A Study to Test if TEV-48574 is Effective in Relieving Asthma

Asthma Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04545385
• Other study ID #: TV48574-AS-20031
• Secondary ID: 2020-001927-15
• Status: Terminated
• Phase: Phase 2
• Start date: October 7, 2020
• Est. completion date: January 17, 2022

Study information

• Verified date: March 2023
• Source: Teva Branded Pharmaceutical Products R&D, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 65
• Est. completion date: January 17, 2022
• Est. primary completion date: January 17, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• TEV-48574
subcutaneous infusion
• Placebo
Matching Placebo

Locations

Country	Name	City	State
Bulgaria	Teva Investigational Site 59159	Kozloduy
Bulgaria	Teva Investigational Site 59166	Montana
Bulgaria	Teva Investigational Site 59163	Plovdiv
Bulgaria	Teva Investigational Site 59189	Plovdiv
Bulgaria	Teva Investigational Site 59190	Plovdiv
Bulgaria	Teva Investigational Site 59164	Ruse
Bulgaria	Teva Investigational Site 59167	Sofia
Bulgaria	Teva Investigational Site 59168	Sofia
Bulgaria	Teva Investigational Site 59160	Stara Zagora
Bulgaria	Teva Investigational Site 59161	Stara Zagora
Bulgaria	Teva Investigational Site 59165	Varna
Bulgaria	Teva Investigational Site 59162	Veliko Tarnovo
Bulgaria	Teva Investigational Site 59192	Vratsa
Czechia	Teva Investigational Site 54197	Brandys nad Labem
Czechia	Teva Investigational Site 54194	Jindrichuv Hradec
Czechia	Teva Investigational Site 54193	Miroslav
Czechia	Teva Investigational Site 54195	Prague 8
Czechia	Teva Investigational Site 54203	Strakonice
Czechia	Teva Investigational Site 54196	Teplice
Germany	Teva Investigational Site 32747	Berlin
Germany	Teva Investigational Site 32741	Frankfurt am Main
Germany	Teva Investigational Site 32759	Frankfurt/Main
Germany	Teva Investigational Site 32744	Geesthacht
Germany	Teva Investigational Site 32739	Hamburg
Germany	Teva Investigational Site 32746	Hannover
Germany	Teva Investigational Site 32756	Leipzig
Germany	Teva Investigational Site 32757	Leipzig
Germany	Teva Investigational Site 32758	Leipzig
Germany	Teva Investigational Site 32742	Luebeck
Germany	Teva Investigational Site 32743	Muenchen
Germany	Teva Investigational Site 32745	Rheine
Poland	Teva Investigational Site 53461	Bydgoszcz
Poland	Teva Investigational Site 53458	Krakaw
Poland	Teva Investigational Site 53457	Krakow
Poland	Teva Investigational Site 53455	Lodz
Poland	Teva Investigational Site 53459	Poznan
Poland	Teva Investigational Site 53483	Poznan
Poland	Teva Investigational Site 53486	Sucha Beskidzka
Poland	Teva Investigational Site 53462	Tarnow
Poland	Teva Investigational Site 53485	Warszawa
Poland	Teva Investigational Site 53456	Wroclaw
Poland	Teva Investigational Site 53460	Wroclaw
United States	Teva Investigational Site 14925	Allen	Texas
United States	Teva Investigational Site 15230	Austin	Texas
United States	Teva Investigational Site 14914	Bakersfield	California
United States	Teva Investigational Site 15220	Baltimore	Maryland
United States	Teva Investigational Site 14912	Bellevue	Nebraska
United States	Teva Investigational Site 14884	Birmingham	Alabama
United States	Teva Investigational Site 14890	Charleston	South Carolina
