Asthma Clinical Trial
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
Verified date | May 2017 |
Source | Hoffmann-La Roche |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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 subcutaneously (SC) 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. During double-blind active treatment extension period, all participants will receive SC injection of lebrikizumab from Week 53 to Week 104. The anticipated time on study treatment is 104 weeks. After study treatment, all participants will complete a 20-week safety follow-up.
Status | Completed |
Enrollment | 1081 |
Est. completion date | January 2, 2017 |
Est. primary completion date | January 2, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility |
Inclusion Criteria: - Asthma diagnosis for greater than equal to (>/=) 12 months prior to 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 micrograms (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 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 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 infection that required treatment with oral antibiotics within 2 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 - 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 |
Country | Name | City | State |
---|---|---|---|
Argentina | Centro Médico Dra de Salvo | Buenos Aires | |
Argentina | Fundación Faicep | Buenos Aires | |
Argentina | Instituto Ave Pulmo | Mar Del Plata | |
Argentina | Centro Respiratorio Quilmes | Quilmes | |
Argentina | Investigaciones en Patologias Respiratorias | San Miguel de Tucuman | |
Australia | Box Hill Hospital; Eastern Clinical Research Unit | Box Hill | Victoria |
Australia | St. Vincent's Hospital Melbourne | Fitzroy | South Australia |
Australia | Western Hospital | Footscray | Victoria |
Australia | Liverpool Hospital | Liverpool BC | New South Wales |
Australia | The Lung Institute of Western Australia; Sir Charles Gairdner Hospital | Nedlands | Western Australia |
Belgium | Cliniques Universitaires St-Luc | Bruxelles | |
Belgium | UZ Gent | Gent | |
Canada | Alberta Health Services | Calgary | Alberta |
Canada | Dr. E. Amer | Mississauga | Ontario |
Canada | Albion Finch Medical Centre | Toronto | Ontario |
Canada | Inspiration Research Limited | Toronto | Ontario |
Canada | Centre d'investigation Clinique Mauricie | Trois-Rivières | Quebec |
Chile | Centro de Investigaciones Medicas Respiratorias | Santiago | |
Chile | Schonffeldt y Guerrero Limitada | Santiago | |
Chile | Hospital Carlos Van Buren | Valparaiso | |
Colombia | Fundacion Neumologica Colombiana | Bogota DC | |
Czechia | Alergopraktik s.r.o. | Jablonec Nad Nisou | |
Czechia | Interni A Pneumologicka Ambulance | Jindrichuv Hradec | |
Czechia | MephaCentrum, a.s. | Ostrava - Poruba | |
Czechia | Alergologie Teplice, s.r.o. | Teplice | |
France | Hopital Calmette; Pneumologie | Lille | |
France | Hopital Nord; CIC | Marseille | |
France | Hôpital Arnaud de Villeneuve | Montpellier | |
France | CHU Nantes - Hôpital Laennec; Service de Pneumologie | Nantes | |
France | Nouvel Hôpital Civil; Pôle de Pathologie Thoracique | Strabourg | |
Germany | Lungenarztpraxis Tegel | Berlin | |
Germany | Pneumologisches Zentrum Wiesloch | Wiesloch | |
Hungary | Kenezy Korhaz Rendelointezet | Debrecen | |
Hungary | Petz Aladar Megyei Oktato Korhaz | Gyor | |
Hungary | C.C.C. Hospital Chest Diseases | Szeged | |
Israel | Barzilai Medical Center; Pulmonary Inst. | Ashkelon | |
Israel | Lady Davis Carmel Medical Center; Cardiovascular Medicine | Haifa | |
Israel | Shaare Zedek Medical Center | Jerusalem | |
Israel | Meir Medical Center; Pulmonary Dept | Kfar Saba | |
Israel | Kaplan Medical Center | Rehovot | |
