Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04847674
Recruitment Status : Active, not recruiting
First Posted : April 19, 2021
Last Update Posted : April 25, 2022
Sponsor:
Information provided by (Responsible Party):
Teva Branded Pharmaceutical Products R&D, Inc.

Tracking Information
First Submitted Date  ICMJE April 5, 2021
First Posted Date  ICMJE April 19, 2021
Last Update Posted Date April 25, 2022
Actual Study Start Date  ICMJE April 6, 2021
Estimated Primary Completion Date July 2, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Test if TEV-53275 is Effective in Relieving Asthma
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Asthma
Intervention  ICMJE
  • 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  ICMJE
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: April 21, 2022)
97
Original Estimated Enrollment  ICMJE
 (submitted: April 15, 2021)
300
Estimated Study Completion Date  ICMJE July 30, 2022
Estimated Primary Completion Date July 2, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04847674
Other Study ID Numbers  ICMJE 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  ICMJE
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  ICMJE Teva Branded Pharmaceutical Products R&D, Inc.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP