Clinical trial NCT04847674: A Study to Test if TEV-53275 is Effective in Relieving Asthma
Official title: A Phase 2, Multicenter, Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Assess the Safety, Efficacy and Pharmacodynamics of TEV 53275 Administered Subcutaneously in Adult Patients With Persistent Eosinophilic Asthma
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Asthma
Keywords: Persistent
Eosinophilic
Asthma
Lead sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Sponsor class: INDUSTRY
First posted: 2021-04-19
Enrollment: 97
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 efficacy of TEV-53275 administered subcutaneously (sc) in adult participants with persistent asthma and an eosinophilic phenotype compared to placebo. A secondary objective is to evaluate the efficacy of TEV-53275 compared to placebo assessed by lung function, asthma symptoms, rescue medication use, and quality of life measures. Another secondary objective is to evaluate the safety and tolerability of TEV-53275 administered sc in adult participants with persistent asthma and an eosinophilic phenotype compared with placebo, and lastly, to evaluate the immunogenicity of TEV-53275 administered sc in adult participants with persistent asthma and an eosinophilic phenotype.

Detailed description: The planned study duration is approximately 16 months.

The total duration of study participation is approximately 34 weeks including up to a 2-week screening period, a 2-week run-in period, a 16-week treatment period, and a follow-up visit 14 weeks after the final treatment visit.

Eligibility criteria: Inclusion Criteria:

* The participant is an adult female or male ≥18 years of age. Note: Age requirements are as specified or allowed by local regulations.
* The participant has a diagnosis of asthma for at least 6 months and has been stable without exacerbation or change in medications for at least 1 month..
* Current Asthma Therapy: The participant has been maintained for at least 1 month on stable doses of:

  * medium or high dose inhaled corticosteroids (ICS)±another controller.
  * any fixed dose combination ICS (low, medium, or high) with long-acting beta agonist (LABA)±another controller.
* Women of non-childbearing potential, or congenitally sterile, or 1-year postmenopausal. Women of childbearing potential must have a negative β-human chorionic gonadotropin (β-HCG) test result and practice a highly effective method of birth control prior to investigational medicinal product (IMP) administration and 30 weeks after the dose of IMP.
* The participant, as judged by the investigator, is able to continue their current asthma maintenance medications throughout the study.

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

Exclusion Criteria:

* Life threatening asthma, defined as a history of asthma episode(s) requiring intubation and/or associated hypercapnea, respiratory arrest, hypoxic seizures, or asthma-related syncopal episode(s).
* The participant has a suspected bacterial or viral infection of the upper or lower respiratory tract, sinus, or middle ear that has not resolved at least 2 weeks before the screening period. Note: Participants who develop an upper respiratory infection/lower respiratory infection (URI/LRI) during the run-in period may rescreen 2 weeks after symptoms resolve and undergo coronavirus disease 2019 (COVID-19) testing.
* Participants with a confirmed infection with COVID-19 within 3 months prior to the screening visit.
* The participant has an eosinophilic condition including hypereosinophilic syndrome, eosinophilic pneumonia, eosinophilic granulomatosis with polyangiitis (EGPA \[Churg Strauss syndrome\]), or allergic bronchopulmonary aspergillosis.
* The participant has an active helminthic or parasitic infection currently or within the last 6 months.
* The participant has a history of malignancy other than fully resected basal cell carcinoma of the skin.
* The participant has any clinically significant, uncontrolled medical or psychiatric condition (treated or untreated) that would interfere with the study schedule or procedures, interpretation of efficacy results, or compromise the participant's safety.
* The participant has known history of, or a positive test result for, hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibodies (Ab), or human immunodeficiency virus (HIV) Types 1 or 2 Ab (according to 4th generation serology testing).
* The participant is a pregnant or lactating woman, or plans to become pregnant during the study.
* The participant has previously participated in a study with TEV-53275.
* The participant has participated in another study of an IMP (or a medical device) within the previous 30 days or is currently participating in another study of an IMP (or a medical device).
* The participant has been treated with a monoclonal antibody used to treat asthma or other inflammatory conditions within the washout period (5 half-lives), has demonstrated hypersensitivity or anaphylaxis to a monoclonal antibody (Appendix G),or is currently using or has used a systemic immunosuppressive medication within the last 6 months. NOTE: Prior depemokimab exposure is prohibited without exception.
* The participant has a history of chronic alcohol or drug abuse within the previous 2 years.
* The participant currently smokes or has a smoking history of 10 pack years or more (a pack year is defined as smoking 1 pack of cigarettes \[20 cigarettes\]/day for 1 year), OR the participant used tobacco products within the past year (eg, cigarettes, cigars, chewing tobacco, or pipe tobacco), OR the participant has smoked marijuana within 1 month, OR the participant has a history of "vaping" tobacco, marijuana, or any other substance within 24 months.
* Vulnerable participants (eg, people kept in detention).