United States	Teva Investigational Site 15221	Charlotte	North Carolina
United States	Teva Investigational Site 14889	Cincinnati	Ohio
United States	Teva Investigational Site 14895	Colorado Springs	Colorado
United States	Teva Investigational Site 15222	Coral Gables	Florida
United States	Teva Investigational Site 15223	Cutler Bay	Florida
United States	Teva Investigational Site 14909	Dallas	Texas
United States	Teva Investigational Site 14917	Denver	Colorado
United States	Teva Investigational Site 14886	Dublin	Ohio
United States	Teva Investigational Site 14888	Edmond	Oklahoma
United States	Teva Investigational Site 14902	El Paso	Texas
United States	Teva Investigational Site 14924	Evansville	Indiana
United States	Teva Investigational Site 14919	Fort Worth	Texas
United States	Teva Investigational Site 14881	Greenfield	Wisconsin
United States	Teva Investigational Site 14911	Hialeah	Florida
United States	Teva Investigational Site 15225	Hialeah	Florida
United States	Teva Investigational Site 14921	Houston	Texas
United States	Teva Investigational Site 15234	Huntington Beach	California
United States	Teva Investigational Site 14897	Kansas City	Kansas
United States	Teva Investigational Site 14903	Lincoln	Nebraska
United States	Teva Investigational Site 14915	Little Rock	Arkansas
United States	Teva Investigational Site 14896	Los Angeles	California
United States	Teva Investigational Site 14913	Los Angeles	California
United States	Teva Investigational Site 14918	Los Angeles	California
United States	Teva Investigational Site 14905	McKinney	Texas
United States	Teva Investigational Site 14883	Miami	Florida
United States	Teva Investigational Site 14900	Miami	Florida
United States	Teva Investigational Site 14904	Missoula	Montana
United States	Teva Investigational Site 15226	Monroe	North Carolina
United States	Teva Investigational Site 14877	North Dartmouth	Massachusetts
United States	Teva Investigational Site 14880	Oklahoma City	Oklahoma
United States	Teva Investigational Site 14908	Panama City	Florida
United States	Teva Investigational Site 14923	Philadelphia	Pennsylvania
United States	Teva Investigational Site 14882	Raleigh	North Carolina
United States	Teva Investigational Site 14910	Rolling Hills Estates	California
United States	Teva Investigational Site 14893	Saint Louis	Missouri
United States	Teva Investigational Site 14922	Saint Louis	Missouri
United States	Teva Investigational Site 14879	San Antonio	Texas
United States	Teva Investigational Site 14907	San Diego	California
United States	Teva Investigational Site 14891	San Jose	California
United States	Teva Investigational Site 15227	Skillman	New Jersey
United States	Teva Investigational Site 14920	Spokane	Washington
United States	Teva Investigational Site 15231	Stockton	California
United States	Teva Investigational Site 14894	Tallahassee	Florida
United States	Teva Investigational Site 15224	Tampa	Florida
United States	Teva Investigational Site 14901	Toledo	Ohio
United States	Teva Investigational Site 14916	Walnut Creek	California
United States	Teva Investigational Site 14878	Westminster	California
United States	Teva Investigational Site 14887	Wilmington	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Teva Branded Pharmaceutical Products R&D, Inc.

