Analysis of Peripheral Blood ILC2s and Th2 Cells in Response to ANB020

NCT ID: NCT04256044

Last Updated: 2020-02-05

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 4 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-11-23
• Study Completion Date: 2018-07-31

Brief Summary

This exploratory laboratory only study will assess alterations in immune cells in blood samples that may be responsive to an inflammatory mediator in asthma called IL-33 (Innate lymphoid type 2 cells, basophils and Th2 cells) in response to treatment with ANB020/placebo (a drug that targets IL-33, in the linked clinical trial ANB020-004). The study will involve additional 10ml blood draws on scheduled study visits in the ANB020-004 clinical trial at baseline, 1 week, 5 weeks, 18 weeks (4 visits total). Total number of subjects is 24 at the same 3 participating UK sites as the main linked clinical trial ANB020-004.

Blood samples will be sent on the same day to a flow cytometry laboratory at the NIHR Leicester Biomedical Research Centre (BRC) - Respiratory. A dedicated post doctoral, trained laboratory scientist will analyse the blood samples for the required cell types using a technique called flow cytometry - this technique identifies cell surface and intercellular markers, that together provide a unique cell identity. The experiments will be supervised by a senior research scientist and flow cytometrist Professor Dave Cousins, at the University of Leicester and results of the experiments will be fed back to AnaptysBio (the linked clinical trial Sponsor). Professor Salman Siddiqui at the University of Leicester will oversee the clinical conduct of this laboratory study and act as the Chief Investigator. Professor Siddiqui is also the local site lead Principal Investigator at Leicester for the linked ANB020-004 clinical trial described below.

The linked study (ANB020-004) is a Double-blind Placebo-Controlled Proof of Concept Study to Investigate ANB020 (a drug that targets an inflammatory mediator called IL-33) Activity in Adult Patients with Severe Eosinophilic Asthma. The expected duration of the study is up to 141 days. Screening period of 7-14 days and treatment and follow-up period of 127 days.

Conditions

Asthma

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Observational

Observational

No interventions assigned to this group

Eligibility Criteria

Exclusion Criteria

-

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Oxford University Hospitals NHS Trust

OTHER

Sponsor Role: collaborator

Medicines Evaluation Unit Ltd

INDUSTRY

Sponsor Role: collaborator

AnaptysBio, Inc.

INDUSTRY

Sponsor Role: collaborator

University of Leicester

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Cousins, Prof

Role: PRINCIPAL_INVESTIGATOR

University of Leicester

Locations

NIHR Leicester Biomedical Research Centre, Glenfield Hospital

Leicester, , United Kingdom

Countries

United Kingdom

Other Identifiers

0628

Identifier Type: -

Identifier Source: org_study_id