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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05158387




Registration number
NCT05158387
Ethics application status
Date submitted
2/12/2021
Date registered
15/12/2021
Date last updated
30/10/2024

Titles & IDs
Public title
Efficacy and Safety of Tozorakimab in Symptomatic Chronic Obstructive Pulmonary Disease With a History of Exacerbations.
Scientific title
A Phase III, Multicentre, Randomised, Double-blind, Chronic-dosing, Parallel-group, Placebo-controlled Study to Evaluate the Efficacy and Safety of Two Dose Regimens of Tozorakimab in Participants With Symptomatic Chronic Obstructive Pulmonary Disease (COPD) With a History of COPD Exacerbations (TITANIA)
Secondary ID [1] 0 0
2021-003771-34
Secondary ID [2] 0 0
D9180C00004
Universal Trial Number (UTN)
Trial acronym
TITANIA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Obstructive Pulmonary Disease (COPD) 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Chronic obstructive pulmonary disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Tozorakimab
Treatment: Drugs - Tozorakimab
Treatment: Drugs - Placebo

Experimental: Tozorakimab Dose 1 - Dosing subcutaneously tozorakimab Dose 1 and placebo

Experimental: Tozorakimab Dose 2 - Dosing subcutaneously tozorakimab Dose 2

Placebo comparator: Placebo - Dosing subcutaneously with equivalent volume to tozorakimab


Treatment: Drugs: Tozorakimab
Administered subcutaneously tozorakimab Dose 1 and placebo through Week 52.

Treatment: Drugs: Tozorakimab
Administered subcutaneously tozorakimab Dose 2 through Week 52.

Treatment: Drugs: Placebo
Placebo administered subcutaneously, equivalent volume to tozorakimab through week 52.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Annualized rate of moderate to severe COPD exacerbations in participants who are former smokers.
Timepoint [1] 0 0
over 52 weeks
Secondary outcome [1] 0 0
Annualized rate of moderate to severe COPD exacerbations in former or current smokers.
Timepoint [1] 0 0
over 52 weeks
Secondary outcome [2] 0 0
Time to first moderate to severe COPD exacerbation in former smokers.
Timepoint [2] 0 0
over 52 weeks
Secondary outcome [3] 0 0
Mean change from baseline in pre-BD, pre-dose trough FEV1 (mL) in former smokers.
Timepoint [3] 0 0
Week 52, or over 52 weeks
Secondary outcome [4] 0 0
Mean change from baseline in pre-BD, pre-dose trough FEV1 (mL) in the overall population of current and former smokers.
Timepoint [4] 0 0
Week 52, or over 52 weeks
Secondary outcome [5] 0 0
Percentage of responders achieving MCID in E-RS:COPD total score in former smokers
Timepoint [5] 0 0
Week 52
Secondary outcome [6] 0 0
Percentage of responders achieving MCID in E-RS:COPD total score in the overall population of current and former smokers.
Timepoint [6] 0 0
Week 52
Secondary outcome [7] 0 0
Mean change from baseline in E-RS:COPD total score in former smokers.
Timepoint [7] 0 0
over 52 weeks
Secondary outcome [8] 0 0
Mean change from baseline in E-RS:COPD total score in the overall population of current and former smokers.
Timepoint [8] 0 0
over 52 weeks
Secondary outcome [9] 0 0
Percentage of responders achieving MCID in SGRQ total score in former smokers.
Timepoint [9] 0 0
Week 52
Secondary outcome [10] 0 0
Percentage of responders achieving MCID in SGRQ total score in the overall population of current and former smokers.
Timepoint [10] 0 0
Week 52
Secondary outcome [11] 0 0
Mean change from baseline in SGRQ total score from in former smokers.
Timepoint [11] 0 0
over 52 weeks
Secondary outcome [12] 0 0
Mean change from baseline in SGRQ total score from in the overall population of current and former smokers.
Timepoint [12] 0 0
over 52 weeks
Secondary outcome [13] 0 0
Time to first severe COPD exacerbation in former smokers.
Timepoint [13] 0 0
over 52 weeks
Secondary outcome [14] 0 0
Annualized rate of severe COPD exacerbations in former smokers.
Timepoint [14] 0 0
over 52 weeks
Secondary outcome [15] 0 0
Change from baseline in CAT total score.
Timepoint [15] 0 0
Week 52
Secondary outcome [16] 0 0
Percentage of participants with a decrease in CAT total score in former smokers.
Timepoint [16] 0 0
Week 52
Secondary outcome [17] 0 0
Proportion of participants having = 1 healthcare resource utilization type in former smokers.
Timepoint [17] 0 0
over 52 weeks
Secondary outcome [18] 0 0
Annualized rate of healthcare resource utilization in former smokers.
Timepoint [18] 0 0
over 52 weeks
Secondary outcome [19] 0 0
The change from baseline in mean number of puffs per day in rescue use in former smokers.
Timepoint [19] 0 0
over 52 weeks
Secondary outcome [20] 0 0
Trough serum concentrations of tozorakimab.
Timepoint [20] 0 0
over 52 weeks
Secondary outcome [21] 0 0
Presence of anti-drug antibodies.
Timepoint [21] 0 0
over 60 weeks

