NCT04256044

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

Completed Last updated 5 February 2020

What this trial tests

trial in Asthma in 4 participants. Completed in 31 July 2018.

Timeline

23 November 2017

Primary endpoint
31 July 2018

31 July 2018

Quick facts

Lead sponsor	University of Leicester
Status	Completed
Study type	OBSERVATIONAL
Enrollment	4
Start date	23 November 2017
Primary completion	31 July 2018
Estimated completion	31 July 2018
Sites	1 location across United Kingdom

Conditions studied

• Asthma — all drugs for Asthma →

Sponsor

University of Leicester

Who can join

Adults 18 to 65, any sex, with Asthma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Interleukin (IL)-33 immunobiology in asthma and airway inflammatory diseases.
   Gaurav R, Poole JA. · · 2022 · cited 19× · PMID 34928757 · DOI 10.1080/02770903.2021.2020815
2. Turning off the alarm - Targeting alarmins and other epithelial mediators of allergic inflammation with biologics.
   Albrecht M. · · 2021 · cited 11× · PMID 33615121 · DOI 10.5414/alx02194e
3. Translational Analysis of Moderate to Severe Asthma GWAS Signals Into Candidate Causal Genes and Their Functional, Tissue-Dependent and Disease-Related Associations.
   Portelli MA, Rakkar K, Hu S, Guo Y, et al · · 2021 · cited 3× · PMID 35386986 · DOI 10.3389/falgy.2021.738741