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CAT-354

Phase 2

Asthma | Monoclonal antibody | Respiratory |AstraZeneca PLC|Last Updated: May 4, 2017

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-BlindCONTROLLEDBiomarker
Total Trials2
Total Enrollment387
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00873860Study to Evaluate the Safety and Efficacy of CAT-354PHASE2 COMPLETED 357Jun 1, 2009Aug 1, 2010Mar 24, 201757 Bulgaria, Germany +3
NCT00638989A Study to Assess Bioavailability and Pharmacokinetics of CAT- 354PHASE1 COMPLETED 30Apr 11, 2008Jun 7, 2008May 4, 20171 United States
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Study Endpoints
Primary Endpoints
Change From Baseline in the Mean Asthma Control Questionnaire (ACQ) Score at Day 92
Day 1 and 92

Asthma Control Questionnaire (ACQ) is a participant-reported questionnaire to assess the asthma control with 6 items assessing night-time waking, symptoms on waking, activity limitation, shortness of breath, wheeze, and rescue short-acting beta agonist use. Each item was rated on a 7-point Likert scale ranging from 0 (no impairment) to 6 (maximum impairment). Overall ACQ score is the mean of the 6 item scores with a score range of 0 (well controlled) to 6 (extremely poor controlled). Data collected on Day 1 prior to dosing was considered as baseline. Results were reported for overall ACQ score.

Absolute Bioavailability of CAT-354 After Subcutaneous Dose
Predose, end of infusion, 30 minutes, 1, 3, 8 and 24 hours post-end of infusion/post-injection on Day 0; Day 3, 5, 7, 9, 14, 21, 28, 35, 42 and 56

Bioavailability (F) is a measurement of the rate and extent to which a drug reaches the systemic circulation. Absolute bioavailability of the subcutaneous doses was assessed by the geometric least-square means ratios of subcutaneous to intravenous dose-normalized area under the serum concentration-time curve from time zero to infinity (AUC \[0 - infinity\]/Dose). AUC (0 - infinity) = Area under the serum concentration versus time curve (AUC) from time zero (predose) to extrapolated infinite time (0 - infinity). It is obtained from AUC (0 - t) plus AUC (t - infinity).

Secondary Endpoints
Time to First Observed Asthma Control
Day 1 to Day 92 and Day 169
Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) Recorded at Study Sites at Day 1, 15, 29, 43, 57, 71, 85, 92, 127 and 169
Day 1, 15, 29, 43, 57, 71, 85, 92, 127 and 169
Change From Baseline in Peak Expiratory Flow (PEF) Recorded at Home Every Week From Day 1 to 169
Day -7 to 1 (predose), Day 2 to 169
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
PlaceboPLACEBO_COMPARATORPlacebo matched to CAT-354 subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
CAT-354 150 mgEXPERIMENTALCAT-354 150 milligram (mg) subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
CAT-354 300 mgEXPERIMENTALCAT-354 300 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
CAT-354 600 mgEXPERIMENTALCAT-354 600 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
CAT-354 150 mg (intravenous)EXPERIMENTALA single dose of CAT-354 150 milligram (mg) intravenous infusion over 30 minutes on Day 0.
CAT-354 150 mg (subcutaneous)EXPERIMENTALA single dose of CAT-354 150 mg injection subcutaneously on Day 0.
CAT-354 300 mg (subcutaneous)EXPERIMENTALA single dose of CAT-354 300 mg injection subcutaneously on Day 0.
Interventions
NameTypeDescription
PlaceboOTHERPlacebo matched to CAT-354 subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
CAT-354 150 mgBIOLOGICALCAT-354 150 milligram (mg) subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
CAT-354 300 mgBIOLOGICALCAT-354 300 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
CAT-354 600 mgBIOLOGICALCAT-354 600 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
CAT-354 150 mg (intravenous)BIOLOGICALA single dose of CAT-354 150 milligram (mg) intravenous infusion over 30 minutes on Day 0.
CAT-354 150 mg (subcutaneous)BIOLOGICALA single dose of CAT-354 150 mg injection subcutaneously on Day 0.
CAT-354 300 mg (subcutaneous)BIOLOGICALA single dose of CAT-354 300 mg injection subcutaneously on Day 0.
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersNo
Study Sites57

Inclusion Criteria: * Male or female subjects * Age 18 to 65 years at the time of Screening * Subjects must have a body mass index (BMI) between 18 and 40 kilogram per square meter (kg/m\^2) * Written informed consent obtained from the subject prior to performing any protocol related procedures, in...

Countries:BulgariaGermanyPolandRomaniaUnited KingdomUnited States
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