A Study of Lebrikizumab in Adolescent Participants With Uncontrolled Asthma Who Are on Inhaled Corticosteroids and a Second Controller Medication

NCT01875003 | Terminated Phase 3 Results FDA Drug

• 2 other identifiers: WB281832012-000180-25
• Study Type: interventional
• Target: 346
• Locations: 21 countries
• Sites: 81

Brief 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 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

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  Week 52

• Absolute Change From Baseline in Pre-Bronchodilator FEV1 at Week 52

  Week 52

• Time to First Asthma Exacerbation

  Baseline up to Week 52

• Change From Baseline in Fractional Exhaled Nitric Oxide (FeNO) at Week 52

  Week 52

• Change From Baseline in Standardized Asthma Quality of Life Questionnaire for 12 Years and Older (AQLQ+12) Overall Score at Week 52

  Week 52

Study Arms (3)

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.

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.

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.

Drug: Lebrikizumab; Drug: Placebo; Drug: Standard of Care

Interventions

Lebrikizumab DRUG

Lebrikizumab will be administered as SC injection at high or low dose Q4W.

Lebrikizumab High; Lebrikizumab Low; Placebo

Placebo DRUG

Lebrikizumab matching placebo will be administered as SC injection Q4W.

Placebo

Standard of Care DRUG

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.

Lebrikizumab High; Lebrikizumab Low; Placebo

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (81)

Southern California Research Center

Mission Viejo, California, 92691, United States

Location

Bensch Research Associates

Stockton, California, 95207, United States

Location

Colorado Children's Hospital; The Breathing Institute

Aurora, Colorado, 80045, United States

Location

IMMUNOe Research Centers

Centennial, Colorado, 80112, United States

Location

Asthma & Allergy; Associates, P.C.

Colorado Springs, Colorado, 80907, United States

Location

Abel and Buchheim

Miami, Florida, 33165, United States

Location

Sarasota Clinical Research

Sarasota, Florida, 34239, United States

Location

Georgia Pain Clinic

Marietta, Georgia, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Asthma, Allergy & Sinus Center

Baltimore, Maryland, 21236, United States

Location

Urban Health Plan, Inc.

The Bronx, New York, 10459, United States

Location

TTS Research

Boerne, Texas, 78006, United States

Location

Allergy & Asthma Res Ctr PA

San Antonio, Texas, 78251, United States

Location

South Texas Allergy and Asthma Medical Professionals

San Antonio, Texas, 78251, United States

Location

Bridgerland Clinical Research

North Logan, Utah, 84341, United States

Location

O & O Alpan, LLC

Fairfax, Virginia, 22030, United States

Location

INAER

Buenos Aires, C1425BEN, Argentina

Location

Instituto Respirar

Mendoza, M5500GFA, Argentina

Location

Centro Integral de Medicina Respiratoria (CIMER)

San Miguel de Tucumán, T4000CHE, Argentina

Location

Investigaciones en Patologias Respiratorias

San Miguel de Tucumán, T4000IAR, Argentina

Location

Instituto Del Buen Aire

Santa Fe, S3000ASF, Argentina

Location

CEMER Centro Médico de Enfermedades Respiratorias

Vicente López, B1602DQD, Argentina

Location

Centro de Referencia em Enfermidades Respiratorias e Alergia - CEAR

Salvador, Estado de Bahia, 41940-455, Brazil

Location

Santa Casa de Misericordia de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90020-090, Brazil

Location

Hospital Sao Lucas - PUCRS

Porto Alegre, Rio Grande do Sul, 90610-000, Brazil

Location

Faculdade de Medicina do ABC - FMABC

Santo André, São Paulo, 09060-650, Brazil

Location

Pesquisare Saúde Sociedade Simples

Santo André, São Paulo, 09080-000, Brazil

Location

Instituto de Pesquisa Clínica e Medicina Avançada Ltda

São Paulo, São Paulo, 05437-010, Brazil

Location

CMPC/Clinica de Alergia Martti Antila

Sorocaba, São Paulo, 18040-425, Brazil

Location

Private Practice - Dr. Brian D. Lyttle

London, Ontario, N6A 5B8, Canada

Location

Hospital Santa Clara

Bogotá, Colombia

Location

Hofstetr Alois MUDr. s.r.o.

Jihlava, 586 01, Czechia

Location

Alergologie Teplice, s.r.o.

Teplice, 415 01, Czechia

Location

Hopital Charles Nicolle; cic

Rouen, 76031, France

Location

Universitaetsklinikum Frankfurt

Frankfurt, 60528, Germany

Location

Evangelisches Krankenhaus Hamm

Hamm, 59063, Germany

Location

Semmelweis Egyetem; Belgyogyaszati es Hematologiai Klinika

Budapest, 1088, Hungary

Location

Heim Pál Gyermekkórház

Budapest, 1089, Hungary

Location

Kenezy Korhaz Rendelointezet

Debrecen, 4031, Hungary

Location

Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont

Szeged, 6720, Hungary

Location

Papp és Társa Bt.

