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NCT01867125

PHASE3

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

Sponsor: Hoffmann-La Roche

View on ClinicalTrials.gov

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. 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.

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

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

1081

Start Date

2013-07-25

Completion Date

2016-12-28

Last Updated

2026-07-17

Healthy Volunteers

Conditions

Asthma

Interventions

DRUG

Lebrikizumab

Lebrikizumab will be administered as SC injection at 125 or 37.5 mg every 4 weeks, for 104 weeks.

DRUG

Placebo

Lebrikizumab matching placebo will be administered as SC injection every 4 weeks for 52 weeks.

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

Locations (181)

Alabama Clinical Research Associates

Pell City, Alabama, United States

Desert Sun Clinical Research LLC

Tucson, Arizona, United States

Allianz Medical and Research Center

Fountain Valley, California, United States

Allergy & Asthma Medical Group & Research Center, Pc

Long Beach, California, United States

Allergy Medical Clinic

Los Angeles, California, United States

CA Allergy & Asthma Med Grp

Los Angeles, California, United States

North Bay Clinical Trials

Napa, California, United States

Choc Psf, Amc

Orange, California, United States

Advances in Medicine

Rancho Mirage, California, United States

Allergy Assoc Medical Group

San Diego, California, United States

Bensch Research Associates

Stockton, California, United States

IMMUNOe Research Centers

Centennial, Colorado, United States

Waterbury Pulmonary Associates

Waterbury, Connecticut, United States

St. Francis Sleep; Allergy & Lung Institute

Clearwater, Florida, United States

Suncoast Research Group LLC

Miami, Florida, United States

Emerald Coast Research Associates

Panama City, Florida, United States

Allergy & Asthma Diagnostic; Treatment Center

Tallahassee, Florida, United States

Florida Pulmonary Research Institute, LLC

Winter Park, Florida, United States

Atlanta Allergy & Asthma Clini

Woodstock, Georgia, United States

Northeast Medical Research Associates, Inc

North Dartmouth, Massachusetts, United States

Midwest Clinical Research LLC

St Louis, Missouri, United States

Montana Medical Research LLC

Missoula, Montana, United States

Heartland Clinical Research Inc.

Omaha, Nebraska, United States

Asthma & Allergy Center, P.C.

Papillion, Nebraska, United States

Allergy & Asthma Associates

Las Vegas, Nevada, United States

Allergy & Asthma Research of Nj, Inc

Mount Laurel, New Jersey, United States

Atlantic Research Center, LLC

Ocean City, New Jersey, United States

Princeton Center For Clinical Research

Skillman, New Jersey, United States

Montefiore Medical Center

The Bronx, New York, United States

Allergy & Asthma Center of NC

High Point, North Carolina, United States

PMG Research of Wilmington

Wilmington, North Carolina, United States

Asthma & Allergy Center

Toledo, Ohio, United States

Cor Clinical Research

Oklahoma City, Oklahoma, United States

Allergy & Asthma Research Grp

Eugene, Oregon, United States

Clinical Research Inst. of Southern Oregon, Pc

Medford, Oregon, United States

Allergy Associates Research Center LLC - CRN

Portland, Oregon, United States

Asthma Allergy Pulm Associates

Philadelphia, Pennsylvania, United States

Grand View Hospital; Clinical Research Department

Sellersville, Pennsylvania, United States

Asthma Allergy Phys of RI

Lincoln, Rhode Island, United States

ADAC Research PA

Greenville, South Carolina, United States

Spartanburg Medical Research

Spartanburg, South Carolina, United States

Tekton Research Inc

Austin, Texas, United States

TTS Research

Boerne, Texas, United States

Pharmaceutical Research & Consulting, Inc.

Dallas, Texas, United States

Pioneer Research Solutions

Houston, Texas, United States

Metroplex Pulmonology & Sleep Center

McKinney, Texas, United States

Quality Assurance Research Ctr

San Antonio, Texas, United States

O & O Alpan, LLC

Fairfax, Virginia, United States

Manassas Clinical Research Center

Manassas, Virginia, United States

Clinical Research Partners, LLC

Richmond, Virginia, United States

Bellingham Asthma, Allergy & Immunology

Bellingham, Washington, United States

ASTHMA, Inc

Seattle, Washington, United States

Premier Clinical Research

Spokane, Washington, United States

Fundacion Faicep

Buenos Aires, Argentina

Centro Médico Dra de Salvo

Buenos Aires, Argentina

Instituto Ave Pulmo

Mar del Plata, Argentina

Centro Respiratorio Quilmes

Quilmes, Argentina

Investigaciones en Patologias Respiratorias

San Miguel de Tucumán, Argentina

Box Hill Hospital; Eastern Clinical Research Unit

Box Hill, Victoria, Australia

Footscray Hospital

Footscray, Victoria, Australia

The Lung Institute of Western Australia; Sir Charles Gairdner Hospital

Nedlands, Western Australia, Australia

Cliniques Universitaires St-Luc

Brussels, Belgium

UZ Gent

Ghent, Belgium

Inspiration Research

Toronto, Ontario, Canada

Albion Finch Medical Centre

Toronto, Ontario, Canada

C.I.C. Mauricie

Trois-Rivières, Quebec, Canada

Centro de Investigaciones Medicas Respiratorias

Santiago, Chile

Schonffeldt y Guerrero Limitada

Santiago, Chile

Fundacion Neumologica Colombiana

Bogota DC, Colombia

Alergopraktik s.r.o.

Jablonec nad Nisou, Czechia

Interni A Pneumologicka Ambulance

Jindřichův Hradec, Czechia

MephaCentrum, a.s.

Ostrava - Poruba, Czechia

Alergologie Teplice, s.r.o.

Teplice, Czechia

Hopital Calmette; Pneumologie

Lille, France

Hôpital Arnaud de Villeneuve

Montpellier, France

CHU Nantes - Hôpital Laennec; Service de Pneumologie

Nantes, France

Nouvel Hopital Civil; Pole de Pathologie Thoracique

Strasbourg, France

Kenezy Korhaz Rendelointezet

Debrecen, Hungary

Petz Aladar Megyei Oktato Korhaz

Győr, Hungary

C.C.C. Hospital Chest Diseases

Szeged, Hungary

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, Israel

Azienda Ospedaliera Mater Domini Di Catanzaro

Catanzaro, Calabria, Italy

Università Degli Studi di Pisa - Ospedale di Cisanello Pisa

Pisa, Tuscany, Italy

Tosei General Hospital; Respiratory and Allergy Medicine

Aichi, Japan

Kyushu Central Hospital

Fukuoka, Japan

National Hospital Organization Mito Medical Center

Higashiibaraki-gun, Japan

Oji General Hospital

Hokkaido, Japan

National Hospital Organization Asahikawa Medical Center

Hokkaido, 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

Tono Chuo Clinic

Mizunami-shi, Japan

Nagaoka Red Cross Hospital

Nagaoka-shi, Japan

Niigata City General Hospital

Niigata, Japan

And 81 more locations on ClinicalTrials.gov