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.

• Register: EUCTR
• Last refreshed on: 3 April 2017
• Main ID: EUCTR2013-003269-33-LV
• Date of registration: 02/01/2014
• Prospective Registration: No
• Primary sponsor: MedImmune LLC( a wholly owned subsidiary of AstraZeneca PLC, One MedImmune Way, Gaithersburg, Maryland, 20878, USA)
• Public title: 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.
• Scientific title: A Phase 2 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of MEDI9929 in Adult Subjects with Inadequately Controlled, Severe Asthma
• Date of first enrolment: 20/12/2013
• Target sample size: 552
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2013-003269-33
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 4
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

Bulgaria, Czech Republic, Hungary, Israel, Japan, Latvia, Lithuania, Serbia, Slovakia, South Africa, Ukraine, United States

Contacts

• Name: Clinical Trial Enquiries
• Affiliation: MedImmune LLC

• Name: Clinical Trial Enquiries
• Affiliation: MedImmune LLC

Key inclusion & exclusion criteria

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.



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09]

Asthma
MedDRA version: 18.0 Level: SOC Classification code 10038738 Term: Respiratory, thoracic and mediastinal disorders System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders

Intervention(s)

Product Name: MEDI9929
Product Code: MEDI9929
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Pending
CAS Number: Pending
Current Sponsor code: MEDI9929
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 70-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use

Primary Outcome(s)

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 Objective: To evaluate MEDI9929 regarding the efficacy, safety, tolerability, PK, IM, health-related quality of life, and other metrics related to asthma control.

Main Objective: To evaluate the effect of MEDI9929 on asthma exacerbations in adult subjects with inadequately controlled, severe asthma.

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: Week 52

Secondary end point(s): To evaluate MEDI9929 regarding the safety, tolerability, PK, IM and other clinical outcomes in asthma.

Secondary ID(s)

2013-003269-33-HU

CD-RI-MEDI9929-1146

Source(s) of Monetary Support

MedImmune LLC