Eligibility
Key inclusion criteria
1. Participant must be = 40 years of age and capable of giving signed informed consent.
2. Documented diagnosis of COPD for at least one year prior to enrolment.
3. Post BD FEV1/FVC < 0.70 and post-BD FEV1 >20% of predicted normal value.
4. Documented history of = 2 moderate or = 1 severe COPD exacerbations within 12 months prior to enrolment.
5. Documented optimized inhaled dual or triple therapy at a stable dose for at least 3 months prior to enrolment.
6. Smoking history of = 10 pack-years.
7. CAT total score =10, with each of the phlegm (sputum) and cough items with a score = 2
Minimum age
40 Years
Maximum age
130 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Clinically important pulmonary disease other than COPD.
2. Radiological findings suggestive of a respiratory disease other than COPD that is significantly contributing to the participant's respiratory symptoms.
3. Current diagnosis of asthma, prior history of asthma, or asthma-COPD overlap. Childhood history of asthma is allowed and defined as asthma diagnosed and resolved before the age of 18.
4. Any unstable disorder, including, but not limited to, cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, haematological, psychiatric disorder, major physical and/or cognitive impairment that could affect safety, study findings or participants ability to complete the study.
5. COPD exacerbation, within 2 weeks prior to randomization, that was treated with systemic corticosteroids and/or antibiotics, and/or led to hospitalization.
6. Active significant infection within the 4 weeks prior to randomization, pneumonia within 6 weeks prior to randomization, or medical condition that predisposes the participant to infection.
7. Suspicion of, or confirmed, ongoing SARS-CoV-2 infection.
8. Significant COVID-19 illness within the 6 months prior to enrolment.
9. Unstable cardiovascular disorder.
10. Diagnosis of cor pulmonale, pulmonary arterial hypertension and/or right ventricular failure.
11. History of known immunodeficiency disorder, including a positive test for HIV-1 or HIV 2.
12. History of positive test or treatment for hepatitis B or hepatitis C (except for cured hepatitis C)
13. Evidence of active liver disease, including jaundice during screening.
14. Malignancy, current or within the past 5 years, except for adequately treated non-invasive basal cell and squamous cell carcinoma of the skin and cervical carcinoma-in-situ treated with apparent success more than one year prior to enrolment. Suspected malignancy or undefined neoplasms.
15. Participants who have evidence of active TB.
16. Participants that have previously received tozorakimab.
17. Any clinically significant abnormal findings in physical examination, vital signs, ECG, or laboratory testing during the screening period, which in the opinion of the investigator may put the participant at risk because of their participation in the study, or may influence the results of the study, or the participant's ability to complete the entire duration of the study.
18. Active vaping of any products or using smoked marijuana within the 6 months prior to randomization and during the study.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
7/02/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/05/2026
Actual
Sample size
Target
1156
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Research Site - Adelaide
Recruitment hospital [2] 0 0
Research Site - Campbelltown
Recruitment hospital [3] 0 0
Research Site - Frankstown
Recruitment hospital [4] 0 0
Research Site - Macquarie University
Recruitment hospital [5] 0 0
Research Site - Melbourne
Recruitment hospital [6] 0 0
Research Site - Nedlands
Recruitment hospital [7] 0 0
Research Site - Southport
Recruitment hospital [8] 0 0
Research Site - Spearwood
Recruitment hospital [9] 0 0
Research Site - Wollongong
Recruitment hospital [10] 0 0
Research Site - Woodville South
Recruitment postcode(s) [1] 0 0
5000 - Adelaide
Recruitment postcode(s) [2] 0 0
2560 - Campbelltown
Recruitment postcode(s) [3] 0 0
3199 - Frankstown
Recruitment postcode(s) [4] 0 0
2109 - Macquarie University
Recruitment postcode(s) [5] 0 0
3000 - Melbourne
Recruitment postcode(s) [6] 0 0
6009 - Nedlands
Recruitment postcode(s) [7] 0 0
4215 - Southport
Recruitment postcode(s) [8] 0 0
6163 - Spearwood
Recruitment postcode(s) [9] 0 0
2500 - Wollongong
Recruitment postcode(s) [10] 0 0
5011 - Woodville South
Recruitment outside Australia
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United States of America
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Alabama
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California
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Delaware
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Indiana
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Kentucky
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Louisiana
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Wisconsin
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Sao Paulo
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São Paulo
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Curico
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Medellin
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Frankfurt
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Marburg
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Peine
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Athens
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Messina
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Roma
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Salerno
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Italy
