Clinical trial NCT04545385: A Study to Test if TEV-48574 is Effective in Relieving Asthma
Official title: A 16-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Proof-of-Concept Study to Evaluate the Efficacy and Safety of TEV-48574 in Adults With T2-low/Non-T2 Severe Uncontrolled Asthma
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Asthma
Keywords: T2 low, non-T2 asthma
Lead sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Sponsor class: INDUSTRY
First posted: 2020-09-11
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of the study is to evaluate the effect of TEV-48574 compared with placebo on loss of asthma control (LoAC) in adult participants with T2-low and non-T2 severe asthma uncontrolled on inhaled corticosteroids plus long-acting beta-agonists (ICS+LABA).

The secondary efficacy objective is to evaluate the effect of TEV-48574 compared with placebo on a range of clinical measures of asthma control.

The duration of participant participation in the study is planned to be up to approximately 30 weeks.


Eligibility criteria: Inclusion Criteria:

* The participant has a diagnosis of asthma for at least 12 months prior to the initial screening visit.
* The participant is able to perform technically acceptable and repeatable spirometry, including with a hand-held spirometer, after training
* The participant has had at least one documented clinical asthma exacerbation in the 18 months prior to (but not within 30 days of) the initial screening visit.
* The participant is a non-smoker for ≥6 months with lifetime history ≤10 pack-years, with no current ecigarette or marijuana use.

NOTE- Additional criteria apply, please contact the investigator for more information

Exclusion Criteria:

* The participant has any concomitant conditions or treatments that could interfere with study conduct.
* The participant is currently pregnant or lactating or is planning to become pregnant during the study.
* The participant has received any live or attenuated vaccine within 15 days of the initial screening visit.

NOTE- Additional criteria apply, please contact the investigator for more information

