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New asthma drug aims to improve breathing without daily pills

NCT ID NCT02104674

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 This study
The trial has finished. Results may not be published yet.
Stopped early
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This status has not been confirmed recently, so it may be out of date.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 Jul 17, 2026 · Last updated Jul 17, 2026

Summary

This phase 3 trial tests whether lebrikizumab, an injectable drug that blocks a protein involved in asthma inflammation, can improve lung function in adults with mild to moderate asthma. Participants receive either lebrikizumab injections, a placebo, or an open-label montelukast pill for 12 weeks. The study measures changes in how much air they can exhale in one second.

What this could mean

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

Active substance
an injectable drug called lebrikizumab, which targets a protein involved in asthma inflammation
What this could lead to
If successful, this could provide a new treatment option for people with mild to moderate asthma that is not well controlled with current therapies.
What could go wrong
This is a phase 3 trial, but results may not show significant benefit over placebo, and lebrikizumab may cause side effects like injection site reactions or infections.

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

313 people

The number who actually took part.

Started

Jun 2014

Finished

Jan 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

18 to 75 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: * 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 Exclusion Criteria: * 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 * 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

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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

  • Advanced Research Institute

    Reno, Nevada, 89511, United States

  • Advances in Medicine

    Rancho Mirage, California, 92270, United States

  • Aggarwal and Associates

    Brampton, Ontario, L6T 0G1, Canada

  • Allergy & Asthma Center

    Waco, Texas, 76712, United States

  • Allergy & Asthma Consultants

    Redwood City, California, 94063, United States

  • Allergy & Asthma Immunology Associates

    Scottsdale, Arizona, 85251, United States

  • Allergy Associates Research Center LLC - CRN

    Portland, Oregon, 97202, United States

  • Allergy Asthma & Sinus Center

    Greenfield, Wisconsin, 53228, United States

  • Allergy Asthma Research Assoc

    Dallas, Texas, 75231, United States

  • Allergy, Asthma & Clinical Research Center

    Oklahoma City, Oklahoma, 73120, United States

  • Anaheim Clinical Trials

    Anaheim, California, 92801, United States

  • Asthma & Allergy Center of Chicago, S.C.

    River Forest, Illinois, 60305, United States

  • Asthma & Allergy Center, P.C.

    Papillion, Nebraska, 68046, United States

  • Atlantic Research Center, LLC

    Ocean City, New Jersey, 07712, United States

  • Bandera Family Health Care

    San Antonio, Texas, 78249, United States

  • CA Allergy & Asthma Med Grp; Medical Group, Inc.

    Los Angeles, California, 90025, United States

  • City Hospital #40 of Resort Administrative District

    Saint Petersburg, Sankt-Peterburg, 197706, Russia

  • Clinical Research Center of Alabama, LLC

    Birmingham, Alabama, 35209, United States

  • Clinical Research Inst. of Southern Oregon, Pc

    Medford, Oregon, 97504, United States

  • Clinical Research Partners, LLC

    Richmond, Virginia, 23220, United States

  • Compartiment Pneumologie; Fundatia Dr. Victor Babes

    Bucharest, 030303, Romania

  • Dr. Anil K. Gupta Medicine Professional Corporation

    Toronto, Ontario, M9V 4B4, Canada

  • Faculdade de Medicina do ABC - FMABC; Oncologia e Hematologia

    Santo André, São Paulo, 09060-650, Brazil

  • Family Allergy & Asthma

    Louisville, Kentucky, 40223, United States

  • Florida Pulmonary Research Institute, LLC

    Winter Park, Florida, 32789, United States

  • GRA?YNA JASIENIAK-PINIS ATOPIA Niepubliczny Zak?ad Opieki Zdrowotnej Poradnie Specjalistyczne

    Krakow, 31-159, Poland

  • Grazyna Pulka Specjalistyczny Osrodek ALL-MED

    Krakow, 31-023, Poland

  • I Engelbrecht Research

    Lyttleton, 0157, South Africa

  • In-Quest Medical Research, LLC

    Duluth, Georgia, 30096, United States

  • Integrated Research Group Inc

    Riverside, California, 92506, United States

  • LLC Medical Center "Alliance-Biomedical - Russian Group"

    Saint Petersburg, 190068, Russia

  • LLC Medical Center"REAVITA"

    Saint Petersburg, 194295, Russia

  • MHAT "Sv. Ivan Rilski" ? Razgrad AD; Department of pnemology and phthisiatry

    Razgrad, 7200, Bulgaria

  • MediTrial s.r.o.

