A Study of Lebrikizumab in Participants With Uncontrolled Asthma Who Are on Inhaled Corticosteroids and a Second Controller Medication
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
2 other identifiers
interventional
1,081
26 countries
181
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 asthma
Started Jul 2013
Longer than P75 for phase_3 asthma
181 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 29, 2013
CompletedFirst Posted
Study publicly available on registry
June 3, 2013
CompletedStudy Start
First participant enrolled
July 25, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 28, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 28, 2016
CompletedResults Posted
Study results publicly available
July 17, 2026
CompletedJuly 17, 2026
June 1, 2026
3.4 years
May 29, 2013
May 1, 2026
June 19, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Adjusted Exacerbation Rate of Asthma During the 52-Week PCP
Asthma exacerbation is defined as new or increased asthma symptoms (i.e., wheeze, cough, dyspnea, chest tightness, and/or night-time awakening due to these symptoms) that lead to systemic corticosteroid (CS) treatment (oral, intravenous (IV), or intramuscular (IM) CS for ≥ 3 days or an emergency department visit with at least one dose of IV or IM CS) or to hospitalization. Results are reported as a 'Number' representing the model-adjusted incidence rate of asthma exacerbations per person-year. To account for early discontinuation, for each patient, the time at risk (in years) was computed as the duration of this time period (last day minus first day \[in days\] plus 1) divided by 365.25. The 'first day' was the day of randomization to the PCP. For patients entering the ATE, the 'last day' was the day prior to ATE randomization. For patients not entering the ATE, the 'last day' was at the last study visit on/prior to Study Day 379 (365 days plus a 14-day window).
Baseline up to 52 weeks
Secondary Outcomes (6)
Absolute Change From Baseline in Pre-Bronchodilator FEV1 at Week 52
Week 52
Time to First Asthma Exacerbation During the 52-week PCP
Baseline up to 52 weeks
Rate of Urgent Asthma-Related Health Care Utilization (HCU) During the 52-week PCP
Baseline up to Week 52
Absolute Change From Baseline in Standardized AQLQ Score at Week 52
Week 52
Absolute Change From Baseline In Asthma Rescue Medication Use at Week 52
Week 52
- +1 more secondary outcomes
Other Outcomes (3)
Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) to Lebrikizumab
Baseline up to Week 124 (assessed at Baseline, Weeks 4, 12, 24, 36, 52 and safety follow-up [20 weeks] or end of study)
Percentage of Participants With Adverse Events (AEs)
Baseline up to Week 52 for Placebo arm. Week 53 to Week 104 for PBO/Lebrikizumab crossover arms. Baseline up to Week 104 for Lebrikizumab-only arms.
Minimum Serum Concentration (Cmin) of Lebrikizumab
Predose (0 hour) at Weeks 4, 12, 24, 36, and 52
Study Arms (3)
Lebrikizumab (125 mg)
EXPERIMENTALParticipants will receive SC injection of lebrikizumab (125 milligrams \[mg\]) every 4 weeks for 104 weeks.
Lebrikizumab (37.5 mg)
EXPERIMENTALParticipants will receive SC injection of lebrikizumab (37.5 mg) every 4 weeks for 104 weeks.
Placebo
PLACEBO 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.
Interventions
Lebrikizumab will be administered as SC injection at 125 or 37.5 mg every 4 weeks, for 104 weeks.
