A Study to Test if TEV-53275 is Effective in Relieving Asthma
Condition: Asthma
MeSH terms: Asthma
Intervention: TEV-53275 Dose A; TEV-53275 Dose B; Placebo
Intervention description: subcutaneous (sc) injection; subcutaneous (sc) injection; Matching subcutaneous (sc) placebo injection
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 97.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Persistent; Eosinophilic; Asthma

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 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