Clinical trial NCT06932263: Dose Range Finding Study to Assess Efficacy and Safety of Tozorakimab in Adults With Uncontrolled Asthma on Medium-to-High Dose Inhaled Corticosteroids
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Asthma
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2025-04-17
Enrollment: 540
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a parallel-group treatment study with 3 arms. Participants will be randomised in a ratio of 1:1:1 to one of the 3 treatment arms.
Primary purpose: TREATMENT

Brief summary: This is a dose-range finding, double-blind, placebo-controlled, phase IIb study designed to assess efficacy and safety of tozorakimab administered subcutaneously in adult participants with uncontrolled asthma receiving medium-to-high dose inhaled corticosteroids.


Eligibility criteria: Inclusion Criteria:

1. Provision of signed and dated written informed consent prior to any study-specific procedures.
2. Adults aged 18-75, inclusive when signing the informed consent.
3. Documented physician-diagnosis of asthma for at least 12 months.
4. Treated with medium or high dose ICS in combination with LABA.
5. Demonstration of uncontrolled asthma through ACQ-6 score ≥ 1.5 .
6. Pre-bronchodilator FEV1 ≥ 40% to ≤ 90% of predicted normal.
7. Documented exacerbation history in the last 12 months and biomarker requirements of:

   1. 2 severe exacerbations OR
   2. 1 severe exacerbation and:

   (i) Eosinophils ≥ 150 cells/µl or (ii) FeNo ≥ 25 ppb
8. Participants need to demonstrate a ≥70% compliance for Asthma Daily Diary.
9. Women of Child Bearing Potential (WOCBP) must have a negative pregnancy test.
10. Contraceptive use by males and females should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.

Exclusion Criteria:

1. Completed treatment for respiratory infection with antibiotics in the 4 weeks prior to Visit 1.
2. Clinically significant pulmonary disease other than asthma .
3. Current smokers, former smokers with \>10 pack-years history.
4. Clinically significant aortic stenosis or pulmonary arterial hypertension.
5. Active tuberculosis, hepatitis, HIV, or current diagnosis of cancer or immune complex disease.
6. Unstable cardiovascular disorders.