    Jind?ich?v Hradec, 377 01, Czechia

  • Medical Center Excelsior OOD

    Sofia, 1000, Bulgaria

  • Medical Center Researchexpert OOD

    Varna, 9000, Bulgaria

  • Medical Center Tara OOD

    Veliko Tarnovo, 5000, Bulgaria

  • Metroplex Pulmonology & Sleep Center

    McKinney, Texas, 75069, United States

  • Midwest Clinical Research LLC

    St Louis, Missouri, 63141, United States

  • Mountainview Clinical Research

    Greer, South Carolina, 29651, United States

  • Multiple-discipline City Hospital #2

    Saint Petersburg, 194354, Russia

  • NZOZ ALL-MED Specjalistyczna Opieka Medyczna

    Wroclaw, 53-201, Poland

  • NZOZ Alergo-Med. Specjalistyczna Przychodnia Lekarska; Poradnia Alergologiczna

    Poznan, 60-823, Poland

  • National Jewish Health

    Denver, Colorado, 80206, United States

  • Newtown Clinical Research

    Johannesburg, 2113, South Africa

  • North Bay Clinical Trials

    Napa, California, 94558, United States

  • O & O Alpan, LLC

    Fairfax, Virginia, 22030, United States

  • Optimal Clinical Trials

    Auckland, 1010, New Zealand

  • Ordinace pro tuberkulozu a respiracni nemoci

    Strakonice, 38601, Czechia

  • Pesquisare Saúde Sociedade Simples

    Santo André, São Paulo, 09080-000, Brazil

  • Pharmaceutical Research & Consulting, Inc.

    Dallas, Texas, 75231, United States

  • Pneumo - KV; Ordinace pneumologie a diagnostiky plicních funkcí

    Karlovy Vary ? Stará Role, 360 17, Czechia

  • Quality Assurance Research Center

    San Antonio, Texas, 78207, United States

  • Regional Clinical Hospital

    Saratov, 410053, Russia

  • Ryazan State Medical University Named after I.P.Pavlov

    Ryazan, Ryazan Oblast, 390026, Russia

  • SBEI HPE "The First St.Petersburg State Medical University n.a. acad. I.P.Pavlova"of MoH of RF

    Saint Petersburg, Sankt-Peterburg, 197022, Russia

  • SHATPD ? Gabrovo EOOD; Department of pneumology

    Gabrovo, 5300, Bulgaria

  • SHATPPD Dr. Dimitar Gramatikov, Ruse Ltd.

    Rousse, 7002, Bulgaria

  • Santa Casa de Misericordia de Porto Alegre

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

  • Sneeze, Wheeze, & Itch Associates

    Normal, Illinois, 61761, United States

  • South Texas Allergy and Asthma Medical Professionals

    San Antonio, Texas, 78251, United States

  • Southern California Institute For Respiratory

    Los Angeles, California, 90048, United States

  • Southern Clinical Trials, Ltd

    Beckenham, 8024, New Zealand

  • Soweto Clinical Trial Centre

    Soweto, 1818, South Africa

  • Specjalistyczny Niepubliczny Zespol Opieki Zdrowotnej; Alergologia Plus Osrodek Diagnostyki.

    Poznan, 60-693, Poland

  • Spitalul Clinic Municipal Dr. Gavril Curteanu Oradea; Sectia Pneumologie I

    Oradea, 410176, Romania

  • Spitalul Clinic de Boli Infectioase si Pneumoftiziologie Dr. Victor Babes; Sectia Pneumologie II

    Craiova, 200446, Romania

  • Spitalul Clinic de Pneumoftiziologie Iasi; Sectia Clinica I Pneumoftiziologie

    Iași, 700115, Romania

  • St. Petersburg State Medical University n.a. I.P. Pavlov

    Saint Petersburg, Sankt-Peterburg, 197089, Russia

  • Storms Clinical Research; Institute

    Colorado Springs, Colorado, 80907, United States

  • Syzygy Clinical Research; ?Unit 3 to 7

    Pretoria Gauteng Province, 0087, South Africa

  • TTS Research

    Boerne, Texas, 78006, United States

  • Texas Institute of chest and Sleep Disorder

    Houston, Texas, 77034, United States

  • The Clinical Research Ctr

    St Louis, Missouri, 63141, United States

  • The Medicines Evaluation Unit

    Manchester, M23 9QZ, United Kingdom

  • Tiervalei Trial Centre

    Cape Town, 7530, South Africa

  • Ufsc - Nupaiva

    Florianópolis, Santa Catarina, 88040-970, Brazil

  • University of Cape Town Lung Institute; Lung Clinical Research

    Cape Town, 7700, South Africa

  • Uniwersytecki Szpital Kliniczny w Bialymstoku Klinika Alergologii i Chorob Wewnetrznych

    Bialystok, 15-276, Poland

  • Ural State Medical University; Pulmonology

    Yekaterinburg, 620109, Russia

  • Urban Health Plan, Inc.

    The Bronx, New York, 10459, United States

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