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University of Kansas' Precision Biologic Interventions for Severe Exacerbation Prone Asthma (PrecISE) Clinical Center

Award Number: UG1HL139119
ORGANIZATION: NATIONAL HEART, LUNG, & BLOOD INSTITUTE
OPDIV: NIH
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/17/2019
PERIOD OF PERFORMANCE END DATE: 06/30/2025

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University of Kansas' Precision Biologic Interventions for Severe Exacerbation Prone Asthma (PrecISE) Clinical Center - Abstract – Washington University's PrecISE Clinical Center The overall impact of severe asthma on individuals affected by this disease as well as society is substantial. Treatment for severe asthma is now focusing on tailoring treatment to particular phenotypes driven by the endotypes yet the evidence for this approach is lacking. Key phenotypes which have supporting evidence for appropriate biomarkers and therapy based on their endotype include eosinophilic-, T2- and mucin-driven disease states. This proposal contains a precision-medicine, biomarker-driven, highly novel adaptive controlled trial to establish a new treatment paradigm for severe asthma as proposed by the NHLBI's Precision Interventions for Severe and/or Exacerbation Prone Asthma (PrecISE) Network RFA. In the current proposal, our overall hypothesis is that a specific phenotype (eosinophilic, T2 or mucin) will respond better to a biologic therapy targeted specifically to that phenotype than an empirical approach. Specifically, we hypothesize that patients with the following phenotypes will differ in treatment responses: i) eosinophilic - treatment with anti-IL5 or anti-IL4Rα monoclonal antibody (mAb) is superior to anti-IgE, ii) T2 - treatment with anti-IL4Rα or –IL5 is superior to anti-IgE and iii) mucus - treatment with either anti-IL4Rα or - IL5 is superior to anti-IgE. In this adaptive trial design, we will use two short-term response indicators, improvement in FEV1 of 100 ml or greater from baseline and/or improvement in asthma control (ACQ) score of 0.5 or greater, to determine if the patient is responding or not. The primary endpoint will be the asthma exacerbation rate. Accordingly, our specific aims are to study adolescent and adult patients with severe persistent exacerbation-prone asthma to: Aim I. Evaluate which biologic therapy, anti-IL4Rα, anti-IL5 or anti-IgE mAb, is most effective among patients with eosinophilic asthma (blood eosinophil ≥300 cells/µL) who demonstrate a short term- response and which demonstrates an acceptable safety profile. Aim II. Evaluate which biologic therapy, anti-IL4Rα, anti-IL5 or anti-IgE mAb, is most effective among patients with T2 asthma (high T2 sputum signature) who demonstrate a short term-response and which demonstrates an acceptable safety profile. Aim III. Evaluate which biologic therapy, anti-IL4Rα, anti-IL5 or anti-IgE mAb, is most effective among patients with mucus-driven asthma (high mucus score on qCT chest) who demonstrate a short term- response and which demonstrates an acceptable safety profile. Aim IV. a. Determine whether airway remodeling (change in qCT wall area) is modified by biologic therapy. Aim IV. b. Evaluate the ability of a positive short-term response within each biologic therapy to predict exacerbations and airway remodeling.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2026 ( Subtotal = -$13,427 )
2026	2022	UNIVERSITY OF KANSAS MEDICAL CENTER RESEARCH INSTITUTE, INC.	3901 RAINBOW BLVD	KANSAS CITY	KS	66160	WYANDOTTE	USA	Lung Diseases Research	000	7	12/22/2025	NON-COMPETING CONTINUATION	-$13,427
														Subtotal = -$13,427

Issue Date FY: 2025 ( Subtotal = $0 )
2025	2022	UNIVERSITY OF KANSAS MEDICAL CENTER RESEARCH INSTITUTE, INC.	3901 RAINBOW BLVD	KANSAS CITY	KS	66160	WYANDOTTE	USA	Lung Diseases Research	000	7	12/10/2024	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2024 ( Subtotal = $1 )
2024	2022	UNIVERSITY OF KANSAS MEDICAL CENTER RESEARCH INSTITUTE, INC.	3901 RAINBOW BLVD	KANSAS CITY	KS	66160	WYANDOTTE	USA	Lung Diseases Research	000	7	8/6/2024	NON-COMPETING CONTINUATION	$1
														Subtotal = $1