Lebrikizumab matching placebo will be administered as SC injection every 4 weeks for 52 weeks.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (181)
Alabama Clinical Research Associates
Pell City, Alabama, 35128, United States
Desert Sun Clinical Research LLC
Tucson, Arizona, 85710, United States
Allianz Medical and Research Center
Fountain Valley, California, 92708, United States
Allergy & Asthma Medical Group & Research Center, Pc
Long Beach, California, 90808, United States
Allergy Medical Clinic
Los Angeles, California, 90025, United States
CA Allergy & Asthma Med Grp
Los Angeles, California, 90025, United States
North Bay Clinical Trials
Napa, California, 94558, United States
Choc Psf, Amc
Orange, California, 92868, United States
Advances in Medicine
Rancho Mirage, California, 92270, United States
Allergy Assoc Medical Group
San Diego, California, 92108, United States
Bensch Research Associates
Stockton, California, 95207, United States
IMMUNOe Research Centers
Centennial, Colorado, 80112, United States
Waterbury Pulmonary Associates
Waterbury, Connecticut, 06708, United States
St. Francis Sleep; Allergy & Lung Institute
Clearwater, Florida, 33765, United States
Suncoast Research Group LLC
Miami, Florida, 33135, United States
Emerald Coast Research Associates
Panama City, Florida, 32405, United States
Allergy & Asthma Diagnostic; Treatment Center
Tallahassee, Florida, 32308, United States
Florida Pulmonary Research Institute, LLC
Winter Park, Florida, 32789, United States
Atlanta Allergy & Asthma Clini
Woodstock, Georgia, 30188, United States
Northeast Medical Research Associates, Inc
North Dartmouth, Massachusetts, 02747, United States
Midwest Clinical Research LLC
St Louis, Missouri, 63141, United States
Montana Medical Research LLC
Missoula, Montana, 59808, United States
Heartland Clinical Research Inc.
Omaha, Nebraska, 68134, United States
Asthma & Allergy Center, P.C.
Papillion, Nebraska, 68046, United States
Allergy & Asthma Associates
Las Vegas, Nevada, 89104, United States
Allergy & Asthma Research of Nj, Inc
Mount Laurel, New Jersey, 08054, United States
Atlantic Research Center, LLC
Ocean City, New Jersey, 07712, United States
Princeton Center For Clinical Research
Skillman, New Jersey, 08558, United States
Montefiore Medical Center
The Bronx, New York, 10461, United States
Allergy & Asthma Center of NC
High Point, North Carolina, 27262, United States
PMG Research of Wilmington
Wilmington, North Carolina, 28401, United States
Asthma & Allergy Center
Toledo, Ohio, 43617, United States
Cor Clinical Research
Oklahoma City, Oklahoma, 73103, United States
Allergy & Asthma Research Grp
Eugene, Oregon, 97401-7721, United States
Clinical Research Inst. of Southern Oregon, Pc
Medford, Oregon, 97504, United States
Allergy Associates Research Center LLC - CRN
Portland, Oregon, 97202, United States
Asthma Allergy Pulm Associates
Philadelphia, Pennsylvania, 19107, United States
Grand View Hospital; Clinical Research Department
Sellersville, Pennsylvania, 18960, United States
Asthma Allergy Phys of RI
Lincoln, Rhode Island, 02865, United States
ADAC Research PA
Greenville, South Carolina, 29607, United States
Spartanburg Medical Research
Spartanburg, South Carolina, 29303, United States
Tekton Research Inc
Austin, Texas, 78745, United States
TTS Research
Boerne, Texas, 78006, United States
Pharmaceutical Research & Consulting, Inc.
Dallas, Texas, 75231, United States
Pioneer Research Solutions
Houston, Texas, 077099, United States
Metroplex Pulmonology & Sleep Center
McKinney, Texas, 75069, United States
Quality Assurance Research Ctr
San Antonio, Texas, 78205, United States
O & O Alpan, LLC
Fairfax, Virginia, 22030, United States
Manassas Clinical Research Center
Manassas, Virginia, 20110, United States
Clinical Research Partners, LLC
Richmond, Virginia, 23220, United States
Bellingham Asthma, Allergy & Immunology
Bellingham, Washington, 98225, United States
ASTHMA, Inc
Seattle, Washington, 98105, United States
Premier Clinical Research
Spokane, Washington, 99202, United States
Fundacion Faicep
Buenos Aires, C1122AAK, Argentina
Centro Médico Dra de Salvo
Buenos Aires, C1426ABP, Argentina
Instituto Ave Pulmo
Mar del Plata, B7602DCK, Argentina
Centro Respiratorio Quilmes
Quilmes, B1878FNR, Argentina
Investigaciones en Patologias Respiratorias
San Miguel de Tucumán, T4000IAR, Argentina
Box Hill Hospital; Eastern Clinical Research Unit
Box Hill, Victoria, 3128, Australia
Footscray Hospital
Footscray, Victoria, 3011, Australia
The Lung Institute of Western Australia; Sir Charles Gairdner Hospital
Nedlands, Western Australia, 6009, Australia
Cliniques Universitaires St-Luc
Brussels, 1200, Belgium
UZ Gent
Ghent, 9000, Belgium
Inspiration Research
Toronto, Ontario, M5T 3A9, Canada
Albion Finch Medical Centre
Toronto, Ontario, M9V4B4, Canada
C.I.C. Mauricie
Trois-Rivières, Quebec, G8T 7A1, Canada
Centro de Investigaciones Medicas Respiratorias
Santiago, 7500692, Chile
Schonffeldt y Guerrero Limitada
Santiago, 7500698, Chile
Fundacion Neumologica Colombiana
Bogota DC, 11001, Colombia
Alergopraktik s.r.o.
Jablonec nad Nisou, 466 01, Czechia
Interni A Pneumologicka Ambulance
Jindřichův Hradec, 377 38, Czechia
MephaCentrum, a.s.
Ostrava - Poruba, 708 68, Czechia
Alergologie Teplice, s.r.o.
Teplice, 415 01, Czechia
Hopital Calmette; Pneumologie
Lille, 59037, France
Hôpital Arnaud de Villeneuve
Montpellier, 34295, France
CHU Nantes - Hôpital Laennec; Service de Pneumologie
Nantes, 44093, France
Nouvel Hopital Civil; Pole de Pathologie Thoracique
Strasbourg, 67091, France
Kenezy Korhaz Rendelointezet
Debrecen, 4031, Hungary
Petz Aladar Megyei Oktato Korhaz
Győr, 9024, Hungary
C.C.C. Hospital Chest Diseases
Szeged, 6722, Hungary
Barzilai Medical Center; Pulmonary Inst.
Ashkelon, 78306, Israel
Lady Davis Carmel Medical Center; Cardiovascular Medicine
Haifa, 34362, Israel
Shaare Zedek Medical Center
Jerusalem, 9103102, Israel
Meir Medical Center; Pulmonary Dept
Kfar Saba, 4428164, Israel
Kaplan Medical Center
Rehovot, 7610001, Israel
Azienda Ospedaliera Mater Domini Di Catanzaro
Catanzaro, Calabria, 88100, Italy
Università Degli Studi di Pisa - Ospedale di Cisanello Pisa
Pisa, Tuscany, 56124, Italy
Tosei General Hospital; Respiratory and Allergy Medicine
Aichi, 489-8642, Japan
Kyushu Central Hospital
Fukuoka, 815-8588, Japan
National Hospital Organization Mito Medical Center
Higashiibaraki-gun, 311-3193, Japan
Oji General Hospital
Hokkaido, 053-8506, Japan
National Hospital Organization Asahikawa Medical Center
Hokkaido, 070-8644, Japan
Yokohama City Minato Red Cross Hospital
Kanagawa, 231-8682, Japan
National Hospital Organization Tokyo National Hospital
Kiyose-shi, 204-8585, Japan
Kochi Medical School Hospital
Kochi, 783-8505, Japan
Oki Clinic
Kodaira-shi, 187-0024, Japan
Takahashi Clinic
Kokubunji-shi, 185-0014, Japan
Tono Chuo Clinic
Mizunami-shi, 509-6134, Japan
Nagaoka Red Cross Hospital
Nagaoka-shi, 940-2085, Japan
Niigata City General Hospital
Niigata, 950-11977, Japan
Iwate Medical University Hospital
Numakunai, 028-3695, Japan
Osaka Metropolitan University Hospital
Osaka, 545-8586, Japan
Senzoku Kokyuuki and Allergy Clinic
Ōta-ku, 145-0063, Japan
Japan Community Health Care Organization Hokkaido Hospital
Sapporo, 062-8618, Japan
Fukuwa Clinic
Tokyo, 103-0027, Japan
Tokyo Center Clinic; Internal Medicine
Tokyo, 103-0028, Japan
Sano Toranomon Clinic
Tokyo, 105-0003, Japan
Showa University Hospital
Tokyo, 142-8666, Japan
Sekino Hospital
Toshima City, 171-0014, Japan
University of Fukui Hospital
Yoshida-gun, 910-1193, Japan
Instituto Jalisciense de Investigacion Clinica S.A. de C.V.
Santa Cecilia, Jalisco, 44700, Mexico
Hospital Dr Angel Leaño universidad Autonoma de Guadalajara AC
Zapopan, 45200, Mexico
NZ Respiratory & Sleep Institute
Auckland, 1051, New Zealand
Dunedin Hospital
Dunedin, New Zealand
RMC Medical Research Ltd
Dunedin, New Zealand
P3 Research
Hastings, 4122, New Zealand
Centrum Medycyny Oddechowej Robert M. Mróz
Bialystok, 15-003, Poland
Specjalistyczne Centrum Medyczne NOWOMED
Krakow, 30-349, Poland
Grazyna Pulka Specjalistyczny Osrodek ALL-MED
Krakow, 31-023, Poland
Niepubliczny Zaklad Opieki Zdrowotnej Centrum Medyczne ProMiMed sp z o.o. sp.k.
Krakow, 31-637, Poland
Poradnia Pulmonologiczna dla Doroslych
Lódz, 90-153, Poland
Centrum Alergologii Teresa Hofman
Poznan, 60-214, Poland
SPZOZ Proszowice
Proszowice, 32-100, Poland
Anna Bogusz Gabinet Alergologiczny
Skarżysko-Kamienna, 26-110, Poland
Medica Pro Familia Sp. z o.o. S.K.A.
Warsaw, 01-868, Poland
Klinika Chorób Wewnetrznych i Alergologii MSW
Warsaw, 02-507, Poland
ALL-MED Specjalistyczna Opieka Medyczna
Wroclaw, 50-445, Poland
Colentina Clinical Hospital
Bucharest, 020125, Romania
Prof.Dr.Octavian Fodor Emergency Clinical Hospital
Cluj-Napoca, 400162, Romania
Spitalul Clinic de Boli Infectioase si Pneumoftiziologie Victor Babes Craiova
Craiova, 200515, Romania
Dr. Victor Babes Pneumology and Infectious Diseases Clinical Hospital
Timișoara, 300310, Romania
Ryazan Regional Clinical Hosp
Ryazan, Ryazan Oblast, 390039, Russia
LLC Medical Center Reavita Med SPb
Saint Petersburg, Sankt-Peterburg, 194354, Russia
SHI Ctr Occupational Pathology
Saint Petersburg, Sankt-Peterburg, 195271, Russia
SIH Kemerovo Regional Clinical Hospital
Kemerovo, 650002, Russia
Russian Uni of People'S Friendship, Med. Faculty; City Clinical Hospital No 64, Internal Diseases
Moscow, 117292, Russia
Central Clinical Hospital #1 of RZhD JCS
Moscow, 125367, Russia
Novosibirsk Municipal Clinical Hospital For Emergency Medicine #2
Novosibirsk, 630008, Russia
City Outpatient Dept #94
Saint Petersburg, 193231, Russia
St-Petersburg Diagnostic Ctr#1; Pulmonology
Saint Petersburg, 194354, Russia
St. Petersburg State Budget Medical Institution Pokrovskaya City Hospital
Saint Petersburg, 197022, Russia
St.-Petersburg SMU n. a. Academician I.P.Pavlov; Therapy Department
Saint Petersburg, 197022, Russia
Smolensk State Medical Academy
Smolensk, 4812, Russia
Tomsk Regional Clinical Hospital
Tomsk, 634063, Russia
Clinical Hospital Center ''Bezanijska Kosa''; Department of Pulmology
Belgrade, 11080, Serbia
Alian s.r.o.
Bardejov, 085 01, Slovakia
Tehelná Clinic, Inc; IMUNO-ALERGO, s. r.o.
Bratislava, 831 03, Slovakia
Plucna ambulancia
Spišská Nová Ves, 052 01, Slovakia
Melomed Hospital Gatesville
Cape Town, 7764, South Africa
Uni of Cape Town Lung Inst.
Cape Town, 7925, South Africa
Vawda Z.Fa Practice
Durban, 4091, South Africa
Gatesville Medical Centre
Gatesville, 7746, South Africa
Deepak Lakha MBCHB Private Practice
Johannesburg, 1820, South Africa
Seoul National University Bundang Hospital
Seongnam-si, 463-707, South Korea
Asan Medical Center
Seoul, 05505, South Korea
Samsung Medical Center
Seoul, 06351, South Korea
Korea University Guro Hospital
Seoul, 08308, South Korea
St. Paul's Hospital, The Catholic University of Korea, College of Medicine
Seoul, 130-709, South Korea
Hospital Universitario Araba
Vitoria-Gasteiz, Alava, 01004, Spain
Hospital de la Santa Creu; i Sant Pau
Barcelona, 08025, Spain
Hospital Germans Trias i Pujol
Barcelona, 08916, Spain
Hosp Univ Fundacion Alcorcon
Madrid, 28922, Spain
Hospital Universitario Doctor Peset
Valencia, 46017, Spain
Atatürk Gö?üs Hastal?klar? ve Gö?üs Cerrahisi E?itim ve Ara?t?rma Hastanesi
Ankara, 06290, Turkey (Türkiye)
Uludag University; Pulmonology and Allergy Department
Bursa, 16059, Turkey (Türkiye)
Izmir Dr. Suat Seren Gogus Hastaliklari ve Cerrahisi Egitim ve Arastirma Hastanesi
Izmir, 35110, Turkey (Türkiye)
Kirikkale Universitesi Tip Fakultesi Hastanesi
Kirikkale, 71100, Turkey (Türkiye)
Mersin University Medical Faculty
Mersin, 33169, Turkey (Türkiye)
Public Institution City Clinical Hospital # 6 of Dnipropetrovsk Regional Board
Dnipro, 49000, Ukraine
Regional Phthisiology and Pulmonology Center
Ivano-Frankivsk, 76018, Ukraine
City Clinical Hospital #27
Kharkiv, 61002, Ukraine
Central Outpatient Hospital of Desnyansky District
Kyiv, 02232, Ukraine
Yanovskyy Inst of Phth. & Pulm; Clinical-functional
Kyiv, 03680, Ukraine
Municipal Institution of Kyiv Regional Council Kyiv Regional Clinical Hospital
Kyiv, 04107, Ukraine
Kyiv City Clinical Hospital #8
Kyiv, 04201, Ukraine
Danylo Halytskyy National Medical University; Lviv
Lviv, 79010, Ukraine
Small Business Private Enterprise Medical Centre Pulse
Vinnytsia, 21001, Ukraine
Non-Commercial Enterprise City Clinical Hospital 1 of Zaporizhzhia City Council
Zaporizhzhia, 69104, Ukraine
St Peters Hospital
Chertsey, KT16 0PZ, United Kingdom
Castle Hill Hospital; Respiratory Medicine
Cottingham, HU16 5JQ, United Kingdom
St James University Hospital; Respiratory Department
Leeds, LS9 7TF, United Kingdom
Related Publications (3)
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.
PMID: 33217063DERIVEDN 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.
PMID: 31803473DERIVEDHanania 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.
PMID: 27616196DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Communications
- Organization
- Hoffmann-La Roche
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 29, 2013
First Posted
June 3, 2013
Study Start
July 25, 2013
Primary Completion
December 28, 2016
Study Completion
December 28, 2016
Last Updated
July 17, 2026
Results First Posted
July 17, 2026
Record last verified: 2026-06