- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01987492
A Study of Lebrikizumab (RO5490255) in Participants With Severe Oral Corticosteroids (OCS) Dependent Asthma
May 19, 2017 updated by: Hoffmann-La Roche
A Phase II, Randomized, Double-Blind, Placebo Controlled, Multicenter Trial to Assess the Oral Corticosteroid-Sparing Effect of Lebrikizumab in Patients With Severe Corticosteroid Dependent Asthma
This randomized, multicenter, double-blind, placebo-controlled, parallel-group study will evaluate the efficacy of lebrikizumab compared with placebo, as measured by the ability of participants to achieve lower daily doses of OCS, among those with severe corticosteroid-dependent asthma.
Prednisone/prednisolone will be the OCS therapy prescribed.
Participants will be randomized to receive lebrikizumab or matching placebo for 44 weeks in a double-blind, placebo-controlled (DBPC) period.
Those who complete the 44-week period may continue into a 32-week active treatment extension (ATE) period, during which all participants will receive lebrikizumab treatment.
Following completion of the ATE period, participants who have both tolerated and derived benefit from treatment with lebrikizumab may continue their lebrikizumab treatment into a long-term extension (LTE) period.
Participants will transition to 24 weeks of safety follow-up upon discontinuation of study drug.
Study Overview
Study Type
Interventional
Enrollment (Actual)
230
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Queensland
-
Brisbane, Queensland, Australia, 4102
- Princess Alexandra Hospital, Department of Respiratory and Sleep Medicine
-
-
Victoria
-
Clayton, Victoria, Australia, 3168
- Monash Medical Centre; Respiratory and Sleep Medicine
-
-
Western Australia
-
Nedlands, Western Australia, Australia, 6009
- Institute for Respiratory Health Inc
-
-
-
-
-
Bruxelles, Belgium, 1070
- Clin Univ de Bxl Hôpital Erasme
-
Genk, Belgium, 3600
- Longartsenpraktijk
-
Gent, Belgium, 9000
- UZ Gent
-
-
-
-
Ontario
-
Toronto, Ontario, Canada, M5T 3A9
- Inspiration Research Limited
-
-
-
-
-
Brno, Czechia, 618 00
- Hornmed
-
Liberec 1, Czechia, 460 63
- Nemocnice Liberec; KNL a.s. - TRN
-
Nový Jičín, Czechia, 741-01
- Nemocnice Nový Jičín
-
Rokycany, Czechia, 337 22
- Rokycanska nemocnice
-
-
-
-
-
Hellerup, Denmark, 2900
- Gentofte Hospital, Klinik for Allergi
-
-
-
-
-
Grenoble Cedex 9, France, 38043
- CHU de Grenoble - Hôpital André Michallon
-
Le Kremlin Bicetre, France, 94275
- CH de Bicetre; Pneumologie
-
Lyon, France, 69004
- Hopital de La Croix Rousse
-
Montpellier, France, 34295
- Hôpital Arnaud de Villeneuve
-
Nantes, France, 44093
- CHU Nantes - Hôpital Laennec; Service de Pneumologie
-
Nice Cedex 1, France, 06001
- CHU de Nice
-
Paris, France, 75877
- Hopital Bichat Claude Bernard ; Service de Pneumologie
-
Pessac, France, 33604
- CHU de Haut Leveque
-
Strabourg, France, 67091
- Nouvel Hôpital Civil; Pôle de Pathologie Thoracique
-
-
-
-
-
Guadalajara, Mexico, 44100
- Instituto Jalisciense de Investigacion Clinica S.A. de C.V.
-
Guadalajara, Mexico, 44130
- Centro Investigacion Medico Biologica y Terapia Avanzada
-
Querétaro, Mexico, 76800
- Centro Integral Médico SJR SC
-
-
-
-
-
Amsterdam, Netherlands, 1105 AZ
- Academisch Medisch Centrum; Afdeling Longziekten, F5-258
-
Hoofddorp, Netherlands, 2134 TM
- Spaarne Ziekenhuis Hoofddorp; Long Geneeskunde
-
Nieuwegein, Netherlands, 3435 CM
- Antonius Ziekenhuis; Dept of Lung Diseases
-
-
-
-
-
Auckland, New Zealand, 1051
- NZ Respiratory & Sleep Institute
-
Dunedin, New Zealand
- Dunedin Hospital
-
Tauranga, New Zealand, 3143
- Clinical Trials Unit, Bay of Plenty District Health Board
-
Wellington, New Zealand
- Medical Research Inst. of New Zealand; Respiratory
-
-
-
-
-
Krakow, Poland, 31-624
- Malopolskie Centrum Alergologii
-
Krakow, Poland, 31-024
- Specjalistyczny Osrodek Alergologiczno-Internistyczny ALL-MED
-
Lodz, Poland, 90-153
- SPZOZ Uniwersytecki Szpital Kliniczny nr 1 im. Norberta Barlickiego Uniwersytetu Medycznego w Lodzi
-
Ostrow Wielkopolski, Poland, 63-400
- Specjalistyczna Poradnia Pulmonologiczna
-
Ruda Śląska, Poland, 41-707
- Niepubliczny Zaklad Opieki Zdrowotnej PROFILAKTYKA Wladyslaw Pierzchala
-
Warszawa, Poland, 02-507
- Klinika Chorób Wewnetrznych i Alergologii MSW
-
Wrocław, Poland, 50-220
- EMC Instytut Medyczny SA; Przychodnia przy ulicy Łowieckiej
-
-
-
-
-
Caguas, Puerto Rico, 00725
- San Juan Bautista School of Medicine-Clinical Research Unit
-
Cidra, Puerto Rico, 00739
- Advanced Medical Concepts, PSC
-
-
-
-
-
Levice, Slovakia, 934 01
- ZAPA JJ Sro
-
Spisska Nova Ves, Slovakia, 052 01
- Plucna ambulancia
-
-
-
-
-
Golnik, Slovenia, 4204
- University Clinic of Pulmonary and Allergic Diseases Golnik
-
-
-
-
-
Barcelona, Spain, 08036
- Hospital Clinic de Barcelona
-
Barcelona, Spain, 08025
- Hospital de la Santa Creu; i Sant Pau
-
Salamanca, Spain, 37007
- Hospital Clinico Universitario de Salamanca; Servicio de Neumologia
-
Valencia, Spain, 46017
- Hospital Universitario Doctor Peset
-
-
La Coruña
-
Santiago de Compostela, La Coruña, Spain, 15706
- Complejo Hospitalario Universitario de Santiago; Servicio de Neumología
-
-
-
-
-
Belfast, United Kingdom, BT9 7AB
- Belfast City Hospital; Respiratory Department
-
Birmingham, United Kingdom, B9 5SS
- Heartlands Hospital; Respiratory Department
-
Glasgow, United Kingdom, G51 4TF
- Royal Hospital for Children
-
Glasgow, United Kingdom, G12 0YN
- Gartnavel General Hospital; Respiratory Department
-
Glasgow, United Kingdom, G31 2ER
- New Lister Buliding, Level 1; Clinical Research Facility
-
Hampshire, United Kingdom, SO16 6YD
- Southampton General Hospital; Respiratory Department
-
Leicester, United Kingdom, LE1 5WW
- Leicester Royal Infirmary NHS Trust
-
Leicester, United Kingdom, LE3 9QP
- Glenfield Hospital; Respiratory -Allergy Unit
-
London, United Kingdom, SW3 6NP
- Royal Brompton Hospital; Respiratory Department
-
London, United Kingdom, EC1A 7BE
- St Bartholomew's Hospital (Barts); Respiratory Department
-
Manchester, United Kingdom, M23 9LT
- Wythenshawe Hospital; North West Lung Research Centre
-
Newcastle upon Tyne, United Kingdom, NE7 7DN
- Freeman Hospital; Respiratory Department
-
Plymouth, United Kingdom, PL6 8DH
- Derriford Hospital; The Lind Research Department
-
Sheffield, United Kingdom, S10 2JF
- Sheffield Clinical Research Facility; National Institute for Health Research
-
-
-
-
California
-
Bakersfield, California, United States, 93301
- Kern Allergy Med Clinic, Inc.
-
Long Beach, California, United States, 90808
- Allergy & Asthma Care Center of Southern California
-
-
Florida
-
Miami, Florida, United States, 33135
- South Florida Research Center, Inc.