Primary outcomes:
measure: Number of Participants Who Experienced Loss of Asthma Control (LoAC) During the Treatment Period
timeFrame: From randomization (Week 0) until Week 16
Secondary outcomes:
measure: Time From Randomization to LoAC During the Treatment Period
timeFrame: From randomization (Week 0) until Week 16
measure: Change From Baseline in Asthma Control Questionnaire 6-Question Version (ACQ-6) Score at Week 16
timeFrame: Baseline, Week 16
measure: Change From Baseline in Percent Predicted Forced Expiratory Volume in the First Second (FEV1) at Week 16
timeFrame: Baseline, Week 16
measure: Change From Baseline in Daily Average Use of Short-acting Beta-agonist (SABA) Quick Relief Medication at Week 16
timeFrame: Baseline, Week 16
measure: Number of Participants Who Had a Clinical Asthma Exacerbation (CAE) During the Treatment Period
timeFrame: From randomization (Week 0) until Week 16
measure: Time From Randomization to First CAE During the Treatment Period for Participants With CAE
timeFrame: From randomization (Week 0) until Week 16
measure: Change From Baseline in Number of Nighttime Awakenings Due to Asthma at Week 16
timeFrame: Baseline, Week 16
measure: Percent Change in ICS Dose During the Treatment Period
timeFrame: From randomization (Week 0) until Week 16
measure: Change From Baseline in Forced Vital Capacity (FVC) at Week 16
timeFrame: Baseline, Week 16
measure: Change From Baseline in Forced Expiratory Flow at 25-75% of Pulmonary Volume (FEF25%-75%) at Week 16
timeFrame: Baseline, Week 16
measure: Change From Baseline in Fractional Exhaled Nitric Oxide (FeNO) at Week 16
timeFrame: Baseline, Week 16
measure: Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
timeFrame: From randomization (Week 0) until Week 24
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Teva Investigational Site 14884
state: Alabama
city: Little Rock
country: United States
facility: Teva Investigational Site 14915
state: Arkansas
city: Bakersfield
country: United States
facility: Teva Investigational Site 14914
state: California
city: Huntington Beach
country: United States
facility: Teva Investigational Site 15234
state: California
city: Los Angeles
country: United States
facility: Teva Investigational Site 14896
state: California
city: Los Angeles
country: United States
facility: Teva Investigational Site 14918
state: California
city: Los Angeles
country: United States
facility: Teva Investigational Site 14913
state: California
city: Rolling Hills Estates
country: United States
facility: Teva Investigational Site 14910
state: California
city: San Diego
country: United States
facility: Teva Investigational Site 14907
state: California
city: San Jose
country: United States
facility: Teva Investigational Site 14891
state: California
city: Stockton
country: United States
facility: Teva Investigational Site 15231
state: California
city: Walnut Creek
country: United States
facility: Teva Investigational Site 14916
state: California
city: Westminster
country: United States
facility: Teva Investigational Site 14878
state: California
city: Colorado Springs
country: United States
facility: Teva Investigational Site 14895
state: Colorado
city: Denver
country: United States
facility: Teva Investigational Site 14917
state: Colorado
city: Coral Gables
country: United States
facility: Teva Investigational Site 15222
state: Florida
city: Cutler Bay
country: United States
facility: Teva Investigational Site 15223
state: Florida
city: Hialeah
country: United States
facility: Teva Investigational Site 14911
state: Florida
city: Hialeah
country: United States
facility: Teva Investigational Site 15225
state: Florida
city: Miami
country: United States
facility: Teva Investigational Site 14900
state: Florida
city: Miami
country: United States
facility: Teva Investigational Site 14883
state: Florida
city: Panama City
country: United States
facility: Teva Investigational Site 14908
state: Florida
city: Tallahassee
country: United States
facility: Teva Investigational Site 14894
state: Florida
city: Tampa
country: United States
facility: Teva Investigational Site 15224
state: Florida
city: Evansville
country: United States
facility: Teva Investigational Site 14924
state: Indiana
city: Kansas City
country: United States
facility: Teva Investigational Site 14897
state: Kansas
city: Baltimore
country: United States
facility: Teva Investigational Site 15220
state: Maryland
city: North Dartmouth
country: United States
facility: Teva Investigational Site 14877
state: Massachusetts
city: Saint Louis
country: United States
facility: Teva Investigational Site 14922
state: Missouri
city: Saint Louis
country: United States
facility: Teva Investigational Site 14893
state: Missouri
city: Missoula
country: United States
facility: Teva Investigational Site 14904
state: Montana
city: Bellevue
country: United States
facility: Teva Investigational Site 14912
state: Nebraska
city: Lincoln
country: United States
facility: Teva Investigational Site 14903
state: Nebraska
city: Skillman
country: United States
facility: Teva Investigational Site 15227
state: New Jersey
city: Charlotte
country: United States
facility: Teva Investigational Site 15221
