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IMA-638 is a biologic

Phase 2

Asthma | Monoclonal antibody | Respiratory |Pfizer, Inc.|Last Updated: Nov 18, 2014

Success Probability

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials1
Total Enrollment30

FDA Designations

No designations recorded

Clinical trial landscape

IMA-638 is a biologic · 1 trial · 1 indication

Phase 2 1
NCT00410280Study Evaluating the Effects of IMA-638 on Allergen-Induced Airway Responses in Subjects With Mild Atopic AsthmaAsthma
COMPLETED30 Analytics
PHASE2COMPLETED
Study Evaluating the Effects of IMA-638 on Allergen-Induced Airway Responses in Subjects With Mild Atopic Asthma
AsthmaUnlock trial analytics

Study Endpoints

Primary Endpoints

Maximum Percent Drop From Pre-allergen Baseline in Forced Expiratory Volume in 1 Second (FEV1) for Late-Phase Asthma Response (LAR) at Screening
Pre-allergen baseline, 3, 4, 5, 6, 7 hours post-allergen inhalation at Screening (Day -14)

Allergen inhalation test was performed at Screening, Day 14 and 35 to elicit airway responses similar to those that follow natural allergen exposure. FEV1 was the maximal volume of air exhaled in 1 second of a forced expiration from a position of full inspiration. LAR was characterized by a fall in FEV1 of more than or equal to (\>=) 15 percent (%) at 3 to 7 hours post-allergen inhalation. Maximum drop in FEV1 relative to the pre-allergen baseline FEV1 between 3 to 7 hours at Screening was reported. Pre-allergen baseline FEV1 was performed in triplicate using spirometry and the best of the 3 values was selected.

Maximum Percent Drop From Pre-allergen Baseline in Forced Expiratory Volume in 1 Second (FEV1) for Late-Phase Asthma Response (LAR) at Day 14
Pre-allergen baseline, 3, 4, 5, 6, 7 hours post-allergen inhalation at Day 14

Allergen inhalation test was performed at Screening, Day 14 and 35 to elicit airway responses similar to those that follow natural allergen exposure. FEV1 was the maximal volume of air exhaled in 1 second of a forced expiration from a position of full inspiration. LAR was characterized by a fall in FEV1 of more than or equal to (\>=) 15 percent (%) at 3 to 7 hours post-allergen inhalation. Maximum drop in FEV1 relative to the pre-allergen baseline FEV1 between 3 to 7 hours on Day 14 was reported. Pre-allergen baseline FEV1 was performed in triplicate using spirometry and the best of the 3 values was selected.

Maximum Percent Drop From Pre-allergen Baseline in Forced Expiratory Volume in 1 Second (FEV1) for Late-Phase Asthma Response (LAR) at Day 35
Pre-allergen baseline, 3, 4, 5, 6, 7 hours post-allergen inhalation at Day 35

Allergen inhalation test was performed at Screening, Day 14 and 35 to elicit airway responses similar to those that follow natural allergen exposure. FEV1 was the maximal volume of air exhaled in 1 second of a forced expiration from a position of full inspiration. LAR was characterized by a fall in FEV1 of more than or equal to (\>=) 15 percent (%) at 3 to 7 hours post-allergen inhalation. Maximum drop in FEV1 relative to the pre-allergen baseline FEV1 between 3 to 7 hours on Day 35 was reported. Pre-allergen baseline FEV1 was performed in triplicate using spirometry and the best of the 3 values was selected.

Secondary Endpoints

Area Under the Percent Drop in Forced Expiratory Volume in 1 Second Curve (AUC FEV1) From Time 3 to 7 Hours for Late-Phase Asthma Response (LAR)
Pre-allergen baseline, 3, 4, 5, 6, 7 hours post-allergen inhalation at Screening (Day -14), Day 14, 35
Maximum Percent Drop From Pre-allergen Baseline in Forced Expiratory Volume in 1 Second (FEV1) for Early-Phase Asthma Response (EAR) at Screening, Day 14 and 35
Pre-allergen baseline, 10, 20, 30, 45, 60, 90, 120, 180 minutes post-allergen inhalation Screening, Day 14, 35
Area Under the Percent Drop in Forced Expiratory Volume in 1 Second Curve (AUC FEV1) From Time 0 to 3 Hours for Early-Phase Asthma Response (EAR)
Pre-allergen baseline, 10, 20, 30, 45, 60, 90, 120, 180 minutes post-allergen inhalation Screening, Day 14, 35
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1OTHER -

Interventions

NameTypeDescription
IMA-638 is a biologicBIOLOGICAL -
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Eligibility Criteria

Age Range18 Years to 60 Years
SexALL
Healthy VolunteersNo
Study Sites4

Inclusion Criteria: Inclusion Criteria: * generally healthy, men and women with mild allergic asthma, aged 18 to 60 years * only asthma med is short-acting bronchodilator used not more than twice weekly * FEV1 greater than 70% predicted and a demonstrated baseline late response to allergen inducti...

Countries:Canada
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Frequently asked questions about IMA-638 is a biologic

What is IMA-638 used for in asthma?

IMA-638 is an investigational biologic being studied for the treatment of asthma. It is a monoclonal antibody in Phase 2 clinical development. In a completed trial, it was evaluated for its effects on allergen-induced airway responses in subjects with mild atopic asthma.

What does IMA-638 target?

IMA-638 is a monoclonal antibody, but its specific molecular target has not been disclosed in available information. The drug is being studied for its effects on allergen-induced airway responses in patients with mild atopic asthma.

Who makes IMA-638?

IMA-638 is being developed by Pfizer, Inc., which trades on the New York Stock Exchange under the ticker symbol PFE. The company is conducting clinical research on this monoclonal antibody for asthma.

What phase is IMA-638 in?

IMA-638 is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 2 trial has been completed, and the drug is not currently in any active clinical trials.

What clinical trials is IMA-638 in?

IMA-638 has been studied in one clinical trial, identified as NCT00410280. This Phase 2 study evaluated the effects of IMA-638 on allergen-induced airway responses in subjects with mild atopic asthma. The trial was completed and enrolled 30 participants in Canada.