AsthmaPhase 2MOLLYNCT00971035
A Study to Evaluate Lebrikizumab (MILR1444A) in Adult Patients With Asthma Who Are Not Taking 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, four-arm, dose-ranging study. The purpose is to evaluate the relationship between the dose of lebrikizumab and the response in terms of the efficacy, safety, and tolerability in patients with asthma who are not on inhaled steroids. 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
- 210 participants
- Where
- No sites listed yet
- Study dates
- Nov 2009to Feb 2011
- 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 ≥ 50 kg and ≤ 150 kg at Visit 1
- Chest radiograph within 12 months of Visit 1 without evidence of a clinically significant abnormality
- Stable 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 Dose-Ranging Study to Evaluate Lebrikizumab (MILR1444A) in Adult Patients With Asthma Who Are Not Taking Inhaled Corticosteroids (MOLLY)
This is a randomized, double-blind, placebo controlled, four-arm, dose-ranging study. The purpose is to evaluate the relationship between the dose of lebrikizumab and the response in terms of the efficacy, safety, and tolerability in patients with asthma who are not on inhaled steroids.
- Conditions
- Asthma
- Being tested
- lebrikizumab (MILR1444A), placebo
- Keywords
- MILR1444A
- 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
lebrikizumab (MILR1444A)Drug
Subcutaneous repeating dose
lebrikizumab (MILR1444A)Drug
Subcutaneous repeating dose
placeboDrug
Subcutaneous repeating dose
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Not described Receives: Drug: lebrikizumab (MILR1444A) |
| B | Experimental | Not described Receives: Drug: lebrikizumab (MILR1444A) |
| C | Experimental | Not described Receives: Drug: lebrikizumab (MILR1444A) |
| D | 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: Baseline to Week 12
Secondary outcomes (7)
Change in pre-bronchodilator FEV1
Measured: Baseline to Week 24
Change in quality of life and symptom scores
Measured: Baseline to Week 12
Change in peak flow
Measured: 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: From the first study-specific procedure through the last observation visit
Incidence of human anti-therapeutic antibodies (ATA)
Measured: Baseline to Week 32
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2009 (estimated)
- Study startNov 2009
- Primary completionDec 2010
- Study completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 210 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
- NCT00971035
- Sponsor's protocol ID
- ILR4660g
- Acronym
- MOLLY
- Status last verified
- Nov 2016
- First submitted
- 1 Sep 2009
- Last updated
- 29 Nov 2016
- Results posted
- No
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 Dose-Ranging Study to Evaluate Lebrikizumab (MILR1444A) in Adult Patients With Asthma Who Are Not Taking Inhaled Corticosteroids (MOLLY)
- ClinicalTrials.gov ID
- NCT00971035
- Acronym / sponsor ID
- MOLLY / ILR4660g
- Conditions
- Asthma
- Keywords
- MILR1444A
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 210 participants (actual)
- Lead sponsor
- Genentech, Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2009
- Primary completion
- Dec 2010 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 3 Sep 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, four-arm, dose-ranging study. The purpose is to evaluate the relationship between the dose of lebrikizumab and the response in terms of the efficacy, safety, and tolerability in patients with asthma who are not on inhaled steroids.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: lebrikizumab (MILR1444A) |
| B | Experimental | Drug: lebrikizumab (MILR1444A) |
| C | Experimental | Drug: lebrikizumab (MILR1444A) |
| D | 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 ≥ 50 kg and ≤ 150 kg at Visit 1
- Chest radiograph within 12 months of Visit 1 without evidence of a clinically significant abnormality
- Stable 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 | A |
| lebrikizumab (MILR1444A)Subcutaneous repeating dose | Drug | B |
| lebrikizumab (MILR1444A)Subcutaneous repeating dose | Drug | C |
| placeboSubcutaneous repeating dose | Drug | D |
Primary outcome
Change in forced expiratory volume in 1 second (FEV1)
Time frame: Baseline to Week 12
7 secondary outcomes
Change in pre-bronchodilator FEV1
Time frame: Baseline to Week 24
Change in quality of life and symptom scores
Time frame: Baseline to Week 12
Change in peak flow
Time frame: 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: From the first study-specific procedure through the last observation visit
Incidence of human anti-therapeutic antibodies (ATA)
Time frame: Baseline to Week 32
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.
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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: Baseline to Week 12). 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 29 Nov 2016.