Issue Date FY: 2022 ( Subtotal = $345,365 )
2022	2022	UNIVERSITY OF KANSAS MEDICAL CENTER RESEARCH INSTITUTE, INC.	4330 SHAWNEE MISSION PKWY	SHAWNEE MISSION	KS	66205	JOHNSON	USA	Lung Diseases Research	000	7	8/30/2022	NON-COMPETING CONTINUATION	$345,365
														Subtotal = $345,365

Issue Date FY: 2021 ( Subtotal = $394,293 )
2021	2021	UNIVERSITY OF KANSAS MEDICAL CENTER RESEARCH INSTITUTE, INC.	4330 SHAWNEE MISSION PKWY	SHAWNEE MISSION	KS	66205	JOHNSON	USA	Lung Diseases Research	000	6	7/21/2021	NON-COMPETING CONTINUATION	$394,293
														Subtotal = $394,293

Issue Date FY: 2020 ( Subtotal = $402,693 )
2020	2020	UNIVERSITY OF KANSAS MEDICAL CENTER RESEARCH INSTITUTE, INC.	4330 SHAWNEE MISSION PKWY	SHAWNEE MISSION	KS	66205	JOHNSON	USA	Lung Diseases Research	003	5	7/24/2020	NON-COMPETING CONTINUATION	$402,693
2020	2019	WASHINGTON UNIVERSITY, THE	ONE BROOKINGS DR	SAINT LOUIS	MO	63130	SAINT LOUIS	USA	Lung Diseases Research	001	3	1/16/2020	NON-COMPETING CONTINUATION	-$65,256
2020	2019	UNIVERSITY OF KANSAS MEDICAL CENTER RESEARCH INSTITUTE, INC.	4330 SHAWNEE MISSION PKWY	SHAWNEE MISSION	KS	66205	JOHNSON	USA	Lung Diseases Research	002	4	1/16/2020	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$222,399
2020	2018	WASHINGTON UNIVERSITY, THE	ONE BROOKINGS DR	SAINT LOUIS	MO	63130	SAINT LOUIS	USA	Lung Diseases Research	000	2	1/16/2020	NON-COMPETING CONTINUATION	-$157,143
														Subtotal = $402,693

Issue Date FY: 2019 ( Subtotal = $408,534 )
2019	2019	WASHINGTON UNIVERSITY, THE	ONE BROOKINGS DR	SAINT LOUIS	MO	63130	SAINT LOUIS	USA	Lung Diseases Research	003	3	9/3/2019	NON-COMPETING CONTINUATION	-$343,278
2019	2019	UNIVERSITY OF KANSAS MEDICAL CENTER RESEARCH INSTITUTE, INC.	4330 SHAWNEE MISSION PKWY	SHAWNEE MISSION	KS	66205	JOHNSON	USA	Lung Diseases Research	002	4	8/31/2019	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$343,278
2019	2019	WASHINGTON UNIVERSITY, THE	ONE BROOKINGS DR	SAINT LOUIS	MO	63130	SAINT LOUIS	USA	Lung Diseases Research	001	3	7/31/2019	NON-COMPETING CONTINUATION	$408,534
2019	2018	WASHINGTON UNIVERSITY, THE	ONE BROOKINGS DR	SAINT LOUIS	MO	63130	SAINT LOUIS	USA	Lung Diseases Research	000	2	5/20/2019	NON-COMPETING CONTINUATION	$0
														Subtotal = $408,534

Issue Date FY: 2018 ( Subtotal = $411,964 )
2018	2018	WASHINGTON UNIVERSITY, THE	ONE BROOKINGS DR	SAINT LOUIS	MO	63130	SAINT LOUIS	USA	Lung Diseases Research	000	2	7/27/2018	NON-COMPETING CONTINUATION	$411,964
														Subtotal = $411,964

Issue Date FY: 2017 ( Subtotal = $275,424 )
2017	2017	WASHINGTON UNIVERSITY, THE	ONE BROOKINGS DR	SAINT LOUIS	MO	63130	SAINT LOUIS	USA	Lung Diseases Research	000	1	9/23/2017	NEW	$275,424
														Subtotal = $275,424

Grand Total All Awards = $2,224,847

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University of Kansas' Precision Biologic Interventions for Severe Exacerbation Prone Asthma (PrecISE) Clinical Center

Award Number: UG1HL139119

ORGANIZATION: NATIONAL HEART, LUNG, & BLOOD INSTITUTE

OPDIV: NIH

AWARD CLASS: COOPERATIVE AGREEMENT

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 09/17/2019

PERIOD OF PERFORMANCE END DATE: 06/30/2025

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