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A Study of Lebrikizumab (RO5490255) in Participants With Severe Oral Corticosteroids (OCS) Dependent Asthma

Primary Purpose

Asthma

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Lebrikizumab
Placebo
Sponsored by
Hoffmann-La Roche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma

Eligibility Criteria

12 Years - 75 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Kern Allergy Med Clinic, Inc.
  • Allergy & Asthma Care Center of Southern California
  • South Florida Research Center, Inc.
  • Georgia Pollens
  • Mount Sinai Medical Center
  • Allergy & Immunology
  • Pioneer Research Solutions
  • Metroplex Pulmonology & Sleep Center
  • Pulmonary Consultants PLLC
  • Princess Alexandra Hospital, Department of Respiratory and Sleep Medicine
  • Monash Medical Centre; Respiratory and Sleep Medicine
  • Institute for Respiratory Health Inc
  • Clin Univ de Bxl Hôpital Erasme
  • Longartsenpraktijk
  • UZ Gent
  • Inspiration Research Limited
  • Hornmed
  • Nemocnice Liberec; KNL a.s. - TRN
  • Nemocnice Nový Jičín
  • Rokycanska nemocnice
  • Gentofte Hospital, Klinik for Allergi
  • CHU de Grenoble - Hôpital André Michallon
  • CH de Bicetre; Pneumologie
  • Hôpital de La Croix Rousse
  • Hôpital Arnaud de Villeneuve
  • CHU Nantes - Hôpital Laennec; Service de Pneumologie
  • CHU de Nice
  • Hopital Bichat Claude Bernard ; Service de Pneumologie
  • CHU de Haut Leveque
  • Nouvel Hôpital Civil; Pôle de Pathologie Thoracique
  • Instituto Jalisciense de Investigacion Clinica S.A. de C.V.
  • Centro Investigacion Medico Biologica y Terapia Avanzada
  • Centro Integral Médico SJR SC
  • Academisch Medisch Centrum; Afdeling Longziekten, F5-258
  • Spaarne Ziekenhuis Hoofddorp; Long Geneeskunde
  • Antonius Ziekenhuis; Dept of Lung Diseases
  • NZ Respiratory & Sleep Institute
  • Dunedin Hospital
  • Clinical Trials Unit, Bay of Plenty District Health Board
  • Medical Research Inst. of New Zealand; Respiratory
  • Specjalistyczny Osrodek Alergologiczno-Internistyczny ALL-MED
  • Malopolskie Centrum Alergologii
  • SPZOZ Uniwersytecki Szpital Kliniczny nr 1 im. Norberta Barlickiego Uniwersytetu Medycznego w Lodzi
  • Specjalistyczna Poradnia Pulmonologiczna
  • Niepubliczny Zaklad Opieki Zdrowotnej PROFILAKTYKA Wladyslaw Pierzchala
  • Klinika Chorób Wewnetrznych i Alergologii MSW
  • EMC Instytut Medyczny SA; Przychodnia przy ulicy Łowieckiej
  • San Juan Bautista School of Medicine-Clinical Research Unit
  • Advanced Medical Concepts, PSC
  • ZAPA JJ Sro
  • Plucna ambulancia
  • University Clinic of Pulmonary and Allergic Diseases Golnik
  • Complejo Hospitalario Universitario de Santiago; Servicio de Neumología
  • Hospital de la Santa Creu; i Sant Pau
  • Hospital Clinic de Barcelona
  • Hospital Clinico Universitario de Salamanca; Servicio de Neumologia
  • Hospital Universitario Doctor Peset
  • Belfast City Hospital; Respiratory Department
  • Heartlands Hospital; Respiratory Department
  • Gartnavel General Hospital; Respiratory Department
  • New Lister Buliding, Level 1; Clinical Research Facility
  • Royal Hospital For Children
  • Southampton General Hospital; Respiratory Department
  • Leicester Royal Infirmary NHS Trust
  • Glenfield Hospital; Respiratory -Allergy Unit
  • St Bartholomew's Hospital (Barts); Respiratory Department
  • Royal Brompton Hospital; Respiratory Department
  • Wythenshawe Hospital; North West Lung Research Centre
  • Freeman Hospital; Respiratory Department
  • Derriford Hospital; The Lind Research Department
  • Sheffield Clinical Research Facility; National Institute for Health Research

