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

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ClinicalTrials.gov Identifier: NCT04847674
Recruitment Status : Recruiting
First Posted : April 19, 2021
Last Update Posted : November 3, 2021
Sponsor:
Information provided by (Responsible Party):
Teva Branded Pharmaceutical Products R&D, Inc.

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.

Condition or disease Intervention/treatment Phase
Asthma Drug: TEV-53275 Dose A Drug: TEV-53275 Dose B Drug: Placebo Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : April 6, 2021
Estimated Primary Completion Date : July 2, 2022
Estimated Study Completion Date : July 30, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arm Intervention/treatment
Experimental: TEV-53275 Dose A Drug: TEV-53275 Dose A
subcutaneous (sc) injection

Experimental: TEV-53275 Dose B Drug: TEV-53275 Dose B
subcutaneous (sc) injection

Placebo Comparator: Placebo Drug: Placebo
Matching subcutaneous (sc) placebo injection




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Percentage of asthma control weeks [ Time Frame: Week 1, Week 12, Week 16 ]
  2. Change from baseline in weekly average of daily morning trough (pre-rescue bronchodilator) FEV1 [ Time Frame: Baseline, Week 12, Week 16 ]
  3. Change from baseline in weekly average of rescue medication use [ Time Frame: Baseline, Week 12, Week 16 ]
  4. Change from baseline in percentage of asthma control days (no symptoms and no rescue medication use) [ Time Frame: Baseline, Week 12, Week 16 ]
  5. Time to first clinical asthma exacerbation (CAE) [ Time Frame: Week 30 ]
  6. 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.

  7. 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.

  8. 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.

  9. Proportion of participants who achieve FEV1:FVC (forced vital capacity) ratio ≥0.80 [ Time Frame: Week 12, Week 16 ]
  10. 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.

  11. Number of participants who reported use of concomitant medications [ Time Frame: Week 30 ]
  12. Number of participants developing antidrug antibodies (ADAs) throughout the study [ Time Frame: Week 30 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 3 months.
  • Current Asthma Therapy: The participant has been maintained for at least 3 months 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 or is currently using or has used a systemic immunosuppressive medication within the last 6 months.
  • 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 or marijuana products within the past year (eg, cigarettes, cigars, chewing tobacco, or pipe tobacco), 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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04847674


Contacts
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Contact: Teva U.S. Medical Information 1-888-483-8279 USMedInfo@tevapharm.com

Locations
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Sponsors and Collaborators
Teva Branded Pharmaceutical Products R&D, Inc.
Investigators
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Study Director: Teva Medical Expert, MD Teva Branded Pharmaceutical Products R&D, Inc.
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Responsible Party: Teva Branded Pharmaceutical Products R&D, Inc.
ClinicalTrials.gov Identifier: NCT04847674    
Other Study ID Numbers: TV53275-AS-20033
First Posted: April 19, 2021    Key Record Dates
Last Update Posted: November 3, 2021
Last Verified: November 2021
Individual Participant Data (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

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Teva Branded Pharmaceutical Products R&D, Inc.:
Persistent
Eosinophilic
Asthma
Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases