Asthma MedDRA version: 19.0 Level: PT Classification code 10003553 Term: Asthma System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Conditions
Interventions
Product Name: MEDI9929
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: TEZEPELUMAB
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentra
Sponsors
Copenhagen University Hospital Bispebjerg
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Written informed consent 2. Age 18 through 75, inclusive at the time of Visit 1 3. Body mass index between 18-40 kg/m2 (both inclusive) and weight = 40 kg at Visit 1. 4. A diagnosis of asthma as defined by GINA (ginasthma.org). 5. ICS (in any dose) on a daily basis for at least three months prior to Visit 1 6. A stable asthma controller regimen with ICS (±LABA) for at least 4 weeks prior to Visit 1 7. A FEV1 value of = 70% at Visit 1 8. ACQ-6 > 1 (partly controlled) at Visit 1 9. PD15 to mannitol =65 years) no F.1.3.1 Number of subjects for this age range 5
Exclusion criteria
Exclusion criteria: 1. Current smokers or subjects with a smoking history of = 10 pack years. Former smokers with < 10 pack years must have stopped for at least 6 months to be eligible. 2. Previous medical history or evidence of an uncontrolled intercurrent illness. 3. Any clinically relevant abnormal findings in hematology or clinical chemistry. 4. Evidence of active liver disease. 5. History of cancer. 6. Acute upper or lower respiratory infections requiring antibiotics or antiviral medications within 15 days prior to Visit 1. 7. A helminth parasitic infection diagnosed within 24 weeks of Visit 1. 8. Known history of active tuberculosis (TB). 9. Positive hepatitis B surface antigen, or hepatitis C virus antibody serology at screening. 10. Oral corticosteroids (any dose for more than 3 days) 12 weeks prior to Visit 1 or during the run-in period. 11. Pregnant, breastfeeding or lactating females. 12. Concomitant respiratory disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: Expected end of trial is Dec 2017.;Primary end point(s): Change in PD15 to mannitol (provoking dose for 15% reduction in FEV1) from V1 to V6 (?PD15 (V6-V1) placebo vs. ?PD15 (V6-V1) MEDI9929) (in doubling doses) Supportive primary objectives: • The change in PD15 to mannitol, expressed as geometric mean calculated by linear interpolation, from baseline (V1) to week 12 (V6) will be compared between treatments. Subjects who are no longer positive to mannitol (PD15>635 mg) after 12 weeks of treatment will be evaluated as having a PD15 of 635mg in the analysis. • Number of mannitol test negative (PD15 > 635mg) subjects at V6 between groups • Change in RDR (Response Dose Ratio) to mannitol measured at V1 and V6 between groups;Main Objective: To investigate whether airway hyperresponsiveness to mannitol decreases in response to treatment with MEDI9929 in patients with asthma;Secondary Objective: To evaluate if a reduced AHR to mannitol following treatment with MEDI9929 is related to a reduction in chymase/CPA-3 positive mast cells. To investigate changes in airway eosinophils and neutrophils in patients treated with MEDI9929 compared to placebo. | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: Expected end of trial is Dec 2017.;Secondary end point(s): Cell count in airway submucosa, airway epithelium and airway smooth muscle measured at V2 and V7: - MCT, MCTC and MCCPA3 - Number / percentage of eosinophils and neutrophils in airway submucosa, sputum and blood. - Level of FeNO. | — |
Countries
Denmark
Contacts
Public ContactAsger Sverrild
Copenhagen University Hospital Bispebjerg
Outcome results
None listed