Recruitment

Recruitment Status
Completed
Estimated Enrollment
130

Inclusion Criterias

Baseline forced expiratory volume in 1 second (FEV1) >/=40% of predicted prior to randomization
Assessment to ensure diagnosis of refractory asthma and OCS dependence on minimal effective or maximum tolerated dose prior to Visit 1 with compliance
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
...
Baseline forced expiratory volume in 1 second (FEV1) >/=40% of predicted prior to randomization
Assessment to ensure diagnosis of refractory asthma and OCS dependence on minimal effective or maximum tolerated dose prior to Visit 1 with compliance
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
Severe asthma despite intensive follow-up by an asthma specialist for >/=6 months prior to Visit 1

Exclusion Criterias

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
History of interstitial lung disease, chronic obstructive pulmonary disease, or other clinically significant lung disease other than asthma
Current smoker or former smoker with a smoking history of more than 15 pack-years
...
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
History of interstitial lung disease, chronic obstructive pulmonary disease, or other clinically significant lung disease other than asthma
Current smoker or former smoker with a smoking history of more than 15 pack-years
Active parasitic infection or Listeria monocytogenes infection within 6 months prior to Visit 1 or during screening
Infection requiring hospital admission or requiring treatment with intravenous (IV) or intramuscular (IM) antibiotics within 4 weeks prior to Visit 1 or during screening
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
Evidence of acute or chronic hepatitis or known liver cirrhosis
Known current malignancy or current evaluation for a potential malignancy
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)
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
For adults: Active tuberculosis requiring treatment within the 12 months prior to Visit 1
For adolescents: History of active tuberculosis requiring treatment
Upper or lower respiratory tract infection within 4 weeks prior to Visit 1 or during screening

Summary

Conditions
Asthma
Type
Interventional
Phase
Phase 2
Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Double (Participant, Investigator)
  • Primary Purpose: Treatment

Participation Requirements

Age
Between 12 years and 75 years
Gender
Both males and females

Inclusion Criterias

Baseline forced expiratory volume in 1 second (FEV1) >/=40% of predicted prior to randomization
Assessment to ensure diagnosis of refractory asthma and OCS dependence on minimal effective or maximum tolerated dose prior to Visit 1 with compliance
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
...
Baseline forced expiratory volume in 1 second (FEV1) >/=40% of predicted prior to randomization
Assessment to ensure diagnosis of refractory asthma and OCS dependence on minimal effective or maximum tolerated dose prior to Visit 1 with compliance
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
Severe asthma despite intensive follow-up by an asthma specialist for >/=6 months prior to Visit 1

Exclusion Criterias

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
History of interstitial lung disease, chronic obstructive pulmonary disease, or other clinically significant lung disease other than asthma
Current smoker or former smoker with a smoking history of more than 15 pack-years
...
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
History of interstitial lung disease, chronic obstructive pulmonary disease, or other clinically significant lung disease other than asthma
Current smoker or former smoker with a smoking history of more than 15 pack-years
Active parasitic infection or Listeria monocytogenes infection within 6 months prior to Visit 1 or during screening
Infection requiring hospital admission or requiring treatment with intravenous (IV) or intramuscular (IM) antibiotics within 4 weeks prior to Visit 1 or during screening
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
Evidence of acute or chronic hepatitis or known liver cirrhosis
Known current malignancy or current evaluation for a potential malignancy
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)
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
For adults: Active tuberculosis requiring treatment within the 12 months prior to Visit 1
For adolescents: History of active tuberculosis requiring treatment
Upper or lower respiratory tract infection within 4 weeks prior to Visit 1 or during screening

Locations

Wellington
Glasgow, G12 0YN
Krakow, 31-024
Miami, Florida, 33135
Glasgow, G51 4TF
...
Wellington
Glasgow, G12 0YN
Krakow, 31-024
Miami, Florida, 33135
Glasgow, G51 4TF
Plymouth, PL6 8DH
Hampshire, SO16 6YD
Ruda Śląska, 41-707
Lodz, 90-153
Salamanca, 37007
Nový Jičín, 741-01
Tulsa, Oklahoma, 74136
Nedlands, Western Australia, 6009
Bakersfield, California, 93301
Auckland, 1051
Gent, 9000
Querétaro, 76800
Tacoma, Washington, 98405
Glasgow, G31 2ER
Rokycany, 337 22
McKinney, Texas, 75069
Bruxelles, 1070
Long Beach, California, 90808
Strabourg, 67091
Krakow, 31-624
London, EC1A 7BE
Ostrow Wielkopolski, 63-400
Pessac, 33604
Cidra, 00739
Le Kremlin Bicetre, 94275
Nice Cedex 1, 06001
Valencia, 46017
Warszawa, 02-507
Albany, Georgia, 31707
New York, New York, 10029
Guadalajara, 44130
Genk, 3600
Caguas, 00725
Nantes, 44093
Spisska Nova Ves, 052 01
Liberec 1, 460 63
Leicester, LE1 5WW
Guadalajara, 44100
Golnik, 4204
Paris, 75877
London, SW3 6NP
Grenoble Cedex 9, 38043
Belfast, BT9 7AB
Amsterdam, 1105 AZ
Tauranga, 3143
Levice, 934 01
Toronto, Ontario, M5T 3A9
Dunedin
Nieuwegein, 3435 CM
Barcelona, 08036
Montpellier, 34295
Houston, Texas, 77008
Brisbane, Queensland, 4102
Wrocław, 50-220
Birmingham, B9 5SS
Sheffield, S10 2JF
Leicester, LE3 9QP
Santiago de Compostela, La Coruña, 15706
Barcelona, 08025
Lyon, 69004
Hellerup, 2900
Brno, 618 00
Hoofddorp, 2134 TM
Manchester, M23 9LT
Clayton, Victoria, 3168
Newcastle upon Tyne, NE7 7DN

Tracking Information

NCT #
NCT01987492
Collaborators
Not Provided
Investigators
Study Director: Clinical Trials Hoffmann-La Roche