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Experimental: Tralokinumab

Phase 3

Uncontrolled Asthma | Monoclonal antibody | Respiratory |AstraZeneca PLC|Last Updated: May 15, 2018

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment856
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02194699A Phase 3 Study to Evaluate the Efficacy and Safety of Tralokinumab in Adults and Adolescents With Uncontrolled AsthmaPHASE3 COMPLETED 856Oct 30, 2014Sep 21, 2017May 15, 2018234 United States, Canada +11
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Study Endpoints
Primary Endpoints
Annualised Asthma Exacerbation Rate (AAER) up to Week 52
Baseline (Week 0) up to Week 52

Asthma exacerbation was defined as a worsening of asthma that led to any of the following: * Use of systemic corticosteroids for at least 3 days; a single depo-injectable dose of corticosteroids was considered equivalent to a 3-day course of systemic corticosteroids. * An emergency room (ER) or urgent care (UC) visit (defined as evaluation and treatment for \<24 hours in an ER or UC centre) due to asthma that required systemic corticosteroids (see above). * An inpatient hospitalisation (defined as admission to an inpatient facility and/or evaluation and treatment in a healthcare facility for ≥24 hours) due to asthma. AAER = number of exacerbations\*365.25 / (follow-up date - date of randomisation + 1) (where maximum follow-up time for a patient was approximately 52 weeks). AAER in the tralokinumab group was compared to that seen in the placebo group up to Week 52 using a negative binomial model; rate ratios and rate reductions are both presented for comparative statistical analyses.

Secondary Endpoints
Percent Change From Baseline to Week 52 in Pre-dose/Pre-bronchodilator (BD) Forced Expiratory Volume in 1 Second (FEV1)
Baseline (Week 0) and Week 52
Change From Baseline to Week 52 in Total Asthma Symptom Score (Bi-weekly Means)
Baseline (Week 0) and Week 52
Change From Baseline to Week 52 in Asthma Quality of Life Questionnaire for 12 Years and Older (AQLQ(S)+12) Total Score
Baseline (Week 0) and Week 52
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
TralokinumabEXPERIMENTALTralokinumab subcutaneous injection
PlaceboPLACEBO_COMPARATORPlacebo subcutaneous injection
Interventions
NameTypeDescription
Experimental: TralokinumabBIOLOGICALTralokinumab subcutaneous injection
PlaceboOTHERPlacebo subcutaneous injection
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Eligibility Criteria
Age Range12 Years — 75 Years
SexALL
Healthy VolunteersNo
Study Sites234

Inclusion Criteria: 1. Age 12 -75 2. Documented physician-diagnosed asthma. 3. Documented treatment with ICS at a total daily dose corresponding to ≥500μg fluticasone propionate dry powder formulation equivalents) and a LABA 4. Morning pre-BD FEV1 value of ≥40 and \<80% value (\<90% for patients 12...

Countries:United StatesCanadaChileCzechiaItalyJapanMexicoPhilippinesRussiaSouth AfricaTaiwanUkraineUnited Kingdom
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