AzTrials
AzTrials

AsthmaPhase 3NCT01868061

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

A Phase 3 study testing Lebrikizumab in people with Asthma, run by Hoffmann-La Roche at 232 sites in 26 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
1,068 participants
Where
232 sitesin 26 countries
Study dates
31 Jul 2013to 2 Jan 2017
Phase
Phase 3
Are there results?
None posted in the registry

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 at 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 microgram (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 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
Show all 14Show 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 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

232 sites in 26 countries.

232 sites in 26 countries

United States66 sites

  • Pulmonary Research of Albingdon

    Abingdon, Virginia, 24210

  • Georgia Pollens

    Albany, Georgia, 31707

  • University of New Mexico; School of Med

    Albuquerque, New Mexico, 87131

  • Allergy Partners of Western NC

    Asheville, North Carolina, 28801

  • Future Search Clinical Trials L.P.

    Austin, Texas, 78756

  • Kern Allergy Med Clinic, Inc.

    Bakersfield, California, 93301

  • Asthma, Allergy & Sinus Center

    Baltimore, Maryland, 21236

  • Chesapeake Clinical Research

    Baltimore, Maryland, 21236

  • Dr. Paul Shapero

    Bangor, Maine, 04401

  • Clinical Research Center of Alabama, LLC

    Birmingham, Alabama, 35209

  • Allergy Consultants PA

    Boca Raton, Florida, 33431

  • Asthma and Allergy Physicians LLC

    Brockton, Mississippi, 02301

  • Allergy & Asthma Centre of Dayton

    Centerville, Ohio, 45458

  • Allergy Associates, Inc.

    Chesterfield, Missouri, 63017

  • Asthma & Allergy; Associates, P.C.

    Colorado Springs, Colorado, 80907

  • Storms Clinical Research; Institute

    Colorado Springs, Colorado, 80907

  • Howard County Center for Lung and Sleep, LLC

    Columbia, Maryland, 21044

  • Neem Research Group, Inc.