Primary outcomes:
measure: Annualised rate of severe asthma exacerbations
timeFrame: Over 26 to 52 weeks
Secondary outcomes:
measure: Annualised rate of severe asthma exacerbations
timeFrame: Over 26 to 52 weeks
measure: Time to first severe asthma exacerbation
timeFrame: Over 26 to 52 weeks
measure: Change from baseline in pre-bronchodilator forced expiratory volume in 1 second (FEV1)
timeFrame: Over weeks 20 to 26
measure: Change from baseline in post-bronchodilator FEV1
timeFrame: At week 26
measure: Change from baseline in the Asthma Control Questionnaire 6 (ACQ-6)
timeFrame: At week 26
measure: Change from baseline in the Asthma Quality of Life Questionnaire for 12 Years and Older (AQLQ12+)
timeFrame: At week 26
measure: Trough serum concentrations of tozorakimab
timeFrame: Over 52 weeks
measure: Anti-drug antibody incidence
timeFrame: Over 52 weeks
Other outcomes:
Locations:
city: Bakersfield
country: United States
facility: Research Site
state: California
city: Huntington Beach
country: United States
facility: Research Site
state: California
city: La Mesa
country: United States
facility: Research Site
state: California
city: Newport Beach
country: United States
facility: Research Site
state: California
city: San Jose
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state: California
city: Wilmington
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city: Tampa
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city: La Plata
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city: Mendoza
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city: Rosario
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city: San Miguel de Tucuman
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city: Caxias do Sul
country: Brazil
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city: Criciuma
country: Brazil
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city: Porto Alegre
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city: Porto Alegre
country: Brazil
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city: Salvador
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city: Santo Andre
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city: Sao Jose Do Rio Preto
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city: Sao Paulo
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city: Sorocaba
country: Brazil
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city: Curico
country: Chile
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country: Chile
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city: Santiago
country: Chile
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city: Santiago
country: Chile
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city: Victoria
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city: Viña del Mar
country: Chile
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city: Baotou
country: China
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city: Changchun
country: China
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city: Chengdu
country: China
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city: Chongqing
country: China
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city: Guangzhou
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city: Haikou
country: China
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city: Hefei
country: China
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city: Hohhot
country: China
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city: Huizhou
country: China
facility: Research Site
city: Qingdao
country: China
facility: Research Site
city: Shanghai
country: China
facility: Research Site
city: Shanghai
country: China
facility: Research Site
city: Shanghai
country: China
facility: Research Site
city: Shenzhen
country: China
facility: Research Site
city: Wenzhou
country: China
facility: Research Site
city: Xuzhou
country: China
facility: Research Site
city: Brest Cedex
country: France
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city: Creteil
country: France
facility: Research Site
city: Lyon Cedex 04
country: France
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city: Marseille
country: France
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city: Pessac
country: France
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city: Strasbourg Cedex
country: France
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city: Suresnes
country: France
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city: Athens
country: Greece
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city: Athens
country: Greece
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city: Ioannina
country: Greece
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city: Patras
country: Greece
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city: Thessaloniki
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city: Thessaloniki
country: Greece
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country: Hungary
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city: Budapest
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country: India
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city: Delhi
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city: Kochi
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city: Lucknow
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city: New Delhi
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city: Vadodara
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city: Jerusalem
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city: Ramat Gan
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city: Catania
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city: Foggia
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city: Genoa
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city: Roma
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city: Fukuoka-shi
country: Japan
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city: Ginowan-shi
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city: Ishinomaki
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city: Kagoshima City
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city: Kawaguchi-shi
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city: Ube
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city: Yokohama-shi
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city: Yokohama-shi
country: Japan
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city: Yokohama
country: Japan
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city: Cheongju-si
country: Korea, Republic of
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city: Daegu
country: Korea, Republic of
facility: Research Site
city: Seoul
country: Korea, Republic of
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city: Seoul
country: Korea, Republic of
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city: Seoul
country: Korea, Republic of
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city: Seoul
country: Korea, Republic of
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country: Korea, Republic of
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country: Korea, Republic of
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city: Lima
country: Peru
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city: Lima
country: Peru
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country: Peru
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city: Lima
country: Peru
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city: Lima
country: Peru
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city: Iloilo City
country: Philippines
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city: Las Pinas
country: Philippines
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city: Lipa City
country: Philippines
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city: Manadaluyong City
country: Philippines
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city: Quezon City
country: Philippines
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city: Roxas City
country: Philippines
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city: Benoni
country: South Africa
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country: South Africa
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city: Cape Town
country: South Africa
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city: Durban
country: South Africa
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country: South Africa
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city: Barcelona
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country: Taiwan
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city: New Taipei
country: Taiwan
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city: Taichung City
country: Taiwan
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city: Taichung
country: Taiwan
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city: Taipei City
country: Taiwan
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city: Taipei City
country: Taiwan
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city: Taipei
country: Taiwan
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city: Taipei
country: Taiwan
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city: Bangkok
country: Thailand
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city: Chiang Rai
country: Thailand
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city: Chonburi
country: Thailand
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city: Khon Kaen
country: Thailand
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city: Mueang Chanthaburi
country: Thailand
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city: Nakhon Sri Thammarat
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city: Ankara
country: Turkey
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city: Bursa
country: Turkey
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city: Gaziantep
country: Turkey
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city: Istanbul
country: Turkey
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city: Kayseri
country: Turkey
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city: Mersin
country: Turkey
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city: Da Nang
country: Vietnam
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city: Hai Phong
country: Vietnam
facility: Research Site
city: Hanoi
country: Vietnam
facility: Research Site
city: Ho Chi Minh City
country: Vietnam
facility: Research Site
city: Ho Chi Minh
country: Vietnam
facility: Research Site
city: Ho Chi Minh
country: Vietnam
facility: Research Site
city: Hue
country: Vietnam
facility: Research Site
Study officials:
References: