AsthmaPhase 2NCT02099656
A Study Evaluating the Effects of Lebrikizumab on Airway Eosinophilic Inflammation in Participants With Uncontrolled Asthma
A Phase 2 study testing Lebrikizumab and Inhaled corticposteroids (ICS) in people with Asthma, run by Hoffmann-La Roche at 28 sites in 6 countries.
Trial summary
This Phase II, randomized, double-blind, placebo-controlled, multicenter study will evaluate the effects of lebrikizumab on airway eosinophilic inflammation in participants with uncontrolled asthma who are using inhaled corticosteroid (ICS) treatment and a second controller medication. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Asthma
- What is being tested?
- Lebrikizumab and Inhaled corticposteroids (ICS)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 28 sitesin 6 countries
- Study dates
- 6 Nov 2014to 13 Oct 2016
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Asthma diagnosis for greater than or equal to (>/=) 12 months prior to Visit 1
- Bronchodilator response demonstrated within the 12 months before Visit 1 or at Visit 1, 2, or 3 of screening
- Pre-bronchodilator FEV1 of 40 percent (%) - 80% predicted at both Visits 2 and 3
- On ICS therapy at a total daily dose of 500-2000 mcg of fluticasone propionate dry powder inhaler (DPI) or equivalent for >/= 6 months prior to Visit 1, with no changes within 4 weeks prior to Visit 1, and no anticipated changes throughout the study
- On an eligible second controller medication (long-acting Beta-agonist [LABA), leukotriene receptor antagonist [LTRA], long-acting muscarinic antagonists [LAMAs] or theophylline) for 6 months prior to Visit 1, with no changes within 4 weeks prior to Visit 1, and no anticipated changes throughout the study
- Uncontrolled asthma at Visit 1 and/or 2 and at Visit 3
- Chest X-ray or computed tomography (CT) scan within 12 months prior to Visit 1 or chest X-ray during the screening period (prior to Visit 3) that confirms the absence of other clinically significant lung disease
- Demonstrated adherence with controller medication during the screening period
Who cannot join
- Maintenance oral corticosteroid therapy, defined as daily alternate-day oral corticosteroid maintenance therapy within 3 months prior to Visit 1
- Treatment with systemic corticosteroids within 4 weeks prior to Visit 1 or during the screening period for any reason, including an acute exacerbation event
- Any infection requiring hospital, intravenous (IV) or intramuscular (IM) antibiotic treatment or any respiratory infection within 4 weeks prior to Visit 1 or during screening. Any infection requiring oral antibiotic treatment with 2 weeks prior to Visit 1 or during screening, or any parasitic infection within 6 months prior to Visit 1 or during screening
- Active tuberculosis requiring treatment within 12 months prior to Visit 1
- Known immunodeficiency, including, but not limited to, human immunodeficiency virus (HIV) infection
- History of interstitial lung disease, chronic obstructive pulmonary disease (COPD), or other clinically significant lung disease other than asthma
Show all 19Show fewer
- Known current malignancy or current evaluation for a potential malignancy
- Unable to safely undergo elective flexible fiberoptic bronchoscopy
- Clinically significant medical disease that is uncontrolled despite treatment, that is likely, in the opinion of the investigator, to impact the participant's ability to participate in the study, or to impact the study assessments
- History of alcohol or drug abuse that would impair or risk the participant's full participation in the study, in the opinion of the investigator
- Current smoker or history of smoking (greater than [>] 10 pack-years), or unwillingness to abstain from smoking for the duration of the study
- Past and/or current use of any anti-interleukin (IL)-13 or anti-IL-4/IL-13 therapy, including lebrikizumab
- Use of a licensed or investigational monoclonal antibody other than anti-IL-13, or anti IL-4/IL-13, including, but not limited to, omalizumab, anti-IL-5, or anti-IL-17, within 6 months or 5 drug half-lives prior to Visit 1 (whichever is longer) or during screening
- Use of a systemic immunomodulatory or immunosuppressive therapy within 3 months or 5 drug half-lives prior to Visit 1 (whichever is longer) or during screening
- Use of other investigational therapy within 4 weeks or 5 drug half-lives prior to Visit 1 (whichever is longer) or during screening
- Initiation of or increase in allergen immunotherapy within 3 months prior to Visit 1 or during screening
- Body mass index >38 kilograms per square meter (kg/m^2)
- Body weight <40 kilograms (kg)
- History of bronchial thermoplasty
Trial locations and contacts
28 sites in 6 countries.