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Lebrikizumab High Dose

Lebrikizumab Low Dose

Placebo

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Relative Change From Baseline in Daily OCS Dose at Week 44

Secondary Outcome Measures

Absolute Change From Baseline in Daily OCS Dose at Week 44
Relative Change From Week 12 in Average OCS Dose at Week 44
Percentage of Participants Achieving at Least a 50 percent (%) Reduction in Their Daily OCS Dose at Week 44 Relative to Baseline
Percentage of Participants Discontinuing OCS Therapy or Having Achieved an Adrenal Maintenance Dose at 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.
Percentage of Participants With Asthma Exacerbations
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.
Percentage of Participants With Adverse Events
Percentage of Participants With Anti-therapeutic Antibodies (ATAs) Against Lebrikizumab
Minimum Observed Serum Lebrikizumab Concentration (Cmin)

Full Information

First Posted
November 12, 2013
Last Updated
May 19, 2017
Sponsor
Hoffmann-La Roche
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1. Study Identification

Unique Protocol Identification Number
NCT01987492
Brief Title
A Study of Lebrikizumab (RO5490255) in Participants With Severe Oral Corticosteroids (OCS) Dependent Asthma
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
February 28, 2014 (Actual)
Primary Completion Date
December 20, 2016 (Actual)
Study Completion Date
December 20, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
230 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lebrikizumab High Dose
Arm Type
Experimental
Arm Description
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.
Arm Title
Lebrikizumab Low Dose
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Lebrikizumab
Other Intervention Name(s)
RO5490255
Intervention Description
Lebrikizumab will be administered as SC injections every 4 weeks at dose and schedule described in arm description.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo matching to lebrikizumab will be administered as SC injections every 4 weeks as per schedule described in arm description.
Primary Outcome Measure Information:
Title
Relative Change From Baseline in Daily OCS Dose at Week 44
Time Frame
Baseline, Week 44
Secondary Outcome Measure Information:
Title
Absolute Change From Baseline in Daily OCS Dose at Week 44
Time Frame
Baseline, Week 44
Title
Relative Change From Week 12 in Average OCS Dose at Week 44
Time Frame
Week 12, Week 44
Title
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
Title
Percentage of Participants Discontinuing OCS Therapy or Having Achieved an Adrenal Maintenance Dose at Week 44
Description
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.
Time Frame
Week 44
Title
Percentage of Participants With Asthma Exacerbations
Description
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.
Time Frame
Baseline up to Week 44
Title
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)
Title
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)
Title
Minimum Observed Serum Lebrikizumab Concentration (Cmin)
Time Frame
Predose (0 hours) at Weeks 4, 12, 24, 36, and 44

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
Facility Name
Kern Allergy Med Clinic, Inc.
City
Bakersfield
State/Province
California
ZIP/Postal Code
93301
Country
United States
Facility Name
Allergy & Asthma Care Center of Southern California
City
Long Beach
State/Province
California
ZIP/Postal Code
90808
Country
United States
Facility Name
South Florida Research Center, Inc.
City
Miami
State/Province
Florida
ZIP/Postal Code
33135
Country
United States
Facility Name
Georgia Pollens
City
Albany
State/Province
Georgia
ZIP/Postal Code
31707
Country
United States
Facility Name
Mount Sinai Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Allergy & Immunology
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74136
Country
United States
Facility Name
Pioneer Research Solutions
City
Houston
State/Province
Texas
ZIP/Postal Code
77008
Country
United States
Facility Name
Metroplex Pulmonology & Sleep Center
City
McKinney
State/Province
Texas
ZIP/Postal Code
75069
Country
United States
Facility Name
Pulmonary Consultants PLLC
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Facility Name
Princess Alexandra Hospital, Department of Respiratory and Sleep Medicine
City
Brisbane
State/Province
Queensland
ZIP/Postal Code
4102
Country
Australia
Facility Name
Monash Medical Centre; Respiratory and Sleep Medicine
City
Clayton
State/Province
Victoria
ZIP/Postal Code
3168
Country
Australia
Facility Name
Institute for Respiratory Health Inc
City
Nedlands
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
Facility Name
Clin Univ de Bxl Hôpital Erasme
City
Bruxelles
ZIP/Postal Code
1070
Country
Belgium
Facility Name
Longartsenpraktijk
City
Genk
ZIP/Postal Code
3600
Country
Belgium
Facility Name
UZ Gent
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
Inspiration Research Limited
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T 3A9
Country
Canada
Facility Name
Hornmed
City
Brno
ZIP/Postal Code
618 00
Country
Czechia
Facility Name
Nemocnice Liberec; KNL a.s. - TRN
City
Liberec 1
ZIP/Postal Code
460 63
Country
Czechia
Facility Name
Nemocnice Nový Jičín
City
Nový Jičín
ZIP/Postal Code
741-01
Country
Czechia
Facility Name
Rokycanska nemocnice
City
Rokycany
ZIP/Postal Code
337 22
Country
Czechia
Facility Name
Gentofte Hospital, Klinik for Allergi
City
Hellerup
ZIP/Postal Code
2900
Country
Denmark
Facility Name
CHU de Grenoble - Hôpital André Michallon
City
Grenoble Cedex 9
ZIP/Postal Code
38043
Country
France
Facility Name
CH de Bicetre; Pneumologie
City
Le Kremlin Bicetre
ZIP/Postal Code
94275
Country
France
Facility Name
Hôpital de La Croix Rousse
City
Lyon
ZIP/Postal Code
69004
Country
France
Facility Name
Hôpital Arnaud de Villeneuve
City
Montpellier
ZIP/Postal Code
34295
Country
France
Facility Name
CHU Nantes - Hôpital Laennec; Service de Pneumologie
City
Nantes
ZIP/Postal Code
44093
Country
France
Facility Name
CHU de Nice
City
Nice Cedex 1
ZIP/Postal Code
06001
Country
France
Facility Name
Hopital Bichat Claude Bernard ; Service de Pneumologie
City
Paris
ZIP/Postal Code
75877
Country
France
Facility Name
CHU de Haut Leveque
City
Pessac
ZIP/Postal Code
33604
Country
France
Facility Name
Nouvel Hôpital Civil; Pôle de Pathologie Thoracique
City
Strabourg
ZIP/Postal Code
67091
Country
France
Facility Name
Instituto Jalisciense de Investigacion Clinica S.A. de C.V.
City
Guadalajara
ZIP/Postal Code
44100
Country
Mexico
Facility Name
Centro Investigacion Medico Biologica y Terapia Avanzada
City
Guadalajara
ZIP/Postal Code
44130
Country
Mexico
Facility Name
Centro Integral Médico SJR SC
City
Querétaro
ZIP/Postal Code
76800
Country
Mexico
Facility Name
Academisch Medisch Centrum; Afdeling Longziekten, F5-258
City
Amsterdam
ZIP/Postal Code
1105 AZ
Country
Netherlands
Facility Name
Spaarne Ziekenhuis Hoofddorp; Long Geneeskunde
City
Hoofddorp
ZIP/Postal Code
2134 TM
Country
Netherlands
Facility Name
Antonius Ziekenhuis; Dept of Lung Diseases
City
Nieuwegein
ZIP/Postal Code
3435 CM
Country
Netherlands
Facility Name
NZ Respiratory & Sleep Institute
City
Auckland
ZIP/Postal Code
1051
Country
New Zealand
Facility Name
Dunedin Hospital
City
Dunedin
Country
New Zealand
Facility Name
