Phase
Condition
Asthma
Treatment
TEV-53275 Dose B
TEV-53275 Dose A
Placebo
Clinical Study ID
Ages > 18 All Genders
Study Summary
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
Study Description
Connect with a study center
Teva Investigational Site 11218
Sherwood Park, Alberta T8H 0N2
CanadaSite Not Available
Teva Investigational Site 11212
Ajax, Ontario L1S 2J5
CanadaSite Not Available
Teva Investigational Site 11211
Toronto, Ontario M5T 3A9
CanadaSite Not Available
Teva Investigational Site 11213
Montreal, Quebec H3G 1L5
CanadaSite Not Available
Teva Investigational Site 11214
Qu?bec, Quebec G1V4W2
CanadaSite Not Available
Teva Investigational Site 11214
Quebec, G1V4W2
CanadaSite Not Available
Teva Investigational Site 11214
Quebec City, G1V4W2
CanadaSite Not Available
Teva Investigational Site 15188
Hoover, Alabama 35244
United StatesSite Not Available
Teva Investigational Site 15174
Peoria, Arizona 85381
United StatesSite Not Available
Teva Investigational Site 15202
Phoenix, Arizona 85031
United StatesSite Not Available
Teva Investigational Site 15205
Tucson, Arizona 85712
United StatesSite Not Available
Teva Investigational Site 15178
Bakersfield, California 93301
United StatesSite Not Available
Teva Investigational Site 15196
Bakersfield, California 93309
United StatesSite Not Available
Teva Investigational Site 15176
Encinitas, California 92024
United StatesSite Not Available
Teva Investigational Site 15156
Huntington Beach, California 92647 6818
United StatesSite Not Available
Teva Investigational Site 15209
Inglewood, California 90303
United StatesSite Not Available
Teva Investigational Site 15143
Los Angeles, California 90025
United StatesSite Not Available
Teva Investigational Site 15194
Los Angeles, California 90017
United StatesSite Not Available
Teva Investigational Site 15212
Los Angeles, California 91436
United StatesSite Not Available
Teva Investigational Site 15151
Mission Viejo, California 92691
United StatesSite Not Available
Teva Investigational Site 15210
North Hollywood, California 91606
United StatesSite Not Available
Teva Investigational Site 15158
Riverside, California 92506
United StatesSite Not Available
Teva Investigational Site 15136
San Jose, California 95117
United StatesSite Not Available
Teva Investigational Site 15157
Stockton, California 95207
United StatesSite Not Available
Teva Investigational Site 15158
Upland, California 91786
United StatesSite Not Available
Teva Investigational Site 15167
Walnut Creek, California 94598
United StatesSite Not Available
Teva Investigational Site 15133
Westminster, California 92683
United StatesSite Not Available
Teva Investigational Site 15166
Colorado Springs, Colorado 80907
United StatesSite Not Available
Teva Investigational Site 15200
Lafayette, Colorado 80026
United StatesSite Not Available
Teva Investigational Site 15139
Wheat Ridge, Colorado 80033
United StatesSite Not Available
Teva Investigational Site 15182
Boynton Beach, Florida 33435
United StatesSite Not Available
Teva Investigational Site 15134
Hialeah, Florida 33016
United StatesSite Not Available
Teva Investigational Site 15147
Hialeah, Florida 33012
United StatesSite Not Available
Teva Investigational Site 15152
Leesburg, Florida 34748
United StatesSite Not Available
Teva Investigational Site 15141
Miami, Florida 33173
United StatesSite Not Available
Teva Investigational Site 15149
Miami, Florida 33144
United StatesSite Not Available
Teva Investigational Site 15206
Miami, Florida 33165
United StatesSite Not Available
Teva Investigational Site 15211
Miami, Florida 33155
United StatesSite Not Available
Teva Investigational Site 15215
Miami, Florida 33165
United StatesSite Not Available
Teva Investigational Site 15169
Miami Lakes, Florida 33014
United StatesSite Not Available
Teva Investigational Site 15170
North Palm Beach, Florida 33408
United StatesSite Not Available
Teva Investigational Site 15130
Orlando, Florida 32819
United StatesSite Not Available
Teva Investigational Site 15140
Tallahassee, Florida 32308-4355
United StatesSite Not Available
Teva Investigational Site 15132
Tampa, Florida 33607
United StatesSite Not Available
Teva Investigational Site 15135
Sugar Hill, Georgia 30518
United StatesSite Not Available
Teva Investigational Site 15183
Normal, Illinois 61761
United StatesSite Not Available
Teva Investigational Site 15198
Overland Park, Kansas 66210
United StatesSite Not Available
Teva Investigational Site 15187
Zachary, Louisiana 70791
United StatesSite Not Available
Teva Investigational Site 15148
Baltimore, Maryland 21236
United StatesSite Not Available
Teva Investigational Site 15148
White Marsh, Maryland 21162
United StatesSite Not Available
Teva Investigational Site 15190
North Dartmouth, Massachusetts 02747
United StatesSite Not Available
Teva Investigational Site 15175
Columbia, Missouri 65203
United StatesSite Not Available
Teva Investigational Site 15145
Rolla, Missouri 65401
United StatesSite Not Available
Teva Investigational Site 15144
Saint Louis, Missouri 63141
United StatesSite Not Available
Teva Investigational Site 15137
Bellevue, Nebraska 68123-4303
United StatesSite Not Available
Teva Investigational Site 15164
Skillman, New Jersey 08558
United StatesSite Not Available
Teva Investigational Site 15165
Bronx, New York 10455
United StatesSite Not Available
Teva Investigational Site 15181
Charlotte, North Carolina 28277
United StatesSite Not Available
Teva Investigational Site 15179
Elizabeth City, North Carolina 27909
United StatesSite Not Available
Teva Investigational Site 15193
Greensboro, North Carolina 27410
United StatesSite Not Available
Teva Investigational Site 15153
Monroe, North Carolina 28112
United StatesSite Not Available
Teva Investigational Site 15168
Raleigh, North Carolina 27607
United StatesSite Not Available
Teva Investigational Site 15173
Cincinnati, Ohio 45231
United StatesSite Not Available
Teva Investigational Site 15131
Toledo, Ohio 43617
United StatesSite Not Available
Teva Investigational Site 15201
Edmond, Oklahoma 73034
United StatesSite Not Available
Teva Investigational Site 15204
Tulsa, Oklahoma 74133
United StatesSite Not Available
Teva Investigational Site 15180
Medford, Oregon 97504
United StatesSite Not Available
Teva Investigational Site 15172
Portland, Oregon 97239
United StatesSite Not Available
Teva Investigational Site 15192
Jenkintown, Pennsylvania 19046
United StatesSite Not Available
Teva Investigational Site 15185
Pittsburgh, Pennsylvania 15241
United StatesSite Not Available
Teva Investigational Site 15161
Clinton, South Carolina 29325
United StatesSite Not Available
Teva Investigational Site 15159
Rock Hill, South Carolina 29732
United StatesSite Not Available
Teva Investigational Site 15162
Austin, Texas 78759
United StatesSite Not Available
Teva Investigational Site 15138
Dallas, Texas 75231
United StatesSite Not Available
Teva Investigational Site 15154
Dallas, Texas 75231
United StatesSite Not Available
Teva Investigational Site 15171
Denton, Texas 76210
United StatesSite Not Available
Teva Investigational Site 15155
El Paso, Texas 79903-3508
United StatesSite Not Available
Teva Investigational Site 15184
Houston, Texas 77070
United StatesSite Not Available
Teva Investigational Site 15189
Houston, Texas 77030
United StatesSite Not Available
Teva Investigational Site 15191
Houston, Texas 77087
United StatesSite Not Available
Teva Investigational Site 15199
Houston, Texas 77084
United StatesSite Not Available
Teva Investigational Site 15160
McKinney, Texas 75069
United StatesSite Not Available
Teva Investigational Site 15197
San Antonio, Texas 78258
United StatesSite Not Available
Teva Investigational Site 15195
Williamsburg, Virginia 23188
United StatesSite Not Available
Teva Investigational Site 15150
Bellingham, Washington 98225
United StatesSite Not Available
Teva Investigational Site 15142
Greenfield, Wisconsin 53228
United StatesSite Not Available
Teva Investigational Site 15142
Milwaukee, Wisconsin 53228
United StatesSite Not Available
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