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

NCT04847674 | Terminated Phase 2 Results DMC FDA Drug

• 2 other identifiers: TV53275-AS-200332021-001439-22
• Study Type: interventional
• Target: 97
• Locations: 2 countries
• Sites: 82

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.

Conditions

Asthma

Keywords

Persistent; Eosinophilic; Asthma

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Clinic-based Standardized Baseline-adjusted Morning Trough (Pre-bronchodilator) FEV1 at Week 12

  FEV1 was the volume of air exhaled in the first second of a forced expiration as measured by spirometer. Least square (LS) mean and standard error (SE) were calculated using a mixed model for repeated measures (MMRM).

  Baseline, Week 12

Secondary Outcomes (23)

• Number of Participants With Well-controlled Asthma Status (Yes Versus No) at Weeks 12 and 16

  Weeks 12 and 16

• 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

  Baseline, up to Week 12, up to Week 16

• 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

  Baseline, up to Week 12, up to Week 16

• 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

  Baseline, up to Week 12, up to Week 16

• Change From Baseline in Clinic-based Standardized Baseline-adjusted Morning Trough (Pre-bronchodilator) FEV1 at Week 16

  Baseline, Week 16

Study Arms (3)

TEV-53275 Dose A

EXPERIMENTAL

Drug: TEV-53275 Dose A

TEV-53275 Dose B

EXPERIMENTAL

Drug: TEV-53275 Dose B

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

TEV-53275 Dose A DRUG

subcutaneous (sc) injection

TEV-53275 Dose A

TEV-53275 Dose B DRUG

subcutaneous (sc) injection

TEV-53275 Dose B

Placebo DRUG

Matching subcutaneous (sc) placebo injection

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Teva Branded Pharmaceutical Products R&D, Inc.: lead

Study Sites (82)

