AsthmaPhase 3NCT02104674
A Study Evaluating the Efficacy and Safety of Lebrikizumab in Adult Patients With Mild to Moderate Asthma
A Phase 3 study testing Lebrikizumab and Montelukast in people with Asthma, run by Hoffmann-La Roche at 82 sites in 11 countries.
Trial summary
This Phase III, randomized, double-blind, placebo-controlled, multicenter study will assess the efficacy and safety of lebrikizumab in adult patients with mild to moderate asthma treated with short-acting beta-agonist (SABA) therapy alone. 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 Montelukast
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 313 participants
- Where
- 82 sitesin 11 countries
- Study dates
- 7 Jun 2014to 22 Jan 2016
- Phase
- Phase 3
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
- Age 18-75 years old at study start
- Asthma diagnosis for >/= 12 months prior to study start
- Bronchodilator response at screening
- Pre-bronchodilator FEV1 of 60% - 85% predicted at both screening visits 2 and 3
- No other clinically significant lung disease as confirmed by chest X-ray or computed tomography (CT) scan
- Stable and symptomatic asthma during the screening period
- Use of effective contraception, as defined by the protocol, until 24 weeks after the last dose
Who cannot join
- Maintenance of corticosteroid therapy, defined as daily or alternate-day oral corticosteroid maintenance therapy within 3 months prior to study start
- Treatment with systemic or inhaled corticosteroids within 4 weeks prior to study start or during the screening period for any reason, including an acute exacerbation event
- Treatment with a leukotriene receptor antagonist (LTRA), long-acting beta-agonist (LABA) long-acting muscarinic antagonist (LAMA), zileuton, roflumilast, or theophylline within 2 weeks prior to study start
- Documented prior treatment failure with Montelukast
- Treatment with intra-articular corticosteroids within 4 weeks prior to study start or during the screening period or anticipated need for intra articular corticosteroids during the course of the study
- Any infection requiring hospital, IV or IM antibiotic treatment or any respiratory infection within 4 weeks of study start. Any infection requiring oral antibiotic treatment within 2 weeks of study start, or any parasitic infection within 6 months of study start
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- Clinically significant abnormality found during screening or clinically significant medical disease that is uncontrolled despite treatment that is likely, in the opinion of the investigator, to impact the patient's ability to participate in the study, or impact the study assessments
- History of interstitial lung disease, chronic obstructive pulmonary disease (COPD), or other clinically significant lung disease other than asthma
- History of alcohol or drug abuse that would impair or risk the patient's full participation in the study, in the opinion of the investigator
- Current or history of smoking (> 10 pack-years), or unwillingness to abstain from smoking for the duration of the study
- Past and/or current use of any anti-IL-13 or anti- IL4/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 study start or during screening
- Use of other investigational therapy within 4 weeks or 5 drug half-lives prior to study start (whichever is longer) or during screening
- Initiation of or change in allergen immunotherapy within 3 months prior to study start or during screening
- Receipt of a live attenuated vaccine within 4 weeks prior to study start of during screening
- Pregnancy or breast feeding
- Body mass index > 38 kg/m2
- Body weight < 40 kg
- History of bronchial thermoplasty
Trial locations and contacts
82 sites in 11 countries.
82 sites in 11 countries
United States38 sites
Anaheim Clinical Trials
Anaheim, California, 92801
Clinical Research Center of Alabama, LLC
Birmingham, Alabama, 35209
TTS Research
Boerne, Texas, 78006
Storms Clinical Research; Institute
Colorado Springs, Colorado, 80907
Allergy Asthma Research Assoc
Dallas, Texas, 75231
Pharmaceutical Research & Consulting, Inc.
Dallas, Texas, 75231
National Jewish Health
Denver, Colorado, 80206
In-Quest Medical Research, LLC
Duluth, Georgia, 30096
O & O Alpan, LLC
Fairfax, Virginia, 22030
Allergy Asthma & Sinus Center
Greenfield, Wisconsin, 53228
Mountainview Clinical Research
Greer, South Carolina, 29651
Texas Institute of chest and Sleep Disorder
Houston, Texas, 77034
CA Allergy & Asthma Med Grp; Medical Group, Inc.
Los Angeles, California, 90025
Southern California Institute For Respiratory
Los Angeles, California, 90048
Family Allergy & Asthma
Louisville, Kentucky, 40223
Metroplex Pulmonology & Sleep Center
McKinney, Texas, 75069
Clinical Research Inst. of Southern Oregon, Pc
Medford, Oregon, 97504
North Bay Clinical Trials
Napa, California, 94558
Sneeze, Wheeze, & Itch Associates
Normal, Illinois, 61761
Atlantic Research Center, LLC
Ocean City, New Jersey, 07712
Allergy, Asthma & Clinical Research Center
Oklahoma City, Oklahoma, 73120
Asthma & Allergy Center, P.C.
