A Study to Evaluate the Efficacy of MEDI-528 on Late Asthmatic Response With Atopic Asthma

NCT00394654 | Completed Phase 2 Results

• 2 other identifiers: MI-CP138NCT00394654
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 3

Brief Summary

This is a Phase 2a, randomized multicenter study to evaluate the efficacy of MEDI-528 on LAR in adult patients with atopic asthma.

Conditions

Asthma

Outcome Measures

Primary Outcomes (6)

• Effect of MEDI-528 on Late Asthmatic Response (LAR) After Inhaled Allergen Challenge at Day 7

  Change from baseline (percent reduction) in mean maximum decline of forced expiratory volume in one second (FEV1) during LAR at 3 to 7 hours after an inhaled allergen challenge.

  Day 7

• Effect of MEDI-528 on LAR After Inhaled Allergen Challenge at Day 28

  Change from baseline (percent reduction) in mean maximum decline of FEV1 during LAR at 3 to 7 hours after an inhaled allergen challenge.

  Day 28

• Effect of MEDI-528 on LAR After Inhaled Allergen Challenge at Day 56

  Change from baseline (percent reduction) in mean maximum decline of FEV1 during LAR at 3 to 7 hours after an inhaled allergen challenge.

  Day 56

• Effect of MEDI-528 on LAR After Inhaled Allergen Challenge at Day 7

  Change from baseline (percent reduction) in mean maximum decline of area under the concentration-time curve (AUC) of the participants FEV1 during LAR at 3 to 7 hours after an inhaled allergen challenge.

  Day 7

• Effect of MEDI-528 on LAR After Inhaled Allergen Challenge at Day 28

  Change from baseline (percent reduction) in mean maximum decline of AUC of the participants FEV1 during LAR at 3 to 7 hours after an inhaled allergen challenge.

  Day 28

• Effect of MEDI-528 on LAR After Inhaled Allergen Challenge at Day 56

  Change from baseline (percent reduction) in mean maximum decline of AUC of the participants FEV1 during LAR at 3 to 7 hours after an inhaled allergen challenge.

  Day 56

Secondary Outcomes (23)

• Incidence of Adverse Events

  Days 0 - 126

• Incidence of Serious Adverse Events

  Days 0 - 126

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

  Days 0, 27, 55, 84, and 126

• Time to Observed Maximum Serum Concentration (Tmax)

  Days 0, 6, 7, 27, 55, 84, and 126

• Time to Observed Maximum Sputum Concentration (Tmax)

  Days -21 to -7, 7, 28, and 56

Study Arms (2)

MEDI528 9 mg/kg

EXPERIMENTAL

MEDI-528 at a single dose of 9 mg/kg administered as an intravenous infusion

Biological: MEDI-528 9 mg/kg

PLACEBO

PLACEBO COMPARATOR

Placebo administered as a single intravenous infusion

Other: Placebo

Interventions

MEDI-528 9 mg/kg BIOLOGICAL

MEDI-528 at a single dose of 9 mg/kg administered as an intravenous infusion

MEDI528 9 mg/kg

Placebo OTHER

Placebo administered as a single intravenous infusion

PLACEBO

Eligibility Criteria

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

You may qualify if:

• Male or female adults, age 18 through 65 years of age at the time of screening;
• Written informed consent obtained from the patient prior to receipt of any study medication or beginning study procedures;
• Previously documented diagnosis of asthma of \> 1 year duration, based on episodic symptoms of airflow obstruction, at least partial reversibility of airflow obstruction, with alternative diagnoses (e.g., chronic obstructive pulmonary disease) ruled out;
• AHR in the methacholine challenge test with a PC20 (provoking concentration of methacholine to cause a 20% fall in FEV1) ≤ 16 mg/mL (Crapo, 2000);
• Have dual response of EAR, defined as a decrease in FEV1 ≥ 20% at 0 to 3 hours after inhalation, and LAR, defined as a decrease in FEV1 ≥ 15% 3 to 7 hours after inhalation, to inhaled allergen;
• Asthma symptoms are adequately controlled on short-acting β2 agonists (e.g., albuterol) alone;
• Have had no significant changes in regular asthma medications and no acute asthma exacerbations requiring corticosteroid rescue, hospitalization, or emergency department visits for at least 4 weeks prior to screening and up through the time of the first dose of study drug on Study Day 0.
• Sexually active women, unless surgically sterile or at least 1 year post-menopausal, must have used an effective method of avoiding pregnancy (including oral or implanted contraceptives, intrauterine device, female condom, diaphragm with spermicide, cervical cap, abstinence, use of a condom by the sexual partner or sterile sexual partner) for 21 days prior to the first dose of study drug on Study Day 0, and must agree to continue using such precautions through Study Day 126. Cessation of birth control after this point should be discussed with a responsible physician. Sexually active men, unless surgically sterile, must likewise use an effective method of birth control (condom) and must agree to continue using such precautions through Study Day 126;
• Able to complete the follow-up period through Study Day 126, as required by the protocol.
• Willing to forego other forms of experimental treatment and study procedures during the study; and
• Able to provide spirometric readings that meet American Thoracic Society (ATS) standards (ATS, 1995).

You may not qualify if:

• Receipt of MEDI-528 in any previous clinical study;
• History of allergy or adverse reactions to any component of the MEDI-528 formulation;
• Lung disease other than allergic asthma (e.g. chronic bronchitis);
• Current use of any systemic or inhaled immunosuppressive drugs, including systemic and inhaled corticosteroids (topical corticosteroids are permitted), long-acting β2 agonists, leukotriene antagonists, cromolyn sodium, nedocromil sodium, theophylline or any inhaled or systemic medication for asthma other than short-acting β2 agonists, for at least 4 weeks prior to study drug administration on Study Day 0.
• Current use of any β-adrenergic antagonist (e.g. propranolol).
• Any disease or illness, other than asthma, that may require the use of systemic corticosteroids during the study period.
• Acute illnesses or evidence of clinically significant active infection, such as fever ³ 38.0°C (100.5°F) at screening and through the time of the study drug administration on Study Day 0;
• Current allergy-vaccination therapy (i.e., desensitization immunotherapy) with less than 3 months of stable maintenance doses prior to the baseline allergen inhalation challenge;
• Receipt of any investigational drug therapy within 30 days or any biologic(s) within 5 half-lives of the agent prior to the first dose of study drug through Study Day 150;
• Receipt of any therapy with a leukocyte-depleting agent unless recovery in white cell count has been documented before screening;
• Pregnancy (sexually active females must have a negative serum pregnancy test at screening and a negative urine pregnancy test prior to study drug administration on Study Day 0);
• Is a nursing mother at the time of study enrollment;
• Evidence of infection with hepatitis B or C virus, or HIV-1 or HIV-2, or active infection with hepatitis A;
• History of significant systemic disease (e.g., cancer; infection; coronary artery disease or other cardiovascular disease; or hematological, renal, hepatic, endocrinologic, neurologic, rheumatologic, or gastrointestinal disease);
• History of cancer other than nonmelanoma skin cancer or cervical carcinoma-in-situ that have been treated successfully with curative therapy;

Sponsors & Collaborators

• MedImmune LLC: lead

Study Sites (3)

McMaster University

Hamilton, Ontario, L8N 3Z5, Canada

Location

Hopital Laval

Québec, Quebec, G1V 4G5, Canada

Location

University of Saskatchewan

Saskatoon, Saskatchewan, S7N 0W8, Canada

Location

MeSH Terms

Conditions

Asthma

Interventions

enokizumab

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Don Raible, MD
• Organization: MedImmune

raibleD@medimmune.com

301-398-0000

Study Officials

• Nestor Molfino, 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: October 31, 2006
• First Posted: November 1, 2006
• Study Start: November 1, 2006
• Primary Completion: August 1, 2007
• Study Completion: January 1, 2008
• Last Updated: December 11, 2013
• Results First Posted: December 11, 2013

Record last verified: 2013-10

Locations

CA (3)