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

• Sponsor: Teva Branded Pharmaceutical Products R&D, Inc. (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT04847674
• Collaborator: (none)
• Enrollment: 97
• Locations: 79
• Arms: 3
• Actual Duration (Months): 12.7
• Patients Per Site: 1.2
• Patients Per Site Per Month: 0.1

Study Details

Study Description

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 97 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: Apr 6, 2021
• Actual Primary Completion Date: Apr 28, 2022
• Actual Study Completion Date: Apr 28, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Change from baseline in morning Forced Expiratory Volume in 1 Second (FEV1). [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 [Week 1, Week 12, Week 16]

2. Change from baseline in weekly average of daily morning trough (pre-rescue bronchodilator) FEV1 [Baseline, Week 12, Week 16]

3. Change from baseline in weekly average of rescue medication use [Baseline, Week 12, Week 16]

4. Change from baseline in percentage of asthma control days (no symptoms and no rescue medication use) [Baseline, Week 12, Week 16]

5. Time to first clinical asthma exacerbation (CAE) [Week 30]

6. Change from baseline in Asthma Control Questionnaire (ACQ-6) [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) [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]) [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 [Week 12, Week 16]

10. Number of participants reporting at least one adverse event [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 [Week 30]

12. Number of participants developing antidrug antibodies (ADAs) throughout the study [Week 30]

Eligibility Criteria

Criteria

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

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Teva Investigational Site 15188	Hoover	Alabama	United States	35244
2	Teva Investigational Site 15174	Peoria	Arizona	United States	85381
3	Teva Investigational Site 15202	Phoenix	Arizona	United States	85031
4	Teva Investigational Site 15205	Tucson	Arizona	United States	85712
5	Teva Investigational Site 15178	Bakersfield	California	United States	93301
6	Teva Investigational Site 15196	Bakersfield	California	United States	93309
7	Teva Investigational Site 15176	Encinitas	California	United States	92024
8	Teva Investigational Site 15156	Huntington Beach	California	United States	92647 6818
9	Teva Investigational Site 15209	Inglewood	California	United States	90303
10	Teva Investigational Site 15194	Los Angeles	California	United States	90017
11	Teva Investigational Site 15143	Los Angeles	California	United States	90025
12	Teva Investigational Site 15151	Mission Viejo	California	United States	92691
13	Teva Investigational Site 15136	San Jose	California	United States	95117
14	Teva Investigational Site 15157	Stockton	California	United States	95207
15	Teva Investigational Site 15158	Upland	California	United States	91786
16	Teva Investigational Site 15167	Walnut Creek	California	United States	94598
17	Teva Investigational Site 15133	Westminster	California	United States	92683
18	Teva Investigational Site 15166	Colorado Springs	Colorado	United States	80907
19	Teva Investigational Site 15200	Lafayette	Colorado	United States	80026
20	Teva Investigational Site 15139	Wheat Ridge	Colorado	United States	80033
21	Teva Investigational Site 15182	Boynton Beach	Florida	United States	33435
22	Teva Investigational Site 15147	Hialeah	Florida	United States	33012
23	Teva Investigational Site 15134	Hialeah	Florida	United States	33016
24	Teva Investigational Site 15152	Leesburg	Florida	United States	34748
25	Teva Investigational Site 15169	Miami Lakes	Florida	United States	33014
26	Teva Investigational Site 15149	Miami	Florida	United States	33144
27	Teva Investigational Site 15211	Miami	Florida	United States	33155
28	Teva Investigational Site 15206	Miami	Florida	United States	33165
29	Teva Investigational Site 15215	Miami	Florida	United States	33165
30	Teva Investigational Site 15141	Miami	Florida	United States	33173
31	Teva Investigational Site 15170	North Palm Beach	Florida	United States	33408
32	Teva Investigational Site 15130	Orlando	Florida	United States	32819
33	Teva Investigational Site 15140	Tallahassee	Florida	United States	32308-4355
34	Teva Investigational Site 15132	Tampa	Florida	United States	33607
35	Teva Investigational Site 15135	Sugar Hill	Georgia	United States	30518
36	Teva Investigational Site 15183	Normal	Illinois	United States	61761
37	Teva Investigational Site 15198	Overland Park	Kansas	United States	66210
38	Teva Investigational Site 15187	Zachary	Louisiana	United States	70791
39	Teva Investigational Site 15148	White Marsh	Maryland	United States	21162
40	Teva Investigational Site 15190	North Dartmouth	Massachusetts	United States	02747
41	Teva Investigational Site 15175	Columbia	Missouri	United States	65203
42	Teva Investigational Site 15145	Rolla	Missouri	United States	65401
43	Teva Investigational Site 15144	Saint Louis	Missouri	United States	63141
44	Teva Investigational Site 15137	Bellevue	Nebraska	United States	68123-4303
45	Teva Investigational Site 15165	Bronx	New York	United States	10455
46	Teva Investigational Site 15181	Charlotte	North Carolina	United States	28277
47	Teva Investigational Site 15179	Elizabeth City	North Carolina	United States	27909
48	Teva Investigational Site 15193	Greensboro	North Carolina	United States	27410
49	Teva Investigational Site 15153	Monroe	North Carolina	United States	28112
50	Teva Investigational Site 15168	Raleigh	North Carolina	United States	27607
51	Teva Investigational Site 15173	Cincinnati	Ohio	United States	45231
52	Teva Investigational Site 15131	Toledo	Ohio	United States	43617
53	Teva Investigational Site 15201	Edmond	Oklahoma	United States	73034
54	Teva Investigational Site 15204	Tulsa	Oklahoma	United States	74133
55	Teva Investigational Site 15180	Medford	Oregon	United States	97504
56	Teva Investigational Site 15172	Portland	Oregon	United States	97239
57	Teva Investigational Site 15192	Jenkintown	Pennsylvania	United States	19046
58	Teva Investigational Site 15185	Pittsburgh	Pennsylvania	United States	15241
59	Teva Investigational Site 15161	Clinton	South Carolina	United States	29325
60	Teva Investigational Site 15159	Rock Hill	South Carolina	United States	29732
61	Teva Investigational Site 15162	Austin	Texas	United States	78759
62	Teva Investigational Site 15138	Dallas	Texas	United States	75231
63	Teva Investigational Site 15154	Dallas	Texas	United States	75231
64	Teva Investigational Site 15171	Denton	Texas	United States	76210
65	Teva Investigational Site 15155	El Paso	Texas	United States	79903-3508
66	Teva Investigational Site 15189	Houston	Texas	United States	77030
67	Teva Investigational Site 15184	Houston	Texas	United States	77070
68	Teva Investigational Site 15199	Houston	Texas	United States	77084
69	Teva Investigational Site 15191	Houston	Texas	United States	77087
70	Teva Investigational Site 15160	McKinney	Texas	United States	75069
71	Teva Investigational Site 15197	San Antonio	Texas	United States	78258
72	Teva Investigational Site 15195	Williamsburg	Virginia	United States	23188
73	Teva Investigational Site 15150	Bellingham	Washington	United States	98225
74	Teva Investigational Site 15142	Greenfield	Wisconsin	United States	53228
75	Teva Investigational Site 11218	Sherwood Park	Alberta	Canada	T8H 0N2
76	Teva Investigational Site 11212	Ajax	Ontario	Canada	L1S 2J5
77	Teva Investigational Site 11211	Toronto	Ontario	Canada	M5T 3A9
78	Teva Investigational Site 11213	Montreal	Quebec	Canada	H3G 1L5
79	Teva Investigational Site 11214	Quebec		Canada	G1V4W2

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: NCT04847674
• Other Study ID Numbers: TV53275-AS-20033; 2021-001439-22
• First Posted: Apr 19, 2021
• Last Update Posted: Aug 16, 2022
• Last Verified: Aug 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
• Keywords provided by Teva Branded Pharmaceutical Products R&D, Inc.: Persistent; Eosinophilic; Asthma
• Additional relevant MeSH terms: Asthma

Study Results

No Results Posted as of Aug 16, 2022