    Columbia, South Carolina, 29201

  • Brookstone Clinical Res Ctr

    Columbus, Georgia, 31904

  • Southeast Regional Research Group

    Columbus, Georgia, 31904

  • Elliot J. Ginchansky, MD, PA

    Dallas, Texas, 75230

  • National Jewish Health

    Denver, Colorado, 80206

  • Colorado Allergy & Asthma Centers, Pc

    Denver, Colorado, 80230

  • Adult Pediatric Allergy Central Jersey

    Edison, New Jersey, 08820

  • EPIMRD, Inc. DBA Western Sky Medical Research

    El Paso, Texas, 79903

  • The Allergy and Asthma Center

    Fort Wayne, Indiana, 46804

  • Allergy and Asthma Relief Experts

    Granada Hills, California, 91344

  • Greenville Pharmaceutical Research

    Greenville, South Carolina, 29615

  • Upstate Pharmaceutical Research; Greenville

    Greenville, South Carolina, 29615

  • Penn State Milton S. Hershey Medical Center

    Hershey, Pennsylvania, 17033

  • East-West Medical Research Institute

    Honolulu, Hawaii, 96814

  • Baylor College of Medicine; Dept of Medicine

    Houston, Texas, 77030

  • Center For Pharmaceutical Research

    Kansas City, Missouri, 64114

  • Clinical Research Consortium

    Las Vegas, Nevada, 89119

  • DataQuest Medical Research

    Lawrenceville, Georgia, 30045

  • Southern California Institute For Respiratory

    Los Angeles, California, 90048

  • University of Wisconsin;Allergy & Asthma Clinical Research

    Madison, Wisconsin, 53792

  • Research Institute of South Florida Inc

    Miami, Florida, 33173

  • Winthrop Univ Hospital

    Mineola, New York, 11501

  • Clinical Research Inst

    Minneapolis, Minnesota, 55402

  • Allergy Associates of Utah

    Murray, Utah, 84107

  • Yale University School Of Medicine

    New Haven, Connecticut, 06510

  • Infinity Medical Research Inc

    North Dartmouth, Massachusetts, 02747

  • Integrity People Services Research Company

    Oklahoma City, Oklahoma, 73103

  • Oklahoma Institute of Allergy and Asthma Clinical Research LLC

    Oklahoma City, Oklahoma, 73131

  • Allergy and Clinical Immunology Associates

    Pittsburgh, Pennsylvania, 15241

  • Allergy & Asthma Consultants

    Redwood City, California, 94063

  • Allergy & Asthma Clin Cen TX

    Round Rock, Texas, 78681

  • Quality Assurance Research Ctr

    San Antonio, Texas, 78205

  • Discovery Clinical Trials

    San Antonio, Texas, 78224

  • Allergy & Asthma Research Center

    San Antonio, Texas, 78229

  • Live Oak Allergy & Asthma Clinic

    San Antonio, Texas, 78233

  • Sarasota Clinical Research

    Sarasota, Florida, 34239

  • Aeroallergy Research Labs

    Savannah, Georgia, 31406

  • Medical Research of Arizona; Allergy, Asthma & Immu

    Scottsdale, Arizona, 85251

  • Clinical Research Center, L.L.C.

    St Louis, Missouri, 63141

  • Patrick V. Perin, MD

    Teaneck, New Jersey, 07666

  • Cotton O'Neil Clinic; Stormont-Vail Hlth Care

    Topeka, Kansas, 66606

  • Quality of Life Medical & Research Center

    Tucson, Arizona, 85712

  • Vital Prospects Clin Res Pc

    Tulsa, Oklahoma, 74136

  • Asthma & Allergy of Idaho

    Twin Falls, Idaho, 83301

  • Integrated Research Group Inc

    Upland, California, 91786

  • Asthma and Allergy Research Associates

    Upland, Pennsylvania, 19013

  • Allergy & Asthma Medical Group; Clinical Research Division

    Walnut Creek, California, 94598

  • Western States Clinical Research, Inc

    Wheat Ridge, Colorado, 80033

  • Atlanta Allergy & Asthma Clini

    Woodstock, Georgia, 30188

Other trials in United States

Japan25 sites

  • Banbuntane Hotokukai Hospital

    Aichi, 454-8509

  • Fukuoka National Hospital

    Fukuoka, 811-1394

  • Hiroshima Allegy & Respiratory Clinic

    Hiroshima, 732-0052

  • Ibarakihigashi National Hospital

    Ibaraki, 319-1113

  • Uno Naikakokyukika Clinic

    Isesaki-shi, 372-0831

  • Yokohama City University Medical Center; Neurology

    Kanagawa, 232-0024

  • Sagamihara National Hospital

    Kanagawa, 252-0392

  • Kumamoto Saishunso National Hospital

    Koshi-shi, 861-1196

  • Kumamoto University Hospital

    Kumamoto, 860-8556

  • Kyoto University Hospital, Respiratory Medicine

    Kyoto, 606-8507

  • Machida Municipal Hospital

    Machida-shi, 194-0023

  • Hikarigaoka Spellman Hospital; Rheumatology

    Miyagi, 983-0833

  • Nagoya Ekisaikai Hospital

    Nagoya, 454-8502

  • Okayama University Hospital

    Okayama, 700-8558

  • Takatsuki Red Cross Hospital; Division of Diabetes / Endocrinology / Lifestyle-Related Disease

    Osaka, 569-1096

  • Kinki University Hospital

    Osaka, 589-8511

  • Kishiwada City Hospital

    Osaka, 596-8501

  • Tohoku Medical and Pharmaceutical University Wakabayashi Hospital

    Sendai, 984-8560

  • Iwata City Hospital

    Shizuoka, 438-8550

  • Takamatsu Municipal Hospital

    Takamatsu, 760-8538

  • Hanzomon Hospital

    Tokyo, 102-0083

  • Tokyo-Eki Center-building Clinic

    Tokyo, 103-0027

  • Center Hospital of the National Center for Global Health and Medicine

    Tokyo, 162-8655

  • Nihon University Itabashi Hospital

    Tokyo, 173-8610

  • Toyama City Hospital

    Toyama, 939-8511

Other trials in Japan

Russia13 sites

  • City Clinical Hospital #13

    Moscow, 115280

  • I.M. Sechenov Moscow State Medical University the Ministry of Health and Social Development of RF

    Moscow, 115446

  • City Clinical Hospital #2

    Novosibirsk, 630051

  • Penza Regional Clinical Hospital Named After N. N. Burdenko; Therapy Department

    Penza, 440026

  • Ryazan Regional Clinincal Cardiology Dispensary

    Ryazan, 390026

  • Municipal Polyclinic #25

    Saint Petersburg, 193312

  • St.Petersburg State Budget Healthcare Institution City Hospital of Saint Venerable Martyr Elizabeth

    Saint Petersburg, 197022

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

    Saint Petersburg, 197089

  • City Hospital #40 of Resort Administrative District

    Saint Petersburg, 197706

  • Saratov State Medical Univ; Clinical Immun & Allerg

    Saratov, 410012

  • Siberian State Medical University

    Tomsk, 634050

  • Municipal Budgetery Clinical Institution of Healthcare; NA Semashko City Hospital

    Yaroslavl, 150002

  • Yaroslavl State Medical Academy - Clinical Hospital #2

    Yaroslavl, 150010

Other trials in Russia

Ukraine13 sites

  • Municipal Institution Cherkasy Regional Hospital of Cherkasy Regional Council

    Cherkasy, 18009

  • MI Dnipropetrovsk clinical association of emergency care of Dnipropetrovsk regional council

    Dnipropetrovsk, 49006

  • Donetsk Municipal Treatment and Prophylactic Institution Central City Clinical Hospital #1

    Donetsk, 83114

  • Municipal Institution of Health Care City Clinical Hospital #13

    Kharkiv, 61035

  • SI Institute of Therapy n.a. L.T. Mala of National Academy of Medical Sciences of Ukraine

    Kharkiv, 61039

  • Kyiv City Tuberculosis Hospital #1; Department of Differential Diagnosis of Lung Diseases

    Kyiv, Kiev Governorate, 02091

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

    Kyiv, 03680

  • City Hospital #1

    Mykolaiv, 54003

  • Municipal Institution Odesa Regional Clinical Hospital

    Odesa, 65025

  • City Clinical Hospital No.1; Therap Ukr Med Stom Acad

    Poltava, 36038

  • Scientific and Research Institute of Invalid Rehabilitation of Moh of Ukraine

    Vinnytsia, 21029

  • LLC Diaservis

    Zaporizhzhya, 69106

  • Municipal Institution Zaporizhzhia City Multifield Clinical Hospital #9

    Zaporizhzhye, 69063

Other trials in Ukraine

Poland12 sites

  • SP ZOZ Bienkowka- Osrodek Zdrowia w Bienkowce

    Bieńnkówka, 34-212

  • GRAŻYNA JASIENIAK-PINIS ATOPIA Niepubliczny Zakład Opieki Zdrowotnej Poradnie Specjalistyczne

    Krakow, 31-159

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

    Lodz, 90-153

  • Specjalistyczna Poradnia Pulmonologiczna

    Ostrów Wielkopolski, 63-400

  • Niepubliczny Zespol Poradni Specjalistycznych PULS Poradnia Chorob Pluc i Gruzlic

    Piła, 64-920

  • ABC-PULMO Poradnia Chorob Pluc

    Radom, 26-600

  • Niepubliczny Zaklad Opieki Zdrowotnej PROFILAKTYKA Wladyslaw Pierzchala

    Ruda Śląska, 41-707

  • Centrum Medyczne Ogrodowa

    Skierniewice, 96-100

  • Alergo Medical Specjalistyczna Przychodnia Lekarska

    Tarnów, 33-100

  • Lexmedica

    Wroclaw, 53-114

  • Dobrostan Gabinety Lekarskie

    Wroclaw, 53-301

  • NZOZ Lekarze Specjalisci

    Wroclaw, 54-239

Other trials in Poland

Bulgaria10 sites

  • Specialized Hospital for Active Treatment for pneumo-phtysiatric diseases

    Rousse, 7002

  • Multiprofile Hospital For Active Treatment - Dr. Bratan Shukerov AD

    Smolyan, 4700

  • 5TH MHAT; Pulmonology

    Sofia, 1233

  • National Multiprofile Hospital Tsar Boris III

    Sofia, 1233

  • Medical Center for Specialized Outpatient Medical Care for Pulmonary Diseases

    Sofia, 1431

  • SHATPD Sveta Sofia; Clin Pulmonary Diseases

    Sofia, 1431

  • Alitera - Med - Medical Center EOOD

    Sofia, 1618

  • Multiprofile Hospital For Active Treatment prof Kirkovich

    Stara Zagora, 6003

  • Diagnostic and Consulting Centre Mladost - M OOD

    Varna, 9020

  • Medical Center Tara OOD

    Veliko Tarnovo, 5000

Other trials in Bulgaria

Peru9 sites

  • Hospital Nacional Adolfo; Guevara Velasco Essalud

    Cusco, Cusco 84

  • Hospital Nacional Luis N Saenz PNP

    Lima, Lima 11

  • Clinica Internacional

    Lima, Lima 1

  • ABK Reuma SRL- Medicentro BioCiencias

    Lima, Lima 21

  • Centro de Investigación Ricardo Palma

    Lima, LIMA 27

  • Instituto Peruano de Investigacion en Ciencias Medicas

    Lima, Lima 32

  • Clinica San Pablo

    Lima, Lima 33

  • Clinica San Borja

    Lima, Lima 41

  • Clinica los Andes

    Miraflores, Lima 18

Other trials in Peru

Italy7 sites

  • Azienda Policlinico Vittorio Emanuele; Pneumologia Riabilitativa E Allergologia

    Catania, Sicily, 95123

  • Asst Santi Paolo E Carlo

    Milan, Lombardy, 20142

  • Azienda Ospedaliera Universitaria di Modena

    Modena, Emilia-Romagna, 41100

  • Azienda Ospedaliera Monaldi

    Naples, Campania, 80131

  • Fondazione IRCCS Policlinico San Matteo di Pavia; S.S. Fisiopatologia Respiratoria

    Pavia, Lombardy, 27100

  • Università Cattolica del Sacro Cuore UOC Allergologia- Policlinico Gemelli

    Rome, Lazio, 00168

  • P.O. Citta' Di Sesto S. Giovanni

    Sesto San Giovanni, Lombardy, 20099

Other trials in Italy

South Africa7 sites

  • Respiratory Research Unit

    Cape Town, 7505

  • Tiervalei Trial Centre

    Cape Town, 7530

  • St Augustines Hospital; Infectoilogy

    Durban, 4001

  • Dr PJ Sebastian

    Durban, 4092

  • Aliwal Shoal Medical Center

    eMkhomazi, 4170

  • Limpopo Clinical Research Initiative; Tamboti Medical Centre

    Tabazimbi, 0380

  • Clinical Projects Research

    Worcester, 6850

Other trials in South Africa

Spain7 sites

  • Instituto de Ciencias Medicas

    Alicante, 03004

  • Hospital Clinic de Barcelona

    Barcelona, 08036

  • Institut Catala de Serveis Medics

    Girona, 17005

  • Hospital Universitario la Paz; Servicio de Alergologia

    Madrid, 28046

  • Hospital Universitario Puerta de Hierro Majadahonda; Servicio de Neumología

    Majadahonda, Madrid, 28222

  • Complexo Hospitalario Universitario de Santiago CHUS - Hospital de Conxo

    Santiago de Compostela, La Coruña, 15706

  • Hospital Universitario Virgen Macarena

    Seville, Sevilla, 41071

Other trials in Spain

South Korea6 sites

  • Chonnam National University Hospital

    Gwangju, 61469

  • Soonchunhyang University Bucheon Hospital

    Gyeonggi-do, 14584

  • Korea University Anam Hospital

    Seoul, 02841

  • Seoul St Mary's Hospital

    Seoul, 06591

  • Seoul National University Hospital; Division of Allergy and Clinical Immunology

    Seoul, 110-744

  • Ewha Womans University Medical Center

    Seoul, 158-050

Other trials in South Korea

Argentina5 sites

  • Instituto de Investigaciones Clinicas-Mar del Plata

    Buenos Aires, B7600FZN

  • Fundacion Cidea

    Buenos Aires, C1125 ABE

  • Centro Respiratorio Infantil

    Rosario, 2000

  • Centro Modelo de Cardiologia

    San Miguel de Tucumán, 4000

  • CEMER Centro Médico de Enfermedades Respiratorias

    Vicente López, B1602DQD

Other trials in Argentina

Australia5 sites

  • AusTrials

    Brisbane, Queensland, 4075

  • Princess Alexandra Hospital, Department of Respiratory and Sleep Medicine

    Brisbane, Queensland, 4102

  • The Lung Institute of Western Australia; Sir Charles Gairdner Hospital

    Nedlands, Western Australia, 6009

  • Concord Repatriation General Hospital; Department Thoracic Medicine

    Sydney, New South Wales, 2139

  • Respiratory Clinical Trials Pty Ltd

    Toorak Gardens, South Australia, 5065

Other trials in Australia

Canada5 sites

  • Cheema Research, Inc

    Mississauga, Ontario, L5A 3V4

  • Del Carpio Jaime Dr - Allergiste & Immunologue

    Montreal, Quebec, H3H 1T8

  • Ottawa Allergy Research Corp

    Ottawa, Ontario, K1Y 4G2

  • Manna Research

    Toronto, Ontario, M9W 4L6

  • Dr Anil Dhar Professional Medicine Corporation

    Windsor, Ontario, N8X-5A6

Other trials in Canada

Israel5 sites

  • Rambam Health Care Campus

    Haifa, 31096

  • Hadassah Medical Center; Pulmonary Institute

    Jerusalem, 9112001

  • Nazareth EMMS Hospital

    Nazareth, 16100

  • Rabin Medical Center

    Petah Tikva, 49100

  • Chaim Sheba Medical Center; Oncology Dept

    Ramat Gan, 5262100

Other trials in Israel

Czechia4 sites

  • Fakultni nemocnice Hradec Kralove

    Hradec Králové, 500 05

  • Thomayerova nemocnice

    Praha 4 - Krc, 140 59

  • Ordinace pro tuberkulozu a respiracni nemoci

    Strakonice, 38601

  • KASMED, s.r.o.; Alergologie a klinicka imunologie

    Tábor, 390 01

Other trials in Czechia

France4 sites

  • Centre Hospitalier Universitaire de Bicêtre

    Le Kremlin-Bicêtre, 94275

  • Hôpital de La Croix Rousse

    Lyon, 69004

  • Groupe Hospitalier Cochin St Vincent de Paul La Roche Guyon

    Paris, 75014

  • Hopital Bichat Claude Bernard ; Service de Pneumologie

    Paris, 75877

Other trials in France

New Zealand4 sites

  • Greenlane Clinical Centre

    Auckland, 1051

  • Canterbury Respiratory Research Group; Respiratory

    Christchurch, 8011

  • P3 Research

    Tauranga, 3110

  • Medical Research Inst. of New Zealand; Respiratory

    Wellington

Other trials in New Zealand

Romania4 sites

  • Spitalul Clinic de Pneumoftiziologie Leon Daniello Cluj-Napoca, Sectia Clinica Pneumologie I

