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

Last updated: May 12, 2023
Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Overall Status: Terminated

Phase

2

Condition

Asthma

Treatment

TEV-53275 Dose B

TEV-53275 Dose A

Placebo

Clinical Study ID

NCT04847674
TV53275-AS-20033
2021-001439-22
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • The participant is an adult female or male ≥18 years of age. Note: Age requirementsare as specified or allowed by local regulations.
  • The participant has a diagnosis of asthma for at least 6 months and has been stablewithout exacerbation or change in medications for at least 1 month..
  • Current Asthma Therapy: The participant has been maintained for at least 1 month onstable doses of:
  • medium or high dose inhaled corticosteroids (ICS)±another controller.
  • any fixed dose combination ICS (low, medium, or high) with long-acting betaagonist (LABA)±another controller.
  • Women of non-childbearing potential, or congenitally sterile, or 1-yearpostmenopausal. Women of childbearing potential must have a negative β-human chorionicgonadotropin (β-HCG) test result and practice a highly effective method of birthcontrol prior to investigational medicinal product (IMP) administration and 30 weeksafter the dose of IMP.
  • The participant, as judged by the investigator, is able to continue their currentasthma maintenance medications throughout the study. NOTE- Additional criteria apply, please contact the investigator for more information.

Exclusion

Exclusion Criteria:

  • Life threatening asthma, defined as a history of asthma episode(s) requiringintubation and/or associated hypercapnea, respiratory arrest, hypoxic seizures, orasthma-related syncopal episode(s).
  • The participant has a suspected bacterial or viral infection of the upper or lowerrespiratory tract, sinus, or middle ear that has not resolved at least 2 weeks beforethe screening period. Note: Participants who develop an upper respiratoryinfection/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 thescreening visit.
  • The participant has an eosinophilic condition including hypereosinophilic syndrome,eosinophilic pneumonia, eosinophilic granulomatosis with polyangiitis (EGPA [ChurgStrauss syndrome]), or allergic bronchopulmonary aspergillosis.
  • The participant has an active helminthic or parasitic infection currently or withinthe last 6 months.
  • The participant has a history of malignancy other than fully resected basal cellcarcinoma of the skin.
  • The participant has any clinically significant, uncontrolled medical or psychiatriccondition (treated or untreated) that would interfere with the study schedule orprocedures, interpretation of efficacy results, or compromise the participant'ssafety.
  • The participant has known history of, or a positive test result for, hepatitis Bsurface antigen (HBsAg), hepatitis C virus (HCV) antibodies (Ab), or humanimmunodeficiency virus (HIV) Types 1 or 2 Ab (according to 4th generation serologytesting).
  • The participant is a pregnant or lactating woman, or plans to become pregnant duringthe 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 orother inflammatory conditions within the washout period (5 half-lives), hasdemonstrated hypersensitivity or anaphylaxis to a monoclonal antibody (Appendix G),oris 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 2years.
  • The participant currently smokes or has a smoking history of 10 pack years or more (apack 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 1month, OR the participant has a history of "vaping" tobacco, marijuana, or any othersubstance within 24 months.
  • Vulnerable participants (eg, people kept in detention). NOTE- Additional criteria apply, please contact the investigator for more information

Study Design

Total Participants: 97
Treatment Group(s): 3
Primary Treatment: TEV-53275 Dose B
Phase: 2
Study Start date:
May 04, 2021
Estimated Completion Date:
April 28, 2022

Study 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.