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Sassari
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Statte
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Italy
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Tradate
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Italy
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Vercelli
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Italy
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Verona
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Lima
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Peru
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Piura
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Baguio
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Philippines
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Manila
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Bialystok
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Grodzisk Mazowiecki
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Lublin
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Ostróda
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Poznan
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Rzeszów
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Skierniewice
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Sosnowiec
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Wolomin
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Wroclaw
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Puerto Rico
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Caguas
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Puerto Rico
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Ponce
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Romania
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Bucharest
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Bucuresti
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Romania
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Cluj-Napoca
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Constanta
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Iasi
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Timisoara
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Russian Federation
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Chelyabinsk
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Izhevsk
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Moscow
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Novosibirsk
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Penza
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Russian Federation
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Perm
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Saint Petersburg
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Saratov
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Tomsk
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Ulyanovsk
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Hsinchu
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Kaohsiung
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Taichung
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Taiwan
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Taipei City
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Taiwan
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Taipei
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Taiwan
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Taoyuan
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Yunlin
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Bang Kra So
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Bangkok
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Khon Kaen
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Muang,
Country [184] 0 0
Thailand
State/province [184] 0 0
Muang
Country [185] 0 0
Thailand
State/province [185] 0 0
Mueang
Country [186] 0 0
Thailand
State/province [186] 0 0
Nakhon Ratchasima
Country [187] 0 0
United Kingdom
State/province [187] 0 0
Blackpool
Country [188] 0 0
United Kingdom
State/province [188] 0 0
Bradford
Country [189] 0 0
United Kingdom
State/province [189] 0 0
Corby
Country [190] 0 0
United Kingdom
State/province [190] 0 0
Enfield
Country [191] 0 0
United Kingdom
State/province [191] 0 0
Glasgow
Country [192] 0 0
United Kingdom
State/province [192] 0 0
Hampshire
Country [193] 0 0
United Kingdom
State/province [193] 0 0
High Wycombe
Country [194] 0 0
United Kingdom
State/province [194] 0 0
London
Country [195] 0 0
United Kingdom
State/province [195] 0 0
Northwood
Country [196] 0 0
United Kingdom
State/province [196] 0 0
Preston
Country [197] 0 0
United Kingdom
State/province [197] 0 0
Shipley
Country [198] 0 0
United Kingdom
State/province [198] 0 0
Wokingham

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AstraZeneca
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this Phase III study is to evaluate the efficacy and safety of tozorakimab Dose 1 and Dose 2 administered subcutaneously (SC) in adult participants with symptomatic COPD and history of = 2 moderate or = 1 severe exacerbation of COPD in the previous 12 months. Participants should be receiving optimised treatment with maintenance inhaled therapy (ICS/LABA/LAMA triple therapy, or dual therapy if triple is not considered appropriate) in stable doses throughout at least 3 months prior to enrolment.
Trial website
https://clinicaltrials.gov/study/NCT05158387
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
AstraZeneca Clinical Study Information Center
Address 0 0
Country 0 0
Phone 0 0
1-877-240-9479
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05158387