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

NCT00590720 | Terminated Phase 2 Results DMC

• 1 other identifier: MI-CP143
• Study Type: interventional
• Target: 11
• Locations: 2 countries
• Sites: 12

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).

Conditions

Asthma

Keywords

Asthma; Bronchitis

Outcome Measures

Primary Outcomes (2)

• Incidence of Adverse Events

  Number of participants experiencing adverse events (includes both adverse events and serious adverse events)

  Days 0 - 150

• Incidence of Serious Adverse Events

  Number of participants experiencing serious adverse events

  Days 0 - 150

Secondary Outcomes (17)

• Incidence of Anti-drug Antibodies (ADA) to MEDI-528

  Days 0, 28, 56, 119, and 150

• Absolute Maximum Change in Forced Expiratory Volume in 1 Second (FEV1)

  Day 28 (15 minutes prior to exercise and 5, 10, 15, 20, and 30 minutes after exercise)

• Absolute Maximum Change in Forced Expiratory Volume in 1 Second (FEV1)

  Day 56 (15 minutes prior to exercise and 5, 10, 15, 20, and 30 minutes after exercise)

• Absolute Maximum Change in Forced Expiratory Volume in 1 Second (FEV1)

  Day 150 (15 minutes prior to exercise and 5, 10, 15, 20, and 30 minutes after exercise)

• Percent Maximum Change in Forced Expiratory Volume in 1 Second (FEV1)

  Day 28 (15 minutes prior to exercise and 5, 10, 15, 20, and 30 minutes after exercise)

Study Arms (2)

MEDI528 50 mg

EXPERIMENTAL

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

Biological: MEDI528 50 mg

PLACEBO

PLACEBO COMPARATOR

Placebo administered as a subcutaneous injection twice weekly for 4 weeks

Other: PLACEBO

Interventions

MEDI528 50 mg BIOLOGICAL

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

MEDI528 50 mg

PLACEBO OTHER

Placebo administered as a subcutaneous injection twice weekly for 4 weeks

PLACEBO

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• MedImmune LLC: lead

Study Sites (12)

Institute of Healthcare Assessment, Inc

San Diego, California, 92120, United States

Location

National Jewish Medical and Research Center

Denver, Colorado, 80206, United States

Location

Waterbury Pulmonary Associates

Waterbury, Connecticut, 06708, United States

Location

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

Tampa, Florida, 33613, United States

Location

Sneeze,Wheeze & Itch Associates, LLC

Normal, Illinois, 61761, United States

Location

Northeast Medical Research Associates, Inc

No. Dartmouth, Massachusetts, 02747, United States

Location

The Clinical Research Center, LLC

St Louis, Missouri, 63141, United States

Location

Creighton University

Omaha, Nebraska, 68131, United States

Location

Bernstein Clinical Research Center

Cincinnati, Ohio, 45231, United States

Location

Calgary COPD & Asthma Program

Calgary, Alberta, T2N4N1, Canada

Location

UHN- Toronto Western Hospital

Toronto, Ontario, M5T2S8, Canada

Location

Centre de Recherche Appliquee en Allergie de Quebec

Québec, Quebec, G1V4M6, Canada

Location

Related Publications (1)

• 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.

  PMID: 21356110 DERIVED

MeSH Terms

Conditions

Asthma; Bronchitis

Interventions

enokizumab

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Joseph Parker, MD
• Organization: MedImmune

parkerj@medimmune.com

301-398-0000

Study Officials

• Joseph Parker, M.D.

  MedImmune LLC

  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: December 26, 2007
• First Posted: January 11, 2008
• Study Start: March 1, 2008
• Primary Completion: December 1, 2008
• Study Completion: October 1, 2009
• Last Updated: March 21, 2014
• Results First Posted: March 21, 2014

Record last verified: 2014-02

Locations

CA (3); US (9)