Teva Investigational Site 15188

Hoover, Alabama, 35244, United States

Location

Teva Investigational Site 15174

Peoria, Arizona, 85381, United States

Location

Teva Investigational Site 15202

Phoenix, Arizona, 85031, United States

Location

Teva Investigational Site 15205

Tucson, Arizona, 85712, United States

Location

Teva Investigational Site 15178

Bakersfield, California, 93301, United States

Location

Teva Investigational Site 15196

Bakersfield, California, 93309, United States

Location

Teva Investigational Site 15176

Encinitas, California, 92024, United States

Location

Teva Investigational Site 15156

Huntington Beach, California, 92647 6818, United States

Location

Teva Investigational Site 15209

Inglewood, California, 90303, United States

Location

Teva Investigational Site 15194

Los Angeles, California, 90017, United States

Location

Teva Investigational Site 15143

Los Angeles, California, 90025, United States

Location

Teva Investigational Site 15212

Los Angeles, California, 91436, United States

Location

Teva Investigational Site 15151

Mission Viejo, California, 92691, United States

Location

Teva Investigational Site 15210

North Hollywood, California, 91606, United States

Location

Teva Investigational Site 15136

San Jose, California, 95117, United States

Location

Teva Investigational Site 15157

Stockton, California, 95207, United States

Location

Teva Investigational Site 15158

Upland, California, 91786, United States

Location

Teva Investigational Site 15167

Walnut Creek, California, 94598, United States

Location

Teva Investigational Site 15133

Westminster, California, 92683, United States

Location

Teva Investigational Site 15166

Colorado Springs, Colorado, 80907, United States

Location

Teva Investigational Site 15200

Lafayette, Colorado, 80026, United States

Location

Teva Investigational Site 15139

Wheat Ridge, Colorado, 80033, United States

Location

Teva Investigational Site 15182

Boynton Beach, Florida, 33435, United States

Location

Teva Investigational Site 15147

Hialeah, Florida, 33012, United States

Location

Teva Investigational Site 15134

Hialeah, Florida, 33016, United States

Location

Teva Investigational Site 15152

Leesburg, Florida, 34748, United States

Location

Teva Investigational Site 15149

Miami, Florida, 33144, United States

Location

Teva Investigational Site 15211

Miami, Florida, 33155, United States

Location

Teva Investigational Site 15206

Miami, Florida, 33165, United States

Location

Teva Investigational Site 15215

Miami, Florida, 33165, United States

Location

Teva Investigational Site 15141

Miami, Florida, 33173, United States

Location

Teva Investigational Site 15169

Miami Lakes, Florida, 33014, United States

Location

Teva Investigational Site 15170

North Palm Beach, Florida, 33408, United States

Location

Teva Investigational Site 15130

Orlando, Florida, 32819, United States

Location

Teva Investigational Site 15140

Tallahassee, Florida, 32308-4355, United States

Location

Teva Investigational Site 15132

Tampa, Florida, 33607, United States

Location

Teva Investigational Site 15135

Sugar Hill, Georgia, 30518, United States

Location

Teva Investigational Site 15183

Normal, Illinois, 61761, United States

Location

Teva Investigational Site 15198

Overland Park, Kansas, 66210, United States

Location

Teva Investigational Site 15187

Zachary, Louisiana, 70791, United States

Location

Teva Investigational Site 15148

Baltimore, Maryland, 21236, United States

Location

Teva Investigational Site 15190

North Dartmouth, Massachusetts, 02747, United States

Location

Teva Investigational Site 15175

Columbia, Missouri, 65203, United States

Location

Teva Investigational Site 15145

Rolla, Missouri, 65401, United States

Location

Teva Investigational Site 15144

St Louis, Missouri, 63141, United States

Location

Teva Investigational Site 15137

Bellevue, Nebraska, 68123-4303, United States

Location

Teva Investigational Site 15164

Skillman, New Jersey, 08558, United States

Location

Teva Investigational Site 15165

The Bronx, New York, 10455, United States

Location

Teva Investigational Site 15181

Charlotte, North Carolina, 28277, United States

Location

Teva Investigational Site 15179

Elizabeth City, North Carolina, 27909, United States

Location

Teva Investigational Site 15193

Greensboro, North Carolina, 27410, United States

Location

Teva Investigational Site 15153

Monroe, North Carolina, 28112, United States

Location

Teva Investigational Site 15168

Raleigh, North Carolina, 27607, United States

Location

Teva Investigational Site 15173

Cincinnati, Ohio, 45231, United States

Location

Teva Investigational Site 15131

Toledo, Ohio, 43617, United States

Location

Teva Investigational Site 15201

Edmond, Oklahoma, 73034, United States

Location

Teva Investigational Site 15204

Tulsa, Oklahoma, 74133, United States

Location

Teva Investigational Site 15180

Medford, Oregon, 97504, United States

Location

Teva Investigational Site 15172

Portland, Oregon, 97239, United States

Location

Teva Investigational Site 15192

Jenkintown, Pennsylvania, 19046, United States

Location

Teva Investigational Site 15185

Pittsburgh, Pennsylvania, 15241, United States

Location

Teva Investigational Site 15161

Clinton, South Carolina, 29325, United States

Location

Teva Investigational Site 15159

Rock Hill, South Carolina, 29732, United States

Location

Teva Investigational Site 15162

Austin, Texas, 78759, United States

Location

Teva Investigational Site 15138

Dallas, Texas, 75231, United States

Location

Teva Investigational Site 15154

Dallas, Texas, 75231, United States

Location

Teva Investigational Site 15171

Denton, Texas, 76210, United States

Location

Teva Investigational Site 15155

El Paso, Texas, 79903-3508, United States

Location

Teva Investigational Site 15189

Houston, Texas, 77030, United States

Location

Teva Investigational Site 15184

Houston, Texas, 77070, United States

Location

Teva Investigational Site 15199

Houston, Texas, 77084, United States

Location

Teva Investigational Site 15191

Houston, Texas, 77087, United States

Location

Teva Investigational Site 15160

McKinney, Texas, 75069, United States

Location

Teva Investigational Site 15197

San Antonio, Texas, 78258, United States

Location

Teva Investigational Site 15195

Williamsburg, Virginia, 23188, United States

Location

Teva Investigational Site 15150

Bellingham, Washington, 98225, United States

Location

Teva Investigational Site 15142

Greenfield, Wisconsin, 53228, United States

Location

Teva Investigational Site 11218

Sherwood Park, Alberta, T8H 0N2, Canada

Location

Teva Investigational Site 11212

Ajax, Ontario, L1S 2J5, Canada

Location

Teva Investigational Site 11211

Toronto, Ontario, M5T 3A9, Canada

Location

Teva Investigational Site 11213

Montreal, Quebec, H3G 1L5, Canada

Location

Teva Investigational Site 11214

Québec, Quebec, G1V4W2, Canada

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Results Point of Contact

• Title: Director, Clinical Research
• Organization: Teva Branded Pharmaceutical Products, R&D Inc.

USMedInfo@tevapharm.com

888-483-8279

Study Officials

• Teva Medical Expert, MD

  Teva Branded Pharmaceutical Products R&D, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 5, 2021
• First Posted: April 19, 2021
• Study Start: May 4, 2021
• Primary Completion: April 28, 2022
• Study Completion: April 28, 2022
• Last Updated: June 8, 2023
• Results First Posted: June 8, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will share

Locations

CA (5); US (77)