A Phase 2A, Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Study to Evaluate the Safety and Effect on Exercise Challenge Testing of Multiple Fixed Subcutaneous Doses of MEDI-528, A Humanized Anti-Interleukin-9 Monoclonal Antibody, in Adults With Stable Asthma and Exercise-Induced Bronchoconstriction

MedImmune LLC12 sites in 2 countries11 target enrollmentMarch 2008

ConditionsAsthma

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Asthma
Sponsor: MedImmune LLC
Enrollment: 11
Locations: 12
Primary Endpoint: Incidence of Adverse Events
Status: Terminated
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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).

Registry

clinicaltrials.gov

Start Date

March 2008

End Date

October 2009

Last Updated

12 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

MedImmune LLC

Responsible Party

Sponsor

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
•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;

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);

Outcomes

Primary Outcomes

Incidence of Adverse Events

Time Frame: Days 0 - 150

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

Incidence of Serious Adverse Events

Time Frame: Days 0 - 150

Number of participants experiencing serious adverse events

Secondary Outcomes

Incidence of Anti-drug Antibodies (ADA) to MEDI-528(Days 0, 28, 56, 119, and 150)
Area Under the Curve (AUC) of Forced Expiratory Volume in 1 Second (FEV1)(Day 150 (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 150 (15 minutes prior to exercise and 5, 10, 15, 20, and 30 minutes after exercise))
Time to Return in Minutes to 90 Percent of Baseline Forced Expiratory Volume in 1 Second (FEV1)(Day 150 (15 minutes prior to exercise and 5, 10, 15, 20, and 30 minutes after exercise))
Mean Trough Concentration (Cmin)(Days 0, 3, 7, 10, 14, 17, 21, 24, 28, 32, 37, 42, 56, 70, 84, 119, and 150)
Mean Trough Concentration at Last Measurable Time Point (Cmin_last)(Days 0, 3, 7, 10, 14, 17, 21, 24, 28, 32, 37, 42, 56, 70, 84, 119, and 150)
Half-life (T1/2)(Days 0, 3, 7, 10, 14, 17, 21, 24, 28, 32, 37, 42, 56, 70, 84, 119, and 150)
Accumulation Index(Days 0 and 24)