A Phase 2A Study to Evaluate the Safety and Effect on Exercise Challenge Testing of MEDI-528 in Adults With Asthma

NCT ID: NCT00590720

Last Updated: 2014-03-21

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-03-31
• Study Completion Date: 2009-10-31

Brief Summary

The main objective of this study is to evaluate the safety and tolerability of multiple fixed doses of MEDI-528 in adult patients with stable asthma and exercise-induced bronchoconstriction (EIB).

Detailed Description

The primary objective of this study is to evaluate the safety and tolerability of multiple fixed escalating SC doses of MEDI-528 in adult patients with stable asthma and exercise-induced bronchoconstriction (EIB).

Conditions

Asthma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

MEDI528 50 mg

MEDI-528 at a dose of 50 mg administered as a subcutaneous injection twice weekly for 4 weeks

Group Type: EXPERIMENTAL

MEDI528 50 mg

Intervention Type: BIOLOGICAL

MEDI-528 at a dose of 50 mg administered as a subcutaneous injection twice weekly for 4 weeks

PLACEBO

Placebo administered as a subcutaneous injection twice weekly for 4 weeks

Group Type: PLACEBO_COMPARATOR

PLACEBO

Intervention Type: OTHER

Placebo administered as a subcutaneous injection twice weekly for 4 weeks

Interventions

MEDI528 50 mg

MEDI-528 at a dose of 50 mg administered as a subcutaneous injection twice weekly for 4 weeks

Intervention Type: BIOLOGICAL

PLACEBO

Placebo administered as a subcutaneous injection twice weekly for 4 weeks

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

Patients must meet all of the following criteria:

• Male or female adults, age 18 through 50 years at the time of screening;
• Weight 50-100 kg and body mass index ≤ 35;
• Written informed consent obtained from the patient prior to receipt of any study medication or beginning study procedures;
• Documented clinical history of asthma and receiving stable treatment for ≥ 1 month prior to Study Day 0;
• Airway hyperresponsiveness (AHR) on methacholine inhalation challenge testing at screening (or a documented history within the past 6 months), with provoking concentration of methacholine to cause a 20% fall in FEV1(subscript) (PC20) ≤ 8 mg/mL (Crapo, 2000);
• Exercise-induced bronchoconstriction (EIB) with a decrease in FEV1 (subscript) of ≥ 15% from pre-exercise challenge testing level at screening;
• Able to provide spirometry readings that meet American Thoracic Society (ATS) and European Respiratory Society (ERS) standards (Miller, 2005);
• Women of childbearing potential, unless surgically sterile or at least 1 year post-menopausal, must use two effective methods of avoiding pregnancy (including oral, transdermal, or implanted contraceptives, intrauterine device, female condom, spermicide, diaphragm, cervical cap, abstinence, contraceptive foam, or use of a condom by the sexual partner or sterile sexual partner) from screening through Study Day 0, and must agree to continue using such precautions through Study Day 150. Cessation of birth control after this point should be discussed with a responsible physician. Men, unless surgically sterile, must likewise use an effective method of birth control (condom with spermicide) and must agree to continue using such precautions from screening through Study Day 150;
• Able to complete the study period, including follow-up period, of up to approximately 150 days; and
• Willing to forego other forms of experimental treatment and study procedures during the study and for 30 days after the follow-up period is completed.

Exclusion Criteria

Patients must have none of the following criteria:

• Receipt of MEDI-528 in any previous clinical study;
• History of allergy or reaction to any component of the study drug formulation;
• Lung disease other than asthma (eg, chronic obstructive pulmonary disease, cystic fibrosis);
• Forced expiratory volume in 1 second (FEV1-subscript) < 70% of predicted values at screening;
• Use of systemic immunosuppressive drugs including systemic corticosteroids, ICS with doses > 800 μg/day budesonide (or another ICS of equivalent dose), long-acting β2 agonists, cromolyn sodium, nedocromil sodium, leukotriene receptor antagonists, theophylline, or omalizumab from screening through Study Day 150;
• Current use of any β-adrenergic antagonist (eg, propranolol);
• Any disease or illness, other than asthma, that is likely to require the use of systemic corticosteroids during the study period;
• Acute illnesses or evidence of significant active infection, such as fever ≥ 38.0°C (100.5°F) from screening through Study Day 0;
• Current allergy vaccination therapy (desensitization immunotherapy);
• Receipt of any investigational drug therapy within 30 days or any biologic(s) within 5 half-lives of the agent prior to screening;
• Pregnancy (women of child bearing potential, unless surgically sterile or at least 1 year postmenopausal, must have a negative serum and urine pregnancy test at screening before methacholine inhalation challenge testing and a negative urine pregnancy test prior to study drug administration on Study Day 0);
• Breastfeeding or lactating woman;
• Evidence of infection with hepatitis B or C virus or HIV-1 or HIV-2, or active infection with hepatitis A; must have negative HIV-1, HIV-2, hepatitis A, B, and C tests at screening;
• History of cancer other than basal cell carcinoma of the skin or cervical carcinoma-in-situ treated with apparent success with curative therapy more than 1 year prior to Study Day 0;
• History of primary immunodeficiency
• History of pancreatitis or currently active gastroduodenal ulcer;
• Current use of tobacco products or a history of use of tobacco products of more than one cigarette per month or equivalent within 1 year prior to randomization or history of smoking of ≥ 10 pack-years;
• History of life-long urinary retention;
• History of anaphylaxis (defined as immediate life-threatening event requiring medical invention);
• Elective surgery planned from screening through Study Day 150;
• Clinically significant abnormality, as determined by the investigator, on 12-lead ECG or chest radiograph at screening;
• History of any disease, evidence of any current disease (other than asthma), any finding upon physical examination, or any laboratory abnormality, that, in the opinion of the investigator or medical monitor, may compromise the safety of the patient in the study or confound the analysis of the study; or
• Any employee of the research site who is involved with the conduct of the study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

MedImmune LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Joseph Parker, M.D.

Role: STUDY_DIRECTOR

MedImmune LLC

Locations

Institute of Healthcare Assessment, Inc

San Diego, California, United States

National Jewish Medical and Research Center

Denver, Colorado, United States

Waterbury Pulmonary Associates

Waterbury, Connecticut, United States

Univ. of South Florida, Asthma, Allergy & Immunology Clinical Research Unit

Tampa, Florida, United States

Sneeze,Wheeze & Itch Associates, LLC

Normal, Illinois, United States

Northeast Medical Research Associates, Inc

No. Dartmouth, Massachusetts, United States

The Clinical Research Center, LLC

St Louis, Missouri, United States

Creighton University

Omaha, Nebraska, United States

Bernstein Clinical Research Center

Cincinnati, Ohio, United States

Calgary COPD & Asthma Program

Calgary, Alberta, Canada

UHN- Toronto Western Hospital

Toronto, Ontario, Canada

Centre de Recherche Appliquee en Allergie de Quebec

Québec, Quebec, Canada

Countries

United States; Canada

References

Parker JM, Oh CK, LaForce C, Miller SD, Pearlman DS, Le C, Robbie GJ, White WI, White B, Molfino NA; MEDI-528 Clinical Trials Group. Safety profile and clinical activity of multiple subcutaneous doses of MEDI-528, a humanized anti-interleukin-9 monoclonal antibody, in two randomized phase 2a studies in subjects with asthma. BMC Pulm Med. 2011 Feb 28;11:14. doi: 10.1186/1471-2466-11-14.

Reference Type: DERIVED

PMID: 21356110 (View on PubMed)

Other Identifiers

MI-CP143

Identifier Type: -

Identifier Source: org_study_id