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

Primary outcomes:
measure: Change From Baseline in Clinic-based Standardized Baseline-adjusted Morning Trough (Pre-bronchodilator) FEV1 at Week 12
timeFrame: Baseline, Week 12
Secondary outcomes:
measure: Number of Participants With Well-controlled Asthma Status (Yes Versus No) at Weeks 12 and 16
timeFrame: Weeks 12 and 16
measure: Change From Baseline in the Weekly Average of Daily Morning Trough (Pre-Rescue Bronchodilator) FEV1 Over 12 Weeks From Week 1 Through 12 and Over 16 Weeks From Week 1 Through 16
timeFrame: Baseline, up to Week 12, up to Week 16
measure: Change From Baseline in Weekly Average of Rescue Medication Use Over 12 Weeks From Week 1 Through 12 and Over 16 Weeks From Week 1 Through 16
timeFrame: Baseline, up to Week 12, up to Week 16
measure: Change From Baseline in Weekly Percentage of Asthma Control Days (No Symptoms and No Rescue Medication Use) Over 12 Weeks From Week 1 Through 12 and Over 16 Weeks From Week 1 Through 16
timeFrame: Baseline, up to Week 12, up to Week 16
measure: Change From Baseline in Clinic-based Standardized Baseline-adjusted Morning Trough (Pre-bronchodilator) FEV1 at Week 16
timeFrame: Baseline, Week 16
measure: Number of Participants Who Achieved Clinic-based FEV1 ≥80% Predicted at Weeks 12 and 16
timeFrame: Weeks 12 and 16
measure: Number of Participants Who Achieved Forced Expiratory Flow at 25% to 75% of Forced Expiratory Volume (FVC) (FEF25-75) ≥70% Predicted at Weeks 12 and 16
timeFrame: Weeks 12 and 16
measure: Change From Baseline in FEF25-75 Over 12 Weeks From Week 1 Through 12 and Over 16 Weeks From Week 1 Through 16
timeFrame: Baseline, up to Week 12, up to Week 16
measure: Time to First Clinical Asthma Exacerbation (CAE)
timeFrame: Baseline up to Week 16
measure: Change From Baseline in Asthma Control Questionnaire (ACQ-6) Score at Weeks 12 and 16
timeFrame: Baseline, Week 12, Week 16
measure: Change From Baseline in Asthma Control Test (ACT) Score at Weeks 12 and 16
timeFrame: Baseline, Week 12, Week 16
measure: Change From Baseline in Standardized Asthma Quality of Life Questionnaire (AQLQ[S]) Overall Score at Weeks 12 and 16
timeFrame: Baseline, Week 12, Week 16
measure: Number of Participants Who Achieved FEV1:FVC Ratio ≥0.80 at Weeks 12 and 16
timeFrame: Weeks 12 and 16
measure: Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
timeFrame: Baseline up to Week 30
measure: Number of Participants Who Received at Least 1 Concomitant Asthma Medication
timeFrame: Baseline up to Week 30
measure: Number of Participants Developing Antidrug Antibodies (ADAs) Throughout the Study
timeFrame: Baseline up to Week 30
measure: Number of Participants With at Least 1 Potentially Clinically Significant Abnormal Serum Chemistry Value
timeFrame: Baseline up to Week 30
measure: Number of Participants With at Least 1 Potentially Clinically Significant Abnormal Hematology Value
timeFrame: Baseline up to Week 30
measure: Number of Participants With at Least 1 Potentially Clinically Significant Urinalysis Abnormalities
timeFrame: Baseline up to Week 30
measure: Number of Participants With at Least 1 Potentially Clinically Significant Abnormal Vital Signs Value
timeFrame: Baseline up to Week 30
measure: Number of Participants With Potentially Clinically Significant Abnormal Electrocardiogram Values
timeFrame: Baseline up to Week 30
measure: Number of Participants With Injection Site Reactions
timeFrame: Baseline up to Week 30
measure: Number of Participants Who Did Not Complete the Study Due to AEs
timeFrame: Baseline up to Week 30
Other outcomes:
Locations:
city: Hoover
country: United States
facility: Teva Investigational Site 15188
state: Alabama
city: Peoria
country: United States
facility: Teva Investigational Site 15174
state: Arizona
city: Phoenix
country: United States
facility: Teva Investigational Site 15202