Italy | Fondazione Salvatore Maugeri. IRCCS - Divisione di Pneumologia | Cassano Murge (BA) | Puglia |
Italy | University of Catanzaro | Catanzaro | Calabria |
Italy | Azienda Ospedaliera di Padova | Padova | Veneto |
Italy | Azienda Ospedaliero Universitaria di Parma | Parma | Emilia-Romagna |
Italy | A.o. Universitaria Pisana; Dipartimento Cardio Toracico | Pisa | Toscana |
Italy | Azienda Ospedaliero Universitaria Ospedali Riuniti Umberto I-G.M. Lancisi-G. Salesi Di Ancona | Torrette - Ancona | Marche |
Japan | Tosei General Hospital; Respiratory and Allergy Medicine | Aichi | |
Japan | Ofuji Clinic | Amagasaki-shi | |
Japan | Kyushu Central Hospital | Fukuoka-shi | |
Japan | National Hospital Organization Mito Medical Center | Higashiibaraki-gun | |
Japan | Hiroshima University Hospital | Hiroshima | |
Japan | National Hospital Organization Asahikawa Medical Center | Hokkaido | |
Japan | Oji General Hospital | Hokkaido | |
Japan | Iwate Medical University Hospital | Iwate | |
Japan | Yokohama City Minato Red Cross Hospital | Kanagawa | |
Japan | National Hospital Organization Tokyo National Hospital | Kiyose-shi | |
Japan | Kochi Medical School Hospital | Kochi | |
Japan | Oki Clinic | Kodaira-shi | |
Japan | Takahashi Clinic | Kokubunji-shi | |
Japan | Dokkyo Medical University Koshigaya Hospital | Koshigaya-shi | |
Japan | Tono Chuo Clinic | Mizunami-shi | |
Japan | Nagaoka Red Cross Hospital | Nagaoka-shi | |
Japan | Niigata City General Hospital | Niigata-shi | |
Japan | Kinki-Chuo Chest Medical Center | Osaka | |
Japan | Osaka City University Hospital | Osaka | |
Japan | Touda Clinic | Osaka | |
Japan | Senzoku Kokyuuki and Allergy Clinic | Ota-ku | |
Japan | Japan Community Health Care Organization Hokkaido Hospital | Sapporo-shi | |
Japan | Fukuwa Clinic | Tokyo | |
Japan | Sano Toranomon Clinic | Tokyo | |
Japan | Showa University Hospital | Tokyo | |
Japan | Teikyo University Hospital | Tokyo | |
Japan | Tokyo Center Clinic; Internal Medicine | Tokyo | |
Japan | Sekino Hospital | Toshima | |
Japan | University of Fukui Hospital | Yoshida-gun | |
Korea, Republic of | Seoul National University Bundang Hospital | Gyeonggi-do | |
Korea, Republic of | Asan Medical Center | Seoul | |
Korea, Republic of | Korea University Guro Hospital | Seoul | |
Korea, Republic of | Samsung Medical Center | Seoul | |
Korea, Republic of | St. Paul's Hospital, The Catholic University of Korea, College of Medicine | Seoul | |
Korea, Republic of | Wonju Christian Hospital | Wonju | |
Mexico | Instituto Jalisciense de Investigacion Clinica S.A. de C.V. | Guadalajara | |
Mexico | Hospital Dr Angel Leaño universidad Autonoma de Guadalajara AC | Zapopan | |
New Zealand | NZ Respiratory & Sleep Institute | Auckland | |
New Zealand | Dunedin Hospital | Dunedin | |
New Zealand | RMC Medical Research Ltd | Dunedin | |
New Zealand | P3 Research | Tauranga | |
Poland | Centrum Medycyny Oddechowej Robert M. Mróz | Bialystok | |
Poland | Prywatna Praktyka Lekarska Gabinet Pediatryczno-Alergologiczny | Bialystok | |
Poland | Grazyna Pulka Specjalistyczny Osrodek ALL-MED | Krakow | |
Poland | Niepubliczny Zaklad Opieki Zdrowotnej Centrum Medyczne ProMiMed sp z o.o. sp.k. | Kraków | |
Poland | Specjalistyczne Centrum Medyczne NOWOMED | Kraków | |
Poland | Poradnia Pulmonologiczna dla Doroslych | Lódz | |
Poland | Centrum Alergologii Teresa Hofman | Poznan | |
Poland | SPZOZ Proszowice | Proszowice | |
Poland | Niepubliczny Specjalistyczny ZOZ Puls-Med s.c. | Skarzysko-Kamienna | |
Poland | Klinika Chorób Wewnetrznych i Alergologii MSW | Warszawa | |
Poland | Medica Pro Familia Sp. z o.o. S.K.A. | Warszawa | |
Poland | ALL-MED Specjalistyczna Opieka Medyczna | Wroclaw | |
Romania | Colentina Clinical Hospital | Bucharest | |
Romania | Prof.Dr.Octavian Fodor Emergency Clinical Hospital | Cluj-Napoca | |
Romania | Spitalul Clinic de Boli Infectioase si Pneumoftiziologie Victor Babes Craiova | Craiova | |
Romania | Dr. Victor Babes Pneumology and Infectious Diseases Clinical Hospital | Timisoara | |
Russian Federation | SIH Kemerovo Regional Clinical Hospital | Kemerovo | |
Russian Federation | Central Clinical Hospital #1 of RZhD JCS | Moscow | |
Russian Federation | Russian Uni of People'S Friendship, Med. Faculty; City Clinical Hospital No 64, Internal Diseases | Moscow | |
Russian Federation | Novosibirsk Municipal Clinical Hospital For Emergency Medicine #2 | Novosibirsk | |
Russian Federation | Ryazan Regional Clinical Hosp | Ryazan | |
Russian Federation | St. George the Martyr City Hospital | Saint Petersburg | |
Russian Federation | St.-Petersburg SMU n. a. Academician I.P.Pavlov; Therapy Department | Saint-Petersburg | |
Russian Federation | Smolensk State Medical Academy | Smolensk | |
Russian Federation | City Outpatient Dept #94 | St Petersburg | |
Russian Federation | SHI Ctr Occupational Pathology | St. Petersburg | |
Russian Federation | St-Petersburg Diagnostic Ctr#1; Pulmonology | St. Petersburg | |
Russian Federation | St. Petersburg State Budget Medical Institution Pokrovskaya City Hospital | St. Petersburg | |
Russian Federation | Tomsk Regional Clinical Hospital | Tomsk | |
Serbia | Clinical Center of Serbia | Belgrade | |
Serbia | Clinical Hospital Center ''Bezanijska Kosa''; Department of Pulmology | Belgrade | |
Serbia | Clinical Hospital Center Zvezdara | Belgrade | |
Slovakia | Alian s.r.o. | Bardejov | |
Slovakia | Tehelná Clinic, Inc; IMUNO-ALERGO, s. r.o. | Bratislava | |
Slovakia | Plucna ambulancia | Spisska Nova Ves | |
South Africa | Melomed Hospital Gatesville | Cape Town | |
South Africa | Uni of Cape Town Lung Inst. | Cape Town | |
South Africa | Vawda Z.Fa Practice | Durban | |
South Africa | Gatesville Medical Centre | Gatesville | |
South Africa | Deepak Lakha MBCHB Private Practice | Johannesburg | |
South Africa | Botho ke Bontle Health Services | Pretoria | |
South Africa | Dr Johannes Breedt; Emmed Research | Pretoria | |
Spain | Hospital de la Santa Creu; i Sant Pau | Barcelona | |
Spain | Hospital Germans Trias i Pujol | Barcelona | |
Spain | Hosp Univ Fundacion Alcorcon | Madrid | |
Spain | Hospital Virgen del Rocio | Sevilla | |
Spain | Hospital Universitario Doctor Peset | Valencia | |
Spain | Hospital Universitario Araba | Vitoria | Alava |
Turkey | Atatürk Gögüs Hastaliklari ve Gögüs Cerrahisi Egitim ve Arastirma Hastanesi | Ankara | |
Turkey | Turgut Ozal Universitesi Tip Fakultesi Bestepe Hastanesi | Ankara | |
Turkey | Uludag University; Pulmonology and Allergy Department | Bursa | |
Turkey | Canakkale Onsekiz Mart Universitesi Tip Fakultesi Hastanesi | Canakkale | |
Turkey | Ege University Medical Faculty | Izmir | |
Turkey | Izmir Dr. Suat Seren Gogus Hastaliklari ve Cerrahisi Egitim ve Arastirma Hastanesi | Izmir | |
Turkey | Kirikkale Universitesi Tip Fakultesi Hastanesi | Kirikkale | |
Turkey | Mersin University Medical Faculty | Mersin | |
Ukraine | Public Institution City Clinical Hospital # 6 of Dnipropetrovsk Regional Board | Dnepropetrovsk | |
Ukraine | Educational Scientific Medical Centre of Donetsk National Medical University; | Donetsk | |
Ukraine | Regional Phthisiology and Pulmonology Center | Ivano-Frankivsk | |
Ukraine | City Clinical Hospital #27 | Kharkiv | |
Ukraine | Medical and Sanitary Unit of OJSC "Kharkiv Tractor Plant n.a. Ordzhonikidze"; Department of Therapy | Kharkiv | |
Ukraine | Central Outpatient Hospital of Desnyansky District | Kyiv | |
Ukraine | Kyiv City Clinical Hospital #8 | Kyiv | |
