AsthmaPhase 3NCT01867125
A Study of Lebrikizumab in Participants With Uncontrolled Asthma Who Are on Inhaled Corticosteroids and a Second Controller Medication
A Phase 3 study testing Lebrikizumab in people with Asthma, run by Hoffmann-La Roche at 181 sites in 26 countries.
Trial summary
This randomized, multicenter, double-blind, placebo-controlled, parallel-group study will evaluate the efficacy and safety of lebrikizumab in participants with asthma whose disease remains uncontrolled despite daily treatment with inhaled corticosteroid (ICS) therapy and at least one 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
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,081 participants
- Where
- 181 sitesin 26 countries
- Study dates
- 25 Jul 2013to 28 Dec 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
- Asthma diagnosis for greater than equal to (>/=) 12 months prior to Visit 1
- Bronchodilator response at Visit 1, 2, or 3
- 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 micrograms (mcg) of fluticasone propionate dry powder inhaler (DPI) or equivalent for >/=6 months prior to Visit 1
- On an eligible second controller medication (long-acting beta-agonist [LABA], leukotriene receptor antagonist [LTRA], long-acting muscarinic antagonist [LAMA], or theophylline) for 6 months prior to Visit 1
- Uncontrolled asthma at Visit 1 and/or Visit 2, and at Visit 3
- Chest X-ray or computed tomography (CT) scan within 3 months prior to Visit 1 or chest X-ray during the screening period (prior to Visit 3) confirming the absence of other clinically significant lung disease
- Demonstrated adherence with controller medication during the screening period
Who cannot join
- History of severe allergic reaction or anaphylactic reaction to a biologic agent or known hypersensitivity to any component of the lebrikizumab injection
- Maintenance oral corticosteroid therapy within 3 months of Visit 1
- Treatment with systemic (oral, intravenous [IV], or intramuscular [IM]) corticosteroids within 4 weeks prior to Visit 1 or during the screening period
- Treatment with intra-articular corticosteroids within 4 weeks prior to Visit 1 or during the screening period or anticipated need for intra-articular corticosteroids during the course of the study
- Infection requiring hospital admission for >/=24 hours or requiring treatment with IV or IM antibiotics within 4 weeks prior to Visit 1 or during screening; Upper or lower respiratory tract infection within 4 weeks prior to Visit 1 or during screening; Active infection that required treatment with oral antibiotics within 2 weeks prior to Visit 1 or during screening; Active parasitic infection or Listeria monocytogenes infection within 6 months prior to Visit 1 or during screening
- Active tuberculosis requiring treatment within 12 months prior to Visit 1
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- Known immunodeficiency, including, but not limited to, human immunodeficiency virus (HIV) infection
- Evidence of acute or chronic hepatitis or known liver cirrhosis
- History of interstitial lung disease, chronic obstructive pulmonary disease (COPD), or other clinically significant lung disease other than asthma
- Known current malignancy or current evaluation for potential malignancy
- Current smoker or former smoker with a history of greater than (>) 10 pack-years
- History of alcohol or drug abuse
- Past and/or current use of any anti-interleukin (IL)-13 or anti-IL-4/IL-13 therapy, including lebrikizumab
- Use of other monoclonal antibody therapy, including omalizumab, within 6 months or 5 drug half-lives prior to Visit 1 (whichever is longer) or during screening
- Initiation of or change in allergen immunotherapy within 3 months prior to Visit 1 or during screening
Trial locations and contacts
181 sites in 26 countries.
181 sites in 26 countries
United States53 sites
Tekton Research Inc
Austin, Texas, 78745
Bellingham Asthma, Allergy & Immunology
Bellingham, Washington, 98225
TTS Research
Boerne, Texas, 78006
IMMUNOe Research Centers
Centennial, Colorado, 80112
St. Francis Sleep; Allergy & Lung Institute
Clearwater, Florida, 33765
Pharmaceutical Research & Consulting, Inc.