Papillion, Nebraska, 68046
Allergy Associates Research Center LLC - CRN
Portland, Oregon, 97202
Advances in Medicine
Rancho Mirage, California, 92270
Allergy & Asthma Consultants
Redwood City, California, 94063
Advanced Research Institute
Reno, Nevada, 89511
Clinical Research Partners, LLC
Richmond, Virginia, 23220
Asthma & Allergy Center of Chicago, S.C.
River Forest, Illinois, 60305
Integrated Research Group Inc
Riverside, California, 92506
Quality Assurance Research Center
San Antonio, Texas, 78207
Bandera Family Health Care
San Antonio, Texas, 78249
South Texas Allergy and Asthma Medical Professionals
San Antonio, Texas, 78251
Allergy & Asthma Immunology Associates
Scottsdale, Arizona, 85251
Midwest Clinical Research LLC
St Louis, Missouri, 63141
The Clinical Research Ctr
St Louis, Missouri, 63141
Urban Health Plan, Inc.
The Bronx, New York, 10459
Allergy & Asthma Center
Waco, Texas, 76712
Florida Pulmonary Research Institute, LLC
Winter Park, Florida, 32789
Russia9 sites
Ryazan State Medical University Named after I.P.Pavlov
Ryazan, Ryazan Oblast, 390026
SBEI HPE "The First St.Petersburg State Medical University n.a. acad. I.P.Pavlova"of MoH of RF
Saint Petersburg, Sankt-Peterburg, 197022
St. Petersburg State Medical University n.a. I.P. Pavlov
Saint Petersburg, Sankt-Peterburg, 197089
City Hospital #40 of Resort Administrative District
Saint Petersburg, Sankt-Peterburg, 197706
LLC Medical Center "Alliance-Biomedical - Russian Group"
Saint Petersburg, 190068
LLC Medical Center"REAVITA"
Saint Petersburg, 194295
Multiple-discipline City Hospital #2
Saint Petersburg, 194354
Regional Clinical Hospital
Saratov, 410053
Ural State Medical University; Pulmonology
Yekaterinburg, 620109
Poland7 sites
Uniwersytecki Szpital Kliniczny w Bialymstoku Klinika Alergologii i Chorob Wewnetrznych
Bialystok, 15-276
Grazyna Pulka Specjalistyczny Osrodek ALL-MED
Krakow, 31-023
GRA?YNA JASIENIAK-PINIS ATOPIA Niepubliczny Zak?ad Opieki Zdrowotnej Poradnie Specjalistyczne
Krakow, 31-159
Specjalistyczny Niepubliczny Zespol Opieki Zdrowotnej; Alergologia Plus Osrodek Diagnostyki.
Poznan, 60-693
NZOZ Alergo-Med. Specjalistyczna Przychodnia Lekarska; Poradnia Alergologiczna
Poznan, 60-823
ALERGO-MED Specjalistyczna Przychodnia Lekarska Sp. z o. o
Tarnów, 33-100
NZOZ ALL-MED Specjalistyczna Opieka Medyczna
Wroclaw, 53-201
Bulgaria6 sites
SHATPD ? Gabrovo EOOD; Department of pneumology
Gabrovo, 5300
MHAT "Sv. Ivan Rilski" ? Razgrad AD; Department of pnemology and phthisiatry
Razgrad, 7200
SHATPPD Dr. Dimitar Gramatikov, Ruse Ltd.
Rousse, 7002
Medical Center Excelsior OOD
Sofia, 1000
Medical Center Researchexpert OOD
Varna, 9000
Medical Center Tara OOD
Veliko Tarnovo, 5000
South Africa6 sites
Tiervalei Trial Centre
Cape Town, 7530
University of Cape Town Lung Institute; Lung Clinical Research
Cape Town, 7700
Newtown Clinical Research
Johannesburg, 2113
I Engelbrecht Research
Lyttleton, 0157
Syzygy Clinical Research; ?Unit 3 to 7
Pretoria Gauteng Province, 0087
Soweto Clinical Trial Centre
Soweto, 1818
Brazil4 sites
Ufsc - Nupaiva
Florianópolis, Santa Catarina, 88040-970
Santa Casa de Misericordia de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90020-090
Faculdade de Medicina do ABC - FMABC; Oncologia e Hematologia
Santo André, São Paulo, 09060-650
Pesquisare Saúde Sociedade Simples
Santo André, São Paulo, 09080-000
Romania4 sites
Compartiment Pneumologie; Fundatia Dr. Victor Babes
Bucharest, 030303
Spitalul Clinic de Boli Infectioase si Pneumoftiziologie Dr. Victor Babes; Sectia Pneumologie II
Craiova, 200446
Spitalul Clinic de Pneumoftiziologie Iasi; Sectia Clinica I Pneumoftiziologie
Iași, 700115
Spitalul Clinic Municipal Dr. Gavril Curteanu Oradea; Sectia Pneumologie I
Oradea, 410176
Czechia3 sites
MediTrial s.r.o.
