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New drug aims to tame teen asthma that inhalers Can't control

NCT ID NCT01875003

Disease control Sponsor: Hoffmann-La Roche Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 30, 2026 · Last updated Jul 01, 2026 · Updated 1 time

Summary

This study tests an experimental drug called lebrikizumab in teenagers aged 12 to 17 whose asthma is not well controlled even with daily inhalers and a second medication. Participants receive either lebrikizumab or a placebo as a shot every 4 weeks for a year, while continuing their usual asthma treatments. The goal is to see if lebrikizumab can reduce asthma attacks and improve lung function.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
lebrikizumab
What this could lead to
If it works, this could offer a new add-on treatment option for teenagers whose asthma remains uncontrolled despite standard inhaler therapy.
What could go wrong
This is an early-phase trial, so the drug may not prove effective or could have side effects. Results may not apply to all asthma patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

346 people

The number who actually took part.

Started

Aug 2013

Finished

Dec 2016

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

12 to 17 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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 Exclusion Criteria: * 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 * History of bronchial thermoplasty

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Conditions

The condition(s) this trial relates to.

asthma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Asthma

Contacts and locations

Locations

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

    Tarnów, 33-100, Poland

  • Abel and Buchheim

    Miami, Florida, 33165, United States

  • Alergologie Teplice, s.r.o.

    Teplice, 415 01, Czechia

  • Allergy & Asthma Res Ctr PA

    San Antonio, Texas, 78251, United States

  • Asthma & Allergy; Associates, P.C.

    Colorado Springs, Colorado, 80907, United States

  • Asthma, Allergy & Sinus Center

    Baltimore, Maryland, 21236, United States

  • Bensch Research Associates

    Stockton, California, 95207, United States

  • Birmingham Heartlands Hospital

    Birmingham, B9 5SS, United Kingdom

  • Bothe ke Bontle Health Services

    Pretoria, 0101, South Africa

  • Bridgerland Clinical Research

    North Logan, Utah, 84341, United States

  • CEMER Centro Médico de Enfermedades Respiratorias

    Vicente López, B1602DQD, Argentina

  • CMPC/Clinica de Alergia Martti Antila

    Sorocaba, São Paulo, 18040-425, Brazil

  • Centro Integral de Medicina Respiratoria (CIMER)

    San Miguel de Tucumán, T4000CHE, Argentina

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

    Guadalajara, Jalisco, 44130, Mexico

  • Centro de Investigación Ricardo Palma

    Lima, LIMA 27, Peru

  • Centro de Referencia em Enfermidades Respiratorias e Alergia - CEAR

    Salvador, Estado de Bahia, 41940-455, Brazil

  • Centrum Alergologii Teresa Hofman

    Poznan, 60-214, Poland

  • Chaim Sheba Medical Center

    Ramat Gan, 5265601, Israel

  • Clinica Internacional

    Lima, Lima 1, Peru

  • Colorado Children's Hospital; The Breathing Institute

    Aurora, Colorado, 80045, United States

  • Consultorio Especialidad Alergologia Pediatrica

    Villahermosa, 86035, Mexico

  • Corporacio Sanitaria Parc Tauli; Servicio de Oncologia

    Sabadell, Barcelona, 8208, Spain

  • Evangelisches Krankenhaus Hamm

    Hamm, 59063, Germany

  • Faculdade de Medicina do ABC - FMABC

    Santo André, São Paulo, 09060-650, Brazil

  • Fondazione IRCCS Policlinico San Matteo

    Pavia, Lombardy, 27100, Italy

  • Georgia Pain Clinic

    Marietta, Georgia, United States

  • Grupo Medico Camino

    DF, Mexico CITY (federal District), Mexico

  • Heim Pál Gyermekkórház

    Budapest, 1089, Hungary

  • Hofstetr Alois MUDr. s.r.o.

    Jihlava, 586 01, Czechia

  • Hopital Charles Nicolle; cic

    Rouen, 76031, France

  • Hospital CUF Porto; Servico de Imunoalergologia

    Senhora Da Hora - Porto, 4460-188, Portugal

  • Hospital Infante D. Pedro; Servico de Imunoalergologia

    Aveiro, 3814-501, Portugal

  • Hospital Particular do Algarve - Unidade de Faro

    Faro, 8005-226, Portugal

  • Hospital Santa Clara

    Bogotá, Colombia

  • Hospital Sao Lucas - PUCRS

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

  • Hospital Universitario Germans Trias i Pujol; Servicio de Farmacia

    Badalona, Barcelona, 08916, Spain

  • Hospital de Manises

    Manises, Valencia, 46940, Spain

  • IMMUNOe Research Centers

    Centennial, Colorado, 80112, United States

  • INAER

    Buenos Aires, C1425BEN, Argentina

  • Imunoalergologia Dzurilla s.r.o.

    Nitra, 949 01, Slovakia

  • Instituto Del Buen Aire

    Santa Fe, S3000ASF, Argentina

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

    Santa Cecilia, Jalisco, 44700, Mexico

  • Instituto Respirar

    Mendoza, M5500GFA, Argentina

  • Instituto de Pesquisa Clínica e Medicina Avançada Ltda

    São Paulo, São Paulo, 05437-010, Brazil

  • Investigaciones en Patologias Respiratorias

    San Miguel de Tucumán, T4000IAR, Argentina

  • Kenezy Korhaz Rendelointezet

    Debrecen, 4031, Hungary

  • Klinika Chorób Wewnetrznych i Alergologii MSW

    Warsaw, 02-507, Poland

  • Malopolskie Centrum Alergologii

    Krakow, 30-727, Poland

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

    Kryvyi Rih, 50082, Ukraine

  • Municipal Institution Zaporizhzhya Regional Clinical Child Hospital

    Zaporizhzhya, 69063, Ukraine

  • Municipal Medical Institution; Chernivtsi Regional Children's Hospital

    Chernivtsi, 58023, Ukraine

  • National Cheng Kung Univ Hosp

    Tainan, 00704, Taiwan

  • O & O Alpan, LLC

    Fairfax, Virginia, 22030, United States

  • Papp és Társa Bt.

    Szigetvár, 7900, Hungary

  • Pesquisare Saúde Sociedade Simples

    Santo André, São Paulo, 09080-000, Brazil

  • Private Practice - Dr. Brian D. Lyttle

    London, Ontario, N6A 5B8, Canada

  • Public Institution City Clinical Hospital # 6 of Dnipropetrovsk Regional Board

    Dnipro, 49000, Ukraine

  • Rambam Health Care Campus

    Haifa, 3109600, Israel

  • Rush University Medical Center

    Chicago, Illinois, 60612, United States

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

    Kyiv, 03680, Ukraine

  • SI Research Centre of Radiation Medicine of AMSU

    Kyiv, 3115, Ukraine

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

    Lodz, 90-153, Poland

  • Santa Casa de Misericordia de Porto Alegre

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

  • Sarasota Clinical Research

    Sarasota, Florida, 34239, United States

  • Schneider Children's Medical Center

    Petah Tikva, 49100, Israel

  • Sebastian Peter

    Durban, 4001, South Africa

  • Semmelweis Egyetem; Belgyogyaszati es Hematologiai Klinika

    Budapest, 1088, Hungary

  • Shaare Zedek Medical Center

    Jerusalem, 9103102, Israel

  • South Texas Allergy and Asthma Medical Professionals

    San Antonio, Texas, 78251, United States

  • Southern California Research Center

    Mission Viejo, California, 92691, United States

  • Soweto Clinical Trial Centre

    Soweto, 1818, South Africa

  • State Institution of Pediatrics Obstetrics and Gynecology of NAMSU

    Kiev, 04050, Ukraine

  • Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont

    Szeged, 6720, Hungary

  • TTS Research

    Boerne, Texas, 78006, United States

  • Uni of Cape Town Lung Inst.

    Cape Town, 7925, South Africa

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

    Monterrey, Nuevo León, 64718, Mexico

  • Universitaetsklinikum Frankfurt

    Frankfurt, 60528, Germany

  • University of Leicester

    Leicester, LE1 7RH, United Kingdom

  • Urban Health Plan, Inc.

    The Bronx, New York, 10459, United States

  • WWCT Lakeview Hospital

    Johannesburg, 1501, South Africa

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

    Lodz, 93-513, Poland

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