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

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.

Study Overview

• Status: Completed
• Conditions: Asthma

• Study Type: Observational
• Enrollment (Actual): 4

Contacts and Locations

Study Locations

• United Kingdom
  • Leicester, United Kingdom, LE3 9QP
    • NIHR Leicester Biomedical Research Centre, Glenfield Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Asthma patients taking part in the link study ANB202-004 (EudraCT 2017-000647-40) will be asked to take part in this observational study, in parallel with the main study.

Description

Inclusion Criteria: Consenting participant in the ANB020-004 clinical trial (EudraCT 2017-000647-40) -

Exclusion Criteria:1) Unwilling to have four additional blood samples (10 mls per sample) for flow cytometry as part of the flow cytometry biomarker study linked to existing ANB020-004 study. (EudraCT 2017-000647-40)

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Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Observational

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To investigate whether treatment with ANB020, a drug that targets IL-33 alters levels of Basophils, Th2 cells or innate lymphoid type 2 cells (ILC2s) in peripheral blood	To investigate whether treatment with ANB020, a drug that targets IL-33 (an inflammatory mediator in asthma) alters levels of Basophils, Th2 cells or innate lymphoid type 2 cells (ILC2s) in peripheral blood in patients receiving active drug compared to placebo, in a linked clinical trial sponsored by AnaptysBio - ANB020-004.	18 weeks

Collaborators and Investigators

• Sponsor: University of Leicester
• Collaborators: Oxford University Hospitals NHS Trust; Medicines Evaluation Unit Ltd; AnaptysBio, Inc.
• Investigators: Principal Investigator: David Cousins, Prof, University of Leicester

Study record dates

Study Major Dates

• Study Start (Actual): November 23, 2017
• Primary Completion (Actual): July 31, 2018
• Study Completion (Actual): July 31, 2018

Study Registration Dates

• First Submitted: February 3, 2020
• First Submitted That Met QC Criteria: February 3, 2020
• First Posted (Actual): February 5, 2020

Study Record Updates

• Last Update Posted (Actual): February 5, 2020
• Last Update Submitted That Met QC Criteria: February 3, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: 0628

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No