Dallas, Texas, 75231
Allergy & Asthma Research Grp
Eugene, Oregon, 97401-7721
O & O Alpan, LLC
Fairfax, Virginia, 22030
Allianz Medical and Research Center
Fountain Valley, California, 92708
ADAC Research PA
Greenville, South Carolina, 29607
Allergy & Asthma Center of NC
High Point, North Carolina, 27262
Pioneer Research Solutions
Houston, Texas, 077099
Allergy & Asthma Associates
Las Vegas, Nevada, 89104
Asthma Allergy Phys of RI
Lincoln, Rhode Island, 02865
Allergy & Asthma Medical Group & Research Center, Pc
Long Beach, California, 90808
Allergy Medical Clinic
Los Angeles, California, 90025
CA Allergy & Asthma Med Grp
Los Angeles, California, 90025
Manassas Clinical Research Center
Manassas, Virginia, 20110
Metroplex Pulmonology & Sleep Center
McKinney, Texas, 75069
Clinical Research Inst. of Southern Oregon, Pc
Medford, Oregon, 97504
Suncoast Research Group LLC
Miami, Florida, 33135
Montana Medical Research LLC
Missoula, Montana, 59808
Allergy & Asthma Research of Nj, Inc
Mount Laurel, New Jersey, 08054
North Bay Clinical Trials
Napa, California, 94558
Northeast Medical Research Associates, Inc
North Dartmouth, Massachusetts, 02747
Atlantic Research Center, LLC
Ocean City, New Jersey, 07712
Cor Clinical Research
Oklahoma City, Oklahoma, 73103
Heartland Clinical Research Inc.
Omaha, Nebraska, 68134
Choc Psf, Amc
Orange, California, 92868
Emerald Coast Research Associates
Panama City, Florida, 32405
Asthma & Allergy Center, P.C.
Papillion, Nebraska, 68046
Alabama Clinical Research Associates
Pell City, Alabama, 35128
Asthma Allergy Pulm Associates
Philadelphia, Pennsylvania, 19107
Allergy Associates Research Center LLC - CRN
Portland, Oregon, 97202
Advances in Medicine
Rancho Mirage, California, 92270
Clinical Research Partners, LLC
Richmond, Virginia, 23220
Quality Assurance Research Ctr
San Antonio, Texas, 78205
Allergy Assoc Medical Group
San Diego, California, 92108
ASTHMA, Inc
Seattle, Washington, 98105
Grand View Hospital; Clinical Research Department
Sellersville, Pennsylvania, 18960
Princeton Center For Clinical Research
Skillman, New Jersey, 08558
Spartanburg Medical Research
Spartanburg, South Carolina, 29303
Premier Clinical Research
Spokane, Washington, 99202
Midwest Clinical Research LLC
St Louis, Missouri, 63141
Bensch Research Associates
Stockton, California, 95207
Allergy & Asthma Diagnostic; Treatment Center
Tallahassee, Florida, 32308
Montefiore Medical Center
The Bronx, New York, 10461
Asthma & Allergy Center
Toledo, Ohio, 43617
Desert Sun Clinical Research LLC
Tucson, Arizona, 85710
Waterbury Pulmonary Associates
Waterbury, Connecticut, 06708
PMG Research of Wilmington
Wilmington, North Carolina, 28401
Florida Pulmonary Research Institute, LLC
Winter Park, Florida, 32789
Atlanta Allergy & Asthma Clini
Woodstock, Georgia, 30188
Japan23 sites
Tosei General Hospital; Respiratory and Allergy Medicine
Aichi, 489-8642
Kyushu Central Hospital
Fukuoka, 815-8588
National Hospital Organization Mito Medical Center
Higashiibaraki-gun, 311-3193
Oji General Hospital
Hokkaido, 053-8506
National Hospital Organization Asahikawa Medical Center
Hokkaido, 070-8644
Yokohama City Minato Red Cross Hospital
Kanagawa, 231-8682
National Hospital Organization Tokyo National Hospital
Kiyose-shi, 204-8585
Kochi Medical School Hospital
Kochi, 783-8505
Oki Clinic
Kodaira-shi, 187-0024
Takahashi Clinic
Kokubunji-shi, 185-0014
Tono Chuo Clinic
Mizunami-shi, 509-6134
Nagaoka Red Cross Hospital
Nagaoka-shi, 940-2085
Niigata City General Hospital
Niigata, 950-11977
Iwate Medical University Hospital
Numakunai, 028-3695
Osaka Metropolitan University Hospital
Osaka, 545-8586
Senzoku Kokyuuki and Allergy Clinic
Ōta-ku, 145-0063
Japan Community Health Care Organization Hokkaido Hospital
Sapporo, 062-8618
Fukuwa Clinic
Tokyo, 103-0027
Tokyo Center Clinic; Internal Medicine
Tokyo, 103-0028
Sano Toranomon Clinic
Tokyo, 105-0003
Showa University Hospital
Tokyo, 142-8666
Sekino Hospital
Toshima City, 171-0014
University of Fukui Hospital
Yoshida-gun, 910-1193
Russia13 sites
SIH Kemerovo Regional Clinical Hospital
Kemerovo, 650002
Russian Uni of People'S Friendship, Med. Faculty; City Clinical Hospital No 64, Internal Diseases
Moscow, 117292
Central Clinical Hospital #1 of RZhD JCS
Moscow, 125367
Novosibirsk Municipal Clinical Hospital For Emergency Medicine #2
Novosibirsk, 630008
Ryazan Regional Clinical Hosp
Ryazan, Ryazan Oblast, 390039
LLC Medical Center Reavita Med SPb
Saint Petersburg, Sankt-Peterburg, 194354
SHI Ctr Occupational Pathology
Saint Petersburg, Sankt-Peterburg, 195271
City Outpatient Dept #94
Saint Petersburg, 193231
St-Petersburg Diagnostic Ctr#1; Pulmonology
Saint Petersburg, 194354
St. Petersburg State Budget Medical Institution Pokrovskaya City Hospital
Saint Petersburg, 197022
St.-Petersburg SMU n. a. Academician I.P.Pavlov; Therapy Department
Saint Petersburg, 197022
Smolensk State Medical Academy
Smolensk, 4812
Tomsk Regional Clinical Hospital
Tomsk, 634063
Poland11 sites
Centrum Medycyny Oddechowej Robert M. Mróz
Bialystok, 15-003
Specjalistyczne Centrum Medyczne NOWOMED
Krakow, 30-349
Grazyna Pulka Specjalistyczny Osrodek ALL-MED
Krakow, 31-023
Niepubliczny Zaklad Opieki Zdrowotnej Centrum Medyczne ProMiMed sp z o.o. sp.k.
Krakow, 31-637
Poradnia Pulmonologiczna dla Doroslych
Lódz, 90-153
Centrum Alergologii Teresa Hofman
Poznan, 60-214
SPZOZ Proszowice
Proszowice, 32-100
Anna Bogusz Gabinet Alergologiczny
Skarżysko-Kamienna, 26-110
Medica Pro Familia Sp. z o.o. S.K.A.
Warsaw, 01-868
Klinika Chorób Wewnetrznych i Alergologii MSW
Warsaw, 02-507
ALL-MED Specjalistyczna Opieka Medyczna
Wroclaw, 50-445
Ukraine10 sites
Public Institution City Clinical Hospital # 6 of Dnipropetrovsk Regional Board
Dnipro, 49000
Regional Phthisiology and Pulmonology Center
Ivano-Frankivsk, 76018
City Clinical Hospital #27
Kharkiv, 61002
Central Outpatient Hospital of Desnyansky District
Kyiv, 02232
Yanovskyy Inst of Phth. & Pulm; Clinical-functional
Kyiv, 03680
Municipal Institution of Kyiv Regional Council Kyiv Regional Clinical Hospital
Kyiv, 04107
Kyiv City Clinical Hospital #8
Kyiv, 04201
Danylo Halytskyy National Medical University; Lviv
Lviv, 79010
Small Business Private Enterprise Medical Centre Pulse
Vinnytsia, 21001
Non-Commercial Enterprise City Clinical Hospital 1 of Zaporizhzhia City Council
Zaporizhzhya, 69104
Argentina5 sites
Fundacion Faicep
Buenos Aires, C1122AAK
Centro Médico Dra de Salvo
Buenos Aires, C1426ABP
Instituto Ave Pulmo
Mar del Plata, B7602DCK
Centro Respiratorio Quilmes
Quilmes, B1878FNR
Investigaciones en Patologias Respiratorias
San Miguel de Tucumán, T4000IAR
Israel5 sites
Barzilai Medical Center; Pulmonary Inst.
Ashkelon, 78306
Lady Davis Carmel Medical Center; Cardiovascular Medicine
Haifa, 34362
Shaare Zedek Medical Center
Jerusalem, 9103102
Meir Medical Center; Pulmonary Dept
Kfar Saba, 4428164
Kaplan Medical Center
Rehovot, 7610001
South Africa5 sites
Melomed Hospital Gatesville
Cape Town, 7764
Uni of Cape Town Lung Inst.
Cape Town, 7925
Vawda Z.Fa Practice
Durban, 4091
Gatesville Medical Centre
Gatesville, 7746
Deepak Lakha MBCHB Private Practice
Johannesburg, 1820
South Korea5 sites
Seoul National University Bundang Hospital
Seongnam-si, 463-707
Asan Medical Center
Seoul, 05505
Samsung Medical Center
Seoul, 06351
Korea University Guro Hospital
Seoul, 08308
St. Paul's Hospital, The Catholic University of Korea, College of Medicine
Seoul, 130-709
Spain5 sites
Hospital de la Santa Creu; i Sant Pau
Barcelona, 08025
Hospital Germans Trias i Pujol
Barcelona, 08916
Hosp Univ Fundacion Alcorcon
Madrid, 28922
Hospital Universitario Doctor Peset
Valencia, 46017
Hospital Universitario Araba
Vitoria-Gasteiz, Alava, 01004
Turkey (Türkiye)5 sites
Atatürk Gö?üs Hastal?klar? ve Gö?üs Cerrahisi E?itim ve Ara?t?rma Hastanesi
Ankara, 06290
Uludag University; Pulmonology and Allergy Department
Bursa, 16059
Izmir Dr. Suat Seren Gogus Hastaliklari ve Cerrahisi Egitim ve Arastirma Hastanesi
Izmir, 35110
Kirikkale Universitesi Tip Fakultesi Hastanesi
Kirikkale, 71100
Mersin University Medical Faculty
Mersin, 33169
Czechia4 sites
Alergopraktik s.r.o.
Jablonec nad Nisou, 466 01
Interni A Pneumologicka Ambulance
Jindřichův Hradec, 377 38
MephaCentrum, a.s.
Ostrava - Poruba, 708 68
Alergologie Teplice, s.r.o.
Teplice, 415 01
France4 sites
Hopital Calmette; Pneumologie
Lille, 59037
Hôpital Arnaud de Villeneuve
Montpellier, 34295
CHU Nantes - Hôpital Laennec; Service de Pneumologie
Nantes, 44093
Nouvel Hopital Civil; Pole de Pathologie Thoracique
Strasbourg, 67091
New Zealand4 sites
NZ Respiratory & Sleep Institute
Auckland, 1051
Dunedin Hospital
Dunedin
RMC Medical Research Ltd
Dunedin
P3 Research
Hastings, 4122
Romania4 sites
Colentina Clinical Hospital
Bucharest, 020125
Prof.Dr.Octavian Fodor Emergency Clinical Hospital
Cluj-Napoca, 400162
Spitalul Clinic de Boli Infectioase si Pneumoftiziologie Victor Babes Craiova
Craiova, 200515
Dr. Victor Babes Pneumology and Infectious Diseases Clinical Hospital
Timișoara, 300310
Australia3 sites
Box Hill Hospital; Eastern Clinical Research Unit
Box Hill, Victoria, 3128
Footscray Hospital
Footscray, Victoria, 3011
The Lung Institute of Western Australia; Sir Charles Gairdner Hospital
Nedlands, Western Australia, 6009
Canada3 sites
Inspiration Research
Toronto, Ontario, M5T 3A9
Albion Finch Medical Centre
Toronto, Ontario, M9V4B4
C.I.C. Mauricie
Trois-Rivières, Quebec, G8T 7A1
Hungary3 sites
Kenezy Korhaz Rendelointezet
Debrecen, 4031
Petz Aladar Megyei Oktato Korhaz
Győr, 9024
C.C.C. Hospital Chest Diseases
Szeged, 6722
Slovakia3 sites
Alian s.r.o.
Bardejov, 085 01
Tehelná Clinic, Inc; IMUNO-ALERGO, s. r.o.
