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

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ClinicalTrials.gov Identifier: NCT01867125
Recruitment Status : Completed
First Posted : June 3, 2013
Last Update Posted : May 19, 2017
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

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.

Condition or disease Intervention/treatment Phase
Asthma Drug: Lebrikizumab Drug: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1081 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : July 31, 2013
Actual Primary Completion Date : January 2, 2017
Actual Study Completion Date : January 2, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma Steroids

Arm Intervention/treatment
Experimental: Lebrikizumab (125 mg)
Participants will receive SC injection of lebrikizumab (125 milligrams [mg]) every 4 weeks for 104 weeks.
Drug: Lebrikizumab
Lebrikizumab will be administered as SC injection at 125 or 37.5 mg every 4 weeks, for 104 weeks.
Other Name: RO5490255

Experimental: Lebrikizumab (37.5 mg)
Participants will receive SC injection of lebrikizumab (37.5 mg) every 4 weeks for 104 weeks.
Drug: Lebrikizumab
Lebrikizumab will be administered as SC injection at 125 or 37.5 mg every 4 weeks, for 104 weeks.
Other Name: RO5490255

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

Placebo Comparator: Placebo
Participants 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.
Drug: Lebrikizumab
Lebrikizumab will be administered as SC injection at 125 or 37.5 mg every 4 weeks, for 104 weeks.
Other Name: RO5490255

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




Primary Outcome Measures :
  1. Rate of Asthma Exacerbations During the 52-Week Placebo-Controlled Period [ Time Frame: Baseline up to 52 weeks ]

Secondary Outcome Measures :
  1. Absolute Change From Baseline in Pre-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1) [ Time Frame: Baseline, Week 52 ]
  2. Time to First Asthma Exacerbation [ Time Frame: Baseline up to 52 weeks ]
  3. Change From Baseline in Standardized Asthma Quality of Life Questionnaire (AQLQ) Score [ Time Frame: Baseline, Week 52 ]
  4. Change from Baseline In Asthma Rescue Medication (Number of Puffs or Nebulized Treatments) [ Time Frame: Baseline, Week 52 ]
  5. Rate of Urgent Asthma-Related Urgent Health Care Utilization [ Time Frame: Baseline up to Week 52 ]
  6. Percentage of Participants With Anti-Therapeutic Antibodies to Lebrikizumab [ Time Frame: Baseline up to Week 124 (assessed at Baseline, Weeks 4, 12, 24, 36, 52, 64, 76, 92, 104, 112, and 124) ]
  7. Change From Baseline in Asthma Control Questionnaire-5 (ACQ-5) Score [ Time Frame: Baseline, Week 52 ]
  8. Percentage of Participants With Adverse Events [ Time Frame: Baseline, Week 124 ]
  9. Minimum Serum Concentration (Cmin) of Lebrikizumab [ Time Frame: Predose (0 hour) on Weeks 4, 12, 24, 36, and 52 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01867125


  Show 230 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01867125     History of Changes
Other Study ID Numbers: GB28688
2013-000175-33 ( EudraCT Number )
First Posted: June 3, 2013    Key Record Dates
Last Update Posted: May 19, 2017
Last Verified: May 2017

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs