 10Show fewer
- History of substance abuse that may impair or risk the patient's full participation in the study, in the judgment of the investigator
- Prior allergic reaction to a monoclonal antibody
- Patients (men and women) of reproductive potential who are not willing to use contraception
- Pregnancy
About this study
Official title: A Phase II, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability and Efficacy of Lebrikizumab (MILR1444A) in Adult Patients With Asthma Who Are Inadequately Controlled on Inhaled Corticosteroids
This is a randomized, double-blind, placebo-controlled study to evaluate the effects of lebrikizumab in patients with asthma who remain inadequately controlled while on chronic therapy with inhaled corticosteroids (ICS).
- Conditions
- Asthma
- Being tested
- lebrikizumab (MILR1444A), placebo
- Keywords
- Adult 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
Subcutaneous repeating dose
placeboDrug
Subcutaneous repeating dose
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: lebrikizumab (MILR1444A) |
| 2 | Placebo comparator | Not described Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in forced expiratory volume in 1 second (FEV1)
Measured: From baseline to Week 12
Secondary outcomes (7)
Change in pre-bronchodilator FEV1
Measured: From baseline to Week 24
Change in quality of life and symptom scores
Measured: From baseline to Week 12
Change in peak flow
Measured: From baseline to Week 1
Rate of asthma exacerbations
Measured: During the 24 week treatment period
Change in rescue medication use
Measured: From baseline to Week 1
Frequency and severity of adverse events
Measured: Through study completion or early study discontinuation
Incidence of human anti-therapeutic antibodies (ATA)
Measured: At the end of the follow-up period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2009 (estimated)
- Study startJul 2009
- Primary completionJul 2010
- Study completionSep 2010
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.
- 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, Investigator
- Enrolment
- 218 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genentech, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michelle Freemer, M.D., Study director, Genentech, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00930163
- Sponsor's protocol ID
- ILR4646g
- Acronym
- MILLY
- Status last verified
- Nov 2016
- First submitted
- 29 Jun 2009
- Last updated
- 29 Nov 2016
- Results posted
- No
Publications
Corren J, Lemanske RF, Hanania NA, Korenblat PE, Parsey MV, Arron JR, Harris JM, Scheerens H, Wu LC, Su Z, Mosesova S, Eisner MD, Bohen SP, Matthews JG. Lebrikizumab treatment in adults with asthma. N Engl J Med. 2011 Sep 22;365(12):1088-98. doi: 10.1056/NEJMoa1106469. Epub 2011 Aug 3.
PubMed 21812663
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability and Efficacy of Lebrikizumab (MILR1444A) in Adult Patients With Asthma Who Are Inadequately Controlled on Inhaled Corticosteroids
- ClinicalTrials.gov ID
- NCT00930163
- Acronym / sponsor ID
- MILLY / ILR4646g
- Conditions
- Asthma
- Keywords
- Adult Asthma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 218 participants (actual)
- Lead sponsor
- Genentech, Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2009
- Primary completion
- Jul 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 30 Jun 2009 (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 randomized, double-blind, placebo-controlled study to evaluate the effects of lebrikizumab in patients with asthma who remain inadequately controlled while on chronic therapy with inhaled corticosteroids (ICS).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: lebrikizumab (MILR1444A) |
| 2 | Placebo comparator | Drug: placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Body weight 40 kg--150 kg
- Chest radiograph with no evidence of clinically significant abnormality
- Uncontrolled asthma
Key exclusion criteria (10 listed)
- Asthma exacerbation during screening
- Known malignancy
- Known immunodeficiency
- Pre-existing lung disease other than asthma
- Uncontrolled clinically significant medical disease
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)Subcutaneous repeating dose | Drug | 1 |
| placeboSubcutaneous repeating dose | Drug | 2 |
Primary outcome
Change in forced expiratory volume in 1 second (FEV1)
Time frame: From baseline to Week 12
7 secondary outcomes
Change in pre-bronchodilator FEV1
Time frame: From baseline to Week 24
Change in quality of life and symptom scores
Time frame: From baseline to Week 12
Change in peak flow
Time frame: From baseline to Week 1
Rate of asthma exacerbations
Time frame: During the 24 week treatment period
Change in rescue medication use
Time frame: From baseline to Week 1
Frequency and severity of adverse events
Time frame: Through study completion or early study discontinuation
Incidence of human anti-therapeutic antibodies (ATA)
Time frame: At the end of the follow-up period
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 29 Nov 2016.
- Derived from this study: PubMed 21812663Corren J, Lemanske RF, Hanania NA, Korenblat PE, Parsey MV, Arron JR, Harris JM, Scheerens H, Wu LC, Su Z, Mosesova S, Eisner MD, Bohen SP, Matthews JG. Lebrikizumab treatment in adults with asthma. N Engl J Med. 2011 Sep 22;365(12):1088-98. doi: 10.1056/NEJMoa1106469. Epub 2011 Aug 3.
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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.
Michelle Freemer, 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 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 3 inclusion and 10 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 29 Nov 2016. 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?
Change in forced expiratory volume in 1 second (FEV1) (time frame: From baseline to Week 12). 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 NCT00930163, 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 29 Nov 2016.