Jind?ich?v Hradec, 377 01
Pneumo - KV; Ordinace pneumologie a diagnostiky plicních funkcí
Karlovy Vary ? Stará Role, 360 17
Ordinace pro tuberkulozu a respiracni nemoci
Strakonice, 38601
Canada2 sites
Aggarwal and Associates
Brampton, Ontario, L6T 0G1
Dr. Anil K. Gupta Medicine Professional Corporation
Toronto, Ontario, M9V 4B4
New Zealand2 sites
Optimal Clinical Trials
Auckland, 1010
Southern Clinical Trials, Ltd
Beckenham, 8024
About this study
Official title: A Phase III, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Lebrikizumab in Adult Patients With Mild to Moderate Asthma
This Phase III, randomized, double-blind, placebo-controlled, multicenter study will assess the efficacy and safety of lebrikizumab in adult patients with mild to moderate asthma treated with short-acting beta-agonist (SABA) therapy alone. Patients will be randomized in a 1:1:1 ratio to receive either blinded lebrikizumab or placebo treatment by subcutaneous (SC) injection (every 4 weeks for a total of 3 doses) or open-label treatment with Singulair (Montelukast; 10 mg daily). Time on study treatment will last 12 weeks.
- Conditions
- Asthma
- Being tested
- Lebrikizumab, Montelukast, Placebo
- 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 125 mg subcutaneous (SC) injection given on Days 1, 29, and 57
MontelukastDrug
Also called Singulair
10 mg tablet given orally once daily for 12 weeks, according to the approved label.
PlaceboOther
Lebrikizumab-matched placebo SC injection given on Days 1, 29, and 57
| Study group | Role | What they receive |
|---|---|---|
| Lebrikizumab | Experimental | Not described Receives: Drug: Lebrikizumab |
| Placebo | Placebo comparator | Not described Receives: Other: Placebo |
| Montelukast | Active comparator | Not described Receives: Drug: Montelukast |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Pre-bronchodilator Forced Expiratory Volume in 1 Second (FEV1) at Week 12
FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. The active comparator treatment arm of open-label montelukast was included in the study design so that the sensitivity of the study could be evaluated with respect to the primary outcome measure, FEV1. Two mixed-effect models of repeated measures (MMRM) were used to estimate the absolute change from baseline values: one for the lebrikizumab vs. placebo primary comparison and the second for the montelukast vs. placebo sensitivity comparison.
Measured: Baseline through Week 12
Secondary outcomes (17)
Lebrikizumab vs. Placebo: Change From Baseline in Asthma Reliever Medication Use at Week 12
Participants could only receive SABA therapy for asthma treatment as asthma reliever medication (<10 puffs daily). SABA use was recorded in the eDiary. A mixed-effect model of repeated measures (MMRM) was used to estimate the absolute change from baseline values for the comparison between the double-blind lebrikizumab and placebo study arms.
Measured: Baseline through Week 12
Lebrikizumab vs. Placebo: Change From Baseline in the Standardized Asthma Quality of Life Questionnaire (AQLQ[S]) Overall Score at Week 12
The AQLQ[S] was used to assess the participant's asthma-specific health-related quality of life. The 32-item questionnaire contains four domains: activity limitations, symptoms, emotional function, and environmental stimuli. The AQLQ[S] has a recall specification of 2 weeks. Participants were asked to think about how they had been during the previous 2 weeks and to respond to each of the 32 questions on a 7-point scale (7 = not impaired at all; 1 = severely impaired). An increase in the AQLQ score indicates a better quality of life. The overall AQLQ score is the mean of all 32 responses and the individual domain scores are the means of the items in those domains. A mixed-effect model of repeated measures (MMRM) was used to estimate the change from baseline values.
Measured: Baseline through Week 12
Change From Baseline in Fractional Exhaled Nitric Oxide (FeNO) Levels at Week 12
Measured: Baseline, Week 12
Montelukast vs. Placebo: Change Fom Baseline in Morning Pre-bronchodilator Peak Expiratory Flow (PEF) at Week 12
PEF is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. The active comparator treatment arm of open-label montelukast was included in the study design so that the sensitivity of the study could be evaluated with respect to this secondary outcome measure of PEF. A mixed-effect model of repeated measures (MMRM) was used to estimate the absolute change from baseline values for the sensitivity comparison between montelukast (open-label, active comparator) and placebo study arms.
Measured: Baseline through Week 12
Lebrikizumab vs. Placebo: Change From Baseline in Morning Pre-bronchodilator PEF at Week 12
Peak expiratory flow (PEF) is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. A mixed-effect model of repeated measures (MMRM) was used to estimate the absolute change from baseline values for the comparison between the double-blind lebrikizumab and placebo study arms.
Measured: Baseline through Week 12
Lebrikizumab vs. Placebo: Number of Participants With Treatment Failure
Treatment failure was defined as a worsening of asthma symptoms (per investigator's assessment of participant report) in association with either relative decline in pre-bronchodilator FEV1 >=20%; or >=20% decline in morning pre-bronchodilator PEF on 2 consecutive days compared with baseline; or use of >=10 puffs of albuterol metered dose inhaler (MDI); or >=2 additional administrations (or any new use) of nebulized short-acting β-agonist (SABA) therapy within any calendar day; or need for any inhaled, oral, or parenteral corticosteroid or for a controller medication. The hazard ratio from the Cox Proportional Hazards model compared the risk of treatment failure for the lebrikizumab-treated and placebo participants.
Measured: Baseline up to Week 12
Lebrikizumab vs. Placebo: Time to Treatment Failure
Treatment failure was defined as a worsening of asthma symptoms (per investigator's assessment of participant report) in association with either relative decline in pre-bronchodilator FEV1 >=20%; or >=20% decline in morning pre-bronchodilator PEF on 2 consecutive days compared with baseline; or use of >=10 puffs of albuterol metered dose inhaler (MDI); or >=2 additional administrations (or any new use) of nebulized short-acting β-agonist (SABA) therapy within any calendar day; or need for any inhaled, oral, or parenteral corticosteroid or for a controller medication. Time to treatment failure was estimated using Kaplan-Meier method.
Measured: Basleine up to Week 12
Change From Baseline in Blood Eosinophil Count at Week 12
Measured: Baseline, Week 12
Change From Baseline in Serum Periostin at Week 12
Measured: Baseline, Week 12
Change From Baseline in Total Immunoglobulin E (IgE) Levels at Week 12
Measured: Baseline, Week 12
Change From Baseline in C-C Motif Chemokine Ligand 13 (CCL-13) Levels at Week 12
Measured: Baseline, Week 12
Change From Baseline in CCL-17 Levels at Week 12
Measured: Baseline, Week 12
Maximum Serum Lebrikizumab Concentration (Cmax) After the First Dose
According to the protocol and statistical analysis plan, a single PK sample was collected per participant after the first dose at the expected time of the maximum serum lebrikizumab concentration.
Measured: Predose on Day 0 and post-Day 1 dose on Day 7
Time to Reach Maximum Lebrikizumab Concentration After the First Dose (Tmax)
According to the protocol and statistical analysis plan, the Tmax, Week1 (first dose) value was estimated on the basis of a single pharmacokinetic (PK) timepoint per participant after the first dose, which was taken at the expected time of the maximum serum lebrikizumab concentration.
Measured: Post-Day 1 dose on Day 7
Elimination Half-Life (t1/2) of Lebrikizumab
According to the protocol and statistical analysis plan, the t1/2 was estimated based on the seven total PK samples collected per participant.
Measured: Predose on Days 0, 28, and 56, and on Days 7, 84, 112, and 140
Predose Serum Lebrikizumab Concentration (Cmin) at Week 4
Measured: Predose on Day 28 (Week 4)
Serum Lebrikizumab Concentration at Week 12
Measured: On Day 84 (Week 12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2014 (estimated)
- Study start7 Jun 2014
- Primary completion22 Jan 2016
- Study completion22 Jan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized in a 1:1:1 ratio to receive lebrikizumab 125 mg, placebo, or Montelukast 10 mg.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 313 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
- NCT02104674
- Sponsor's protocol ID
- WA29249
- Other IDs
- 2013-004625-81
- Status last verified
- Jun 2026
- First submitted
- 26 Mar 2014
- Last updated
- 17 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Korenblat P, Kerwin E, Leshchenko I, Yen K, Holweg CTJ, Anzures-Cabrera J, Martin C, Putnam WS, Governale L, Olsson J, Matthews JG. Efficacy and safety of lebrikizumab in adult patients with mild-to-moderate asthma not receiving inhaled corticosteroids. Respir Med. 2018 Jan;134:143-149. doi: 10.1016/j.rmed.2017.12.006. Epub 2017 Dec 13.
PubMed 29413502