    Cluj-Napoca, 400371

  • Spitalul Clinic de Pneumoftiziologie Palazu Mare Constanta

    Palazu Mare, 900002

  • Targu Mures Clinical Emergency County Hospital

    Târgu Mureş, 540100

  • Dr. Victor Babes Pneumology and Infectious Diseases Clinical Hospital

    Timișoara, 300310

Other trials in Romania

United Kingdom4 sites

  • Raigmore Hospital

    Inverness, IV2 3UV

  • Royal Preston Hospital

    Preston, PR2 9HT

  • Royal Hallamshire Hospital; Department of Oncology

    Sheffield, S10 2JF

  • Southmead Hospital

    Westbury-on-Trym, Bristol, BS10 5NB

Other trials in United Kingdom

Germany3 sites

  • Medaimun GmbH

    Frankfurt am Main, 60596

  • Pneumologisches Forschungsinstitut

    Großhansdorf, 22927

  • Praxis Dr. med. Hermann A. Trauth

    Marburg, 35037

Other trials in Germany

Hungary3 sites

  • Debreceni Egyetem, Klinikai Kozpont, Tudogyogyaszati Klinika

    Debrecen, 4032

  • Selye János Kórház és Rendelőintézet; Allergológiai Szakrendelés

    Komárom, 2900

  • Markusovszky Egyetemi Oktatokorhaz

    Szombathely, 9700

Other trials in Hungary

Mexico3 sites

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

    Guadalajara, 44130

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

    Monterrey, 64718

  • Consultorio Especialidad Alergologia Pediatrica

    Villahermosa, 86035

Other trials in Mexico

Serbia3 sites

  • Clinical Center of Serbia

    Belgrade, 11000

  • Institute of Lung Diseases Vojvodina

    Kamenitz, 21204

  • Clinical Hospital Centre Zemun

    Zemun, 11080

Other trials in Serbia

Slovakia3 sites

  • Pneumo-Alergo Centrum s.r.o.

    Bratislava, 821 06

  • ZAPA JJ Sro

    Levice, 934 01

  • Imunoalergologia Dzurilla s.r.o.

    Nitra, 949 01

Other trials in Slovakia

Belgium2 sites

  • Private Practice

    Jambes, 5100

  • UZ Leuven Gasthuisberg

    Leuven, 3000

Other trials in Belgium

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 as subcutaneous (SC) injection 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. Participants who were assigned to placebo during the placebo-controlled period of the trial will be re-randomized at Week 52 to receive blinded SC lebrikizumab 37.5 milligrams (mg) or 125 mg every 4 weeks from Weeks 53 to 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 groups in NCT01868061
Study groupRoleWhat they receive
Lebrikizumab (125 mg)ExperimentalParticipants will receive SC injection of lebrikizumab (125 mg) every 4 weeks for 104 weeks.
Receives: Drug: Lebrikizumab
Lebrikizumab (37.5 mg)ExperimentalParticipants will receive SC injection of lebrikizumab (37.5 mg) every 4 weeks for 104 weeks.
Receives: Drug: Lebrikizumab
PlaceboPlacebo comparatorParticipants 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.

  1. Rate of Asthma Exacerbations During the 52-Week Placebo-Controlled Period

    Measured: Baseline up to Week 52

Secondary outcomes (9)

  1. Absolute Change From Baseline in Pre-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1)

    Measured: Baseline, Week 52

  2. Time to First Asthma Exacerbation

    Measured: Baseline up to Week 52

  3. Change From Baseline in Standardized Asthma Quality of Life Questionnaire (AQLQ) Score

    Measured: Baseline, Week 52

  4. Change from Baseline In Asthma Rescue Medication (Number of Puffs or Nebulized Treatments)

    Measured: Baseline, Week 52

  5. Rate of Urgent Asthma-Related Urgent Health Care Utilization

    Measured: Baseline up to Week 52

  6. Percentage of Participants With Adverse Events

    Measured: Baseline up to Week 124

  7. Percentage of Participants With Anti-Therapeutic Antibodies to Lebrikizumab

    Measured: Baseline up to Week 124 (assessed at Baseline, Weeks 4, 12, 24, 36, 52, 64, 76, 92, 104, 112, and 124)

  8. Change From Baseline in Asthma Control Questionnaire-5 (ACQ-5) Score

    Measured: Baseline, Week 52

  9. Minimum Serum Concentration (Cmin) of Lebrikizumab

    Measured: Predose (0 hour) on 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.

  1. First posted4 Jun 2013 (estimated)
  2. Study start31 Jul 2013
  3. Primary completion2 Jan 2017
  4. Study completion2 Jan 2017

Resources

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
1,068 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01868061
Sponsor's protocol ID
GB28689
Other IDs
2013-000176-15
Status last verified
May 2017
First submitted
30 May 2013
Last updated
19 May 2017
Results posted
No

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 33217063

  • N 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 31803473

  • Hanania 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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Lebrikizumab in people with Asthma, run by Hoffmann-La Roche at 232 sites in 26 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 May 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 232 sites in United States, Japan, Russia, Ukraine, Poland and 21 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of Asthma Exacerbations During the 52-Week Placebo-Controlled Period (time frame: Baseline up to Week 52). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01868061, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2017.

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