Connect with a study center

  • Teva Investigational Site 11218

    Sherwood Park, Alberta T8H 0N2
    Canada

    Site Not Available

  • Teva Investigational Site 11212

    Ajax, Ontario L1S 2J5
    Canada

    Site Not Available

  • Teva Investigational Site 11211

    Toronto, Ontario M5T 3A9
    Canada

    Site Not Available

  • Teva Investigational Site 11213

    Montreal, Quebec H3G 1L5
    Canada

    Site Not Available

  • Teva Investigational Site 11214

    Qu?bec, Quebec G1V4W2
    Canada

    Site Not Available

  • Teva Investigational Site 11214

    Quebec, G1V4W2
    Canada

    Site Not Available

  • Teva Investigational Site 11214

    Quebec City, G1V4W2
    Canada

    Site Not Available

  • Teva Investigational Site 15188

    Hoover, Alabama 35244
    United States

    Site Not Available

  • Teva Investigational Site 15174

    Peoria, Arizona 85381
    United States

    Site Not Available

  • Teva Investigational Site 15202

    Phoenix, Arizona 85031
    United States

    Site Not Available

  • Teva Investigational Site 15205

    Tucson, Arizona 85712
    United States

    Site Not Available

  • Teva Investigational Site 15178

    Bakersfield, California 93301
    United States

    Site Not Available

  • Teva Investigational Site 15196

    Bakersfield, California 93309
    United States

    Site Not Available

  • Teva Investigational Site 15176

    Encinitas, California 92024
    United States

    Site Not Available

  • Teva Investigational Site 15156

    Huntington Beach, California 92647 6818
    United States

    Site Not Available

  • Teva Investigational Site 15209

    Inglewood, California 90303
    United States

    Site Not Available

  • Teva Investigational Site 15143

    Los Angeles, California 90025
    United States

    Site Not Available

  • Teva Investigational Site 15194

    Los Angeles, California 90017
    United States

    Site Not Available

  • Teva Investigational Site 15212

    Los Angeles, California 91436
    United States

    Site Not Available

  • Teva Investigational Site 15151

    Mission Viejo, California 92691
    United States

    Site Not Available

  • Teva Investigational Site 15210

    North Hollywood, California 91606
    United States

    Site Not Available

  • Teva Investigational Site 15158

    Riverside, California 92506
    United States

    Site Not Available

  • Teva Investigational Site 15136

    San Jose, California 95117
    United States

    Site Not Available

  • Teva Investigational Site 15157

    Stockton, California 95207
    United States

    Site Not Available

  • Teva Investigational Site 15158

    Upland, California 91786
    United States

    Site Not Available

  • Teva Investigational Site 15167

    Walnut Creek, California 94598
    United States

    Site Not Available

  • Teva Investigational Site 15133

    Westminster, California 92683
    United States

    Site Not Available

  • Teva Investigational Site 15166

    Colorado Springs, Colorado 80907
    United States

    Site Not Available

  • Teva Investigational Site 15200

    Lafayette, Colorado 80026
    United States

    Site Not Available

  • Teva Investigational Site 15139

    Wheat Ridge, Colorado 80033
    United States

    Site Not Available

  • Teva Investigational Site 15182

    Boynton Beach, Florida 33435
    United States

    Site Not Available

  • Teva Investigational Site 15134

    Hialeah, Florida 33016
    United States

    Site Not Available

  • Teva Investigational Site 15147

    Hialeah, Florida 33012
    United States

    Site Not Available

  • Teva Investigational Site 15152

    Leesburg, Florida 34748
    United States

    Site Not Available

  • Teva Investigational Site 15141

    Miami, Florida 33173
    United States

    Site Not Available

  • Teva Investigational Site 15149

    Miami, Florida 33144
    United States

    Site Not Available

  • Teva Investigational Site 15206

    Miami, Florida 33165
    United States

    Site Not Available

  • Teva Investigational Site 15211

    Miami, Florida 33155
    United States

    Site Not Available

  • Teva Investigational Site 15215

    Miami, Florida 33165
    United States

    Site Not Available

  • Teva Investigational Site 15169

    Miami Lakes, Florida 33014
    United States

    Site Not Available

  • Teva Investigational Site 15170

    North Palm Beach, Florida 33408
    United States

    Site Not Available

  • Teva Investigational Site 15130

    Orlando, Florida 32819
    United States

    Site Not Available

  • Teva Investigational Site 15140

    Tallahassee, Florida 32308-4355
    United States

    Site Not Available

  • Teva Investigational Site 15132

    Tampa, Florida 33607
    United States

    Site Not Available

  • Teva Investigational Site 15135

    Sugar Hill, Georgia 30518
    United States

    Site Not Available

  • Teva Investigational Site 15183

    Normal, Illinois 61761
    United States

    Site Not Available

  • Teva Investigational Site 15198

    Overland Park, Kansas 66210
    United States

    Site Not Available

  • Teva Investigational Site 15187

    Zachary, Louisiana 70791
    United States

    Site Not Available

  • Teva Investigational Site 15148

    Baltimore, Maryland 21236
    United States

    Site Not Available

  • Teva Investigational Site 15148

    White Marsh, Maryland 21162
    United States

    Site Not Available

  • Teva Investigational Site 15190

    North Dartmouth, Massachusetts 02747
    United States

    Site Not Available

  • Teva Investigational Site 15175

    Columbia, Missouri 65203
    United States

    Site Not Available

  • Teva Investigational Site 15145

    Rolla, Missouri 65401
    United States

    Site Not Available

  • Teva Investigational Site 15144

    Saint Louis, Missouri 63141
    United States

    Site Not Available

  • Teva Investigational Site 15137

    Bellevue, Nebraska 68123-4303
    United States

    Site Not Available

  • Teva Investigational Site 15164

    Skillman, New Jersey 08558
    United States

    Site Not Available

  • Teva Investigational Site 15165

    Bronx, New York 10455
    United States

    Site Not Available

  • Teva Investigational Site 15181

    Charlotte, North Carolina 28277
    United States

    Site Not Available

  • Teva Investigational Site 15179

    Elizabeth City, North Carolina 27909
    United States

    Site Not Available

  • Teva Investigational Site 15193

    Greensboro, North Carolina 27410
    United States

    Site Not Available

  • Teva Investigational Site 15153

    Monroe, North Carolina 28112
    United States

    Site Not Available

  • Teva Investigational Site 15168

    Raleigh, North Carolina 27607
    United States

    Site Not Available

  • Teva Investigational Site 15173

    Cincinnati, Ohio 45231
    United States

    Site Not Available

  • Teva Investigational Site 15131

    Toledo, Ohio 43617
    United States

    Site Not Available

  • Teva Investigational Site 15201

    Edmond, Oklahoma 73034
    United States

    Site Not Available

  • Teva Investigational Site 15204

    Tulsa, Oklahoma 74133
    United States

    Site Not Available

  • Teva Investigational Site 15180

    Medford, Oregon 97504
    United States

    Site Not Available

  • Teva Investigational Site 15172

    Portland, Oregon 97239
    United States

    Site Not Available

  • Teva Investigational Site 15192

    Jenkintown, Pennsylvania 19046
    United States

    Site Not Available

  • Teva Investigational Site 15185

    Pittsburgh, Pennsylvania 15241
    United States

    Site Not Available

  • Teva Investigational Site 15161

    Clinton, South Carolina 29325
    United States

    Site Not Available

  • Teva Investigational Site 15159

    Rock Hill, South Carolina 29732
    United States

    Site Not Available

  • Teva Investigational Site 15162

    Austin, Texas 78759
    United States

    Site Not Available

  • Teva Investigational Site 15138

    Dallas, Texas 75231
    United States

    Site Not Available

  • Teva Investigational Site 15154

    Dallas, Texas 75231
    United States

    Site Not Available

  • Teva Investigational Site 15171

    Denton, Texas 76210
    United States

    Site Not Available

  • Teva Investigational Site 15155

    El Paso, Texas 79903-3508
    United States

    Site Not Available

  • Teva Investigational Site 15184

    Houston, Texas 77070
    United States

    Site Not Available

  • Teva Investigational Site 15189

    Houston, Texas 77030
    United States

    Site Not Available

  • Teva Investigational Site 15191

    Houston, Texas 77087
    United States

    Site Not Available

  • Teva Investigational Site 15199

    Houston, Texas 77084
    United States

    Site Not Available

  • Teva Investigational Site 15160

    McKinney, Texas 75069
    United States

    Site Not Available

  • Teva Investigational Site 15197

    San Antonio, Texas 78258
    United States

    Site Not Available

  • Teva Investigational Site 15195

    Williamsburg, Virginia 23188
    United States

    Site Not Available

  • Teva Investigational Site 15150

    Bellingham, Washington 98225
    United States

    Site Not Available

  • Teva Investigational Site 15142

    Greenfield, Wisconsin 53228
    United States

    Site Not Available

  • Teva Investigational Site 15142

    Milwaukee, Wisconsin 53228
    United States

    Site Not Available

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