Study Evaluating the Effect of IMA-638 in Subjects With Persistent Asthma

NCT00425061 | Completed Phase 2 Results

• 2 other identifiers: 3174K1-201B2421007
• Study Type: interventional
• Target: 159
• Locations: 2 countries
• Sites: 82

Brief Summary

Primary purpose is to assess if IMA-638 is safe and improves asthma in subjects with persistent asthma.

Conditions

Asthma

Outcome Measures

Primary Outcomes (2)

• Change From Baseline in Morning (Ante Meridiem) Peak Expiratory Flow Rate (AM PEFR) at Day 112 - Stage 1

  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.

  Baseline, Day 112

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

  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.

  Baseline, Day 112

Secondary Outcomes (19)

• 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

• Change From Baseline in Asthma Control Questionnaire-5 (ACQ-5) Score at Day 8, 28, 56, 84 and 112 - Stage 1

  Baseline, Day 8, 28, 56, 84, 112

• Change From Baseline in Asthma Control Questionnaire-5 (ACQ-5) Score at Day 8, 28, 56, 84 and 112 - Stage 2/3

  Baseline, Day 8, 28, 56, 84, 112

Other Outcomes (10)

• Number of Participants With Vital Sign Abnormalities of Potential Clinical Importance Stage 1

  Baseline up to Day 112

• Number of Participants With Vital Sign Abnormalities of Potential Clinical Importance - Stage 2/3

  Baseline up to Day 112

• Number of Participants With Clinically Important Changes in Physical Findings - Stage 1

  Baseline up to Day 112

Study Arms (3)

1

EXPERIMENTAL

Biological: IMA-638

2

EXPERIMENTAL

Biological: IMA-638

3

PLACEBO COMPARATOR

Other: placebo

Interventions

IMA-638 BIOLOGICAL

SC Injection, 12 weeks

1

placebo OTHER

placebo

3

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 prior to the screening visit and must remain constant during the study.
• FEV1 ≥ 55% to ≤ 80% predicted and demonstrated improvement in FEV1 (L) with inhaled albuterol (salbutamol) (reversibility) of ≥ 12%.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (82)

Alabama Allergy and Asthma Center

Birmingham, Alabama, 35209, United States

Location

Alabama Allergy & Asthma Clinic

Montgomery, Alabama, 36106, United States

Location

Little Rock Allergy & Asthma

Little Rock, Arkansas, 72205, United States

Location

Pacific Coast Allergy

Crescent City, California, 95531, United States

Location

ABM Research Center

Fresno, California, 93720, United States

Location

Allergy and Asthma Care Center of Southern California

Long Beach, California, 90808, United States

Location

Allergy Medical Clinic

Los Angeles, California, 90025, United States

Location

Advances in Medicine

Rancho Mirage, California, 92270, United States

Location

Penisula Research Associates

Rolling Hills Estates, California, 90274, United States

Location

Sharp Rees-Stealy Medical Group

San Diego, California, 92101, United States

Location

Allergy Associates Medical Group, Inc.

San Diego, California, 92120, United States

Location

Allergy & Asthma Assoc of Santa Clara Valley Research Ctr

San Jose, California, 95117, United States

Location

San Jose Clinical Research, Inc.

San Jose, California, 95128, United States

Location

Bensch Research Associates

Stockton, California, 95207, United States

Location

Allergy and Immunology Medical Group

Vista, California, 92083, United States

Location

Allergy & Asthma Clinical Research, Inc.

Walnut Creek, California, 94598, United States

Location

National Jewish Medical & Research Center

Denver, Colorado, 80206, United States

Location

Colorado Allergy and Asthma Centers

Denver, Colorado, 80230, United States

Location

Waterbury Pulmonary Associates

Waterbury, Connecticut, 06708, United States

Location

Brandon-Valico Center for Allergy & Asthma Research, LLC

Valrico, Florida, 33594, United States

Location

Roberson Allergy & Asthma

West Palm Beach, Florida, 33401, United States

Location

Georgia Pollens CRC, Inc.

Albany, Georgia, 31707, United States

Location

DataQuest Medical Research

Lawrenceville, Georgia, 30045, United States

Location

Aero Allergy Research Labs of Savannah, Inc. 505 Eisenhower

Savannah, Georgia, 31406, United States

Location

Allergy and Asthma Center of Chicago

River Forest, Illinois, 60305, United States

Location

Fort Wayne Medical Institute

Fort Wayne, Indiana, 46815, United States

Location

South Bend Clinic

South Bend, Indiana, 46617, United States

Location

College Park Family Care Center

Overland Park, Kansas, 66210, United States

Location

Kansas City Allergy & Asthma

Overland Park, Kansas, 66210, United States

Location

Abraham Research, PLLC

Crescent Springs, Kentucky, 41017, United States

Location

Clinical Research Specialists

Metairie, Louisiana, 70006, United States

Location

Allergy and Arthritis Family

Gardner, Massachusetts, 01440, United States

Location

Center for Clinical Research

Taunton, Massachusetts, 02780, United States

Location

Clinical Research Institute

Minneapolis, Minnesota, 55402, United States

Location

Mississippi Asthma and Allergy Clinic, P.A.

Jackson, Mississippi, 39202, United States

Location

Midwest Clinical Research LLC

St Louis, Missouri, 63141, United States

Location

The Clinical Research Center LLC

St Louis, Missouri, 63141, United States

Location

Montana Medical Research, Inc

Missoula, Montana, 59808, United States

Location

Midwest Allergy and Asthma Clinic

Omaha, Nebraska, 68130, United States

Location

Allergy and Asthma Assoc

Las Vegas, Nevada, 89102, United States

Location

Princeton Center for Clinical Research

Skillman, New Jersey, 08558, United States

Location

Pulmonary and Allergy Associates

Summit, New Jersey, 07901, United States

Location

Pulmonary & Critical Care Services, P.C.5 Palisades Dr., Su

Albany, New York, 12205, United States

Location

AAIR Research Center

Rochester, New York, 14618, United States

Location

Montefiore Medical Center

The Bronx, New York, 10461, United States

Location

Regional Allergy and Asthma Consultants, P.A.

Asheville, North Carolina, 28801, United States

Location

AAC Research, PC

Mt Pleasant, North Carolina, 29464, United States

Location

North Carolina Clinical Research

Raleigh, North Carolina, 27607, United States

Location

Allergy & Respiratory Center

Canton, Ohio, 44718, United States

Location

New Horizons Clinical Research

Cincinnati, Ohio, 45242, United States

Location

Toledo Center for Clinial Researcch

Sylvania, Ohio, 43560, United States

Location

Allergy, Asthma & Clinical Research Center

Oklahoma City, Oklahoma, 73120, United States

Location

Allergy and Asthma Research Group

Eugene, Oregon, 97401, United States

Location

Allergy, Asthma and Dermatology Research Center, LLC 3975 Me

Lake Oswego, Oregon, 97035, United States

Location

Clinical Research Institute of Southern Oregon

Medford, Oregon, 97504, United States

Location

Allergy Associates Research Center

Portland, Oregon, 97213, United States

Location

Valley Clinical Research Center

Bethlehem, Pennsylvania, 18020, United States

Location

Allergy & Asthma Research of New Jersey

Philadelphia, Pennsylvania, 19115, United States

Location

Allergy and Clinical Immunology

Pittsburgh, Pennsylvania, 15241, United States

Location

Pulmonary and Allergy Associates

Sellersville, Pennsylvania, 18960, United States

Location

AAPRI Clinical Research Institute

Lincoln, Rhode Island, 02865, United States

Location

Allergic Disease and Asthma Center Research, PA

Greenville, South Carolina, 29607, United States

Location

AAC Research, PC

Mt. Pleasant, South Carolina, 29464, United States

Location

East Tennessee Center for Clinical Research

Knoxville, Tennessee, 37909, United States

Location

Lovelace Scientific Resources

Austin, Texas, 78759, United States

Location

Allergy and Asthma Research Center of El Paso

El Paso, Texas, 79925, United States

Location

Family Center for Asthma & Allergic Diseases

Friendswood, Texas, 77546, United States

Location

Allergy and Asthma Associates

Houston, Texas, 77054, United States

Location

Clinical Trials North Houston

Houston, Texas, 77070, United States

Location

Clinical Trial Network

Houston, Texas, 77074, United States

Location

The Allergy and Asthma Clinic of Central Texas

Killeen, Texas, 76542, United States

Location

Allergy Asthma and Immunology

San Antonio, Texas, 78229, United States

Location

Timber Lane Allergy and Asthma Research LLC

South Burlington, Vermont, 05403, United States

Location

Virginia Adult & Pediatric Allergy & Asthma, P.C.

Richmond, Virginia, 23229, United States

Location

University of Wisconsin Medical School

Madison, Wisconsin, 53792, United States

Location

Auroroa Health Care, Inc.

Milwaukee, Wisconsin, 53209, United States

Location

Alpha Medical Research Inc.

Mississauga, Ontario, L5A 3V4, Canada

Location

Alexander Medical Innovations Inc.

Niagara Falls, Ontario, L2G 1J4, Canada

Location

Allergy and Asthma Research Centre

Ottawa, Ontario, K1Y 4G2, Canada

Location

Recherche Invascor Inc

Longueuil, Quebec, J4N 1E1, Canada

Location

Hopital du Sacre-Coeur de Montreal

Montreal, Quebec, H4J 1C5, Canada

Location

CIC Mauricie Inc.

Trois-Rivières, Quebec, G8T 7A1, Canada

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Asthma

Interventions

anrukinzumab

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Limitations and Caveats

The study was stopped early due to futility of the interim efficacy analysis results. Hence, only safety results and key efficacy results were presented for this study.

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 18, 2007
• First Posted: January 22, 2007
• Study Start: February 1, 2007
• Primary Completion: August 1, 2008
• Study Completion: August 1, 2008
• Last Updated: January 14, 2015
• Results First Posted: January 14, 2015

Record last verified: 2015-01

Locations

US (76); CA (6)