28 sites in 6 countries
United States16 sites
Brigham and Women's Hospital; Pulmonary Division
Boston, Massachusetts, 02115
Northwestern University
Chicago, Illinois, 60611
University of Miami School of Medicine - Sylvester at Deerfield
Deerfield Beach, Florida, Suite 200
Duke University Medical Center
Durham, North Carolina, 27705
UTMB Pathology Clinical Services
Galveston, Texas, 77555-0743
Baylor College of Medicine
Houston, Texas, 77030
University of Iowa Hospitals & Clinics; Internal Medicine
Iowa City, Iowa, 52242
LAC-USC Medical Center
Los Angeles, California, 90033
Yale School of Medicine
New Haven, Connecticut, 06510
Pen Memory Center
Philadelphia, Pennsylvania, 19104
Temple University Hospital ; Lung Center
Philadelphia, Pennsylvania, 19140
University of Pittsburgh Medical Center Health System
Pittsburgh, Pennsylvania, 15213
University of California Davis Health System; Division of Pulmonary and Critical Care Medicine
Sacramento, California, 95817
Washington University; Pediatrics
St Louis, Missouri, 63110
University of Arizona
Tucson, Arizona, 85724-5030
Wake Forest University Baptist Medical Center; Gastroenterology & Digestive Health
Winston-Salem, North Carolina, 27157-1045
Canada4 sites
University of Calgary
Calgary, Alberta, T2N 2T9
University of Alberta Hospital-SCC/WCM
Edmonton, Alberta, T6G 2S2
McMaster University Health Sciences Center
Hamilton, Ontario, L8N 3Z5
VGH Research Pavilion
Vancouver, British Columbia, V5Z 1L8
United Kingdom4 sites
Queen's University Belfast; NICRN Respiratory Research Office
Belfast, BT9 7AB
Glenfield Hospital
Leicester, LE3 9QP
St Mary's Hospital
London, W2 1NY
The Medicines Evaluation Unit
Manchester, M23 9QZ
France2 sites
Hôpital Arnaud de Villeneuve
Montpellier, 34295
Groupe Hospitalier Sud - Hôpital Haut Lévêque
Pessac, 33600
About this study
Official title: A Phase II, Randomized, Double-Blind, Placebo-Controlled Bronchoscopy Study to Evaluate the Effects of Lebrikizumab on Airway Eosinophilic Inflammation in Patients With Uncontrolled Asthma on Inhaled Corticosteroids and a Second Controller Medication
This Phase II, randomized, double-blind, placebo-controlled, multicenter study will evaluate the effects of lebrikizumab on airway eosinophilic inflammation in participants with uncontrolled asthma who are using inhaled corticosteroid (ICS) treatment and a second controller medication. Enrolled participants will undergo a 3-week screening period during which assessments, including a bronchoscopy procedure, will be made. Participants will subsequently be randomized to receive lebrikizumab or placebo by subcutaneous (SC) injection on Day 1, Day 8, Week 4, and Week 8. Participants will continue their standard of care therapy throughout the study. End of treatment assessments will be taken at Week 12. Total study period, including screening and follow-up, is expected to last 23 weeks.
- Conditions
- Asthma
- Being tested
- Lebrikizumab, Placebo, Inhaled corticposteroids (ICS), Second Asthma Controller Medication
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LebrikizumabDrug
Also called RO5490255
Lebrikizumab will be administered by SC injection on Day 1, Day 8, Week 4, and Week 8.
PlaceboDrug
Lebrikizumab matching placebo will be administered by SC injection on Day 1, Day 8, Week 4, and Week 8.
Inhaled corticposteroids (ICS)Drug
Participants will continue their ICS controller therapy, as they are receiving prior to screening, throughout the study. Protocol does not specify any particular ICS.
Second Asthma Controller MedicationDrug
Participants will continue their asthma controller therapy, as they are receiving prior to screening, throughout the study.