Bratislava, 831 03
Plucna ambulancia
Spišská Nová Ves, 052 01
United Kingdom3 sites
St Peters Hospital
Chertsey, KT16 0PZ
Castle Hill Hospital; Respiratory Medicine
Cottingham, HU16 5JQ
St James University Hospital; Respiratory Department
Leeds, LS9 7TF
Belgium2 sites
Cliniques Universitaires St-Luc
Brussels, 1200
UZ Gent
Ghent, 9000
Chile2 sites
Centro de Investigaciones Medicas Respiratorias
Santiago, 7500692
Schonffeldt y Guerrero Limitada
Santiago, 7500698
Italy2 sites
Azienda Ospedaliera Mater Domini Di Catanzaro
Catanzaro, Calabria, 88100
Università Degli Studi di Pisa - Ospedale di Cisanello Pisa
Pisa, Tuscany, 56124
Mexico2 sites
Instituto Jalisciense de Investigacion Clinica S.A. de C.V.
Santa Cecilia, Jalisco, 44700
Hospital Dr Angel Leaño universidad Autonoma de Guadalajara AC
Zapopan, 45200
Serbia1 site
Clinical Hospital Center ''Bezanijska Kosa''; Department of Pulmology
Belgrade, 11080
About this study
Official title: A Phase III, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Lebrikizumab in Patients With Uncontrolled Asthma Who Are on Inhaled Corticosteroids and a Second Controller Medication
This randomized, multicenter, double-blind, placebo-controlled, parallel-group study will evaluate the efficacy and safety of lebrikizumab in participants with asthma whose disease remains uncontrolled despite daily treatment with inhaled corticosteroid (ICS) therapy and at least one second controller medication. Participants will be randomized in 1:1:1 ratio to receive double-blind treatment with either lebrikizumab ("high" or "low") or placebo, administered subcutaneously (SC) every 4 weeks for 52 weeks, in addition to their standard-of-care therapy. This will be followed by a 52-week double-blind active treatment extension. During double-blind active treatment extension period, all participants will receive SC injection of lebrikizumab from Week 53 to Week 104. The anticipated time on study treatment is 104 weeks. After study treatment, all participants will complete a 20-week safety follow-up.
- Conditions
- Asthma
- Being tested
- Lebrikizumab, 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 will be administered as SC injection at 125 or 37.5 mg every 4 weeks, for 104 weeks.
PlaceboDrug
Lebrikizumab matching placebo will be administered as SC injection every 4 weeks for 52 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Lebrikizumab (125 mg) | Experimental | Participants will receive SC injection of lebrikizumab (125 milligrams [mg]) every 4 weeks for 104 weeks. Receives: Drug: Lebrikizumab |
| Lebrikizumab (37.5 mg) | Experimental | Participants will receive SC injection of lebrikizumab (37.5 mg) every 4 weeks for 104 weeks. Receives: Drug: Lebrikizumab; Drug: Placebo |
| Placebo | Placebo comparator | Participants will receive SC injection of lebrikizumab matching placebo every 4 weeks for 52 weeks during placebo-controlled period and then SC injection of lebrikizumab at 125 or 37.5 mg for 52 weeks during active treatment extension period. Receives: Drug: Lebrikizumab; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adjusted Exacerbation Rate of Asthma During the 52-Week PCP
Asthma exacerbation is defined as new or increased asthma symptoms (i.e., wheeze, cough, dyspnea, chest tightness, and/or night-time awakening due to these symptoms) that lead to systemic corticosteroid (CS) treatment (oral, intravenous (IV), or intramuscular (IM) CS for ≥ 3 days or an emergency department visit with at least one dose of IV or IM CS) or to hospitalization.
Results are reported as a 'Number' representing the model-adjusted incidence rate of asthma exacerbations per person-year. To account for early discontinuation, for each patient, the time at risk (in years) was computed as the duration of this time period (last day minus first day [in days] plus 1) divided by 365.25. The 'first day' was the day of randomization to the PCP. For patients entering the ATE, the 'last day' was the day prior to ATE randomization. For patients not entering the ATE, the 'last day' was at the last study visit on/prior to Study Day 379 (365 days plus a 14-day window).
Measured: Baseline up to 52 weeks
Secondary outcomes (6)
Absolute Change From Baseline in Pre-Bronchodilator FEV1 at Week 52
FEV1 is the maximal amount of air, which can be forcefully exhaled in one second. Measurements were performed before use of bronchodilator. Reported is the absolute change from baseline in FEV1 to the end of the placebo-controlled period at Week 52.
Measured: Week 52
Time to First Asthma Exacerbation During the 52-week PCP
An asthma exacerbation is defined as new or increased asthma symptoms (including wheeze, cough, dyspnea, chest tightness, and/or night-time awakening due to these symptoms) that lead to treatment with systemic corticosteroids or to hospitalisation. Treatment with systemic corticosteroids is defined as treatment with oral, intravenous (IV), or intramuscular (IM) corticosteroids for at least 3 days or an emergency department visit with at least one dose of IV or IM corticosteroids. Reported is the time to first asthma exacerbation during the 52-week placebo-controlled period.
Measured: Baseline up to 52 weeks
Rate of Urgent Asthma-Related Health Care Utilization (HCU) During the 52-week PCP
Urgent health care utilization was defined as hospitalizations, emergency department visits, and acute care visits.
Results are reported as a 'Number' representing the model-adjusted incidence rate of urgent asthma-related HCU events per person-year. To account for early discontinuation, for each patient, the time at risk (in years) was computed as the duration of this time period (last day minus first day [in days] plus 1) divided by 365.25. The 'first day' was the day of randomization to the PCP. For patients entering the ATE, the 'last day' was the day prior to ATE randomization. For patients not entering the ATE, the 'last day' was at the last study visit on/prior to Study Day 379 (365 days plus a 14-day window).
Measured: Baseline up to Week 52
Absolute Change From Baseline in Standardized AQLQ Score at Week 52
Asthma-specific health-related quality of life was assessed by the overall score of the Standardized AQLQ. The AQLQ is a self-administered test with 32 questions; each with seven possible answers ranging from 1 to 7 with a higher score being more favorable. Total score is calculated as follows: sum of items 1to 32 divided by 32 for a score range of 1 to 7 with a higher score indicating a better outcome. Reported is the change in AQLQ score from baseline to the end of the placebo-controlled period at Week 52.
Measured: Week 52
Absolute Change From Baseline In Asthma Rescue Medication Use at Week 52
Reported here is the change in the number of puffs or nebulized treatments of asthma rescue medication from baseline to the end of the PCP at Week 52.
Measured: Week 52
Absolute Change From Baseline in ACQ-5 Score at Week 52
The ACQ-5 is test with 5 questions; each with seven possible answers ranging from 0 to 6 with a lower score being more favorable. Total score range is 0 to 30 with a lower score indicating a better outcome. Reported is the change in ACQ-5 score from baseline to the end of the PCP at Week 52.
Measured: Baseline, Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2013 (estimated)
- Study start25 Jul 2013
- Primary completion28 Dec 2016
- Study completion28 Dec 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 (3)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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 1,081 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
- NCT01867125
- Sponsor's protocol ID
- GB28688
- Other IDs
- 2013-000175-33
- Status last verified
- Jun 2026
- First submitted
- 29 May 2013
- Last updated
- 17 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Chen M, Shepard K 2nd, Yang M, Raut P, Pazwash H, Holweg CTJ, Choo E. Overlap of allergic, eosinophilic and type 2 inflammatory subtypes in moderate-to-severe asthma. Clin Exp Allergy. 2021 Apr;51(4):546-555. doi: 10.1111/cea.13790. Epub 2021 Jan 7.
PubMed 33217063N Bauer R, Yang X, L Staton T, Olsson J, Holweg CTJ, R Arron J, Matthews JG, Choy DF. Seasonal variability of lung function and Asthma Quality of Life Questionnaire Scores in adults with uncontrolled asthma. BMJ Open Respir Res. 2019 Nov 11;6(1):e000406. doi: 10.1136/bmjresp-2019-000406. eCollection 2019.
PubMed 31803473Hanania NA, Korenblat P, Chapman KR, Bateman ED, Kopecky P, Paggiaro P, Yokoyama A, Olsson J, Gray S, Holweg CT, Eisner M, Asare C, Fischer SK, Peng K, Putnam WS, Matthews JG. Efficacy and safety of lebrikizumab in patients with uncontrolled asthma (LAVOLTA I and LAVOLTA II): replicate, phase 3, randomised, double-blind, placebo-controlled trials. Lancet Respir Med. 2016 Oct;4(10):781-796. doi: 10.1016/S2213-2600(16)30265-X. Epub 2016 Sep 5.
PubMed 27616196