Study to Evaluate the Efficacy and Safety of MEDI-563 in Adults With Uncontrolled Asthma

Asthma Clinical Trial

Official title:

A Phase 2b, Dose-ranging Study to Evaluate the Efficacy and Safety of MEDI-563 in Adults With Uncontrolled Asthma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01238861
• Other study ID #: MI-CP220
• Secondary ID: 2010-020126-17
• Status: Completed
• Phase: Phase 2
• First received: November 9, 2010
• Last updated: September 16, 2014
• Start date: December 2010
• Est. completion date: August 2013

Study information

• Verified date: September 2014
• Source: MedImmune LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The primary objective of the study is to evaluate the effect of multiple-dose subcutaneous administrations of MEDI-563 on adults with uncontrolled asthma.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 965
• Est. completion date: August 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Age 18 through 75 years at the time of screening.

• Adequate contraception from screening through end of trial.

• Weight of > 45 kg but = 150 kg (> 100 lb but = 330 lb).

• History of physician-diagnosed asthma for at least 12 months prior to screening.

• Physician prescribed daily use of medium-dose or high-dose ICS plus LABA for at least 12 months prior to screening.

• Willingness to switch to an ICS/LABA combination product.

• Dose of other asthma controller medications must be stable for at least 30 days prior to screening.

• At least 2 documented asthma exacerbations in the 12 months prior to screening that required use of a systemic corticosteroid burst.

• For subjects 65 years of age or older, a chest x-ray (CXR) or chest computed tomography (CT) that is normal for an asthmatic population.

• Ability and willingness to complete the study to Week 66, and if needed to Week 92.

Exclusion Criteria:

• Known history of allergy or reaction to any component of the investigational product formulation.

• History of anaphylaxis to any biologic therapy.

• Unexplained diarrhea within 30 days prior to screening or diagnosis of helminth parasitic infestation within 6 months prior to screening.

• Use of immunosuppressive medication within 3 months prior to screening. Chronic oral prednisone or equivalent up to 10 mg daily or 20 mg every other day for asthma is allowed.

• Oral corticosteroid burst or short-acting systemic corticosteroid within 30 days prior to screening or during the screening/run-in period.

• Acute upper or lower respiratory infections requiring antibiotics or antiviral medications within 30 days prior to the screening or during the screening/run-in period.

• Receipt of immunoglobulin or blood products within 30 days prior to screening.

• Receipt of any marketed or investigational biologic within 4 months or 5 half-lives prior to screening, whichever is longer.

• Receipt of any investigational nonbiologic within 30 days or 5 half-lives prior to screening, whichever is longer.

• Previously received MEDI-563.

• Any clinically relevant abnormal findings in physical examination.

• Past history of clinically significant cardiac disease or any electrocardiogram (ECG) abnormality.

• Breastfeeding or lactating women.

• History of alcohol or drug abuse within 12 months prior to screening.

• History of any known primary immunodeficiency disorder.

• Positive medical history for hepatitis B or C. Subjects with a history of hepatitis B vaccination without history of hepatitis B are allowed to enroll.

• A positive human immunodeficiency virus (HIV) test or subject taking antiretroviral medications.

• History of cigarette smoking = 10 pack-years or smoking within 12 months prior to screening.

• Known exposure to inhaled occupational agents or fumes with an established diagnosis of occupational asthma.

• History of cancer, except for basal cell carcinoma or in situ carcinoma of the cervix treated with apparent success with curative therapy = 12 months prior to screening or other malignancies treated with apparent success with curative therapy = 5 years prior to screening.

• Stable dose of allergy vaccination regimen for less than 30 days prior to screening.

• Subjects unable to demonstrate acceptable inhaler and peak flow meter techniques.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• MEDI-563
Subcutaneous repeating dose
• MEDI-563
Subcutaneous repeating dose
• MEDI-563
Subcutaneous repeating dose
• Placebo
Subcutaneous repeating dose

Locations

Country	Name	City	State
Argentina	Research Site	Caba
Argentina	Research Site	Ciudad de Buenos Aires
Argentina	Research Site	Santa Fe
Argentina	Research Site	Tucumán
Brazil	Research Site	Curitiba
Brazil	Research Site	Florianópolis
Brazil	Research Site	Juiz de Fora
Brazil	Research Site	Porto Alegre
Brazil	Research Site	Rio de Janeiro
Brazil	Research Site	Salvador
Brazil	Research Site	Santo André
Brazil	Research Site	Sao Paulo
Brazil	Research Site	São Paulo
Bulgaria	Research Site	Pleven
Bulgaria	Research Site	Ruse
Bulgaria	Research Site	Sofia
Bulgaria	Research Site	Troyan
Canada	Research Site	Brampton	Ontario
Canada	Research Site	La Malbaie	Quebec
Canada	Research Site	Quebec
Canada	Research Site	Toronto	Ontario
Colombia	Research Site	Bogota
Colombia	Research Site	Bogotá
Mexico	Research Site	Guadalajara
Mexico	Research Site	Mexico
Mexico	Research Site	Monterrey
Mexico	Research Site	Morelia
Mexico	Research Site	Villahermosa
Mexico	Research Site	Zapopan
Peru	Research Site	Lima
Peru	Research Site	San Borja
Peru	Research Site	San Isidro
Peru	Research Site	Surco
Poland	Research Site	Bialystok
Poland	Research Site	Bydgoszcz
Poland	Research Site	Lódz
Poland	Research Site	Lublin
Poland	Research Site	Ostrów Wielkopolski
Poland	Research Site	Pila
Poland	Research Site	Poznan
Poland	Research Site	Tarnów
Poland	Research Site	Warszawa
Russian Federation	Research Site	Barnaul
Russian Federation	Research Site	Chelyabinsk
Russian Federation	Research Site	Ekaterinburg
Russian Federation	Research Site	Kazan
Russian Federation	Research Site	Moscow
Russian Federation	Research Site	Novosibirsk
Russian Federation	Research Site	Saint Petersburg
Russian Federation	Research Site	Saint-Petersburg
Russian Federation	Research Site	St-Petersburg
United States	Research Site	Baltimore	Maryland
United States	Research Site	Bellevue	Nebraska
United States	Research Site	Birmingham	Alabama
United States	Research Site	Blue Bell	Pennsylvania
United States	Research Site	Boerne	Texas
United States	Research Site	Cincinnati	Ohio
United States	Research Site	Colarado Springs	Colorado
United States	Research Site	Denver	Colorado
United States	Research Site	Kissimmee	Florida
United States	Research Site	Los Angeles	California
United States	Research Site	Normal	Illinois
United States	Research Site	Oklahoma City	Oklahoma
United States	Research Site	Orange	California
United States	Research Site	Pittsburgh	Pennsylvania
United States	Research Site	Rochester	New York
United States	Research Site	Rochester	Minnesota
United States	Research Site	San Antonio	Texas
United States	Research Site	San Diego	California
United States	Research Site	Seattle	Washington
United States	Research Site	St Louis	Missouri
United States	Research Site	St. Louis	Missouri
United States	Research Site	Stockbridge	Georgia
United States	Research Site	Stockton	California
United States	Research Site	Summit	New Jersey
United States	Research Site	Tampa	Florida
United States	Research Site	Warwick	Rhode Island
United States	Research Site	Waterbury	Connecticut
United States	Research Site	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
MedImmune LLC

Countries where clinical trial is conducted

United States,  Argentina,  Brazil,  Bulgaria,  Canada,  Colombia,  Mexico,  Peru,  Poland,  Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate the effect of multiple-dose subcutaneous administrations of MEDI-563		12-15 months	Yes
Secondary	Evaluate the safety and tolerability of MEDI-563	To evaluate the safety and tolerability of MEDI-563.; To determine the optimal dose of MEDI-563 to be used in Phase 3 studies.; To describe the immunogenicity (IM) and pharmacokinetics (PK) of MEDI-563.; To assess the effect of MEDI-563 on other assessments of clinical activity (i.e, asthma control and pulmonary function).; To assess the effect of MEDI-563 on health-related quality of life.	12-15 months	Yes

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