A Phase III Study of Lebrikizumab in Patients with Uncontrolled Asthma

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

Status

Unknown

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080222268

Enrollment

1050

Registered

2013-10-30

Start date

2013-10-30

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma

Interventions

investigational material(s) Generic name etc : RO5490255 INN of investigational material : lebrikizumab Therapeutic category code : 229 Other agents affecting respiratory organs Dosage and Administrat

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Bronchodilator response (defined as >= 12% relative improvement in FEV1) - Pre-bronchodilator FEV1 of 40%-80% predicted - On ICS therapy of protocol spedified dose and an eligible second controller medication - Uncontrolled asthma

Exclusion criteria

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 - History of interstitial lung disease, COPD, or other clinically significant lung disease other than asthma - Current smoker, former smoker with smoking history of > 10 pack-years - Past and/or current use of any anti-IL-13 or anti-IL-4/IL-13 therapy, including lebrikizumab - Female patients of reproductive potential who are unwilling to use a highly effective method of contraception for the duration of the study - Pregnant or lactating - Body mass index > 38 kg/m2 - Body weight < 40 kg

Design outcomes

Primary

Measure	Time frame
Rate of asthma exacerbations Rate of asthma exacerbations will be compared between each active treatment arm and the placebo arm	—

Secondary

Measure	Time frame
- FEV1 - Time to First Asthma Exacerbation - Fractional Exhaled Nitric Oxide - Asthma-Specific Health-Related Quality of Life - Asthma Rescue Medication Use - Unscheduled Asthma-Related Medical Visits - the difference in mean relative change in pre-bronchodilator FEV1 from baseline to Week 52 - the hazard ratio of time to the first protocol-defined asthma exacerbation - the mean change in FeNO level from baseline to Week 52 - the difference in mean change in the overall score of AQLQ(S) from baseline to Week 52 - the mean change in number of puffs or nebulized treatments of rescue medication from baseline to Week 52 - the rate of urgent asthma-related health care utilization during the placebo-controlled period	—

Measure

Time frame

- FEV1 - Time to First Asthma Exacerbation - Fractional Exhaled Nitric Oxide - Asthma-Specific Health-Related Quality of Life - Asthma Rescue Medication Use - Unscheduled Asthma-Related Medical Visits - the difference in mean relative change in pre-bronchodilator FEV1 from baseline to Week 52 - the hazard ratio of time to the first protocol-defined asthma exacerbation - the mean change in FeNO level from baseline to Week 52 - the difference in mean change in the overall score of AQLQ(S) from baseline to Week 52 - the mean change in number of puffs or nebulized treatments of rescue medication from baseline to Week 52 - the rate of urgent asthma-related health care utilization during the placebo-controlled period

—

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026