Szigetvár, 7900, Hungary

Location

Rambam Health Care Campus

Haifa, 3109600, Israel

Location

Shaare Zedek Medical Center

Jerusalem, 9103102, Israel

Location

Schneider Children's Medical Center

Petah Tikva, 49100, Israel

Location

Chaim Sheba Medical Center

Ramat Gan, 5265601, Israel

Location

Fondazione IRCCS Policlinico San Matteo

Pavia, Lombardy, 27100, Italy

Location

Centro de Investigacion Medico Biologico y Terapia Avanzada, S.C.

Guadalajara, Jalisco, 44130, Mexico

Location

Instituto Jalisciense de Investigacion Clinica S.A. de C.V.

Santa Cecilia, Jalisco, 44700, Mexico

Location

Grupo Medico Camino

DF, Mexico CITY (federal District), Mexico

Location

Unidad de Investigacion Clinica En Medicina (Udicem) S.C.

Monterrey, Nuevo León, 64718, Mexico

Location

Consultorio Especialidad Alergologia Pediatrica

Villahermosa, 86035, Mexico

Location

Clinica Internacional

Lima, Lima 1, Peru

Location

Centro de Investigación Ricardo Palma

Lima, LIMA 27, Peru

Location

Malopolskie Centrum Alergologii

Krakow, 30-727, Poland

Location

SPZOZ Uniwersytecki Szpital Kliniczny nr 1 im. Norberta Barlickiego Uniwersytetu Medycznego w Lodzi

Lodz, 90-153, Poland

Location

Wojewódzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi

Lodz, 93-513, Poland

Location

Centrum Alergologii Teresa Hofman

Poznan, 60-214, Poland

Location

ALERGO-MED Specjalistyczna Przychodnia Lekarska Sp. z o. o

Tarnów, 33-100, Poland

Location

Klinika Chorób Wewnetrznych i Alergologii MSW

Warsaw, 02-507, Poland

Location

Hospital Infante D. Pedro; Servico de Imunoalergologia

Aveiro, 3814-501, Portugal

Location

Hospital Particular do Algarve - Unidade de Faro

Faro, 8005-226, Portugal

Location

Hospital CUF Porto; Servico de Imunoalergologia

Senhora Da Hora - Porto, 4460-188, Portugal

Location

Imunoalergologia Dzurilla s.r.o.

Nitra, 949 01, Slovakia

Location

Uni of Cape Town Lung Inst.

Cape Town, 7925, South Africa

Location

Sebastian Peter

Durban, 4001, South Africa

Location

WWCT Lakeview Hospital

Johannesburg, 1501, South Africa

Location

Bothe ke Bontle Health Services

Pretoria, 0101, South Africa

Location

Soweto Clinical Trial Centre

Soweto, 1818, South Africa

Location

Hospital Universitario Germans Trias i Pujol; Servicio de Farmacia

Badalona, Barcelona, 08916, Spain

Location

Corporacio Sanitaria Parc Tauli; Servicio de Oncologia

Sabadell, Barcelona, 8208, Spain

Location

Hospital de Manises

Manises, Valencia, 46940, Spain

Location

National Cheng Kung Univ Hosp

Tainan, 00704, Taiwan

Location

Municipal Medical Institution; Chernivtsi Regional Children's Hospital

Chernivtsi, 58023, Ukraine

Location

Public Institution City Clinical Hospital # 6 of Dnipropetrovsk Regional Board

Dnipro, 49000, Ukraine

Location

State Institution of Pediatrics Obstetrics and Gynecology of NAMSU

Kiev, 04050, Ukraine

Location

Municipal Institution "Kryvyi Rih City Clinical Hospital #8" of Dnipropetrovsk Regional Council

Kryvyi Rih, 50082, Ukraine

Location

SI National Institute of Phthisiology and Pulmonology n.a. F.G.Yanovskyi under NAMS of Ukraine

Kyiv, 03680, Ukraine

Location

SI Research Centre of Radiation Medicine of AMSU

Kyiv, 3115, Ukraine

Location

Municipal Institution Zaporizhzhya Regional Clinical Child Hospital

Zaporizhzhya, 69063, Ukraine

Location

Birmingham Heartlands Hospital

Birmingham, B9 5SS, United Kingdom

Location

University of Leicester

Leicester, LE1 7RH, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 35846226 DERIVED

MeSH Terms

Conditions

Asthma

Interventions

lebrikizumab; Standard of Care

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Limitations and Caveats

The enrollment was closed, and dosing was terminated in this study following the sponsor's decision to discontinue development of lebrikizumab. Thus, this study was treated as exploratory (rather than confirmatory).

Results Point of Contact

• Title: Medical Communications
• Organization: Hoffmann-La Roche

genentech@druginfo.com

800-821-8590

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 7, 2013
• First Posted: June 11, 2013
• Study Start: August 13, 2013
• Primary Completion: December 28, 2016
• Study Completion: December 28, 2016
• Last Updated: June 30, 2026
• Results First Posted: June 30, 2026

Record last verified: 2026-06

Locations

BR (7); US (16); TW (1); SL (1); UA (7); PE (2); CA (1); ES (3); GB (2); AR (6); IL (4); PT (3); CO (1); CZ (2); FR (1); HU (5); PL (6); ME (5); DE (2); ZA (5); IT (1)