Actively Recruiting
A Phase IIb, Multicentre, Double-blind, Placebo-controlled Dose Range Finding Study to Assess Efficacy and Safety of Tozorakimab in Adult Participants With Uncontrolled Asthma on Medium-to High Dose Inhaled Corticosteroids
Led by AstraZeneca · Updated on 2026-05-29
540
Participants Needed
213
Research Sites
38 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the efficacy and safety of tozorakimab, a drug administered under the skin, in adults with uncontrolled asthma who are already using medium-to-high doses of inhaled corticosteroids. This phase IIb study is designed as a double-blind, placebo-controlled trial to find the right dose range of tozorakimab for this group. The study aims to better understand how tozorakimab may impact asthma control and reduce severe asthma attacks in this population. Participants will be randomly assigned to one of three groups: one receiving a lower dose of tozorakimab, another receiving a higher dose or placebo, and a third group receiving placebo injections. All treatments are given by subcutaneous injection. The study will last for 26 to 52 weeks, during which the participants will be closely monitored for asthma exacerbations and lung function changes. This includes assessing how well tozorakimab is tolerated and how it affects asthma symptoms and quality of life. During the study, participants will undergo regular assessments including lung function tests, questionnaires about asthma control and quality of life, and blood tests to measure drug levels and immune response. Researchers will track the annual rate of severe asthma flare-ups as the main outcome. Safety will be monitored throughout the study period, and participants will be followed for up to one year. The study is designed to ensure participants receive careful observation and support while contributing valuable information about tozorakimab’s potential use in asthma treatment.
CONDITIONS
Brief Title
Dose Range Finding Study to Assess Efficacy and Safety of Tozorakimab in Adults With Uncontrolled Asthma on Medium-to-High Dose Inhaled Corticosteroids
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 75 years at the time of informed consent
- Signed and dated written informed consent prior to any study procedures
- Physician-diagnosed asthma for at least 12 months
- Treated with medium or high dose inhaled corticosteroids combined with a long-acting beta agonist
- Uncontrolled asthma with an Asthma Control Questionnaire 6 (ACQ-6) score of 1.5 or higher
- Pre-bronchodilator forced expiratory volume in 1 second (FEV1) between 40% and 90% of predicted normal
- History of asthma exacerbations in the last 12 months with either 2 severe exacerbations, or 1 severe exacerbation plus elevated eosinophils (≥150 cells/µl) or FeNO (≥25 ppb)
- At least 70% compliance with the Asthma Daily Diary
- Women of childbearing potential must have a negative pregnancy test
- Use of contraception by males and females consistent with local regulations during the study
You will not qualify if you...
- Treatment for respiratory infection with antibiotics completed within 4 weeks before starting the study
- Significant lung diseases other than asthma
- Current smokers or former smokers with more than 10 pack-years history
- Clinically significant aortic stenosis or pulmonary arterial hypertension
- Active tuberculosis, hepatitis, HIV, cancer, or immune complex disease
- Unstable cardiovascular conditions
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 26 to 52 weeks
Participants receive subcutaneous doses of Tozorakimab or placebo while continuing their usual asthma medications.
Regular visits during treatment period
Trial Site Locations
Total: 213 locations
1
Research Site
Bakersfield, California, United States, 93301
Actively Recruiting
2
Research Site
Huntington Beach, California, United States, 92647
Withdrawn
3
Research Site
La Mesa, California, United States, 91942
Terminated
4
Research Site
Newport Beach, California, United States, 92663
Actively Recruiting
5
Research Site
San Jose, California, United States, 95117
Actively Recruiting
6
Research Site
Wilmington, Delaware, United States, 19805
Terminated
7
Research Site
Cutler Bay, Florida, United States, 33189
Suspended
8
Research Site
Hialeah, Florida, United States, 33012
Suspended
9
Research Site
Hialeah, Florida, United States, 33015
Suspended
10
Research Site
Leesburg, Florida, United States, 34748
Withdrawn
11
Research Site
Miami, Florida, United States, 33155
Suspended
12
Research Site
Miami, Florida, United States, 33175
Suspended
13
Research Site
Orlando, Florida, United States, 32819
Suspended
14
Research Site
Palmetto Bay, Florida, United States, 33157
Suspended
15
Research Site
Tampa, Florida, United States, 33607
Suspended
16
Research Site
Winter Park, Florida, United States, 32789
Suspended
17
Research Site
Boise, Idaho, United States, 83706
Withdrawn
18
Research Site
Noblesville, Indiana, United States, 46060
Actively Recruiting
19
Research Site
West Des Moines, Iowa, United States, 50266
Actively Recruiting
20
Research Site
Hutchinson, Kansas, United States, 67502
Not Yet Recruiting
21
Research Site
Kansas City, Kansas, United States, 66160
Not Yet Recruiting
22
Research Site
Louisville, Kentucky, United States, 40218
Actively Recruiting
23
Research Site
White Marsh, Maryland, United States, 21162
Withdrawn
24
Research Site
Farmington Hills, Michigan, United States, 48336
Actively Recruiting
25
Research Site
Warren, Michigan, United States, 48088
Withdrawn
26
Research Site
St Louis, Missouri, United States, 63141
Withdrawn
27
Research Site
Bellevue, Nebraska, United States, 68123
Withdrawn
28
Research Site
Grand Island, Nebraska, United States, 68803
Actively Recruiting
29
Research Site
Omaha, Nebraska, United States, 68134
Actively Recruiting
30
Research Site
Toms River, New Jersey, United States, 08755
Actively Recruiting
31
Research Site
Maspeth, New York, United States, 11378
Actively Recruiting
32
Research Site
Asheville, North Carolina, United States, 28803
Withdrawn
33
Research Site
Huntersville, North Carolina, United States, 28078
Withdrawn
34
Research Site
Kings Mountain, North Carolina, United States, 28086
Actively Recruiting
35
Research Site
Pinehurst, North Carolina, United States, 28374
Not Yet Recruiting
36
Research Site
Toledo, Ohio, United States, 43617
Actively Recruiting
37
Research Site
Edmond, Oklahoma, United States, 73034
Withdrawn
38
Research Site
Grants Pass, Oregon, United States, 97527
Withdrawn
39
Research Site
Medford, Oregon, United States, 97504
Actively Recruiting
40
Research Site
Portland, Oregon, United States, 97202
Actively Recruiting
41
Research Site
DuBois, Pennsylvania, United States, 15801
Terminated
42
Research Site
Philadelphia, Pennsylvania, United States, 19140
Actively Recruiting
43
Research Site
Smithfield, Pennsylvania, United States, 15478
Actively Recruiting
44
Research Site
Rock Hill, South Carolina, United States, 29732
Actively Recruiting
45
Research Site
Knoxville, Tennessee, United States, 37919
Terminated
46
Research Site
Austin, Texas, United States, 78759
Actively Recruiting
47
Research Site
Forney, Texas, United States, 75126
Terminated
48
Research Site
Kingwood, Texas, United States, 77339
Actively Recruiting
49
Research Site
Sugar Land, Texas, United States, 77478
Not Yet Recruiting
50
Research Site
Tyler, Texas, United States, 75708
Withdrawn
51
Research Site
Victoria, Texas, United States, 77901
Actively Recruiting
52
Research Site
Roy, Utah, United States, 84067
Terminated
53
Research Site
Bellingham, Washington, United States, 98225
Terminated
54
Research Site
Kingwood, West Virginia, United States, 26537
Actively Recruiting
55
Research Site
Milwaukee, Wisconsin, United States, 53228
Actively Recruiting
56
Research Site
CABA, Argentina, C1425BEN
Actively Recruiting
57
Research Site
Ciudad de Buenos Aires, Argentina, 1128
Withdrawn
58
Research Site
Ciudad de Buenos Aires, Argentina, 1425
Actively Recruiting
59
Research Site
La Plata, Argentina, B1900
Actively Recruiting
60
Research Site
Mendoza, Argentina, 5500
Actively Recruiting
61
Research Site
Rosario, Argentina, 2000
Actively Recruiting
62
Research Site
San Miguel de Tucumán, Argentina, 4000
Actively Recruiting
63
Research Site
Caxias do Sul, Brazil, 95070-560
Withdrawn
64
Research Site
Criciúma, Brazil, 88811-000
Actively Recruiting
65
Research Site
Porto Alegre, Brazil, 9061-000
Actively Recruiting
66
Research Site
Porto Alegre, Brazil, 91350-200
Actively Recruiting
67
Research Site
Salvador, Brazil, 40050 410
Withdrawn
68
Research Site
Santo André, Brazil, 09080-110
Withdrawn
69
Research Site
São José do Rio Preto, Brazil, 15090-000
Actively Recruiting
70
Research Site
São Paulo, Brazil, 04014-002
Actively Recruiting
71
Research Site
São Paulo, Brazil, 05403-000
Actively Recruiting
72
Research Site
Sorocaba, Brazil, 18040-425
Actively Recruiting
73
Research Site
Curicó, Chile, 3341643
Active, Not Recruiting
74
Research Site
Quillota, Chile, 2260000
Active, Not Recruiting
75
Research Site
Santiago, Chile, 7500657
Active, Not Recruiting
76
Research Site
Santiago, Chile, 7501126
Active, Not Recruiting
77
Research Site
Santiago, Chile, 7750495
Active, Not Recruiting
78
Research Site
Temuco, Chile, 4810345
Active, Not Recruiting
79
Research Site
Viña del Mar, Chile, 2540488
Active, Not Recruiting
80
Research Site
Baotou, China, 014010
Actively Recruiting
81
Research Site
Changchun, China, 130021
Actively Recruiting
82
Research Site
Chengdu, China, 610000
Actively Recruiting
83
Research Site
Chongqing, China, 400010
Actively Recruiting
84
Research Site
Guangzhou, China, 510163
Actively Recruiting
85
Research Site
Haikou, China, 570311
Actively Recruiting
86
Research Site
Hefei, China, 230061
Actively Recruiting
87
Research Site
Hohhot, China, 10050
Actively Recruiting
88
Research Site
Huizhou, China, 516001
Actively Recruiting
89
Research Site
Qingdao, China, 266011
Actively Recruiting
90
Research Site
Shanghai, China, 200025
Actively Recruiting
91
Research Site
Shanghai, China, 200065
Actively Recruiting
92
Research Site
Shanghai, China, 201114
Actively Recruiting
93
Research Site
Shenzhen, China, 518020
Actively Recruiting
94
Research Site
Wenzhou, China, 325027
Actively Recruiting
95
Research Site
Xuzhou, China, 221000
Actively Recruiting
96
Research Site
Brest, France, 29200
Actively Recruiting
97
Research Site
Créteil, France, 94010
Actively Recruiting
98
Research Site
Lyon, France, 69317
Actively Recruiting
99
Research Site
Marseille, France, 13015
Actively Recruiting
100
Research Site
Pessac, France, 33604
Actively Recruiting
101
Research Site
Strasbourg, France, 67091
Actively Recruiting
102
Research Site
Suresnes, France, 92150
Actively Recruiting
103
Research Site
Athens, Greece, 11521
Actively Recruiting
104
Research Site
Athens, Greece, 17562
Actively Recruiting
105
Research Site
Ioannina, Greece, 45500
Withdrawn
106
Research Site
Pátrai, Greece, 26500
Active, Not Recruiting
107
Research Site
Thessaloniki, Greece, 57001
Actively Recruiting
108
Research Site
Thessaloniki, Greece, 57010
Active, Not Recruiting
109
Research Site
Balassagyarmat, Hungary, 2660
Actively Recruiting
110
Research Site
Budapest, Hungary, 1036
Withdrawn
111
Research Site
Budapest, Hungary, 1121
Withdrawn
112
Research Site
Debrecen, Hungary, 4032
Actively Recruiting
113
Research Site
Gödöllő, Hungary, 2100
Actively Recruiting
114
Research Site
Pécs, Hungary, 7635
Actively Recruiting
115
Research Site
Törökbálint, Hungary, 2045
Actively Recruiting
116
Research Site
Belagavi, India, 590010
Actively Recruiting
117
Research Site
Coimbatore, India, 641028
Actively Recruiting
118
Research Site
Dehradun, India, 248001
Actively Recruiting
119
Research Site
Delhi, India, 110029
Actively Recruiting
120
Research Site
Faridabad, India, 121012
Withdrawn
121
Research Site
Gurgaon, India, 122001
Actively Recruiting
122
Research Site
Kochi, India, 682027
Actively Recruiting
123
Research Site
Lucknow, India, 226003
Suspended
124
Research Site
New Delhi, India, 110005
Actively Recruiting
125
Research Site
Vadodara, India, 391760
Actively Recruiting
126
Research Site
Haifa, Israel, 3109601
Actively Recruiting
127
Research Site
Jerusalem, Israel, 91120
Actively Recruiting
128
Research Site
Kfar Saba, Israel, 44281
Actively Recruiting
129
Research Site
Ramat Gan, Israel, 52621
Actively Recruiting
130
Research Site
Rehovot, Israel, 76100
Not Yet Recruiting
131
Research Site
Catania, Italy, 95123
Actively Recruiting
132
Research Site
Foggia, Italy, 71100
Actively Recruiting
133
Research Site
Genoa, Italy, 16132
Actively Recruiting
134
Research Site
Roma, Italy, 00168
Actively Recruiting
135
Research Site
Fukuoka, Japan, 811-1394
Actively Recruiting
136
Research Site
Ginowan-shi, Japan, 901-2214
Actively Recruiting
137
Research Site
Hiroshima, Japan, 730-0013
Actively Recruiting
138
Research Site
Ishinomaki, Japan, 986-8522
Actively Recruiting
139
Research Site
Kawaguchi-shi, Japan, 332-8558
Actively Recruiting
140
Research Site
Kiyose-shi, Japan, 204-8585
Actively Recruiting
141
Research Site
Kobe, Japan, 650-0017
Actively Recruiting
142
Research Site
Meguro-ku, Japan, 152-8902
Actively Recruiting
143
Research Site
Miura, Japan, 238-0111
Actively Recruiting
144
Research Site
Neyagawa, Japan, 572-8551
Actively Recruiting
145
Research Site
Sapporo, Japan, 060-0033
Actively Recruiting
146
Research Site
Sapporo, Japan, 064-0804
Actively Recruiting
147
Research Site
Takamatsu, Japan, 761-8073
Actively Recruiting
148
Research Site
Ube, Japan, 755-8505
Actively Recruiting
149
Research Site
Yokohama, Japan, 232-0024
Actively Recruiting
150
Research Site
Yokohama, Japan, 232-0066
Actively Recruiting
151
Research Site
Yokohama, Japan, 245-8575
Actively Recruiting
152
Research Site
Lima, Peru, 15046
Actively Recruiting
153
Research Site
Lima, Peru, 15082
Actively Recruiting
154
Research Site
Lima, Peru, 15088
Actively Recruiting
155
Research Site
Lima, Peru, LIMA 1
Actively Recruiting
156
Research Site
Lima, Peru, LIMA 21
Withdrawn
157
Research Site
Lima, Peru, LIMA 33
Suspended
158
Research Site
Iloilo City, Philippines, 5000
Actively Recruiting
159
Research Site
Las Piñas, Philippines, 1742
Withdrawn
160
Research Site
Lipa City, Philippines, 4217
Actively Recruiting
161
Research Site
Manadaluyong City, Philippines, 1552
Actively Recruiting
162
Research Site
Quezon City, Philippines, 1100
Actively Recruiting
163
Research Site
Roxas City, Philippines, 5800
Withdrawn
164
Research Site
Bellville, South Africa, 7530
Actively Recruiting
165
Research Site
Benoni, South Africa, 1501
Actively Recruiting
166
Research Site
Brackenfell, South Africa, 7560
Actively Recruiting
167
Research Site
Cape Town, South Africa, 7700
Actively Recruiting
168
Research Site
Durban, South Africa, 4093
Actively Recruiting
169
Research Site
eMkhomazi, South Africa, 4170
Actively Recruiting
170
Research Site
Somerset West, South Africa, 7130
Actively Recruiting
171
Research Site
Cheongju-si, South Korea, 28644
Actively Recruiting
172
Research Site
Daegu, South Korea, 42415
Actively Recruiting
173
Research Site
Seoul, South Korea, 03080
Actively Recruiting
174
Research Site
Seoul, South Korea, 03312
Actively Recruiting
175
Research Site
Seoul, South Korea, 03722
Actively Recruiting
176
Research Site
Seoul, South Korea, 05505
Actively Recruiting
177
Research Site
Seoul, South Korea, 06591
Actively Recruiting
178
Research Site
Seoul, South Korea, 08308
Actively Recruiting
179
Research Site
Barcelona, Spain, 08003
Actively Recruiting
180
Research Site
Barcelona, Spain, 8025
Actively Recruiting
181
Research Site
Madrid, Spain, 28041
Actively Recruiting
182
Research Site
Málaga, Spain, 29010
Actively Recruiting
183
Research Site
Mérida, Spain, 06800
Withdrawn
184
Research Site
Patraix, Spain, 46017
Actively Recruiting
185
Research Site
Santander, Spain, 39008
Actively Recruiting
186
Research Site
Kaohsiung City, Taiwan, 80756
Actively Recruiting
187
Research Site
New Taipei City, Taiwan, 231
Actively Recruiting
188
Research Site
Taichung, Taiwan, 40705
Actively Recruiting
189
Research Site
Taichung, Taiwan, 433004
Actively Recruiting
190
Research Site
Taipei, Taiwan, 10002
Actively Recruiting
191
Research Site
Taipei, Taiwan, 110
Actively Recruiting
192
Research Site
Taipei, Taiwan, 11220
Actively Recruiting
193
Research Site
Taipei, Taiwan, 11696
Actively Recruiting
194
Research Site
Bangkok, Thailand, 10700
Actively Recruiting
195
Research Site
Chanthaburi, Thailand, 22000
Actively Recruiting
196
Research Site
Chiang Rai, Thailand, 57000
Actively Recruiting
197
Research Site
Chon Buri, Thailand, 20000
Actively Recruiting
198
Research Site
Khon Kaen, Thailand, 40002
Actively Recruiting
199
Research Site
Nakhon Sri Thammarat, Thailand, 80000
Actively Recruiting
200
Research Site
Adana, Turkey (Türkiye), 01330
Actively Recruiting
201
Research Site
Ankara, Turkey (Türkiye), 06280
Actively Recruiting
202
Research Site
Bursa, Turkey (Türkiye), 16059
Actively Recruiting
203
Research Site
Gaziantep, Turkey (Türkiye), 27470
Actively Recruiting
204
Research Site
Istanbul, Turkey (Türkiye), 34890
Actively Recruiting
205
Research Site
Kayseri, Turkey (Türkiye), 38039
Actively Recruiting
206
Research Site
Mersin, Turkey (Türkiye), 33079
Actively Recruiting
207
Research Site
Da Nang, Vietnam, 550000
Actively Recruiting
208
Research Site
Haiphong, Vietnam, 180000
Actively Recruiting
209
Research Site
Hanoi, Vietnam, 100000
Actively Recruiting
210
Research Site
Ho Chi Minh City, Vietnam, 10000
Actively Recruiting
211
Research Site
Ho Chi Minh City, Vietnam, 700000
Actively Recruiting
212
Research Site
Ho Chi Minh City, Vietnam, 700000
Withdrawn
213
Research Site
Huế, Vietnam, 530000
Actively Recruiting
Research Team
A
AstraZeneca Clinical Study Information Center
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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