Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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EUCTR |
Last refreshed on:
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18 June 2018 |
Main ID: |
EUCTR2013-003269-33-BG |
Date of registration:
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24/02/2014 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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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.
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Scientific title:
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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:
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14/04/2014 |
Target sample size:
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552 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2013-003269-33 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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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
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): yes
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): no
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Countries of recruitment
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Bulgaria
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Czech Republic
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Hungary
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Israel
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Japan
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Latvia
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Lithuania
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Serbia
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Slovakia
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South Africa
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Ukraine
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United States
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Contacts
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Name:
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Clinical Trial Enquiries
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Address:
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1 MedImmune Way
20878
Gaithersburg
United States |
Telephone:
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Email:
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clinicaltrialenquiries@medimmune.com |
Affiliation:
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MedImmune LLC |
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Name:
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Clinical Trial Enquiries
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Address:
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1 MedImmune Way
20878
Gaithersburg
United States |
Telephone:
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Email:
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clinicaltrialenquiries@medimmune.com |
Affiliation:
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MedImmune LLC |
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Key inclusion & exclusion criteria
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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
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Health Condition(s) or Problem(s) studied
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Asthma MedDRA version: 19.0
Level: SOC
Classification code 10038738
Term: Respiratory, thoracic and mediastinal disorders
System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
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Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09]
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Intervention(s)
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Product Name: MEDI9929 Product Code: MEDI9929 Pharmaceutical Form: Solution for injection INN or Proposed INN: Not Applicable CAS Number: 1572943-04-4 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
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Primary Outcome(s)
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Main Objective: To evaluate the effect of MEDI9929 on asthma exacerbations in adult subjects with inadequately controlled, severe asthma.
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Secondary Objective: To evaluate MEDI9929 regarding the efficacy, safety, tolerability, PK, IM, health-related quality of life, and other metrics related to asthma control.
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Timepoint(s) of evaluation of this end point: Week 52
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Primary end point(s): The primary endpoint is the annualized asthma exacerbation rate measured at Week 52.
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Secondary Outcome(s)
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Timepoint(s) of evaluation of this end point: Week 52
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Secondary end point(s): To evaluate MEDI9929 regarding the safety, tolerability, PK, IM and other clinical outcomes in asthma.
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Secondary ID(s)
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CD-RI-MEDI9929-1146
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2013-003269-33-HU
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Source(s) of Monetary Support
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MedImmune LLC
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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