Countries where clinical trial is conducted

United States,  Bulgaria,  Czechia,  Germany,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants Who Experienced Loss of Asthma Control (LoAC) During the Treatment Period	The LoAC was defined as any 1 of the following during the treatment period: - morning peak expiratory flow (PEF) decrease =30% from baseline on 2 consecutive days or morning handheld forced expiratory volume in the first second of exhalation (FEV1) decrease =20% from baseline on 2 consecutive days; - increase in short-acting beta-agonist (SABA)/quick-relief medication =6 puffs over baseline use in 24 hours on 2 consecutive days; increase in inhaled corticosteroids (ICS) dose =4 × most recent dose; - systemic corticosteroid use; - asthma emergency room (ER) visit or hospitalization.	From randomization (Week 0) until Week 16
Secondary	Time From Randomization to LoAC During the Treatment Period	Time (in days) from randomization to LoAC during the treatment period is the interval from randomization to the occurrence of the LoAC. The LoAC was defined as any 1 of the following during the treatment period: - morning PEF decrease =30% from baseline on 2 consecutive days or morning handheld FEV1 decrease =20% from baseline on 2 consecutive days; - increase in SABA/quick-relief medication =6 puffs over baseline use in 24 hours on 2 consecutive days; increase in ICS dose =4 × most recent dose; - systemic corticosteroid use; - asthma ER visit or hospitalization.	From randomization (Week 0) until Week 16
Secondary	Change From Baseline in Asthma Control Questionnaire 6-Question Version (ACQ-6) Score at Week 16	The ACQ-6 is a 6-item validated asthma assessment tool that has been widely used. Six questions are self-assessments (completed by the participant), 5 questions assessing asthma symptoms: night-time waking, symptoms on waking, activity limitation, shortness of breath, wheezing, and 1 question for short-acting bronchodilator use. Each item on the ACQ-6 has a possible score ranges from 0 to 6, and the total score is the mean of all responses. The total score ranging from 0-6 (0=totally controlled and 6=severely uncontrolled). A higher score indicated poorer asthma control.	Baseline, Week 16
Secondary	Change From Baseline in Percent Predicted Forced Expiratory Volume in the First Second (FEV1) at Week 16	FEV1 (measured by handheld spirometer) is the volume of air that can be forcibly exhaled from the lungs in the first second. The percent predicted FEV1 equals the participant's observed FEV1 divided by the participant's predicted FEV1 (determined by height and race) and converted to a percentage by multiplying by 100%.	Baseline, Week 16
Secondary	Change From Baseline in Daily Average Use of Short-acting Beta-agonist (SABA) Quick Relief Medication at Week 16	Number of inhalations/puffs of SABA/quick relief inhaler used was recorded in the e-diary daily.	Baseline, Week 16
Secondary	Number of Participants Who Had a Clinical Asthma Exacerbation (CAE) During the Treatment Period	The CAEs during the study were defined as a worsening of asthma symptoms resulting in any 1 of the following: - the use of systemic corticosteroids (oral or injectable); - an emergency department visit due to asthma treated with systemic corticosteroids; - an inpatient hospitalization due to asthma.; Worsening asthma included new or increased symptoms or signs that either worried the participant or were related to an asthma-specific alert (if available through the e-diary/handheld spirometer).	From randomization (Week 0) until Week 16
Secondary	Time From Randomization to First CAE During the Treatment Period for Participants With CAE	The CAEs during the study were defined as a worsening of asthma symptoms resulting in any 1 of the following: - the use of systemic corticosteroids (oral or injectable); - an emergency department visit due to asthma treated with systemic corticosteroids; - an inpatient hospitalization due to asthma.; Worsening asthma included new or increased symptoms or signs that either worried the participant or were related to an asthma-specific alert (if available through the e-diary/handheld spirometer).	From randomization (Week 0) until Week 16
Secondary	Change From Baseline in Number of Nighttime Awakenings Due to Asthma at Week 16	Participants recorded the number of nighttime awakenings due to asthma in the e-diary daily, in the morning.	Baseline, Week 16
Secondary	Percent Change in ICS Dose During the Treatment Period	The ICS dose was not collected in the participant diary as planned.	From randomization (Week 0) until Week 16
Secondary	Change From Baseline in Forced Vital Capacity (FVC) at Week 16	FVC (measured by handheld spirometer) is the volume of air that can be forcibly and completely blown out after full inspiration, measured in liters.	Baseline, Week 16
Secondary	Change From Baseline in Forced Expiratory Flow at 25-75% of Pulmonary Volume (FEF25%-75%) at Week 16	The FEF25%-75% (measured by handheld spirometer) is the forced expiratory flow from 25% to 75% of FVC	Baseline, Week 16
Secondary	Change From Baseline in Fractional Exhaled Nitric Oxide (FeNO) at Week 16	FeNO was performed prior to the on-site spirometry.	Baseline, Week 16
Secondary	Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	An AE was defined as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. Serious adverse events (SAEs) included death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized the participant and required medical intervention to prevent 1 of the outcomes listed in this definition. AEs were considered treatment emergent (TEAEs) if onset occurred on or after the first dose date. A summary of serious and non-serious AEs regardless of causality is located in 'Reported Adverse Events module'. AEs include clinically significant changes from baseline in any one of the following categories: clinical laboratory test results, vital signs, ECG findings.	From randomization (Week 0) until Week 24