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

NCT04256044 | Completed

• 1 other identifier: 0628
• Study Type: observational
• Target: 4
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Observational

Observational

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

Sponsors & Collaborators

• University of Leicester: lead
• Oxford University Hospitals NHS Trust: collaborator
• Medicines Evaluation Unit Ltd: collaborator
• AnaptysBio, Inc.: collaborator

Study Sites (1)

NIHR Leicester Biomedical Research Centre, Glenfield Hospital

Leicester, LE3 9QP, United Kingdom

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• David Cousins, Prof

  University of Leicester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2020
• First Posted: February 5, 2020
• Study Start: November 23, 2017
• Primary Completion: July 31, 2018
• Study Completion: July 31, 2018
• Last Updated: February 5, 2020

Record last verified: 2020-01

Locations

GB (1)