Inadequately Controlled AsthmaPhase 3NCT02902809
A Study to Evaluate the Safety of Tralokinumab in Adults and Adolescents With Uncontrolled Asthma
A Phase 3 study testing Tralokinumab open-label in people with Inadequately Controlled Asthma, run by AstraZeneca at 3 sites in Japan.
Trial summary
A 52-Week, Open-Label, Multicentre Study to Evaluate the Safety of Tralokinumab in Japanese Adults and Adolescents with Asthma Inadequately Controlled on Inhaled Corticosteroid plus Long-Acting β2-Agonist Read more about this study
- Who is it for?
- Ages 12 to 75 years
- Conditions the study is for
- Inadequately Controlled Asthma
- What is being tested?
- Tralokinumab open-label
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 3 sitesJapan
- Study dates
- 11 Nov 2016to 19 Jan 2018
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age 12 - 75 yrs
- Documented physician-diagnosed asthma
- Documented treatment with inhaled corticosteroid (ICS) at a total daily dose corresponding to ≥500 µg fluticasone propionate dry powder formulation equivalents and a long-acting beta-2 agonist (LABA)
- Pre-bronchodilator (BD) forced expiratory volume at one second (FEV1) value of ≥40% of their Predicted Normal Value (PNV)
- Asthma Control Questionnaire-6 (ACQ-6) score ≥1.5
Who cannot join
- Pulmonary disease other than asthma
- History of anaphylaxis following any biologic therapy
- Hepatitis B, C or HIV
- Pregnant of breastfeeding
- History or cancer
- Current tobacco smoking or a history or tobacco smoking for ≥10 pack-years
- Previous receipt of tralokinumab
Trial locations and contacts
3 sites in 1 country.
Japan3 sites
Research Site
Chūōku, 103-0027
Research Site
tabashi City, 173-8610
Research Site
Yokohama, 236-0004
About this study
Official title: A 52-Week, Open-Label, Multicentre Study to Evaluate the Safety of Tralokinumab in Japanese Adults and Adolescents With Asthma Inadequately Controlled on Inhaled Corticosteroid Plus Long-Acting β2-Agonist
A 52-Week, Open-Label, Multicentre Study to Evaluate the Safety of Tralokinumab in Japanese Adults and Adolescents with Asthma Inadequately Controlled on Inhaled Corticosteroid plus Long-Acting β2-Agonist
Read the detailed description
This is a 52-week, open-label, multi-centre study designed to evaluate the safety of tralokinumab in a fixed 300 mg dose every 2 weeks, administered subcutaneously in adults and adolescents with indequately controlled asthma on medium to high dose inhaled corticosteroid plus long acting β-2 antagonist. Approximately 26 Japanese subjects will be recruited to receive 22 completed.
- Conditions
- Inadequately Controlled Asthma
- Being tested
- Tralokinumab open-label
- Keywords
- open-label study, tralokinumab, subcutaneous, inadequately controlled asthma, asthma, medium to high-dose of inhaled corticosteroid, long-acting β2-agonist
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tralokinumab open-labelBiological
Also called Tralokinumab
Subcutaneous injection; fixed dose; 300 mg
| Study group | Role | What they receive |
|---|---|---|
| Open-label study to evaluate safety | Experimental | A fixed 300 mg dose every 2 weeks (Q2W) of tralokinumab administered subcutaneously in subjects with inadequately controlled asthma on medium to high-dose of inhaled corticosteroid plus long-acting β2-agonist. Receives: Biological: Tralokinumab open-label |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE was development of an undesirable medical condition or deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to product. An undesirable medical condition can be symptoms, signs or the abnormal results of an investigation. In clinical studies, an AE can include an undesirable medical condition occurring at any time, including run-in or washout periods, even if no study treatment has been administered. A SAE was an AE occurred during any study phase that fulfils one or more of the following criteria: death; immediately life-threatening, in-patient or prolongation of existing hospitalization; persistent or significant disability/incapacity or substantial disruption of ability to conduct normal life functions; congenital abnormality or birth defect; important medical event that may jeopardise participant or may require medical intervention to prevent one of the outcomes listed above.
Measured: From Screening (Day -14) up to 14 weeks after end of treatment (Week 66).
Number of Participants With Clinical Laboratory Abnormalities
Blood and urine samples for determination of clinical chemistry, haematology and urinalysis parameters were taken at the times. Changes in haematology and clinical chemistry variables between baseline and each subsequent scheduled assessment were evaluated. Baseline is defined as the last available value measured prior to the first dose of study treatment. The change from baseline is defined as the treatment period value minus the baseline period value. Absolute values were compared to the relevant reference range and classified as low (below range), normal (within range or on limits) or high (above range). The AstraZeneca extended reference ranges were used for laboratory variables (where they exist). All values (absolute and change) falling outside the reference ranges were flagged. Urinalysis data were categorised as negative (0), trace or positive (+) at each time point.
Measured: From Screening (Day -14) up to 14 weeks after end of treatment (Week 66).
Number of Participants With Abnormal Physical Examinations
Physical examination included assessment of general appearance, skin, head and neck (including eyes, ears, nose, mouth and throat), lymph nodes, abdomen, musculoskeletal (including spine and extremities), cardiovascular, respiratory, and neurological systems. Criteria for abnormal physical findings were based on investigator's discretion.
Measured: From Screening (Day -14) up to 14 weeks after end of treatment (Week 66).
Number of Participants With Vital Signs Abnormalities
Vital signs that were planned to be assessed included parameters such as pulse, systolic blood pressure, diastolic blood pressure, respiration rate and body temperature.
Measured: From Screening (Day -14) up to 14 weeks after end of treatment (Week 66).
Number of Participants With 12-Lead Electrocardiogram (ECG) Abnormalities
The ECG assessments were performed using an ECG device prior to blood drawing, spirometry, investigational product administration and bronchodilator administration. ECG data and evaluation was planned to be performed by the site Investigator.
Measured: At Day -14 and Week 52.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2016 (estimated)
- Study start11 Nov 2016
- Primary completion19 Jan 2018
- Study completion19 Jan 2018
Why it stopped: The study was terminated due to the discontinuation of the tralokinumab asthma program (as per the results of the Phase III study \[D2210C00008\])
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Inadequately Controlled AsthmaStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Takeshi Kaneko, MD, PhD, Principal investigator, Yokohama City University Graduate School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02902809
- Sponsor's protocol ID
- D2210C00029
- Status last verified
- Jul 2019
- First submitted
- 13 Sep 2016
- Last updated
- 6 Sep 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Panettieri RA Jr, Wang M, Braddock M, Bowen K, Colice G. Tralokinumab for the treatment of severe, uncontrolled asthma: the ATMOSPHERE clinical development program. Immunotherapy. 2018 Mar 1;10(6):473-490. doi: 10.2217/imt-2017-0191. Epub 2018 Mar 14.
PubMed 29536781
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 52-Week, Open-Label, Multicentre Study to Evaluate the Safety of Tralokinumab in Japanese Adults and Adolescents With Asthma Inadequately Controlled on Inhaled Corticosteroid Plus Long-Acting β2-Agonist
- ClinicalTrials.gov ID
- NCT02902809
- Acronym / sponsor ID
- D2210C00029
- Conditions
- Inadequately Controlled Asthma
- Keywords
- open-label study, tralokinumab, subcutaneous, inadequately controlled asthma, asthma, medium to high-dose of inhaled corticosteroid, long-acting β2-agonist
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was terminated due to the discontinuation of the tralokinumab asthma program (as per the results of the Phase III study \[D2210C00008\])
- Enrolment
- 28 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 11 Nov 2016 (actual)
- Primary completion
- 19 Jan 2018 (actual)
- Study completion
- 19 Jan 2018 (actual)
- First posted
- 16 Sep 2016 (estimated)
- Results
- Posted 6 Sep 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A 52-Week, Open-Label, Multicentre Study to Evaluate the Safety of Tralokinumab in Japanese Adults and Adolescents with Asthma Inadequately Controlled on Inhaled Corticosteroid plus Long-Acting β2-Agonist
Detailed description
This is a 52-week, open-label, multi-centre study designed to evaluate the safety of tralokinumab in a fixed 300 mg dose every 2 weeks, administered subcutaneously in adults and adolescents with indequately controlled asthma on medium to high dose inhaled corticosteroid plus long acting β-2 antagonist. Approximately 26 Japanese subjects will be recruited to receive 22 completed.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Open-label study to evaluate safety | Experimental | Biological: Tralokinumab open-labelA fixed 300 mg dose every 2 weeks (Q2W) of tralokinumab administered subcutaneously in subjects with inadequately controlled asthma on medium to high-dose of inhaled corticosteroid plus long-acting β2-agonist. |
Who may qualify
- Ages
- 12 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Age 12 - 75 yrs
- Documented physician-diagnosed asthma
- Documented treatment with inhaled corticosteroid (ICS) at a total daily dose corresponding to ≥500 µg fluticasone propionate dry powder formulation equivalents and a long-acting beta-2 agonist (LABA)
- Pre-bronchodilator (BD) forced expiratory volume at one second (FEV1) value of ≥40% of their Predicted Normal Value (PNV)
- Asthma Control Questionnaire-6 (ACQ-6) score ≥1.5
Key exclusion criteria (7 listed)
- Pulmonary disease other than asthma
- History of anaphylaxis following any biologic therapy
- Hepatitis B, C or HIV
- Pregnant of breastfeeding
- History or cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tralokinumab open-labelAlso: TralokinumabSubcutaneous injection; fixed dose; 300 mg | Biological | Open-label study to evaluate safety |
Primary outcome
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: From Screening (Day -14) up to 14 weeks after end of treatment (Week 66).
An AE was development of an undesirable medical condition or deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to product. An undesirable medical condition can be symptoms, signs or the abnormal results of an investigation. In clinical studies, an AE can include an undesirable medical condition occurring at any time, including run-in or washout periods, even if no study treatment has been administered. A SAE was an AE occurred during any study phase that fulfils one or more of the following criteria: death; immediately life-threatening, in-patient or prolongation of existing hospitalization; persistent or significant disability/incapacity or substantial disruption of ability to conduct normal life functions; congenital abnormality or birth defect; important medical event that may jeopardise participant or may require medical intervention to prevent one of the outcomes listed above.
Number of Participants With Clinical Laboratory Abnormalities
Time frame: From Screening (Day -14) up to 14 weeks after end of treatment (Week 66).
Blood and urine samples for determination of clinical chemistry, haematology and urinalysis parameters were taken at the times. Changes in haematology and clinical chemistry variables between baseline and each subsequent scheduled assessment were evaluated. Baseline is defined as the last available value measured prior to the first dose of study treatment. The change from baseline is defined as the treatment period value minus the baseline period value. Absolute values were compared to the relevant reference range and classified as low (below range), normal (within range or on limits) or high (above range). The AstraZeneca extended reference ranges were used for laboratory variables (where they exist). All values (absolute and change) falling outside the reference ranges were flagged. Urinalysis data were categorised as negative (0), trace or positive (+) at each time point.
Number of Participants With Abnormal Physical Examinations
Time frame: From Screening (Day -14) up to 14 weeks after end of treatment (Week 66).
Physical examination included assessment of general appearance, skin, head and neck (including eyes, ears, nose, mouth and throat), lymph nodes, abdomen, musculoskeletal (including spine and extremities), cardiovascular, respiratory, and neurological systems. Criteria for abnormal physical findings were based on investigator's discretion.
Number of Participants With Vital Signs Abnormalities
Time frame: From Screening (Day -14) up to 14 weeks after end of treatment (Week 66).
Vital signs that were planned to be assessed included parameters such as pulse, systolic blood pressure, diastolic blood pressure, respiration rate and body temperature.
Number of Participants With 12-Lead Electrocardiogram (ECG) Abnormalities
Time frame: At Day -14 and Week 52.
The ECG assessments were performed using an ECG device prior to blood drawing, spirometry, investigational product administration and bronchodilator administration. ECG data and evaluation was planned to be performed by the site Investigator.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 29536781Panettieri RA Jr, Wang M, Braddock M, Bowen K, Colice G. Tralokinumab for the treatment of severe, uncontrolled asthma: the ATMOSPHERE clinical development program. Immunotherapy. 2018 Mar 1;10(6):473-490. doi: 10.2217/imt-2017-0191. Epub 2018 Mar 14.
- Statistical Analysis PlanLink provided by the sponsor.
- Clinical Study ProtocolLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Takeshi Kaneko, MD, PhD principal investigator
Yokohama City University Graduate School of Medicine
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tralokinumab open-label in people with Inadequately Controlled Asthma, run by AstraZeneca at 3 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Sep 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) (time frame: From Screening (Day -14) up to 14 weeks after end of treatment (Week 66).). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02902809, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Sep 2019.