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IMA-638

Phase 2

Asthma | Small molecule | Respiratory |Pfizer, Inc.|Last Updated: Jan 14, 2015

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_CONTROLLED
Total Trials2
Total Enrollment159
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00425061Study Evaluating the Effect of IMA-638 in Subjects With Persistent AsthmaPHASE2 COMPLETED 159Feb 1, 2007Aug 1, 2008Jan 14, 201582 United States, Canada
NCT00339872Study Evaluating IMA-638 in AsthmaPHASE1 COMPLETED -Feb 1, 2006Apr 1, 2007Dec 5, 20071 United States
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Study Endpoints
Primary Endpoints
Change From Baseline in Morning (Ante Meridiem) Peak Expiratory Flow Rate (AM PEFR) at Day 112 - Stage 1
Baseline, Day 112

The PEFR is a participant's maximum speed of expiration, as measured with a peak flow meter. All participants were issued with the peak flow meter and instructed to perform the activity in triplicate in the morning prior to taking bronchodilator. The best among the 3 readings was selected.

Change From Baseline in Morning (Ante Meridiem) Peak Expiratory Flow Rate (AM PEFR) at Day 112 - Stage 2/3
Baseline, Day 112

The PEFR is a participant's maximum speed of expiration, as measured with a peak flow meter. All participants were issued with the peak flow meter and instructed to perform the activity in triplicate in the morning prior to taking bronchodilator. The best among the 3 readings was selected.

Safety will be measured by evaluating physical examinations, spirometry, vital signs, electrocardiograms (ECGs), and clinical laboratory test results.
Secondary Endpoints
Change From Baseline in Pre-beta-agonist Forced Expiratory Volume in 1 Second (FEV1) at Day 8, 28, 56, 84 and 112 - Stage 1
Baseline, Day 8, 28, 56, 84, 112
Change From Baseline in Pre-beta-agonist Forced Expiratory Volume in 1 Second (FEV1) at Day 8, 28, 56, 84 and 112 - Stage 2/3
Baseline, Day 8, 28, 56, 84, 112
Change From Baseline in Airway Hyper-reactivity at Day 28 and 112
Baseline, Day 28, 112
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
1EXPERIMENTAL -
2EXPERIMENTAL -
3PLACEBO_COMPARATOR -
Interventions
NameTypeDescription
IMA-638BIOLOGICALSC Injection, 12 weeks
placeboOTHERplacebo
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Eligibility Criteria
Age Range18 Years — 80 Years
SexALL
Healthy VolunteersNo
Study Sites82

Inclusion Criteria: * Generally healthy men and women with persistent asthma, 18 to 70 years of age, with body weight between 50 kg and 115 kg. * History of treatment with a medium to high dose of inhaled corticosteroids (ICS), with or without long-acting beta-agonists (LABA), for at least 2 months...

Countries:United StatesCanada
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