| Study group | Role | What they receive |
|---|---|---|
| Lebrikizumab | Experimental | Participants with uncontrolled asthma on ICS therapy (not specified in the protocol) and a second controller medication, will receive SC injection of lebrikizumab on Days 1 and 8, and on Weeks 4 and 8. Receives: Drug: Lebrikizumab; Drug: Inhaled corticposteroids (ICS); Drug: Second Asthma Controller Medication |
| Placebo | Placebo comparator | Participants with uncontrolled asthma on ICS therapy (not specified in the protocol) and a second controller medication, will receive SC injection of lebrikizumab matching placebo on Days 1 and 8, and on Weeks 4 and 8. Receives: Drug: Placebo; Drug: Inhaled corticposteroids (ICS); Drug: Second Asthma Controller Medication |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relative Change From Baseline in the Number of Airway Submucosal Eosinophils per Surface Area of Basal Lamina (Cells per Square Millimeter [Cells/mm^2])
Measured: From Baseline to Week 12
Secondary outcomes (22)
Absolute Change From Baseline in Number of Airway Submucosal Eosinophils per Surface Area of Basal Lamina (Cells/mm^2)
Measured: From Baseline to Week 12
Relative Change From Baseline in the Number of Airway Epithelial Eosinophils per Surface Area of Basal Lamina (Cells/mm^2)
Measured: From Baseline to Week 12
Absolute Change From Baseline in Number of Airway Epithelial Eosinophils per Surface Area of Basal Lamina (Cells/mm^2)
Measured: From Baseline to Week 12
Relative Change From Baseline in Number of Airway Submucosal Eosinophils per Volume of Submucosa (Cells per Cubic Millimeter [Cells/mm^3])
Measured: From Baseline to Week 12
Absolute Change From Baseline in Number of Airway Submucosal Eosinophils per Volume of Submucosa (Cells/mm^3)
Measured: From Baseline to Week 12
Relative Change From Baseline in Number of Airway Epithelial Eosinophils per Volume of Epithelium (Cells/mm^3)
Measured: From Baseline to Week 12
Absolute Change From Baseline in Number of Airway Epithelial Eosinophils per Volume of Epithelium (Cells/mm^3)
Measured: Form Baseline to Week 12
Change From Baseline in Blood Eosinophil Count
Measured: From Baseline to Week 12
Change From Baseline in Immunoglobulin E (IgE) Levels
Measured: From Baseline to Week 12
Change From Baseline in Serum Periostin Levels
Measured: From Baseline to Week 12
Change From Baseline in Chemokine Ligand (CCL)-13 Levels
Measured: From Baseline to Week 12
Change From Baseline in CCL-17 Levels
Measured: From Baseline to Week 12
Change From Baseline in Lung Epithelial Cell Chloride Channel Accessory 1 (CLCA1) Gene Expression
Measured: From Baseline to Week 12
Change From Baseline in Lung Epithelial Cell SerpinB2 Gene Expression at Week 12
Measured: From Baseline to Week 12
Change From Baseline in Lung Epithelial Cell CCL-26 Gene Expression
Measured: From Baseline to Week 12
Change From Baseline in Lung Epithelial Cell Nitric Oxide Synthase 2 (NOS2) Gene Expression
Measured: From Baseline to Week 12
Change From Baseline in Lung Epithelial Cell Periostin (POSTN) Gene Expression
Measured: From Baseline to Week 12
Relative Change From Baseline in Fractional Exhaled Nitric Oxide (FeNO)
Measured: From Baseline to Week 12
Relative Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1)
Measured: From Baseline to Week 12
Percentage of Participants With Treatment-Emergent Adverse Events
Measured: From Baseline to Week 20
Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) to Lebrikizumab
Measured: Baseline up to Week 20 (assessed at Baseline, Weeks 8 and 20/dosing termination or early termination)
Serum Lebrikizumab Concentration at Week 12
Measured: Predose (Hour 0) at Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2014 (estimated)
- Study start6 Nov 2014
- Primary completion13 Oct 2016
- Study completion13 Oct 2016
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 Hoffmann-La RocheThe 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
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02099656
- Sponsor's protocol ID
- GB29260
- Other IDs
- 2014-000275-14, 2014
- Status last verified
- Sep 2017
- First submitted
- 26 Mar 2014
- Last updated
- 6 Sep 2017
- Results posted
- No
Publications
Austin CD, Gonzalez Edick M, Ferrando RE, Solon M, Baca M, Mesh K, Bradding P, Gauvreau GM, Sumino K, FitzGerald JM, Israel E, Bjermer L, Bourdin A, Arron JR, Choy DF, Olsson JK, Abreu F, Howard M, Wong K, Cai F, Peng K, Putnam WS, Holweg CTJ, Matthews JG, Kraft M, Woodruff PG; CLAVIER Investigators. A randomized, placebo-controlled trial evaluating effects of lebrikizumab on airway eosinophilic inflammation and remodelling in uncontrolled asthma (CLAVIER). Clin Exp Allergy. 2020 Dec;50(12):1342-1351. doi: 10.1111/cea.13731. Epub 2020 Oct 4.