Clinical Trials Unit, Bay of Plenty District Health Board
City
Tauranga
ZIP/Postal Code
3143
Country
New Zealand
Facility Name
Medical Research Inst. of New Zealand; Respiratory
City
Wellington
Country
New Zealand
Facility Name
Specjalistyczny Osrodek Alergologiczno-Internistyczny ALL-MED
City
Krakow
ZIP/Postal Code
31-024
Country
Poland
Facility Name
Malopolskie Centrum Alergologii
City
Krakow
ZIP/Postal Code
31-624
Country
Poland
Facility Name
SPZOZ Uniwersytecki Szpital Kliniczny nr 1 im. Norberta Barlickiego Uniwersytetu Medycznego w Lodzi
City
Lodz
ZIP/Postal Code
90-153
Country
Poland
Facility Name
Specjalistyczna Poradnia Pulmonologiczna
City
Ostrow Wielkopolski
ZIP/Postal Code
63-400
Country
Poland
Facility Name
Niepubliczny Zaklad Opieki Zdrowotnej PROFILAKTYKA Wladyslaw Pierzchala
City
Ruda Śląska
ZIP/Postal Code
41-707
Country
Poland
Facility Name
Klinika Chorób Wewnetrznych i Alergologii MSW
City
Warszawa
ZIP/Postal Code
02-507
Country
Poland
Facility Name
EMC Instytut Medyczny SA; Przychodnia przy ulicy Łowieckiej
City
Wrocław
ZIP/Postal Code
50-220
Country
Poland
Facility Name
San Juan Bautista School of Medicine-Clinical Research Unit
City
Caguas
ZIP/Postal Code
00725
Country
Puerto Rico
Facility Name
Advanced Medical Concepts, PSC
City
Cidra
ZIP/Postal Code
00739
Country
Puerto Rico
Facility Name
ZAPA JJ Sro
City
Levice
ZIP/Postal Code
934 01
Country
Slovakia
Facility Name
Plucna ambulancia
City
Spisska Nova Ves
ZIP/Postal Code
052 01
Country
Slovakia
Facility Name
University Clinic of Pulmonary and Allergic Diseases Golnik
City
Golnik
ZIP/Postal Code
4204
Country
Slovenia
Facility Name
Complejo Hospitalario Universitario de Santiago; Servicio de Neumología
City
Santiago de Compostela
State/Province
La Coruña
ZIP/Postal Code
15706
Country
Spain
Facility Name
Hospital de la Santa Creu; i Sant Pau
City
Barcelona
ZIP/Postal Code
08025
Country
Spain
Facility Name
Hospital Clinic de Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hospital Clinico Universitario de Salamanca; Servicio de Neumologia
City
Salamanca
ZIP/Postal Code
37007
Country
Spain
Facility Name
Hospital Universitario Doctor Peset
City
Valencia
ZIP/Postal Code
46017
Country
Spain
Facility Name
Belfast City Hospital; Respiratory Department
City
Belfast
ZIP/Postal Code
BT9 7AB
Country
United Kingdom
Facility Name
Heartlands Hospital; Respiratory Department
City
Birmingham
ZIP/Postal Code
B9 5SS
Country
United Kingdom
Facility Name
Gartnavel General Hospital; Respiratory Department
City
Glasgow
ZIP/Postal Code
G12 0YN
Country
United Kingdom
Facility Name
New Lister Buliding, Level 1; Clinical Research Facility
City
Glasgow
ZIP/Postal Code
G31 2ER
Country
United Kingdom
Facility Name
Royal Hospital For Children
City
Glasgow
ZIP/Postal Code
G51 4TF
Country
United Kingdom
Facility Name
Southampton General Hospital; Respiratory Department
City
Hampshire
ZIP/Postal Code
SO16 6YD
Country
United Kingdom
Facility Name
Leicester Royal Infirmary NHS Trust
City
Leicester
ZIP/Postal Code
LE1 5WW
Country
United Kingdom
Facility Name
Glenfield Hospital; Respiratory -Allergy Unit
City
Leicester
ZIP/Postal Code
LE3 9QP
Country
United Kingdom
Facility Name
St Bartholomew's Hospital (Barts); Respiratory Department
City
London
ZIP/Postal Code
EC1A 7BE
Country
United Kingdom
Facility Name
Royal Brompton Hospital; Respiratory Department
City
London
ZIP/Postal Code
SW3 6NP
Country
United Kingdom
Facility Name
Wythenshawe Hospital; North West Lung Research Centre
City
Manchester
ZIP/Postal Code
M23 9LT
Country
United Kingdom
Facility Name
Freeman Hospital; Respiratory Department
City
Newcastle upon Tyne
ZIP/Postal Code
NE7 7DN
Country
United Kingdom
Facility Name
Derriford Hospital; The Lind Research Department
City
Plymouth
ZIP/Postal Code
PL6 8DH
Country
United Kingdom
Facility Name
Sheffield Clinical Research Facility; National Institute for Health Research
City
Sheffield
ZIP/Postal Code
S10 2JF
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

A Study of Lebrikizumab (RO5490255) in Participants With Severe Oral Corticosteroids (OCS) Dependent Asthma

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