Overview

Effect of OC000459 on Eosinophilic Airway Inflammation in Severe Asthma

Status:
Completed
Trial end date:
2018-08-02
Target enrollment:
0
Participant gender:
All
Summary
The aim is to study the effect of OC000459 on eosinophilic airway inflammation and asthma control in subjects with severe, refractory eosinophilic asthma.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Atopix Therapeutics, Ltd.
Chiesi Farmaceutici S.p.A.
Collaborator:
Atopix Therapeutics, Ltd.
Treatments:
Indoleacetic Acids
Criteria
Inclusion Criteria:

- Show evidence of reversible airflow obstruction documented within the previous 12
months or prior to Randomisation.

- Meet the European Respiratory Society/American Thoracic Society (ERS/ATS) criteria for
severe asthma at Screening.

- Have documented evidence of eosinophilic airway inflammation during the 12 months
prior to Screening.

- Have evidence of eosinophilic airway inflammation at Screening as reflected by an
induced sputum eosinophil count of ≥3%.

- Subjects who are taking oral corticosteroids (OCS) must be receiving a 20 mg
prednisolone equivalent dose, or less, daily for at least four weeks before the first
dose of study drug. The dose of OCS should be unchanged for at least 14 days prior to
the Baseline visit.

Exclusion Criteria:

- Treatment with XolairTM or anti-Th2 biologicals within 6 months prior to screening.

- Subjects with clinically significant abnormal serum biochemistry, haematology and
urine examination values

- Subjects who have been hospitalised in the last 3 months.

- History of more than 2 episodes of confirmed bacterial lower respiratory tract
infection or current lower respiratory tract infection.

- Subjects are current smokers or have a smoking history of >15 pack years.

- Significant comorbidity that in the Investigator's opinion is likely to impact the
subject's participation in a 26 week study.

- Presence of a clinically important lung condition other than asthma, malignancy or
previous history of cancer in remission for less than 12 months, clinically important
liver or kidney disease, uncontrolled clinically significant cardiovascular disease,
hypereosinophilic syndromes such as Churg-Strauss Syndrome or eosinophilic
oesophagitis.