state: Arizona
city: Tucson
country: United States
facility: Teva Investigational Site 15205
state: Arizona
city: Bakersfield
country: United States
facility: Teva Investigational Site 15178
state: California
city: Bakersfield
country: United States
facility: Teva Investigational Site 15196
state: California
city: Encinitas
country: United States
facility: Teva Investigational Site 15176
state: California
city: Huntington Beach
country: United States
facility: Teva Investigational Site 15156
state: California
city: Inglewood
country: United States
facility: Teva Investigational Site 15209
state: California
city: Los Angeles
country: United States
facility: Teva Investigational Site 15194
state: California
city: Los Angeles
country: United States
facility: Teva Investigational Site 15143
state: California
city: Los Angeles
country: United States
facility: Teva Investigational Site 15212
state: California
city: Mission Viejo
country: United States
facility: Teva Investigational Site 15151
state: California
city: North Hollywood
country: United States
facility: Teva Investigational Site 15210
state: California
city: San Jose
country: United States
facility: Teva Investigational Site 15136
state: California
city: Stockton
country: United States
facility: Teva Investigational Site 15157
state: California
city: Upland
country: United States
facility: Teva Investigational Site 15158
state: California
city: Walnut Creek
country: United States
facility: Teva Investigational Site 15167
state: California
city: Westminster
country: United States
facility: Teva Investigational Site 15133
state: California
city: Colorado Springs
country: United States
facility: Teva Investigational Site 15166
state: Colorado
city: Lafayette
country: United States
facility: Teva Investigational Site 15200
state: Colorado
city: Wheat Ridge
country: United States
facility: Teva Investigational Site 15139
state: Colorado
city: Boynton Beach
country: United States
facility: Teva Investigational Site 15182
state: Florida
city: Hialeah
country: United States
facility: Teva Investigational Site 15147
state: Florida
city: Hialeah
country: United States
facility: Teva Investigational Site 15134
state: Florida
city: Leesburg
country: United States
facility: Teva Investigational Site 15152
state: Florida
city: Miami Lakes
country: United States
facility: Teva Investigational Site 15169
state: Florida
city: Miami
country: United States
facility: Teva Investigational Site 15149
state: Florida
city: Miami
country: United States
facility: Teva Investigational Site 15211
state: Florida
city: Miami
country: United States
facility: Teva Investigational Site 15206
state: Florida
city: Miami
country: United States
facility: Teva Investigational Site 15215
state: Florida
city: Miami
country: United States
facility: Teva Investigational Site 15141
state: Florida
city: North Palm Beach
country: United States
facility: Teva Investigational Site 15170
state: Florida
city: Orlando
country: United States
facility: Teva Investigational Site 15130
state: Florida
city: Tallahassee
country: United States
facility: Teva Investigational Site 15140
state: Florida
city: Tampa
country: United States
facility: Teva Investigational Site 15132
state: Florida
city: Sugar Hill
country: United States
facility: Teva Investigational Site 15135
state: Georgia
city: Normal
country: United States
facility: Teva Investigational Site 15183
state: Illinois
city: Overland Park
country: United States
facility: Teva Investigational Site 15198
state: Kansas
city: Zachary
country: United States
facility: Teva Investigational Site 15187
state: Louisiana
city: Baltimore
country: United States
facility: Teva Investigational Site 15148
state: Maryland
city: North Dartmouth
country: United States
facility: Teva Investigational Site 15190
state: Massachusetts
city: Columbia
country: United States
facility: Teva Investigational Site 15175
state: Missouri
city: Rolla
country: United States
facility: Teva Investigational Site 15145
state: Missouri
city: Saint Louis
country: United States
facility: Teva Investigational Site 15144
state: Missouri
city: Bellevue
country: United States
facility: Teva Investigational Site 15137
state: Nebraska
city: Skillman
country: United States
facility: Teva Investigational Site 15164
state: New Jersey
city: Bronx
country: United States
facility: Teva Investigational Site 15165
state: New York
city: Charlotte
country: United States
facility: Teva Investigational Site 15181
state: North Carolina
city: Elizabeth City
country: United States
facility: Teva Investigational Site 15179
state: North Carolina
city: Greensboro
country: United States
facility: Teva Investigational Site 15193
state: North Carolina
city: Monroe
country: United States
facility: Teva Investigational Site 15153
state: North Carolina
city: Raleigh
country: United States
facility: Teva Investigational Site 15168
state: North Carolina
city: Cincinnati
country: United States
facility: Teva Investigational Site 15173
state: Ohio
city: Toledo
country: United States
facility: Teva Investigational Site 15131
state: Ohio
city: Edmond
country: United States
facility: Teva Investigational Site 15201
state: Oklahoma
city: Tulsa
country: United States
facility: Teva Investigational Site 15204
state: Oklahoma
city: Medford
country: United States
facility: Teva Investigational Site 15180
state: Oregon
city: Portland
country: United States
facility: Teva Investigational Site 15172
state: Oregon
city: Jenkintown
country: United States
facility: Teva Investigational Site 15192
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Teva Investigational Site 15185
state: Pennsylvania
city: Clinton
country: United States
facility: Teva Investigational Site 15161
state: South Carolina
city: Rock Hill
country: United States
facility: Teva Investigational Site 15159
state: South Carolina
city: Austin
country: United States
facility: Teva Investigational Site 15162
state: Texas
city: Dallas
country: United States
facility: Teva Investigational Site 15138
state: Texas
city: Dallas
country: United States
facility: Teva Investigational Site 15154
state: Texas
city: Denton
country: United States
facility: Teva Investigational Site 15171
state: Texas
city: El Paso
country: United States
facility: Teva Investigational Site 15155
state: Texas
city: Houston
country: United States
facility: Teva Investigational Site 15189
state: Texas
city: Houston
country: United States
facility: Teva Investigational Site 15184
state: Texas
city: Houston
country: United States
facility: Teva Investigational Site 15199
state: Texas
city: Houston
country: United States
facility: Teva Investigational Site 15191
state: Texas
city: McKinney
country: United States
facility: Teva Investigational Site 15160
state: Texas
city: San Antonio
country: United States
facility: Teva Investigational Site 15197
state: Texas
city: Williamsburg
country: United States
facility: Teva Investigational Site 15195
state: Virginia
city: Bellingham
country: United States
facility: Teva Investigational Site 15150
state: Washington
city: Greenfield
country: United States
facility: Teva Investigational Site 15142
state: Wisconsin
city: Sherwood Park
country: Canada
facility: Teva Investigational Site 11218
state: Alberta
city: Ajax
country: Canada
facility: Teva Investigational Site 11212
state: Ontario
city: Toronto
country: Canada
facility: Teva Investigational Site 11211
state: Ontario
city: Montreal
country: Canada
facility: Teva Investigational Site 11213
state: Quebec
city: Quebec
country: Canada
facility: Teva Investigational Site 11214
Study officials:
affiliation: Teva Branded Pharmaceutical Products R&D, Inc.
name: Teva Medical Expert, MD
role: STUDY_DIRECTOR
References: