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A Study to Test if TEV-48574 is Effective in Relieving Asthma

Sponsor
Teva Branded Pharmaceutical Products R&D, Inc. (Industry)
Overall Status
Terminated
CT.gov ID
NCT04545385
Collaborator
(none)
65
Enrollment
97
Locations
2
Arms
16.7
Actual Duration (Months)
0.7
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The primary objective of the study is to evaluate the effect of TEV-48574 compared with placebo on loss of asthma control (LoAC) in adult patients with T2-low and non-T2 severe asthma uncontrolled on inhaled corticosteroids plus long-acting beta-agonists (ICS+LABA).

The secondary efficacy objective is to evaluate the effect of TEV-48574 compared with placebo on a range of clinical measures of asthma control.

The duration of patient participation in the study is planned to be up to approximately 30 weeks.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
65 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A 16-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Proof-of-Concept Study to Evaluate the Efficacy and Safety of TEV-48574 in Adults With T2-low/Non-T2 Severe Uncontrolled Asthma
Actual Study Start Date :
Aug 26, 2020
Actual Primary Completion Date :
Jan 17, 2022
Actual Study Completion Date :
Jan 17, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: TEV-48574

The patients will receive the investigational medicinal product (IMP) loading dose on the day of randomization and the subsequent corresponding IMP maintenance dose every 2 weeks for a total of 8 doses (1 loading dose and 7 maintenance doses).

Drug: TEV-48574
subcutaneous infusion
Placebo Comparator: Placebo

Matching Placebo

Drug: Placebo
Matching Placebo

Outcome Measures

Primary Outcome Measures

  1. Proportion of patients who experience loss of asthma control (LoAC) during the treatment period. [16 week treatment period]

Secondary Outcome Measures

  1. Time from randomization to LoAC during the treatment period [16 week treatment period]

  2. Change in Asthma Control Questionnaire 6-question version (ACQ-6) score at end-of-treatment (EOT) and throughout the study [16 week treatment period]

    Six questions are self-assessments (completed by the patient). 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.

  3. FEV1 (% predicted, L) at EOT and throughout the study [16 week treatment period]

    Forced expiratory volume in the first second (FEV1) measured in liters

  4. Frequency of use of SABA quick relief medication at EOT and throughout the study [16 week treatment period]

  5. Proportion of patients who have a clinical asthma exacerbation (CAE) during the treatment period [16 week treatment period]

    CAE is defined as a worsening of asthma symptoms

  6. Time from randomization to first CAE during the treatment period [16 week treatment period]

  7. Number of nighttime awakenings due to asthma during the treatment period [16 week treatment period]

  8. Percent decrease in ICS dose during the treatment period [16 week treatment period]

  9. Mean change in FVC (L) [24 weeks]

    Forced vital capacity in liters (FVC) (L) is the volume of air that can be forcibly blown out after full inspiration, measured in liters assessed by hand-held spirometry at end of treatment (EOT) and throughout the study.

  10. Mean change in FEF 25%-75% (L/S) [24 weeks]

    The forced expiratory flow (FEF) from 25% to 75% of the pulmonary volume, measured in liters per second (L/S), assessed by hand-held spirometry at end of treatment (EOT) and throughout the study.

  11. Fractional exhaled nitric oxide (FeNO) throughout the study [16 week treatment period]

  12. Frequency of adverse events [24 weeks]

  13. Incidence of abnormal clinical laboratory test results (serum chemistry, hematology, and urinalysis) throughout the study [24 weeks]

  14. Incidence of abnormal vital signs [24 Weeks]

  15. Incidence of abnormal standard 12-lead electrocardiogram (ECG) findings [24 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • The participant has a diagnosis of asthma for at least 12 months prior to the initial screening visit.

  • The participant is able to perform technically acceptable and repeatable spirometry, including with a hand-held spirometer, after training

  • The participant has had at least one documented clinical asthma exacerbation in the 18 months prior to (but not within 30 days of) the initial screening visit.

  • The participant is a non-smoker for ≥6 months with lifetime history ≤10 pack-years, with no current ecigarette or marijuana use.

NOTE- Additional criteria apply, please contact the investigator for more information

Exclusion Criteria:

  • The participant has any concomitant conditions or treatments that could interfere with study conduct.

  • The participant is currently pregnant or lactating or is planning to become pregnant during the study.

  • The participant has received any live or attenuated vaccine within 15 days of the initial screening visit.

NOTE- Additional criteria apply, please contact the investigator for more information

Contacts and Locations

Locations

Site City State Country Postal Code
1 Teva Investigational Site 14884 Birmingham Alabama United States 35209
2 Teva Investigational Site 14915 Little Rock Arkansas United States 72205
3 Teva Investigational Site 14914 Bakersfield California United States 93301
4 Teva Investigational Site 15234 Huntington Beach California United States 92647
5 Teva Investigational Site 14896 Los Angeles California United States 90025
6 Teva Investigational Site 14918 Los Angeles California United States 90025
7 Teva Investigational Site 14913 Los Angeles California United States 90048
8 Teva Investigational Site 14910 Rolling Hills Estates California United States 90274-7604
9 Teva Investigational Site 14907 San Diego California United States 92123
10 Teva Investigational Site 14891 San Jose California United States 95117
11 Teva Investigational Site 15231 Stockton California United States 95207
12 Teva Investigational Site 14916 Walnut Creek California United States 94598
13 Teva Investigational Site 14878 Westminster California United States 92683
14 Teva Investigational Site 14895 Colorado Springs Colorado United States 80907
15 Teva Investigational Site 14917 Denver Colorado United States 80246
16 Teva Investigational Site 15222 Coral Gables Florida United States 33134
17 Teva Investigational Site 15223 Cutler Bay Florida United States 33189
18 Teva Investigational Site 14911 Hialeah Florida United States 33012
19 Teva Investigational Site 15225 Hialeah Florida United States 33015
20 Teva Investigational Site 14900 Miami Florida United States 33134
21 Teva Investigational Site 14883 Miami Florida United States 33173
22 Teva Investigational Site 14908 Panama City Florida United States 32405
23 Teva Investigational Site 14894 Tallahassee Florida United States 32308-4355
24 Teva Investigational Site 15224 Tampa Florida United States 33607
25 Teva Investigational Site 14924 Evansville Indiana United States 47713
26 Teva Investigational Site 14897 Kansas City Kansas United States 66160
27 Teva Investigational Site 15220 Baltimore Maryland United States 21236
28 Teva Investigational Site 14877 North Dartmouth Massachusetts United States 02747-3322
29 Teva Investigational Site 14922 Saint Louis Missouri United States 63110
30 Teva Investigational Site 14893 Saint Louis Missouri United States 63141
31 Teva Investigational Site 14904 Missoula Montana United States 59808
32 Teva Investigational Site 14912 Bellevue Nebraska United States 68123-4303
33 Teva Investigational Site 14903 Lincoln Nebraska United States 68505-2343
34 Teva Investigational Site 15227 Skillman New Jersey United States 08558
35 Teva Investigational Site 15221 Charlotte North Carolina United States 28277
36 Teva Investigational Site 15226 Monroe North Carolina United States 28112
37 Teva Investigational Site 14882 Raleigh North Carolina United States 27607
38 Teva Investigational Site 14887 Wilmington North Carolina United States 28401
39 Teva Investigational Site 14889 Cincinnati Ohio United States 45231
40 Teva Investigational Site 14886 Dublin Ohio United States 43016
41 Teva Investigational Site 14901 Toledo Ohio United States 43617
42 Teva Investigational Site 14888 Edmond Oklahoma United States 73034
43 Teva Investigational Site 14880 Oklahoma City Oklahoma United States 73112-4432
44 Teva Investigational Site 14923 Philadelphia Pennsylvania United States 19140
45 Teva Investigational Site 14890 Charleston South Carolina United States 29406
46 Teva Investigational Site 14925 Allen Texas United States 75013
47 Teva Investigational Site 15230 Austin Texas United States 78759
48 Teva Investigational Site 14909 Dallas Texas United States 75231
49 Teva Investigational Site 14902 El Paso Texas United States 79903-3508
50 Teva Investigational Site 14919 Fort Worth Texas United States 76244
51 Teva Investigational Site 14921 Houston Texas United States 77030
52 Teva Investigational Site 14905 McKinney Texas United States 75069
53 Teva Investigational Site 14879 San Antonio Texas United States 78229
54 Teva Investigational Site 14920 Spokane Washington United States 99204
55 Teva Investigational Site 14881 Greenfield Wisconsin United States 53228
56 Teva Investigational Site 59159 Kozloduy Bulgaria 999999
57 Teva Investigational Site 59166 Montana Bulgaria 999999
58 Teva Investigational Site 59163 Plovdiv Bulgaria 4002
59 Teva Investigational Site 59189 Plovdiv Bulgaria 4003
60 Teva Investigational Site 59190 Plovdiv Bulgaria 4003
61 Teva Investigational Site 59164 Ruse Bulgaria 7002
62 Teva Investigational Site 59168 Sofia Bulgaria 1000
63 Teva Investigational Site 59167 Sofia Bulgaria 1606
64 Teva Investigational Site 59160 Stara Zagora Bulgaria 6001
65 Teva Investigational Site 59161 Stara Zagora Bulgaria 999999
66 Teva Investigational Site 59165 Varna Bulgaria 9020
67 Teva Investigational Site 59162 Veliko Tarnovo Bulgaria 5000
68 Teva Investigational Site 59192 Vratsa Bulgaria 3001
69 Teva Investigational Site 54197 Brandys nad Labem Czechia 25001
70 Teva Investigational Site 54194 Jindrichuv Hradec Czechia 999999
71 Teva Investigational Site 54193 Miroslav Czechia 671 721
72 Teva Investigational Site 54195 Prague 8 Czechia 182 00
73 Teva Investigational Site 54203 Strakonice Czechia 999999
74 Teva Investigational Site 54196 Teplice Czechia 415 01
75 Teva Investigational Site 32747 Berlin Germany 10787
76 Teva Investigational Site 32741 Frankfurt am Main Germany 60596
77 Teva Investigational Site 32759 Frankfurt/Main Germany 60389
78 Teva Investigational Site 32744 Geesthacht Germany 21502
79 Teva Investigational Site 32739 Hamburg Germany 22299
80 Teva Investigational Site 32746 Hannover Germany 30173
81 Teva Investigational Site 32757 Leipzig Germany 4357
82 Teva Investigational Site 32758 Leipzig Germany 4357
83 Teva Investigational Site 32756 Leipzig Germany ?04275
84 Teva Investigational Site 32742 Luebeck Germany 23552
85 Teva Investigational Site 32743 Muenchen Germany 81241
86 Teva Investigational Site 32745 Rheine Germany 48431
87 Teva Investigational Site 53461 Bydgoszcz Poland 85-231
88 Teva Investigational Site 53457 Krakow Poland 31-559
89 Teva Investigational Site 53458 Krakow Poland 999999
90 Teva Investigational Site 53455 Lodz Poland 90-302
91 Teva Investigational Site 53483 Poznan Poland 60 - 823
92 Teva Investigational Site 53459 Poznan Poland 60-214
93 Teva Investigational Site 53486 Sucha Beskidzka Poland 34200
94 Teva Investigational Site 53462 Tarnow Poland 33-100
95 Teva Investigational Site 53485 Warszawa Poland 01-868
96 Teva Investigational Site 53460 Wroclaw Poland 53-201
97 Teva Investigational Site 53456 Wroclaw Poland 53-301

Sponsors and Collaborators

  • Teva Branded Pharmaceutical Products R&D, Inc.

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Teva Branded Pharmaceutical Products R&D, Inc.
ClinicalTrials.gov Identifier:
NCT04545385
Other Study ID Numbers:
  • TV48574-AS-20031
  • 2020-001927-15
First Posted:
Sep 11, 2020
Last Update Posted:
Apr 22, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Asthma

Study Results

No Results Posted as of Apr 22, 2022