A clinical trial to investigate the effects of MEDI9929, a drug used in clinical research, in adults with uncontrolled, severe asthma, a disease that causes variable and recurring inflammation of the airways leading to difficulty in breathing.

Phase 1

• Conditions: Asthma; MedDRA version: 18.0Level: SOCClassification code 10038738Term: Respiratory, thoracic and mediastinal disordersSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09]

• Registration Number: EUCTR2013-003269-33-LV
• Lead Sponsor: MedImmune LLC( a wholly owned subsidiary of AstraZeneca PLC, One MedImmune Way, Gaithersburg, Maryland, 20878, USA)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01-02
• Last Update Posted: 3 April 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 552

Inclusion Criteria

• Age and weight range as defined in the protocol.

• Documented Physician-diagnosed asthma in line with the protocol requirements.

• Subjects must have received a physician-prescribed asthma controller
regimen as outlined in the protocol.

• Able to meet the pulmonary function requirements and other defined asthma metrics/measures as outlined in the study protocol.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 510
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 42

Exclusion Criteria

• Established diagnosis of occupational asthma.

• Current smokers or subjects with a smoking history of = 10 pack years.

• Any concomitant respiratory disease, including acute upper or lower respiratory infections.

• Known history of active tuberculosis (TB).

• Receipt of any marketed or investigational biologic agent within 4 months or 5 half lives prior to Visit 1 (Week 5), whichever is longer.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the effect of MEDI9929 on asthma exacerbations in adult subjects with inadequately controlled, severe asthma.;Secondary Objective: To evaluate MEDI9929 regarding the efficacy, safety, tolerability, PK, IM, health-related quality of life, and other metrics related to asthma control.;Primary end point(s): The primary endpoint is the annualized asthma exacerbation rate measured at Week 52.;Timepoint(s) of evaluation of this end point: Week 52

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): To evaluate MEDI9929 regarding the safety, tolerability, PK, IM and other clinical outcomes in asthma.;Timepoint(s) of evaluation of this end point: Week 52