AsthmaPhase 3NCT01875003
A Study of Lebrikizumab in Adolescent 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 81 sites in 21 countries.
Trial summary
This randomized, multicenter, double-blind, placebo-controlled, parallel-group study will evaluate the efficacy, safety, and tolerability of lebrikizumab in adolescent participants with asthma whose disease remains uncontrolled despite daily treatment with inhaled corticosteroids (ICS) therapy and at least one second… Read more about this study
- Who is it for?
- Ages 12 to 17 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
- 346 participants
- Where
- 81 sitesin 21 countries
- Study dates
- 13 Aug 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 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Asthma diagnosis for greater than or equal to (>/=) 12 months prior to Visit 1
- Bronchodilator response during screening
- Pre-bronchodilator FEV1 of 40 percent (%) - 90% predicted at both Visits 2 and 3
- On high dose ICS therapy for >/= 6 months prior to Visit 1
- On an eligible second controller medication for 6 months prior to Visit 1
- Uncontrolled asthma as defined by the protocol both during screening and at the time of randomization
- 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 prior to 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 that meets the following criteria: Any infection requiring hospital admission or requiring treatment with IV or IM antibiotics within 4 weeks prior to Visit 1 or during screening; any active infection that required treatment with oral antibiotics within 2 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 parasitic infection or Listeria monocytogenes infection within 6 months prior to Visit 1 or during screening
- History of active tuberculosis requiring treatment
Show all 16Show fewer
- Known immunodeficiency, including, but not limited to, human immunodeficiency virus (HIV) infection
- Evidence of acute or chronic hepatitis or known liver cirrhosis
- History of cystic fibrosis, bronchiectasis, and/or other clinically significant lung disease other than asthma
- Diagnosis or history of 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 (whichever is longer) prior to Visit 1
- Initiation of or change in allergen immunotherapy within 3 months prior to Visit 1 or during screening
- History of bronchial thermoplasty
Trial locations and contacts
81 sites in 21 countries.
81 sites in 21 countries
United States16 sites
Colorado Children's Hospital; The Breathing Institute
Aurora, Colorado, 80045
Asthma, Allergy & Sinus Center
Baltimore, Maryland, 21236
TTS Research
Boerne, Texas, 78006
IMMUNOe Research Centers
Centennial, Colorado, 80112
Rush University Medical Center
Chicago, Illinois, 60612
Asthma & Allergy; Associates, P.C.
Colorado Springs, Colorado, 80907
O & O Alpan, LLC
Fairfax, Virginia, 22030
Georgia Pain Clinic
Marietta, Georgia
Abel and Buchheim
Miami, Florida, 33165
Southern California Research Center
Mission Viejo, California, 92691
Bridgerland Clinical Research
North Logan, Utah, 84341
Allergy & Asthma Res Ctr PA
San Antonio, Texas, 78251
South Texas Allergy and Asthma Medical Professionals
San Antonio, Texas, 78251
Sarasota Clinical Research
Sarasota, Florida, 34239
Bensch Research Associates
Stockton, California, 95207
Urban Health Plan, Inc.
