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.

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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-003269-33-HU

Enrollment

552

Registered

2013-11-29

Start date

2014-02-18

Completion date

Unknown

Last updated

2017-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

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 mill

Eligibility

Sex/Gender

All

Inclusion 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

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.

Design outcomes

Primary

Measure	Time frame
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	—

Measure

Time frame

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

Measure	Time frame
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	—

Countries

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

Contacts

Public ContactClinical Trial Enquiries

MedImmune LLC

clinicaltrialenquiries@medimmune.com

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026