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IMA-638

Phase 2

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

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

Clinical trial landscape

IMA-638 · 3 trials · 2 indications

Phase 2 1Phase 1 2
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, vital signs, electrocardiograms (ECGs), and clinical laboratory test results.
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 being studied for the treatment of asthma. It has been evaluated in clinical trials for persistent asthma and in healthy volunteers. The drug is being developed by Pfizer, Inc. and is currently in Phase 2 clinical development.

Who makes IMA-638?

IMA-638 is being developed by Pfizer, Inc., a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol PFE. The drug is an investigational small molecule being studied for the treatment of asthma.

What phase is IMA-638 in?

IMA-638 is in Phase 2 clinical development for asthma. It has completed Phase 1 and Phase 2 trials, including a Phase 2 study in subjects with persistent asthma. The drug is investigational and has not been approved by regulatory authorities.

What clinical trials is IMA-638 in?

IMA-638 has been studied in three completed clinical trials. These include NCT00339872, a Phase 1 study in asthma; NCT00340327, a Phase 1 study in healthy Japanese volunteers; and NCT00425061, a Phase 2 study in subjects with persistent asthma. All trials are completed.

Is IMA-638 FDA approved?

IMA-638 is not FDA approved. It is an investigational drug currently in Phase 2 clinical development for asthma. The drug has completed clinical trials but has not received regulatory approval for any indication.