The Bronx, New York, 10459
Brazil7 sites
Santa Casa de Misericordia de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90020-090
Hospital Sao Lucas - PUCRS
Porto Alegre, Rio Grande do Sul, 90610-000
Centro de Referencia em Enfermidades Respiratorias e Alergia - CEAR
Salvador, Estado de Bahia, 41940-455
Faculdade de Medicina do ABC - FMABC
Santo André, São Paulo, 09060-650
Pesquisare Saúde Sociedade Simples
Santo André, São Paulo, 09080-000
Instituto de Pesquisa Clínica e Medicina Avançada Ltda
São Paulo, São Paulo, 05437-010
CMPC/Clinica de Alergia Martti Antila
Sorocaba, São Paulo, 18040-425
Ukraine7 sites
Municipal Medical Institution; Chernivtsi Regional Children's Hospital
Chernivtsi, 58023
Public Institution City Clinical Hospital # 6 of Dnipropetrovsk Regional Board
Dnipro, 49000
State Institution of Pediatrics Obstetrics and Gynecology of NAMSU
Kiev, 04050
Municipal Institution "Kryvyi Rih City Clinical Hospital #8" of Dnipropetrovsk Regional Council
Kryvyi Rih, 50082
SI National Institute of Phthisiology and Pulmonology n.a. F.G.Yanovskyi under NAMS of Ukraine
Kyiv, 03680
SI Research Centre of Radiation Medicine of AMSU
Kyiv, 3115
Municipal Institution Zaporizhzhya Regional Clinical Child Hospital
Zaporizhzhya, 69063
Argentina6 sites
INAER
Buenos Aires, C1425BEN
Instituto Respirar
Mendoza, M5500GFA
Centro Integral de Medicina Respiratoria (CIMER)
San Miguel de Tucumán, T4000CHE
Investigaciones en Patologias Respiratorias
San Miguel de Tucumán, T4000IAR
Instituto Del Buen Aire
Santa Fe, S3000ASF
CEMER Centro Médico de Enfermedades Respiratorias
Vicente López, B1602DQD
Poland6 sites
Malopolskie Centrum Alergologii
Krakow, 30-727
SPZOZ Uniwersytecki Szpital Kliniczny nr 1 im. Norberta Barlickiego Uniwersytetu Medycznego w Lodzi
Lodz, 90-153
Wojewódzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi
Lodz, 93-513
Centrum Alergologii Teresa Hofman
Poznan, 60-214
ALERGO-MED Specjalistyczna Przychodnia Lekarska Sp. z o. o
Tarnów, 33-100
Klinika Chorób Wewnetrznych i Alergologii MSW
Warsaw, 02-507
Hungary5 sites
Semmelweis Egyetem; Belgyogyaszati es Hematologiai Klinika
Budapest, 1088
Heim Pál Gyermekkórház
Budapest, 1089
Kenezy Korhaz Rendelointezet
Debrecen, 4031
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont
Szeged, 6720
Papp és Társa Bt.
Szigetvár, 7900
Mexico5 sites
Grupo Medico Camino
DF, Mexico CITY (federal District)
Centro de Investigacion Medico Biologico y Terapia Avanzada, S.C.
Guadalajara, Jalisco, 44130
Unidad de Investigacion Clinica En Medicina (Udicem) S.C.
Monterrey, Nuevo León, 64718
Instituto Jalisciense de Investigacion Clinica S.A. de C.V.
Santa Cecilia, Jalisco, 44700
Consultorio Especialidad Alergologia Pediatrica
Villahermosa, 86035
South Africa5 sites
Uni of Cape Town Lung Inst.
Cape Town, 7925
Sebastian Peter
Durban, 4001
WWCT Lakeview Hospital
Johannesburg, 1501
Bothe ke Bontle Health Services
Pretoria, 0101
Soweto Clinical Trial Centre
Soweto, 1818
Israel4 sites
Rambam Health Care Campus
Haifa, 3109600
Shaare Zedek Medical Center
Jerusalem, 9103102
Schneider Children's Medical Center
Petah Tikva, 49100
Chaim Sheba Medical Center
Ramat Gan, 5265601
Portugal3 sites
Hospital Infante D. Pedro; Servico de Imunoalergologia
Aveiro, 3814-501
Hospital Particular do Algarve - Unidade de Faro
Faro, 8005-226
Hospital CUF Porto; Servico de Imunoalergologia
Senhora Da Hora - Porto, 4460-188
Spain3 sites
Hospital Universitario Germans Trias i Pujol; Servicio de Farmacia
Badalona, Barcelona, 08916
Hospital de Manises
Manises, Valencia, 46940
Corporacio Sanitaria Parc Tauli; Servicio de Oncologia
Sabadell, Barcelona, 8208
Czechia2 sites
Hofstetr Alois MUDr. s.r.o.
Jihlava, 586 01
Alergologie Teplice, s.r.o.
