Effect of OC000459 on Eosinophilic Airway Inflammation in Severe Asthma

NCT ID: NCT02560610

Last Updated: 2019-08-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-09-30
• Study Completion Date: 2018-08-02

Brief Summary

The aim is to study the effect of OC000459 on eosinophilic airway inflammation and asthma control in subjects with severe, refractory eosinophilic asthma.

Detailed Description

At week 12 subjects not on oral corticosteroids (OCS) will complete the treatment period and return after 4 weeks for final follow up visit. Those subjects who were taking OCS at baseline will continue for a maximum of 12 additional weeks, double blind period during which their current OCS treatment will be titrated down according to their clinical response.

Conditions

Severe Eosinophilic Asthma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

OC000459

Once daily dose of 50mg OC000459 tablets orally for 12/24 weeks

Group Type: ACTIVE_COMPARATOR

OC000459

Intervention Type: DRUG

Placebo

Once daily dose of placebo tablets orally for 12/24 weeks

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Interventions

OC000459

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Atopix Therapeutics, Ltd.

INDUSTRY

Sponsor Role: collaborator

Chiesi Farmaceutici S.p.A.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ian Pavord, Professor

Role: PRINCIPAL_INVESTIGATOR

University of Oxford

Locations

University of Oxford

Oxford, Oxfordshire, United Kingdom

Countries

United Kingdom

Related Links

https://www.clinicaltrialsregister.eu/ctr-search/trial/2015-001833-26/results

Study Record on EU Clinical Trials Register including results

Other Identifiers

2015-001833-26

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

OC000459/019/15

Identifier Type: -

Identifier Source: org_study_id