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corticposteroids

Phase 2

Asthma | Small molecule | Respiratory |Roche Holding AG|Last Updated: Sep 6, 2017

Target and mechanism

ModalitySmall molecule

Also known as Inhaled corticposteroids (ICS)

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment64

FDA Designations

No designations recorded

Clinical trial landscape

corticposteroids · 1 trial · 1 indication

Phase 2 1
NCT02099656A Study Evaluating the Effects of Lebrikizumab on Airway Eosinophilic Inflammation in Participants With Uncontrolled AsthmaAsthma
COMPLETED64 Analytics
PHASE2COMPLETED
A Study Evaluating the Effects of Lebrikizumab on Airway Eosinophilic Inflammation in Participants With Uncontrolled Asthma
AsthmaUnlock trial analytics

Study Endpoints

Primary Endpoints

Relative Change From Baseline in the Number of Airway Submucosal Eosinophils per Surface Area of Basal Lamina (Cells per Square Millimeter [Cells/mm^2])
From Baseline to Week 12

Secondary Endpoints

Absolute Change From Baseline in Number of Airway Submucosal Eosinophils per Surface Area of Basal Lamina (Cells/mm^2)
From Baseline to Week 12
Relative Change From Baseline in the Number of Airway Epithelial Eosinophils per Surface Area of Basal Lamina (Cells/mm^2)
From Baseline to Week 12
Absolute Change From Baseline in Number of Airway Epithelial Eosinophils per Surface Area of Basal Lamina (Cells/mm^2)
From Baseline to Week 12
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
LebrikizumabEXPERIMENTALParticipants with uncontrolled asthma on ICS therapy (not specified in the protocol) and a second controller medication, will receive SC injection of lebrikizumab on Days 1 and 8, and on Weeks 4 and 8.
PlaceboPLACEBO_COMPARATORParticipants with uncontrolled asthma on ICS therapy (not specified in the protocol) and a second controller medication, will receive SC injection of lebrikizumab matching placebo on Days 1 and 8, and on Weeks 4 and 8.

Interventions

NameTypeDescription
LebrikizumabDRUGLebrikizumab will be administered by SC injection on Day 1, Day 8, Week 4, and Week 8.
PlaceboDRUGLebrikizumab matching placebo will be administered by SC injection on Day 1, Day 8, Week 4, and Week 8.
Inhaled corticposteroids (ICS)DRUGParticipants will continue their ICS controller therapy, as they are receiving prior to screening, throughout the study. Protocol does not specify any particular ICS.
Second Asthma Controller MedicationDRUGParticipants will continue their asthma controller therapy, as they are receiving prior to screening, throughout the study.
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Eligibility Criteria

Age Range18 Years to 75 Years
SexALL
Healthy VolunteersNo
Study Sites28

Inclusion Criteria: * Asthma diagnosis for greater than or equal to (\>/=) 12 months prior to Visit 1 * Bronchodilator response demonstrated within the 12 months before Visit 1 or at Visit 1, 2, or 3 of screening * Pre-bronchodilator FEV1 of 40 percent (%) - 80% predicted at both Visits 2 and 3 * O...

Countries:United StatesCanadaFranceIrelandSwedenUnited Kingdom
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