PubMed 32909660
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Randomized, Double-Blind, Placebo-Controlled Bronchoscopy Study to Evaluate the Effects of Lebrikizumab on Airway Eosinophilic Inflammation in Patients With Uncontrolled Asthma on Inhaled Corticosteroids and a Second Controller Medication
- ClinicalTrials.gov ID
- NCT02099656
- Acronym / sponsor ID
- GB29260
- Conditions
- Asthma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- 6 Nov 2014 (actual)
- Primary completion
- 13 Oct 2016 (actual)
- Study completion
- 13 Oct 2016 (actual)
- First posted
- 31 Mar 2014 (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 Phase II, randomized, double-blind, placebo-controlled, multicenter study will evaluate the effects of lebrikizumab on airway eosinophilic inflammation in participants with uncontrolled asthma who are using inhaled corticosteroid (ICS) treatment and a second controller medication. Enrolled participants will undergo a 3-week screening period during which assessments, including a bronchoscopy procedure, will be made. Participants will subsequently be randomized to receive lebrikizumab or placebo by subcutaneous (SC) injection on Day 1, Day 8, Week 4, and Week 8. Participants will continue their standard of care therapy throughout the study. End of treatment assessments will be taken at Week 12. Total study period, including screening and follow-up, is expected to last 23 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lebrikizumab | Experimental | Drug: Lebrikizumab, Drug: Inhaled corticposteroids (ICS), Drug: Second Asthma Controller MedicationParticipants with uncontrolled asthma on ICS therapy (not specified in the protocol) and a second controller medication, will receive SC injection of lebrikizumab on Days 1 and 8, and on Weeks 4 and 8. |
| Placebo | Placebo comparator | Drug: Placebo, Drug: Inhaled corticposteroids (ICS), Drug: Second Asthma Controller MedicationParticipants with uncontrolled asthma on ICS therapy (not specified in the protocol) and a second controller medication, will receive SC injection of lebrikizumab matching placebo on Days 1 and 8, and on Weeks 4 and 8. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Asthma diagnosis for greater than or equal to (>/=) 12 months prior to Visit 1
- Bronchodilator response demonstrated within the 12 months before Visit 1 or at Visit 1, 2, or 3 of screening
- Pre-bronchodilator FEV1 of 40 percent (%) - 80% predicted at both Visits 2 and 3
- On ICS therapy at a total daily dose of 500-2000 mcg of fluticasone propionate dry powder inhaler (DPI) or equivalent for >/= 6 months prior to Visit 1, with no changes within 4 weeks prior to Visit 1, and no anticipated changes throughout the study
- On an eligible second controller medication (long-acting Beta-agonist [LABA), leukotriene receptor antagonist [LTRA], long-acting muscarinic antagonists [LAMAs] or theophylline) for 6 months prior to Visit 1, with no changes within 4 weeks prior to Visit 1, and no anticipated changes throughout the study
Key exclusion criteria (19 listed)
- Maintenance oral corticosteroid therapy, defined as daily alternate-day oral corticosteroid maintenance therapy within 3 months prior to Visit 1
- Treatment with systemic corticosteroids within 4 weeks prior to Visit 1 or during the screening period for any reason, including an acute exacerbation event
- Any infection requiring hospital, intravenous (IV) or intramuscular (IM) antibiotic treatment or any respiratory infection within 4 weeks prior to Visit 1 or during screening. Any infection requiring oral antibiotic treatment with 2 weeks prior to Visit 1 or during screening, or any parasitic infection within 6 months prior to Visit 1 or during screening
- Active tuberculosis requiring treatment within 12 months prior to Visit 1
- Known immunodeficiency, including, but not limited to, human immunodeficiency virus (HIV) infection
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 |
|---|---|---|
| LebrikizumabAlso: RO5490255Lebrikizumab will be administered by SC injection on Day 1, Day 8, Week 4, and Week 8. | Drug | Lebrikizumab |
| PlaceboLebrikizumab matching placebo will be administered by SC injection on Day 1, Day 8, Week 4, and Week 8. | Drug | Placebo |
| Inhaled corticposteroids (ICS)Participants will continue their ICS controller therapy, as they are receiving prior to screening, throughout the study. Protocol does not specify any particular ICS. | Drug | Lebrikizumab, Placebo |
| Second Asthma Controller MedicationParticipants will continue their asthma controller therapy, as they are receiving prior to screening, throughout the study. | Drug | Lebrikizumab, Placebo |
Primary outcome
Relative Change From Baseline in the Number of Airway Submucosal Eosinophils per Surface Area of Basal Lamina (Cells per Square Millimeter [Cells/mm^2])
Time frame: From Baseline to Week 12
22 secondary outcomes
Absolute Change From Baseline in Number of Airway Submucosal Eosinophils per Surface Area of Basal Lamina (Cells/mm^2)
Time frame: From Baseline to Week 12
Relative Change From Baseline in the Number of Airway Epithelial Eosinophils per Surface Area of Basal Lamina (Cells/mm^2)
Time frame: From Baseline to Week 12
Absolute Change From Baseline in Number of Airway Epithelial Eosinophils per Surface Area of Basal Lamina (Cells/mm^2)
Time frame: From Baseline to Week 12
Relative Change From Baseline in Number of Airway Submucosal Eosinophils per Volume of Submucosa (Cells per Cubic Millimeter [Cells/mm^3])
Time frame: From Baseline to Week 12
Absolute Change From Baseline in Number of Airway Submucosal Eosinophils per Volume of Submucosa (Cells/mm^3)
Time frame: From Baseline to Week 12
Relative Change From Baseline in Number of Airway Epithelial Eosinophils per Volume of Epithelium (Cells/mm^3)
Time frame: From Baseline to Week 12
Absolute Change From Baseline in Number of Airway Epithelial Eosinophils per Volume of Epithelium (Cells/mm^3)
Time frame: Form Baseline to Week 12
Change From Baseline in Blood Eosinophil Count
Time frame: From Baseline to Week 12
Change From Baseline in Immunoglobulin E (IgE) Levels
Time frame: From Baseline to Week 12
Change From Baseline in Serum Periostin Levels
Time frame: From Baseline to Week 12
Change From Baseline in Chemokine Ligand (CCL)-13 Levels
Time frame: From Baseline to Week 12
Change From Baseline in CCL-17 Levels
Time frame: From Baseline to Week 12
Change From Baseline in Lung Epithelial Cell Chloride Channel Accessory 1 (CLCA1) Gene Expression
Time frame: From Baseline to Week 12
Change From Baseline in Lung Epithelial Cell SerpinB2 Gene Expression at Week 12
Time frame: From Baseline to Week 12
Change From Baseline in Lung Epithelial Cell CCL-26 Gene Expression
Time frame: From Baseline to Week 12
Change From Baseline in Lung Epithelial Cell Nitric Oxide Synthase 2 (NOS2) Gene Expression
Time frame: From Baseline to Week 12
Change From Baseline in Lung Epithelial Cell Periostin (POSTN) Gene Expression
Time frame: From Baseline to Week 12
Relative Change From Baseline in Fractional Exhaled Nitric Oxide (FeNO)
Time frame: From Baseline to Week 12
Relative Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1)
Time frame: From Baseline to Week 12
Percentage of Participants With Treatment-Emergent Adverse Events
Time frame: From Baseline to Week 20
Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) to Lebrikizumab
Time frame: Baseline up to Week 20 (assessed at Baseline, Weeks 8 and 20/dosing termination or early termination)
Serum Lebrikizumab Concentration at Week 12
Time frame: Predose (Hour 0) at Week 12
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 Sep 2017.
- Derived from this study: PubMed 32909660Austin CD, Gonzalez Edick M, Ferrando RE, Solon M, Baca M, Mesh K, Bradding P, Gauvreau GM, Sumino K, FitzGerald JM, Israel E, Bjermer L, Bourdin A, Arron JR, Choy DF, Olsson JK, Abreu F, Howard M, Wong K, Cai F, Peng K, Putnam WS, Holweg CTJ, Matthews JG, Kraft M, Woodruff PG; CLAVIER Investigators. A randomized, placebo-controlled trial evaluating effects of lebrikizumab on airway eosinophilic inflammation and remodelling in uncontrolled asthma (CLAVIER). Clin Exp Allergy. 2020 Dec;50(12):1342-1351. doi: 10.1111/cea.13731. Epub 2020 Oct 4.
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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.
Clinical Trials study director
Hoffmann-La Roche
28 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lebrikizumab and Inhaled corticposteroids (ICS) in people with Asthma, run by Hoffmann-La Roche at 28 sites in 6 countries.
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 8 inclusion and 19 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 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 sites in United States, Canada, United Kingdom, France, Ireland and 1 more country. 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?
Relative Change From Baseline in the Number of Airway Submucosal Eosinophils per Surface Area of Basal Lamina (Cells per Square Millimeter [Cells/mm^2]) (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 NCT02099656, 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 Sep 2017.