Ukraine | Municipal Institution of Kyiv Regional Council Kyiv Regional Clinical Hospital | Kyiv | |
Ukraine | Yanovskyy Inst of Phth. & Pulm; Clinical-functional | Kyiv | |
Ukraine | Danylo Halytskyy National Medical University; Lviv | Lviv | |
Ukraine | Small Business Private Enterprise Medical Centre Pulse | Vinnytsya | |
Ukraine | Municipal Institution of Health Care "Yevpatoriya City Hospital ?1 | Yevpatoriya | |
Ukraine | SI Dept. Clin. Hospital of Zaporizhzhia-2 Railway Station of SE Prydniprovska Zaliznytsia | Zaporizhzhia | |
United Kingdom | St Peters Hospital | Chertsey | |
United Kingdom | Castle Hill Hospital; Respiratory Medicine | Cottingham | |
United Kingdom | Ninewells Hospital; Asthma and Allergy Research Group | Dundee | |
United Kingdom | St James University Hospital; Respiratory Department | Leeds | |
United Kingdom | University North Tees | Teesside | |
United States | Central PA Asth & Allergy Care; Research Division | Altoona | Pennsylvania |
United States | Tekton Research Inc | Austin | Texas |
United States | Bellingham Asthma, Allergy & Immunology | Bellingham | Washington |
United States | TTS Research | Boerne | Texas |
United States | IMMUNOe International Research Centers | Centennial | Colorado |
United States | St. Francis Sleep; Allergy & Lung Institute | Clearwater | Florida |
United States | Pharmaceutical Research & Consulting, Inc. | Dallas | Texas |
United States | Southeastern Lung Care | Decatur | Georgia |
United States | Creekside Medical Research | DeLand | Florida |
United States | Allergy & Asthma Research Center of El Paso | El Paso | Texas |
United States | Allergy & Asthma Research Grp | Eugene | Oregon |
United States | O & O Alpan, LLC | Fairfax | Virginia |
United States | Clinical Trial Connection | Flagstaff | Arizona |
United States | Allianz Medical and Research Center | Fountain Valley | California |
United States | Infusion Associates | Grand Rapids | Michigan |
United States | ADAC Research PA | Greenville | South Carolina |
United States | Clinical Research Partners, LLC | Henrico | Virginia |
United States | Allergy & Asthma Center of NC | High Point | North Carolina |
United States | Pioneer Research Solutions | Houston | Texas |
United States | Iowa Clinical Research Corporation | Iowa City | Iowa |
United States | Allergy & Asthma Associates | Las Vegas | Nevada |
United States | Asthma Allergy Phys of RI | Lincoln | Rhode Island |
United States | Allergy & Asthma Medical Group & Research Center, Pc | Long Beach | California |
United States | Alliance Research LLC | Long Beach | California |
United States | Allergy Medical Clinic | Los Angeles | California |
United States | CA Allergy & Asthma Med Grp | Los Angeles | California |
United States | Dean Clinic | Madison | Wisconsin |
United States | Manassas Clinical Research Center | Manassas | Virginia |
United States | Metroplex Pulmonology & Sleep Center | McKinney | Texas |
United States | Clinical Research Inst. of Southern Oregon, Pc | Medford | Oregon |
United States | South Florida Research Phase I-IV, Inc | Miami | Florida |
United States | Suncoast Research Group LLC | Miami | Florida |
United States | Laporte County Institute For Clinical Research | Michigan City | Indiana |
United States | Montana Medical Research LLC | Missoula | Montana |
United States | Allergy & Asthma Research of Nj, Inc | Mount Laurel | New Jersey |
United States | North Bay Clinical Trials | Napa | California |
United States | North Shore University Hosp | New Hyde Park | New York |
United States | Northeast Medical Research Associates, Inc | North Dartmouth | Massachusetts |
United States | Allergy & Asthma Care of FL; Clinical Research | Ocala | Florida |
United States | Atlantic Research Center, LLC | Ocean City | New Jersey |
United States | Cor Clinical Research | Oklahoma City | Oklahoma |
United States | Lynn Health Science Institute | Oklahoma City | Oklahoma |
United States | Heartland Clinical Research Inc. | Omaha | Nebraska |
United States | Choc Psf, Amc | Orange | California |
United States | Emerald Coast Research Associates | Panama City | Florida |
United States | Asthma & Allergy Center, P.C. | Papillion | Nebraska |
United States | Alabama Clinical Research Associates | Pell City | Alabama |
United States | Asthma Allergy Pulm Associates | Philadelphia | Pennsylvania |
United States | Allergy Associates Research Center | Portland | Oregon |
United States | Advances in Medicine | Rancho Mirage | California |
United States | Midwest Clinical Research LLC | Saint Louis | Missouri |
United States | Washington Univ. School of Med | Saint Louis | Missouri |
United States | Quality Assurance Research Ctr | San Antonio | Texas |
United States | Allergy Assoc Medical Group | San Diego | California |
United States | UCSF School of Medicine | San Francisco | California |
United States | ASTHMA, Inc | Seattle | Washington |
United States | Grand View Hospital; Clinical Research Department | Sellersville | Pennsylvania |
United States | Princeton Center For Clinical Research | Skillman | New Jersey |
United States | Spartanburg Medical Research | Spartanburg | South Carolina |
United States | Marycliff Allergy Specialists | Spokane | Washington |
United States | Bensch Research Associates | Stockton | California |
United States | Allergy & Asthma Diagnostic; Treatment Center | Tallahassee | Florida |
United States | Montefiore Medical Center | The Bronx | New York |
United States | Asthma & Allergy Center | Toledo | Ohio |
United States | Desert Sun Clinical Research LLC | Tucson | Arizona |
United States | Waterbury Pulmonary Associates | Waterbury | Connecticut |
United States | PMG Research of Wilmington | Wilmington | North Carolina |
United States | Florida Pulmonary Research Institute, LLC | Winter Park | Florida |
United States | Atlanta Allergy & Asthma Clini | Woodstock | Georgia |
Lead Sponsor | Collaborator |
---|---|
Hoffmann-La Roche |
United States, Argentina, Australia, Belgium, Canada, Chile, Colombia, Czechia, France, Germany, Hungary, Israel, Italy, Japan, Korea, Republic of, Mexico, New Zealand, Poland, Romania, Russian Federation, Serbia, Slovakia, South Africa, Spain, Turkey, Ukraine, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Rate of Asthma Exacerbations During the 52-Week Placebo-Controlled Period | Baseline up to 52 weeks | ||
Secondary | Absolute Change From Baseline in Pre-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1) | Baseline, Week 52 | ||
Secondary | Time to First Asthma Exacerbation | Baseline up to 52 weeks | ||
Secondary | Change From Baseline in Standardized Asthma Quality of Life Questionnaire (AQLQ) Score | Baseline, Week 52 | ||
Secondary | Change from Baseline In Asthma Rescue Medication (Number of Puffs or Nebulized Treatments) | Baseline, Week 52 | ||
Secondary | Rate of Urgent Asthma-Related Urgent Health Care Utilization | Baseline up to Week 52 | ||
Secondary | Percentage of Participants With Anti-Therapeutic Antibodies to Lebrikizumab | Baseline up to Week 124 (assessed at Baseline, Weeks 4, 12, 24, 36, 52, 64, 76, 92, 104, 112, and 124) | ||
Secondary | Change From Baseline in Asthma Control Questionnaire-5 (ACQ-5) Score | Baseline, Week 52 | ||
Secondary | Percentage of Participants With Adverse Events | Baseline, Week 124 | ||
Secondary | Minimum Serum Concentration (Cmin) of Lebrikizumab | Predose (0 hour) on Weeks 4, 12, 24, 36, and 52 |
Status | Clinical Trial | Phase | |
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