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Clinical Trials List

Protocol NumberD9180C00004
NCT Number(ClinicalTrials.gov Identfier)NCT05158387
Active

2022-01-01 - 2026-12-31

Phase III

Not yet recruiting1

Recruiting9

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)

  • Trial Applicant

  • Sponsor

    AstraZeneca

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/02/01

Investigators and Locations

Principal Investigator Chau-Chyun Sheu Division of Thoracic Medicine
Kaohsiung Medical Univeristy Chung-Ho Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Liang-wen Hang Division of Thoracic Medicine
China Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 魏裕峰 Division of Thoracic Medicine
E-DA Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chung-Yu Chen Division of Thoracic Medicine
National Taiwan University Hospital Yunlin Branch 

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Ming -Cheng Chan Division of Thoracic Medicine
Taichung Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chun-Hua Wang Division of Thoracic Medicine
Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 耿立達 Division of Thoracic Medicine
National Taiwan University Hospital Hsin-Chu Branch

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator HAO-CHIEN WANG Division of Thoracic Medicine
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Pai-Chien Chou Division of Thoracic Medicine
Taipei Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator Chung-Yu Chen Division of Thoracic Medicine
國立臺灣大學醫學院附設醫院雲林分院

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Chronic Obstructive Pulmonary Disease

Objectives

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.

Test Drug

MEDI3506

Active Ingredient

MEDI3506

Dosage Form

Vial

Dosage

150

Endpoints

To evaluate the effect of 2 dose regimens of MEDI3506 as add on to SoC compared with SoC plus placebo on the rate of moderate to severe COPD exacerbations in former smokers.

Inclution Criteria

Age
1 Participant must be ≥ 40 years of age at the time of signing the ICF.
Type of Participant and Disease Characteristics
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 (as
assessed by central spirometry at screening).
4 Documented history of ≥ 2 moderate or ≥ 1 severe COPD exacerbations within 12 months
prior to enrolment:
(a) An exacerbation is considered moderate if it required treatment with systemic
corticosteroids and/or antibiotics, and severe if it required hospitalisation. Note:
hospitalisation is defined as an inpatient admission ≥ 24 hours in the hospital, in an
observation area, emergency department, or other equivalent healthcare facility
depending on the country and healthcare system.
(b) At least one qualifying exacerbation should have been treated with systemic
corticosteroids.
(c) Events treated with antibiotics alone qualify as a moderate exacerbation only when
antibiotic was specifically prescribed for worsening of COPD symptoms.
(d) Previous exacerbations should be confirmed to have occurred while the participant
was on stable dual or triple (ICS/LABA/LAMA) maintenance inhaled therapy for
COPD and not as a result of a gap or step down in the treatment.
(e) At least one qualifying exacerbation should have occurred while on the most recent
stable uninterrupted therapy (see inclusion criterion 5(a) and section 6.5.2) prior to
enrolment.
5 Documented optimised treatment with COPD inhaled maintenance therapy
(ICS/LABA/LAMA triple therapy, or dual therapy if triple is not indicated or
contraindicated) and at a stable dose for at least 3 months prior to enrolment. During this
period:
(a) Individual component changes or switches between devices are allowed as long as
the participant remains on the same class therapies in equivalent doses 1
.
(b) Short-term changes in background treatment regimen during COPD exacerbation are
acceptable.
(c) Short-acting muscarinic antagonist taken at regular scheduled interval (at a minimum
frequency of 3 times daily) will be considered equivalent to LAMA.
(d) If participant is being treated with any oral COPD maintenance therapy (eg,
macrolides, xanthines, roflumilast), these treatments must also be stable for at least 3
months prior to enrolment (see Section 6.5.2).
6 Smoking history of ≥ 10 pack-years:
(a) Former smokers will be defined as participants who are currently not smoking and
with smoking cessation ≥ 6 months prior to screening with an intention to quit
permanently.
(b) Current smokers will be defined as participants who are currently smoking tobacco
(at least one cigarette per day on average during the past 7 days) and are not currently
participating in smoking cessation.
(c) Electronic cigarette (e-cigarette) use does not contribute to the pack-year count for
eligibility.
7 CAT total score ≥ 10, with each of the phlegm (sputum) and cough items with a score ≥ 2,
at both screening (V1) and randomisation (V2).
8 At least 70% daily PRO completion during the entire screening period, with at least 50%
daily PRO completion in the 14-day period prior to randomisation.
9 At least 70% compliance with COPD maintenance inhaled therapy (defined as taking
COPD maintenance inhaled medication as scheduled for the day) during the entire
screening period.
10 Able to read and use electronic devices.
Reproduction
11 Female participants of childbearing potential must have a negative serum pregnancy test
at V1 and a negative urine pregnancy test at V2.
12 Contraceptive use by males and females should be consistent with local regulations
regarding the methods of contraception for those participating in clinical studies.
a) Male participants:
 Non-sterile 2 male participants who are sexually active with a female partner of
childbearing potential must agree to use a male condom while engaging in sexual
activity from enrolment throughout the study duration and until 14 weeks after
last dose of IP. In countries where spermicide is available, it is strongly
recommended. It is also strongly recommended for the female partner of a male
participant to use a highly effective method of contraception throughout this
period.
 Non-sterilised male patients should also refrain from biologically fathering a
child or donating sperm during the same period.
b) Female participants:
 Females not of childbearing potential are defined as females who are either
permanently sterilised (hysterectomy, bilateral oophorectomy, or bilateral
salpingectomy), or who are postmenopausal. Females will be considered
postmenopausal if they have been amenorrhoeic for 12 months prior to the
planned date of randomisation without an alternative medical cause. The
following age-specific requirements apply:
• Females < 50 years old would be considered postmenopausal if they have
been amenorrhoeic for 12 months or more following cessation of exogenous
hormonal treatment and follicle stimulating hormone (FSH) levels in the
postmenopausal range.
• Females ≥ 50 years old would be considered postmenopausal if they have
been amenorrhoeic for 12 months or more following cessation of all
exogenous hormonal treatment.
 Females of childbearing potential who are sexually active with a non-sterilised
male partner must agree to use one highly effective method of birth control, as
defined below, from enrolment throughout the study and until at least 14 weeks
after last dose of IP. Cessation of contraception after this point should be
discussed with a responsible physician. Periodic abstinence (calendar,
symptothermal, post-ovulation methods), withdrawal (coitus interruptus),
spermicides only, and lactational amenorrhoea method are not acceptable methods
of contraception. Female condom and male condom should not be used together.
 A highly effective method of contraception is defined as one that can achieve a
failure rate of less than 1% per year when used consistently and correctly. Highly
effective birth control methods include: sexual abstinence (periodic abstinence eg,
calendar, ovulation, symptothermal, post-ovulation methods, declaration of
abstinence for the duration of exposure to IP, and withdrawal are not acceptable
methods of contraception), a vasectomised partner, Implanon®, bilateral tubal
occlusion, intrauterine device/levonorgestrel intrauterine system, Depo-Provera™
injections, oral contraceptive, and Evra Patch™, Xulane™, or NuvaRing®.
It is highly recommended for the male partner of a female participant who is of
childbearing potential to use a male condom whilst engaging in sexual activity
throughout this period.
 Note there are no contraception requirements for female participants who are not
of childbearing potential. However, all female participants should refrain from egg
cell donation and breastfeeding throughout the study.
Informed Consent
13 Capable of giving signed informed consent as described in Appendix A which includes
compliance with the requirements and restrictions listed in the ICF and in this protocol.
Additional Criterion for Optional Genetic Research
14 Provision of signed and dated written Optional Genetic Research Information informed
consent prior to collection of samples for optional genetic research that supports Genomic
Initiative.

Exclusion Criteria

Medical Conditions
1 Clinically important pulmonary disease other than COPD (eg, active lung infection,
clinically significant bronchiectasis, pulmonary fibrosis, cystic fibrosis, hypoventilation
syndrome associated with obesity, lung cancer, alpha 1 anti-trypsin deficiency, and
primary ciliary dyskinesia).
2 Radiological findings suggestive of a respiratory disease other than COPD that is
contributing to the participant’s respiratory symptoms. Radiological findings of solitary
pulmonary nodules without appropriate follow up and demonstration of stability as per
standard of care, or findings suggestive of acute infection.
3 Current diagnosis of asthma according to the GINA or other accepted guidelines, prior
history of asthma, or asthma-COPD overlap 3
. Childhood history of asthma is allowed and
defined as asthma diagnosed and resolved (ie, not requiring the use of any maintenance or
rescue medication) 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, in
the opinion of the investigator, could:
(a) Affect the safety of the participant throughout the study.
(b) Influence the findings of the study or their interpretation.
(c) Impede the participant’s ability to complete the entire duration of the study and/or
comply with the study visit schedule and procedures.
5 COPD exacerbation, within 2 weeks prior to randomisation, that was treated with
systemic corticosteroids and/or antibiotics, and/or led to hospitalisation (based on last
dose of corticosteroids or antibiotics, or last date of hospitalisation, whichever occurred
later).
6 Active significant infection (viral, bacterial, or fungal infections requiring treatment with
systemic antibiotic, antiviral, or antifungal medication, respectively) within the 4 weeks
prior to randomisation, pneumonia within 6 weeks prior to randomisation, 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, defined as:
(a) A diagnosis of COVID-19 pneumonia based on radiological assessment.
(b) A diagnosis of COVID-19 with significant new findings from pulmonary imaging
tests.
(c) A diagnosis of COVID-19 requiring hospitalisation and/or oxygen supplementation
therapy.
9 Unstable cardiovascular disorder (including but not limited to: ischaemic heart disease,
arrhythmia, cardiomyopathy, unstable moderate to severe heart failure (NYHA class
III-IV and or LVEF < 30%), clinically significant aortic stenosis, uncontrolled arterial
hypertension, or any other relevant cardiovascular condition), that, in the investigator’s
judgement may put the participant at risk or negatively affect the outcome of the study.
10 Diagnosis of cor pulmonale, pulmonary arterial hypertension and/or right ventricular
failure.
11 History of active severe inflammatory bowel disease or colitis within one year prior to
enrolment, or unexplained diarrhoea within the 4 weeks prior to randomisation.
12 History of known immunodeficiency disorder, including a positive test for HIV-1 or
HIV-2.
13 History of positive test or treatment for hepatitis B or hepatitis C. For hepatitis B testing,
any of the following would exclude the participant from the study:
(a) Positive test for HBsAg.
(b) Positive test for anti-HBc.
Note: participants with a history of hepatitis B vaccination without a history of hepatitis B
are permitted.
14 Evidence of active liver disease, including jaundice, ALT or AST > 2 × ULN, or TBL
> 2 × ULN (unless due to Gilbert’s disease) during screening. Note: transient increase of
ALT/AST/TBL level that resolves by the time of randomisation is acceptable if, in the
investigator’s opinion, the participant does not have active liver disease and meets other
eligibility criteria.
15 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.
16 Participants who, in the opinion of the investigator or qualified designee, have evidence
of active TB. Participants with a recent (within 2 years) first-time or newly positive
purified protein derivative (PPD) test or QuantiFERON-TB (QFT) test need to complete
an appropriate course of treatment before being considered for enrolment. Evaluation will
be according to the local standard of care and may consist of history and physical
examinations, chest X-ray, and/or TB test as determined by local guidelines.
17 History of partial or total lung resection (single lobe or segmentectomy is acceptable).
Surgical or endoscopic (eg, valves) lung volume reduction within the 6 months prior to
enrolment. Expected need for lung volume reduction surgery during the study.
18 Scheduled major surgical procedure during the course of the study. Minor elective
procedures are allowed.
Prior/Concomitant Therapy
19 Treatment with systemic corticosteroids or other immunosuppressive medication within
2 weeks prior to randomisation.
20 Long-term oxygen therapy (LTOT) > 4.0 L/min. While breathing supplemental oxygen,
participants should demonstrate an oxyhaemoglobin saturation ≥ 89%. In order to be
admitted to the study, participants on long-term oxygen therapy have to be ambulatory
and able to attend clinic visits.
21 Participants with use, or need for chronic use, of any non-invasive positive pressure
ventilation device. Participants using continuous positive airway pressure for sleep
apnoea syndrome are permitted in the study.
22 Participation in, or scheduled for, an intensive (active) COPD rehabilitation program
(participants who are in the maintenance phase of a rehabilitation program are eligible to
take part).
23 Receipt of blood products or immunoglobulins within 30 days prior to randomisation.
24 Receipt of live attenuated vaccines within 30 days prior to randomisation.
25 Chronic use of immunosuppressive medication at screening and/or randomisation
(including but not limited to: methotrexate, troleandomycin, cyclosporine, azathioprine,
rectal corticosteroids, and systemic corticosteroids), or expected need for chronic use
during the study.
26 Chronic use of antibiotics if the duration of treatment is < 3 months prior to enrolment.
Chronic macrolide or other antibiotic therapy is allowed provided the participant has been
on a stable dose/regimen for ≥ 3 months prior to enrolment and has had at least one
COPD exacerbation while on stable therapy
27 Use of allergen immunotherapy within 3 months of randomisation, except for stable
maintenance dose allergen-specific immunotherapy started 4 weeks prior to V1.
28 Use of interferon gamma within 3 months of randomisation.
Prior/Concurrent Clinical Study Experience
29 Receipt of any marketed or investigational biologic product for any reason within
4 months or 5 half-lives prior to randomisation, whichever is longer.
30 Participation in any interventional clinical trial or receipt of any investigational nonbiologic product within 30 days or 5 half-lives prior to randomisation, whichever is
longer.
31 Participants that have previously received MEDI3506.
32 Known history of:
a) Severe allergic reaction to a systemic monoclonal antibody
b) Allergy or reaction to any component of the IP formulation.
Diagnostic Assessments
33 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 his/her 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. If abnormal findings suggest a transient effect, participants may be
retested at the discretion of the investigator prior to randomisation.
Other Exclusions
34 Active vaping of any products (eg, nicotine, tetrahydrocannabinol [THC]) within the 6
months prior to randomisation and during the study. Note: active vaping is defined as at
least one vape a day on average, over last 7 days.
35 History of alcohol or drug abuse within the past year, which may compromise the study
data interpretation, as judged by investigator or AstraZeneca study physician.
36 Involvement in the planning and/or conduct of the study (applies to both AstraZeneca
staff and/or staff at the study site).
37 Participants undergoing donation of blood, plasma, or platelets within the past 90 days
prior to enrollment.

The Estimated Number of Participants

  • Taiwan

    41 participants

  • Global

    1060 participants

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