A Study to Test if TEV-53275 is Effective in Relieving Asthma

NCT ID: NCT04847674

Last Updated: 2023-06-08

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 97 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-04
• Study Completion Date: 2022-04-28

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.

Conditions

Asthma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

TEV-53275 Dose A

Group Type: EXPERIMENTAL

TEV-53275 Dose A

Intervention Type: DRUG

subcutaneous (sc) injection

TEV-53275 Dose B

Group Type: EXPERIMENTAL

TEV-53275 Dose B

Intervention Type: DRUG

subcutaneous (sc) injection

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Matching subcutaneous (sc) placebo injection

Interventions

TEV-53275 Dose A

subcutaneous (sc) injection

Intervention Type: DRUG

TEV-53275 Dose B

subcutaneous (sc) injection

Intervention Type: DRUG

Placebo

Matching subcutaneous (sc) placebo injection

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Teva Branded Pharmaceutical Products R&D, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Teva Medical Expert, MD

Role: STUDY_DIRECTOR

Teva Branded Pharmaceutical Products R&D, Inc.

Locations

Teva Investigational Site 15188

Hoover, Alabama, United States

Teva Investigational Site 15174

Peoria, Arizona, United States

Teva Investigational Site 15202

Phoenix, Arizona, United States

Teva Investigational Site 15205

Tucson, Arizona, United States

Teva Investigational Site 15178

Bakersfield, California, United States

Teva Investigational Site 15196

Bakersfield, California, United States

Teva Investigational Site 15176

Encinitas, California, United States

Teva Investigational Site 15156

Huntington Beach, California, United States

Teva Investigational Site 15209

Inglewood, California, United States

Teva Investigational Site 15194

Los Angeles, California, United States

Teva Investigational Site 15143

Los Angeles, California, United States

Teva Investigational Site 15212

Los Angeles, California, United States

Teva Investigational Site 15151

Mission Viejo, California, United States

Teva Investigational Site 15210

North Hollywood, California, United States

Teva Investigational Site 15136

San Jose, California, United States

Teva Investigational Site 15157

Stockton, California, United States

Teva Investigational Site 15158

Upland, California, United States

Teva Investigational Site 15167

Walnut Creek, California, United States

Teva Investigational Site 15133

Westminster, California, United States

Teva Investigational Site 15166

Colorado Springs, Colorado, United States

Teva Investigational Site 15200

Lafayette, Colorado, United States

Teva Investigational Site 15139

Wheat Ridge, Colorado, United States

Teva Investigational Site 15182

Boynton Beach, Florida, United States

Teva Investigational Site 15147

Hialeah, Florida, United States

Teva Investigational Site 15134

Hialeah, Florida, United States

Teva Investigational Site 15152

Leesburg, Florida, United States

Teva Investigational Site 15149

Miami, Florida, United States

Teva Investigational Site 15211

Miami, Florida, United States

Teva Investigational Site 15206

Miami, Florida, United States

Teva Investigational Site 15215

Miami, Florida, United States

Teva Investigational Site 15141

Miami, Florida, United States

Teva Investigational Site 15169

Miami Lakes, Florida, United States

Teva Investigational Site 15170

North Palm Beach, Florida, United States

Teva Investigational Site 15130

Orlando, Florida, United States

Teva Investigational Site 15140

Tallahassee, Florida, United States

Teva Investigational Site 15132

Tampa, Florida, United States

Teva Investigational Site 15135

Sugar Hill, Georgia, United States

Teva Investigational Site 15183

Normal, Illinois, United States

Teva Investigational Site 15198

Overland Park, Kansas, United States

Teva Investigational Site 15187

Zachary, Louisiana, United States

Teva Investigational Site 15148

Baltimore, Maryland, United States

Teva Investigational Site 15190

North Dartmouth, Massachusetts, United States

Teva Investigational Site 15175

Columbia, Missouri, United States

Teva Investigational Site 15145

Rolla, Missouri, United States

Teva Investigational Site 15144

St Louis, Missouri, United States

Teva Investigational Site 15137

Bellevue, Nebraska, United States

Teva Investigational Site 15164

Skillman, New Jersey, United States

Teva Investigational Site 15165

The Bronx, New York, United States

Teva Investigational Site 15181

Charlotte, North Carolina, United States

Teva Investigational Site 15179

Elizabeth City, North Carolina, United States

Teva Investigational Site 15193

Greensboro, North Carolina, United States

Teva Investigational Site 15153

Monroe, North Carolina, United States

Teva Investigational Site 15168

Raleigh, North Carolina, United States

Teva Investigational Site 15173

Cincinnati, Ohio, United States

Teva Investigational Site 15131

Toledo, Ohio, United States

Teva Investigational Site 15201

Edmond, Oklahoma, United States

Teva Investigational Site 15204

Tulsa, Oklahoma, United States

Teva Investigational Site 15180

Medford, Oregon, United States

Teva Investigational Site 15172

Portland, Oregon, United States

Teva Investigational Site 15192

Jenkintown, Pennsylvania, United States

Teva Investigational Site 15185

Pittsburgh, Pennsylvania, United States

Teva Investigational Site 15161

Clinton, South Carolina, United States

Teva Investigational Site 15159

Rock Hill, South Carolina, United States

Teva Investigational Site 15162

Austin, Texas, United States

Teva Investigational Site 15138

Dallas, Texas, United States

Teva Investigational Site 15154

Dallas, Texas, United States

Teva Investigational Site 15171

Denton, Texas, United States

Teva Investigational Site 15155

El Paso, Texas, United States

Teva Investigational Site 15189

Houston, Texas, United States

Teva Investigational Site 15184

Houston, Texas, United States

Teva Investigational Site 15199

Houston, Texas, United States

Teva Investigational Site 15191

Houston, Texas, United States

Teva Investigational Site 15160

McKinney, Texas, United States

Teva Investigational Site 15197

San Antonio, Texas, United States

Teva Investigational Site 15195

Williamsburg, Virginia, United States

Teva Investigational Site 15150

Bellingham, Washington, United States

Teva Investigational Site 15142

Greenfield, Wisconsin, United States

Teva Investigational Site 11218

Sherwood Park, Alberta, Canada

Teva Investigational Site 11212

Ajax, Ontario, Canada

Teva Investigational Site 11211

Toronto, Ontario, Canada

Teva Investigational Site 11213

Montreal, Quebec, Canada

Teva Investigational Site 11214

Québec, Quebec, Canada

Countries

United States; Canada

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2021-001439-22

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

TV53275-AS-20033

Identifier Type: -

Identifier Source: org_study_id