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

• ClinicalTrials.gov Identifier: NCT04847674
• Recruitment Status: Active, not recruiting
• First Posted: April 19, 2021
• Last Update Posted: April 25, 2022
• Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
• Information provided by (Responsible Party): Teva Branded Pharmaceutical Products R&D, Inc.

Tracking Information

• First Submitted Date: April 5, 2021
• First Posted Date: April 19, 2021
• Last Update Posted Date: April 25, 2022
• Actual Study Start Date: April 6, 2021
• Estimated Primary Completion Date: July 2, 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 15, 2021)

Change from baseline in morning Forced Expiratory Volume in 1 Second (FEV1). [ Time Frame: Baseline, Week 12 ]

FEV1 was the volume of air exhaled in the first second of a forced expiration as measured by spirometer. FEV1 was defined as the predose trough morning percent predicted FEV1 measurement at the randomization visit (Baseline [Day 1]) at the investigational center.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: April 15, 2021)

• Percentage of asthma control weeks [ Time Frame: Week 1, Week 12, Week 16 ]
• Change from baseline in weekly average of daily morning trough (pre-rescue bronchodilator) FEV1 [ Time Frame: Baseline, Week 12, Week 16 ]
• Change from baseline in weekly average of rescue medication use [ Time Frame: Baseline, Week 12, Week 16 ]
• Change from baseline in percentage of asthma control days (no symptoms and no rescue medication use) [ Time Frame: Baseline, Week 12, Week 16 ]
• Time to first clinical asthma exacerbation (CAE) [ Time Frame: Week 30 ]
• Change from baseline in Asthma Control Questionnaire (ACQ-6) [ Time Frame: Baseline, Week 12, Week 16 ]
  Six questions are self-assessments (completed by the participant). Each item on the ACQ-6 has a possible score ranging from 0 to 6 (0=no impairment; 6=maximum impairment), and the total score is the mean of all responses.
• Change from baseline in Asthma Control Test (ACT) [ Time Frame: Baseline, Week 12, Week 16 ]
  A participant self-administered tool for identifying those with poorly controlled asthma comprising 5 items. Total scores range from 5 (poor control of asthma) to 25 (complete control of asthma), with higher scores reflecting greater asthma control.
• Change from baseline in Standardized Asthma Quality of Life Questionnaire (AQLQ[S]) [ Time Frame: Baseline, Week 12, Week 16 ]
  The questionnaire is a tool to measure the impact of asthma on a participant's quality of life (physical, emotional, social, and occupational). The questionnaire contains 32 items with a 2-week recall period and uses a 7-point Likert scale (7=not impaired at all to 1=severely impaired). Scores range from 1 to 7, with higher scores indicating better quality of life.
• Proportion of participants who achieve FEV1:FVC (forced vital capacity) ratio ≥0.80 [ Time Frame: Week 12, Week 16 ]
• Number of participants reporting at least one adverse event [ Time Frame: Week 30 ]
  Adverse events will include clinically significant laboratory test results (serum chemistry, hematology, and urinalysis), vital signs, 12-lead electrocardiogram (ECG) results, and injection site reactions.
• Number of participants who reported use of concomitant medications [ Time Frame: Week 30 ]
• Number of participants developing antidrug antibodies (ADAs) throughout the study [ Time Frame: Week 30 ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Study to Test if TEV-53275 is Effective in Relieving Asthma
• Official Title: A Phase 2, Multicenter, Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Assess the Safety, Efficacy and Pharmacodynamics of TEV 53275 Administered Subcutaneously in Adult Patients With Persistent Eosinophilic Asthma
• 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.

• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Asthma

Intervention

• Drug: TEV-53275 Dose A
  subcutaneous (sc) injection
• Drug: TEV-53275 Dose B
  subcutaneous (sc) injection
• Drug: Placebo
  Matching subcutaneous (sc) placebo injection

Study Arms

• Experimental: TEV-53275 Dose A
  Intervention: Drug: TEV-53275 Dose A
• Experimental: TEV-53275 Dose B
  Intervention: Drug: TEV-53275 Dose B
• Placebo Comparator: Placebo
  Intervention: Drug: Placebo

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Active, not recruiting
• Actual Enrollment (submitted: April 21, 2022): 97
• Original Estimated Enrollment (submitted: April 15, 2021): 300
• Estimated Study Completion Date: July 30, 2022
• Estimated Primary Completion Date: July 2, 2022 (Final data collection date for primary outcome measure)

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 patient 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Canada, United States

Administrative Information

• NCT Number: NCT04847674
• Other Study ID Numbers: TV53275-AS-20033; 2021-001439-22 ( EudraCT Number )
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Yes
• Plan Description: Qualified researchers may request access to patient level data and related study documents including the study protocol and the statistical analysis plan. Requests will be reviewed for scientific merit, product approval status, and conflicts of interest. Patient level data will be de-identified and study documents will be redacted to protect the privacy of trial participants and to protect commercially confidential information. Please email USMedInfo@tevapharm.com to make your request

• Current Responsible Party: Teva Branded Pharmaceutical Products R&D, Inc.
• Original Responsible Party: Same as current
• Current Study Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Teva Medical Expert, MD; Teva Branded Pharmaceutical Products R&D, Inc.

• PRS Account: Teva Branded Pharmaceutical Products R&D, Inc.
• Verification Date: April 2022