-
-
Georgia
-
Albany, Georgia, United States, 31707
- Georgia Pollens
-
-
New York
-
New York, New York, United States, 10029
- Mount Sinai Medical Center
-
-
Oklahoma
-
Tulsa, Oklahoma, United States, 74136
- Allergy & Immunology
-
-
Texas
-
Houston, Texas, United States, 77008
- Pioneer Research Solutions
-
McKinney, Texas, United States, 75069
- Metroplex Pulmonology & Sleep Center
-
-
Washington
-
Tacoma, Washington, United States, 98405
- Pulmonary Consultants PLLC
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
12 years to 75 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Severe asthma despite intensive follow-up by an asthma specialist for >/=6 months prior to Visit 1
- Baseline forced expiratory volume in 1 second (FEV1) >/=40% of predicted prior to randomization
- Receiving high doses of inhaled glucocorticosteroids at a total daily dose of >/=1500 micrograms (mcg) beclomethasone dipropionate or equivalent and long-acting beta-adrenoceptor agonist (LABA), with or without an additional controller, for at least 3 months prior to Visit 1
- Chronic treatment with maintenance OCS for >/=6 months prior to Visit 1
- Assessment to ensure diagnosis of refractory asthma and OCS dependence on minimal effective or maximum tolerated dose prior to Visit 1 with compliance
Exclusion Criteria:
- History of a severe allergic reaction or anaphylactic reaction to a biologic agent or known hypersensitivity to any component of the lebrikizumab injection
- Asthma exacerbation within 28 days prior to Visit 1 or during screening (prior to Visit 3)
- For adults: Active tuberculosis requiring treatment within the 12 months prior to Visit 1
- For adolescents: History of active tuberculosis requiring treatment
- Evidence of acute or chronic hepatitis or known liver cirrhosis
- Known current malignancy or current evaluation for a potential malignancy
- History of interstitial lung disease, chronic obstructive pulmonary disease, or other clinically significant lung disease other than asthma
- Infection requiring hospital admission or requiring treatment with intravenous (IV) or intramuscular (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
- Current smoker or former smoker with a smoking history of more than 15 pack-years
- Current use of an immunomodulatory/ immunosuppressive therapy or past use within 3 months or 5 drug half-lives (whichever is longer) prior to Visit 1
- Use of a licensed or investigational monoclonal antibody other than anti-interleukin (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 (whichever is longer) prior to Visit 1
- Receipt of a live attenuated vaccine within the 4 weeks prior to Visit 1 during screening or anticipation of receipt of a live attenuated vaccine throughout the study
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Lebrikizumab High Dose
Participants will receive lebrikizumab at high dose level as subcutaneous (SC) injection every 4 weeks during the 44-week DBPC period, followed by a 32-week ATE period, and during the LTE period.
|
Lebrikizumab will be administered as SC injections every 4 weeks at dose and schedule described in arm description.
Other Names:
|
Experimental: Lebrikizumab Low Dose
Participants will receive lebrikizumab at low dose level as SC injection every 4 weeks during the 44-week DBPC period, followed by a 32-week ATE period, and during the LTE period.
|
Lebrikizumab will be administered as SC injections every 4 weeks at dose and schedule described in arm description.
Other Names:
|
Placebo Comparator: Placebo
Participants will receive placebo matching to lebrikizumab SC injection every 4 weeks during the 44-week DBPC period.
Participants will then be randomized to receive either high- or low-dose lebrikizumab every 4 weeks during the 32-week ATE period and will continue same treatment in the LTE period.
|
Lebrikizumab will be administered as SC injections every 4 weeks at dose and schedule described in arm description.
Other Names:
Placebo matching to lebrikizumab will be administered as SC injections every 4 weeks as per schedule described in arm description.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Relative Change From Baseline in Daily OCS Dose at Week 44
Time Frame: Baseline, Week 44
|
Baseline, Week 44
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Absolute Change From Baseline in Daily OCS Dose at Week 44
Time Frame: Baseline, Week 44
|
Baseline, Week 44
|
|
Relative Change From Week 12 in Average OCS Dose at Week 44
Time Frame: Week 12, Week 44
|
Week 12, Week 44
|
|
Percentage of Participants Achieving at Least a 50 percent (%) Reduction in Their Daily OCS Dose at Week 44 Relative to Baseline
Time Frame: Baseline, Week 44
|
Baseline, Week 44
|
|
Percentage of Participants Discontinuing OCS Therapy or Having Achieved an Adrenal Maintenance Dose at Week 44
Time Frame: Week 44
|
Percentage of participants discontinuing OCS therapy or having achieved adrenal maintenance dose (cortisol level less than or equal to 100 nanomoles per liter) will be reported.
