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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01987492
First Posted: November 19, 2013
Last Update Posted: May 22, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Hoffmann-La Roche
  Purpose
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.

Condition Intervention Phase
Asthma Drug: Lebrikizumab Drug: Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Relative Change From Baseline in Daily OCS Dose at Week 44 [ Time Frame: Baseline, Week 44 ]

Secondary Outcome Measures:
  • Absolute Change From Baseline in Daily OCS Dose at Week 44 [ Time Frame: Baseline, Week 44 ]
  • Relative Change From Week 12 in Average OCS Dose at Week 44 [ Time Frame: 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 ]
  • 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.

  • 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.

  • 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) ]
  • 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) ]
  • Minimum Observed Serum Lebrikizumab Concentration (Cmin) [ Time Frame: Predose (0 hours) at Weeks 4, 12, 24, 36, and 44 ]

Enrollment: 230
Actual Study Start Date: February 28, 2014
Study Completion Date: December 20, 2016
Primary Completion Date: December 20, 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Drug: Lebrikizumab
Lebrikizumab will be administered as SC injections every 4 weeks at dose and schedule described in arm description.
Other Name: RO5490255
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.
Drug: Lebrikizumab
Lebrikizumab will be administered as SC injections every 4 weeks at dose and schedule described in arm description.
Other Name: RO5490255
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.
Drug: Lebrikizumab
Lebrikizumab will be administered as SC injections every 4 weeks at dose and schedule described in arm description.
Other Name: RO5490255
Drug: Placebo
Placebo matching to lebrikizumab will be administered as SC injections every 4 weeks as per schedule described in arm description.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   12 Years to 75 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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): NCT01987492


  Show 71 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01987492     History of Changes
Other Study ID Numbers: WB28182
2012-000190-24 ( EudraCT Number )
First Submitted: November 12, 2013
First Posted: November 19, 2013
Last Update Posted: May 22, 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