Teplice, 415 01
Germany2 sites
Universitaetsklinikum Frankfurt
Frankfurt, 60528
Evangelisches Krankenhaus Hamm
Hamm, 59063
Peru2 sites
Clinica Internacional
Lima, Lima 1
Centro de Investigación Ricardo Palma
Lima, LIMA 27
United Kingdom2 sites
Birmingham Heartlands Hospital
Birmingham, B9 5SS
University of Leicester
Leicester, LE1 7RH
About this study
Official title: A Phase III, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, and Tolerability of Lebrikizumab in Adolescent 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, safety, and tolerability of lebrikizumab in adolescent participants with asthma whose disease remains uncontrolled despite daily treatment with inhaled corticosteroids (ICS) therapy and at least one second controller medication. Participants will be randomized in a 1:1:1 ratio to receive double-blind treatment with either lebrikizumab ('High' or 'Low') or placebo, administered as subcutaneous (SC) every 4 weeks (Q4W) for 52 weeks, in addition to their standard-of-care therapy. This will be followed by an optional 52-week double-blind active-treatment extension. The anticipated time on study treatment is up to 104 weeks. Participants who complete the study to Week 104, discontinue prematurely or decide not to take part in the optional active-treatment extension will transition to the 20-week safety follow-up period.
- Conditions
- Asthma
- Being tested
- Lebrikizumab, Placebo, Standard of Care
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LebrikizumabDrug
Lebrikizumab will be administered as SC injection at high or low dose Q4W.
PlaceboDrug
Lebrikizumab matching placebo will be administered as SC injection Q4W.
Standard of CareDrug
Participants will continue to receive ICS therapy (total daily dose of 500-2000 mcg fluticasone propionate DPI or equivalent) along with at least one second controller medications (e.g. long-acting beta agonists [LABAs], leukotriene receptor antagonists (LTRAs), long-acting muscarinic antagonists (LAMAs), or theophylline) as standard of care.
| Study group | Role | What they receive |
|---|---|---|
| Lebrikizumab High | Experimental | Participants with uncontrolled asthma on ICS therapy (total daily dose of 500-2000 micrograms [mcg] of fluticasone propionate dry powder inhaler [DPI] or equivalent) and a second controller medication, will receive SC injection of lebrikizumab (high dose) Q4W for 52 weeks during placebo-controlled period and up to 76 weeks or 104 weeks for participants who will be willing to take part in optional active-treatment extension period. Receives: Drug: Lebrikizumab; Drug: Standard of Care |
| Lebrikizumab Low | Experimental | Participants with uncontrolled asthma on ICS therapy (total daily dose of 500-2000 mcg of fluticasone propionate DPI or equivalent) and a second controller medication, will receive SC injection of lebrikizumab (low dose) Q4W for 52 weeks during placebo-controlled period and up to 76 weeks or 104 weeks for participants who will be willing to take part in optional active-treatment extension period. Receives: Drug: Lebrikizumab; Drug: Standard of Care |
| Placebo | Placebo comparator | Participants with uncontrolled asthma on ICS therapy (total daily dose of 500-2000 mcg of fluticasone propionate DPI or equivalent) and a second controller medication, will receive SC injection of lebrikizumab matching placebo Q4W for 52 weeks during placebo-controlled period and then SC injection of lebrikizumab at high or low dose will be administered from Weeks 52 to 76 or 104 to participants who are willing to take part in optional active-treatment extension period. Receives: Drug: Lebrikizumab; Drug: Placebo; Drug: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Asthma Exacerbations During 52-Week Placebo Controlled Period
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 hospitalization. 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 1 dose of IV or IM corticosteroids. Rate of asthma exacerbation = total number of exacerbation events divided by total follow-up time in patient years.
Measured: Baseline up to Week 52
Secondary outcomes (9)
Percent Change From Baseline in Pre-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1) at Week 52
FEV1 is the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. The baseline FEV1 was obtained from the last spirometric analysis performed before the first study treatment administration. The percentage change in pre-bronchodilator FEV1 was defined as the change in FEV1 (in liters) from baseline divided by the FEV1 (in liters) at baseline multiplied by 100.
Measured: Week 52
Absolute Change From Baseline in Pre-Bronchodilator FEV1 at Week 52
FEV1 is the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. The baseline FEV1 was obtained from the last spirometric analysis performed before the first study treatment administration. 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
An asthma exacerbation was 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 hospitalization. Treatment with systemic corticosteroids was defined as treatment with oral, IV, or IM corticosteroids for at least 3 days or an emergency department visit with at least 1 dose of IV or IM corticosteroids. Median time to first protocol-defined asthma exacerbation was estimated using Kaplan-Meier analysis. 95% Confidence interval (CI) for median was computed using the method of Brookmeyer and Crowley.
Measured: Baseline up to Week 52
Change From Baseline in Fractional Exhaled Nitric Oxide (FeNO) at Week 52
Measurement of FeNO (in parts per billion [ppb]) was performed using a hand-held portable NIOX MINO® device, in accordance with guidelines published by the American Thoracic Society (ATS) and described in the pulmonary function testing manual.
Measured: Week 52
Change From Baseline in Standardized Asthma Quality of Life Questionnaire for 12 Years and Older (AQLQ+12) Overall Score at Week 52
The Standardized AQLQ+12 was used to assess the participants' asthma-specific health-related quality of life. The AQLQ+12 had a recall specification of 2 weeks. The AQLQ+12 was a 32-item questionnaire with 4 domains: activity limitations, symptoms, emotional function, and environmental stimuli. Each of the 32 questions were scored on a scale 1-7. The overall AQLQ+12 score is the mean of the responses to each of the 32 questions, and ranges from 1 to 7. A score 7 indicated no impairments due to asthma, and a score of 1 indicated severe impairment.
Measured: Week 52
Change From Baseline in Asthma Rescue Medication Use at Week 52
Participants were allowed to use short-acting bronchodilators as asthma rescue medication. Baseline asthma rescue medication use was defined as the average number of puffs per day over the 7 days prior to and on the day of randomization. Participants must have recorded their asthma rescue medication use for at least 4 days to have a baseline score calculated. The post-baseline asthma medication use for any timepoint was defined as the average number of puffs per day over the last 28 days on or prior to the timepoint. Participants must have recorded their asthma rescue medication use for at least 14 days during a 28-day interval to have a score calculated for the respective timepoint. For nebulizer use, one treatment (inhalation) was considered equivalent to 4 puffs.
Measured: Week 52
Rate of Urgent Asthma-Related Health Care Utilization (HCU) Events
Urgent asthma-related HCU events included hospitalizations, emergency department visits, and acute care visits. Rate of urgent asthma-related HCU events = total number of urgent asthma-related HCU events divided by total follow-up time in patient years.
Measured: Baseline up to Week 52
Injection Acceptability Questionnaire (IAQ) Score
The acceptability of the injections of study drug was addressed by measuring the level of pain that participants experienced. Participants assessed pain associated with study drug administration using the IAQ within 10 minutes of study drug administration. The IAQ score ranged from 0 to 10; where 0 = no pain and 10 = worst pain imaginable.
Measured: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48
Minimum Observed Serum Concentration (Ctrough) for Lebrikizumab
Participants who received at least one dose of lebrikizumab and had at least one post-baseline evaluable sample were included in the analysis. Results of post-dose samples which were less than reportable were set to 0.045 micrograms per milliliter (mcg/mL) that is half of minimum quantifiable concentration value (0.09 mcg/mL).
Measured: Predose (Hour 0) at Weeks 4, 12, 24, 36, and 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2013 (estimated)
- Study start13 Aug 2013
- Primary completion28 Dec 2016
- Study completion28 Dec 2016
Why it stopped: Sponsor decision to discontinue lebrikizumab development for the treatment of asthma.
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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 346 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
- NCT01875003
- Sponsor's protocol ID
- WB28183
- Other IDs
- 2012-000180-25
- Status last verified
- Jun 2026
- First submitted
- 7 Jun 2013
- Last updated
- 30 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
Publications
Szefler SJ, Roberts G, Rubin AS, Zielen S, Kuna P, Alpan O, Anzures-Cabrera J, Chen Q, Holweg CTJ, Kaminski J, Putnam WS, Matthews JG, Kamath N. Efficacy, safety, and tolerability of lebrikizumab in adolescent patients with uncontrolled asthma (ACOUSTICS). Clin Transl Allergy. 2022 Jul 14;12(7):e12176. doi: 10.1002/clt2.12176. eCollection 2022 Jul.
PubMed 35846226