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

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT01987492
• Date of registration: 12/11/2013
• Prospective Registration: Yes
• Primary sponsor: Hoffmann-La Roche
• Public title: A Study of Lebrikizumab (RO5490255) in Participants With Severe Oral Corticosteroids (OCS) Dependent Asthma
• Scientific 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
• Date of first enrolment: February 28, 2014
• Target sample size: 230
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01987492
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 2

Countries of recruitment

Australia, Belgium, Bulgaria, Canada, Czech Republic, Czechia, Denmark, France, Mexico, Netherlands, New Zealand, Poland, Puerto Rico, Slovakia, Slovenia, Spain, United Kingdom, United States

Contacts

• Name: Clinical Trials
• Affiliation: Hoffmann-La Roche

Key inclusion & exclusion 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



Age minimum: 12 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Asthma

Intervention(s)

Drug: Lebrikizumab

Drug: Placebo

Primary Outcome(s)

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

Secondary Outcome(s)

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 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 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]

Percentage of Participants Discontinuing OCS Therapy or Having Achieved an Adrenal Maintenance Dose at Week 44 [Time Frame: Week 44]

Relative Change From Week 12 in Average OCS Dose at Week 44 [Time Frame: Week 12, Week 44]

Absolute Change From Baseline in Daily OCS Dose at Week 44 [Time Frame: Baseline, Week 44]

Percentage of Participants With Asthma Exacerbations [Time Frame: Baseline up to Week 44]

Secondary ID(s)

2012-000190-24

WB28182

Source(s) of Monetary Support

Please refer to primary and secondary sponsors