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IMA-638

Phase 2

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

IMA-638 development status

Highest phase Phase 2
Registered trials 3 across 2 sponsors since Jun 2006

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials2
Total Enrollment159

FDA Designations

No designations recorded

IMA-638 clinical trials

IMA-638 · 2 trials · 1 indication

Phase 2 1Phase 1 1
NCT00425061Study Evaluating the Effect of IMA-638 in Subjects With Persistent AsthmaAsthma
COMPLETED159 Analytics
PHASE2COMPLETED
Study Evaluating the Effect of IMA-638 in Subjects With Persistent Asthma
AsthmaUnlock trial analytics

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 to 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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Frequently asked questions about IMA-638

What is IMA-638 used for?

IMA-638 is an investigational small molecule developed for the treatment of asthma, a respiratory condition. It was studied in adults with persistent asthma. Both of its clinical trials have been completed, and it is not currently listed as an active development program.

Who makes IMA-638?

IMA-638 is developed by Pfizer, Inc., which trades under the ticker PFE. Pfizer sponsored the clinical studies of the drug in asthma, including a Phase 2 trial and a Phase 1 trial conducted in the United States and Canada.

What phase is IMA-638 in?

IMA-638 reached Phase 2 clinical development for asthma. Two trials have been completed: a Phase 2 study and a Phase 1 study. No trials are currently active, and the drug is investigational rather than approved.

What clinical trials is IMA-638 in?

IMA-638 has been studied in two completed trials. NCT00425061 was a Phase 2 study evaluating the effect of IMA-638 in subjects with persistent asthma, enrolling 159 participants in the United States and Canada. NCT00339872 was a Phase 1 study of IMA-638 in asthma conducted in the United States.

How was IMA-638 studied in its asthma trials?

The IMA-638 trials in asthma were randomized, double-blind, and placebo-controlled, enrolling adults 18 years and older. The Phase 2 trial NCT00425061 enrolled 159 participants across the United States and Canada. Neither trial selected patients based on a biomarker.