|
Week 44
|
Percentage of Participants With Asthma Exacerbations
Time Frame: Baseline up to Week 44
|
An asthma exacerbation is defined as new or increased asthma symptoms (including wheeze, cough, dyspnea, chest tightness, or nocturnal awakenings due to these symptoms) that lead to treatment with systemic corticosteroids greater than or equal to (>/=) 30 milligrams (mg) or 0.5 mg per kilogram (kg) for >/=3 consecutive days or to hospitalization.
|
Baseline up to Week 44
|
Percentage of Participants With Adverse Events
Time Frame: Baseline up to 24 weeks after last dose administration (up to a minimum of approximately 2 years)
|
Baseline up to 24 weeks after last dose administration (up to a minimum of approximately 2 years)
|
|
Percentage of Participants With Anti-therapeutic Antibodies (ATAs) Against Lebrikizumab
Time Frame: Predose (0 hours) at Weeks 0, 4, 12, 24, 36, 44, 52, 64, and 76, at early discontinuation (up to a minimum of approximately 2 years), and at 24 weeks after last dose administration (up to a minimum of approximately 2 years)
|
Predose (0 hours) at Weeks 0, 4, 12, 24, 36, 44, 52, 64, and 76, at early discontinuation (up to a minimum of approximately 2 years), and at 24 weeks after last dose administration (up to a minimum of approximately 2 years)
|
|
Minimum Observed Serum Lebrikizumab Concentration (Cmin)
Time Frame: Predose (0 hours) at Weeks 4, 12, 24, 36, and 44
|
Predose (0 hours) at Weeks 4, 12, 24, 36, and 44
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 28, 2014
Primary Completion (Actual)
December 20, 2016
Study Completion (Actual)
December 20, 2016
Study Registration Dates
First Submitted
November 12, 2013
First Submitted That Met QC Criteria
November 12, 2013
First Posted (Estimate)
November 19, 2013
Study Record Updates
Last Update Posted (Actual)
May 22, 2017
Last Update Submitted That Met QC Criteria
May 19, 2017
Last Verified
May 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- WB28182
- 2012-000190-24 (EudraCT Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Asthma
-
Vanderbilt University Medical CenterNot yet recruitingAsthma in Children | Asthma Attack | Asthma Acute | Acute Asthma Exacerbation | Asthma; StatusUnited States
-
University of California, San FranciscoCompletedAsthma in Children | Asthma Attack | Asthma Acute | Asthma ChronicUnited States
-
Johann Wolfgang Goethe University HospitalCompleted
-
Parc de Salut MarRecruitingAsthma in Children | Persistent Asthma | Asthma ExacerbationSpain
-
Universita di VeronaCompleted
-
Forest LaboratoriesCompleted
-
Brunel UniversityKarolinska InstitutetUnknown
-
Value Outcomes Ltd.AstraZenecaCompletedAsthma, Bronchial | Bronchial Asthma | Asthma Chronic | Asthma; EosinophilicCzechia
-
Johann Wolfgang Goethe University HospitalCompletedExercise-induced AsthmaGermany
Clinical Trials on Lebrikizumab
-
Eli Lilly and CompanyCompleted
-
Hoffmann-La RocheCompletedChronic Obstructive Pulmonary DiseaseUnited States, Canada, Bulgaria, Hungary, Russian Federation, Denmark, Argentina, Mexico, Poland
-
Genentech, Inc.Completed
-
Genentech, Inc.CompletedHealthy VolunteerUnited States
-
Eli Lilly and CompanyNot yet recruiting
-
Eli Lilly and CompanyActive, not recruiting
-
Eli Lilly and CompanyDermira, Inc.CompletedAtopic DermatitisUnited States, Canada, Australia, Poland
-
Hoffmann-La RocheWithdrawn
-
Eli Lilly and CompanyRecruiting
-
Hoffmann-La RocheCompletedAsthmaSpain, Belgium, United States, Italy, Canada, Israel, Korea, Republic of, Slovakia, Hungary, Serbia, Japan, Russian Federation, France, United Kingdom, Turkey, Romania, New Zealand, Australia, Argentina, Poland, Ukraine, Mexico, Cze... and more