A Phase III Study of Lebrikizumab in Adolescent Patients with Uncontrolled Asthma

A PHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO ASSESS THE EFFICACY, SAFETY, AND TOLERABILITY OF LEBRIKIZUMAB IN ADOLESCENT 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-jRCT2080223137

Enrollment

375

Registered

2016-03-09

Start date

2016-03-09

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%-90% 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, clinically significant lung disease other than asthma -Past and/or current use of any anti-IL-13 or anti-IL-4/IL-13 therapy, including lebrikizumab -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+12 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+12 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