state: North Carolina
city: Monroe
country: United States
facility: Teva Investigational Site 15226
state: North Carolina
city: Raleigh
country: United States
facility: Teva Investigational Site 14882
state: North Carolina
city: Wilmington
country: United States
facility: Teva Investigational Site 14887
state: North Carolina
city: Cincinnati
country: United States
facility: Teva Investigational Site 14889
state: Ohio
city: Dublin
country: United States
facility: Teva Investigational Site 14886
state: Ohio
city: Toledo
country: United States
facility: Teva Investigational Site 14901
state: Ohio
city: Edmond
country: United States
facility: Teva Investigational Site 14888
state: Oklahoma
city: Oklahoma City
country: United States
facility: Teva Investigational Site 14880
state: Oklahoma
city: Philadelphia
country: United States
facility: Teva Investigational Site 14923
state: Pennsylvania
city: Charleston
country: United States
facility: Teva Investigational Site 14890
state: South Carolina
city: Allen
country: United States
facility: Teva Investigational Site 14925
state: Texas
city: Austin
country: United States
facility: Teva Investigational Site 15230
state: Texas
city: Dallas
country: United States
facility: Teva Investigational Site 14909
state: Texas
city: El Paso
country: United States
facility: Teva Investigational Site 14902
state: Texas
city: Fort Worth
country: United States
facility: Teva Investigational Site 14919
state: Texas
city: Houston
country: United States
facility: Teva Investigational Site 14921
state: Texas
city: McKinney
country: United States
facility: Teva Investigational Site 14905
state: Texas
city: San Antonio
country: United States
facility: Teva Investigational Site 14879
state: Texas
city: Spokane
country: United States
facility: Teva Investigational Site 14920
state: Washington
city: Greenfield
country: United States
facility: Teva Investigational Site 14881
state: Wisconsin
city: Kozloduy
country: Bulgaria
facility: Teva Investigational Site 59159
city: Montana
country: Bulgaria
facility: Teva Investigational Site 59166
city: Plovdiv
country: Bulgaria
facility: Teva Investigational Site 59163
city: Plovdiv
country: Bulgaria
facility: Teva Investigational Site 59189
city: Plovdiv
country: Bulgaria
facility: Teva Investigational Site 59190
city: Ruse
country: Bulgaria
facility: Teva Investigational Site 59164
city: Sofia
country: Bulgaria
facility: Teva Investigational Site 59168
city: Sofia
country: Bulgaria
facility: Teva Investigational Site 59167
city: Stara Zagora
country: Bulgaria
facility: Teva Investigational Site 59160
city: Stara Zagora
country: Bulgaria
facility: Teva Investigational Site 59161
city: Varna
country: Bulgaria
facility: Teva Investigational Site 59165
city: Veliko Tarnovo
country: Bulgaria
facility: Teva Investigational Site 59162
city: Vratsa
country: Bulgaria
facility: Teva Investigational Site 59192
city: Brandys nad Labem
country: Czechia
facility: Teva Investigational Site 54197
city: Jindrichuv Hradec
country: Czechia
facility: Teva Investigational Site 54194
city: Miroslav
country: Czechia
facility: Teva Investigational Site 54193
city: Prague 8
country: Czechia
facility: Teva Investigational Site 54195
city: Strakonice
country: Czechia
facility: Teva Investigational Site 54203
city: Teplice
country: Czechia
facility: Teva Investigational Site 54196
city: Berlin
country: Germany
facility: Teva Investigational Site 32747
city: Frankfurt am Main
country: Germany
facility: Teva Investigational Site 32741
city: Frankfurt/Main
country: Germany
facility: Teva Investigational Site 32759
city: Geesthacht
country: Germany
facility: Teva Investigational Site 32744
city: Hamburg
country: Germany
facility: Teva Investigational Site 32739
city: Hannover
country: Germany
facility: Teva Investigational Site 32746
city: Leipzig
country: Germany
facility: Teva Investigational Site 32757
city: Leipzig
country: Germany
facility: Teva Investigational Site 32758
city: Leipzig
country: Germany
facility: Teva Investigational Site 32756
city: Luebeck
country: Germany
facility: Teva Investigational Site 32742
city: Muenchen
country: Germany
facility: Teva Investigational Site 32743
city: Rheine
country: Germany
facility: Teva Investigational Site 32745
city: Bydgoszcz
country: Poland
facility: Teva Investigational Site 53461
city: Krakaw
country: Poland
facility: Teva Investigational Site 53458
city: Krakow
country: Poland
facility: Teva Investigational Site 53457
city: Lodz
country: Poland
facility: Teva Investigational Site 53455
city: Poznan
country: Poland
facility: Teva Investigational Site 53483
city: Poznan
country: Poland
facility: Teva Investigational Site 53459
city: Sucha Beskidzka
country: Poland
facility: Teva Investigational Site 53486
city: Tarnow
country: Poland
facility: Teva Investigational Site 53462
city: Warszawa
country: Poland
facility: Teva Investigational Site 53485
city: Wroclaw
country: Poland
facility: Teva Investigational Site 53460
city: Wroclaw
country: Poland
facility: Teva Investigational Site 53456
Study officials:
affiliation: Teva Branded Pharmaceutical Products R&D, Inc.
name: Teva Medical Expert, MD
role: STUDY_DIRECTOR
References: