Idiopathic Pulmonary FibrosisPhase 2NCT02036580

D2212C00002 J-Phase II Study

A Phase 2 study testing tralokinumab cohort 1 and tralokinumab cohort 2 in people with Idiopathic Pulmonary Fibrosis, run by AstraZeneca at 5 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of the study is to evaluate the safety and tolerability of multiple-doses of tralokinumab in Japanese patients with Idiopathic Pulmonary Fibrosis. Read more about this study

Who is it for?: Ages 50 years and older
Conditions the study is for: Idiopathic Pulmonary Fibrosis
What is being tested?: tralokinumab cohort 1 and tralokinumab cohort 2
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 37 participants
Where: 5 sitesJapan
Study dates: Jan 2014to Nov 2015
Phase: Phase 2
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 50 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Provision of informed consent prior to any study specific procedures
Confirmed IPF diagnosis for ≤ 5 years prior to Visit 1 (screening). Confirmation of diagnosis of IPF
Mild to moderate IPF to include all of the following at Visit 1
FVC ≥ 50% and ≤ 90% predicted normal
Partial pressure of oxygen in arterial blood (PaO2) of ≥ 55 mmHg on room air, or oxygen saturation by pulse oximetry (SpO2) of ≥ 90% on room air at rest
Hemoglobin-corrected diffusion capacity for carbon monoxide (DLCO) ≥ 30% and ≤ 90% predicted normal

Who cannot join

History of clinically significant environmental exposure (eg, domestic and occupational) to a known cause of pulmonary fibrosis
Diagnosis of connective tissue disease or drug toxicity as the likely cause of the interstitial disease
A suspected IPF exacerbation not fully resolved and treatment completed ≤ 14 days prior to Visit 1
A suspected IPF exacerbation during the screening period
A FEV1/FVC ratio < 0.70 at the time of Visit 1 (postbronchodilator)
The extent of emphysema on the HRCT is greater than the extent of fibrosis

Trial locations and contacts

5 sites in 1 country.

City, postcode or hospital

5 sites in 1 country

Japan5 sites

Research Site
Fukuoka
Research Site
Himeji-shi
Research Site
Seto-shi
Research Site
Shibuya-ku
Research Site
Yokohama

Other trials in Japan

About this study

Official title: A Phase 2, Multicenter, Double-Blind Within Cohort, Dose-escalation Study to Evaluate the Safety and Tolerability of Multiple Doses of CAT-354 (Tralokinumab) in Japanese Patients With Idiopathic Pulmonary Fibrosis

The purpose of the study is to evaluate the safety and tolerability of multiple-doses of tralokinumab in Japanese patients with Idiopathic Pulmonary Fibrosis.

Read the detailed description

This is a phase II, multicenter, blinded within cohort, dose-escalation study to evaluate the safety and tolerability of two ascending doses of tralokinumab in Japanese patients aged ≥ 50 years with mild to moderate Idiopathic Pulmonary Fibrosis.

Conditions: Idiopathic Pulmonary Fibrosis
Being tested: tralokinumab cohort 1, tralokinumab cohort 2, Placebo
Keywords: Japan, Phase2, Safety, Tolerability, Idiopathic Pulmonary Fibrosis, IPF, CAT-354, Tralokinumab
Medical subject headings: Idiopathic Pulmonary Fibrosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

tralokinumab cohort 1Biological
Tralokinumab is a human recombinant monoclonal antibody (MAb) of the subclass that specifically binds human IL-13, blocking interactions with the IL-13 receptor
tralokinumab cohort 2Biological
Tralokinumab is a human recombinant monoclonal antibody (MAb) of the subclass that specifically binds human IL-13, blocking interactions with the IL-13 receptor
PlaceboOther

Study groups in NCT02036580
Study group	Role	What they receive
Low Dose	Experimental	Investigational product Tralokinumab Receives: Biological: tralokinumab cohort 1
High Dose	Experimental	Investigational product Tralokinumab Receives: Biological: tralokinumab cohort 2
Placebo	Placebo comparator	Placebo Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Safety and Tolerability Primarily Assessed by the Number of Patients With Adverse Events
Adverse events and serious adverse events using the Safety Population. Other variables used for the safety assessments include electrocardiogram, vital signs, and routine laboratory assessments. These variables as well as their changes from baseline will be summarized descriptively.
Measured: From baseline to Week 48 (treatment-emergent only)

Secondary outcomes (2)

Serum Tralokinumab Concentration Data
Serum tralokinumab concentration data will be summarized by treatment group.
Measured: From baseline to Week 48 (Week 0 [post-dose, within +5 minutes after end of infusion], Week 4 [pre-dose], Week 12 [pre-dose]. Week 28, Week 40, Week 48)
Immunogenecity
The incidence rate of positive serum antibodies to tralokinumab will be reported.
Measured: From baseline to Week 48

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2014Nov 2015

First posted15 Jan 2014 (estimated)
Study startJan 2014
Primary completionNov 2015
Study completionNov 2015

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.
Other trials for Idiopathic Pulmonary FibrosisStudies 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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 37 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02036580
Sponsor's protocol ID: D2212C00002
Status last verified: Jan 2017
First submitted: 13 Jan 2014
Last updated: 23 Feb 2017
Results posted: Yes, on ClinicalTrials.gov

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingPhase 2
A Study to Find Out Whether BI 765423 Has an Effect on Lung Function in People With Idiopathic Pulmonary Fibrosis (IPF) With or Without Standard Treatment
Idiopathic Pulmonary Fibrosis
RecruitingPhase 2
Study to Evaluate the Efficacy, Safety, and Tolerability of PIPE 791 in Subjects With Idiopathic Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
RecruitingObservational study
Natural History of Noncirrhotic Portal Hypertension
Cystic Fibrosis, Immunologic Deficiency Syndrome
RecruitingObservational study
Collection of Airway, Blood and/or Urine Specimens From Subjects for Research Studies
Chronic Obstructive Pulmonary Disease (COPD), Smoking
RecruitingPhase 3
Trial to Evaluate the Efficacy and Safety of LYT-100 (Deupirfenidone) Compared to Pirfenidone in Adults With Idiopathic Pulmonary Fibrosis (IPF)
Idiopathic Pulmonary Fibrosis (IPF)

All Idiopathic Pulmonary Fibrosis trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 2, Multicenter, Double-Blind Within Cohort, Dose-escalation Study to Evaluate the Safety and Tolerability of Multiple Doses of CAT-354 (Tralokinumab) in Japanese Patients With Idiopathic Pulmonary Fibrosis
ClinicalTrials.gov ID: NCT02036580
Acronym / sponsor ID: D2212C00002
Conditions: Idiopathic Pulmonary Fibrosis
Keywords: Japan, Phase2, Safety, Tolerability, Idiopathic Pulmonary Fibrosis, IPF, CAT-354, Tralokinumab
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 37 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Collaborators: MedImmune LLC
Study start: Jan 2014
Primary completion: Nov 2015 (actual)
Study completion: Nov 2015 (actual)
First posted: 15 Jan 2014 (estimated)
Results: Posted 23 Feb 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of the study is to evaluate the safety and tolerability of multiple-doses of tralokinumab in Japanese patients with Idiopathic Pulmonary Fibrosis.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Low Dose	Experimental	Biological: tralokinumab cohort 1Investigational product Tralokinumab
High Dose	Experimental	Biological: tralokinumab cohort 2Investigational product Tralokinumab
Placebo	Placebo comparator	Other: PlaceboPlacebo

Who may qualify

Ages: 50 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Provision of informed consent prior to any study specific procedures
Confirmed IPF diagnosis for ≤ 5 years prior to Visit 1 (screening). Confirmation of diagnosis of IPF
Mild to moderate IPF to include all of the following at Visit 1

Key exclusion criteria (6 listed)

History of clinically significant environmental exposure (eg, domestic and occupational) to a known cause of pulmonary fibrosis
Diagnosis of connective tissue disease or drug toxicity as the likely cause of the interstitial disease
A suspected IPF exacerbation not fully resolved and treatment completed ≤ 14 days prior to Visit 1
A suspected IPF exacerbation during the screening period
A FEV1/FVC ratio < 0.70 at the time of Visit 1 (postbronchodilator)

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 cohort 1Tralokinumab is a human recombinant monoclonal antibody (MAb) of the subclass that specifically binds human IL-13, blocking interactions with the IL-13 receptor	Biological	Low Dose
tralokinumab cohort 2Tralokinumab is a human recombinant monoclonal antibody (MAb) of the subclass that specifically binds human IL-13, blocking interactions with the IL-13 receptor	Biological	High Dose
Placebo	Other	Placebo

Primary outcome

Safety and Tolerability Primarily Assessed by the Number of Patients With Adverse Events
Time frame: From baseline to Week 48 (treatment-emergent only)
Adverse events and serious adverse events using the Safety Population. Other variables used for the safety assessments include electrocardiogram, vital signs, and routine laboratory assessments. These variables as well as their changes from baseline will be summarized descriptively.

2 secondary outcomes

Serum Tralokinumab Concentration Data
Time frame: From baseline to Week 48 (Week 0 [post-dose, within +5 minutes after end of infusion], Week 4 [pre-dose], Week 12 [pre-dose]. Week 28, Week 40, Week 48)
Immunogenecity
Time frame: From baseline to Week 48

Results and safety

Results posted to the registry on 23 Feb 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Low Dose	8	7
High Dose	8	7
Placebo	4	4

Primary outcome: Safety and Tolerability Primarily Assessed by the Number of Patients With Adverse Events

Time frame: From baseline to Week 48 (treatment-emergent only). Number. Unit: Patients

Measure	Low Dose n = 8	High Dose n = 8	Placebo n = 4
At lease one adverse events	8	7	2
At least one IP related adverse event	1	2	0
At least one adverse event of ≥ grade 3 severity	1	0	0
Death (grade 5 severity)	0	0	0
At least one serious adverse event	2	1	1
At least one serious and ≥ grade 3 severity event	0	0	0
At least one IP related serious adverse event	0	0	0
At least one event leading to IP discontinuation	2	0	0

Population analysed: Safety population

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: From baseline to Week 48 (treatment-emergent only). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Low Dose	2 of 8 (25%)	8 of 8 (100%)	Not reported
High Dose	1 of 8 (12.5%)	7 of 8 (87.5%)	Not reported
Placebo	1 of 4 (25%)	2 of 4 (50%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Idiopathic Pulmonary Fibrosis

Active, not recruitingPhase 2
A Study to Find Out Whether BI 765423 Has an Effect on Lung Function in People With Idiopathic Pulmonary Fibrosis (IPF) With or Without Standard Treatment
Idiopathic Pulmonary Fibrosis
RecruitingPhase 2
Study to Evaluate the Efficacy, Safety, and Tolerability of PIPE 791 in Subjects With Idiopathic Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
RecruitingObservational study
Natural History of Noncirrhotic Portal Hypertension
Cystic Fibrosis, Immunologic Deficiency Syndrome
RecruitingObservational study
Collection of Airway, Blood and/or Urine Specimens From Subjects for Research Studies
Chronic Obstructive Pulmonary Disease (COPD), Smoking
RecruitingPhase 3
Trial to Evaluate the Efficacy and Safety of LYT-100 (Deupirfenidone) Compared to Pirfenidone in Adults With Idiopathic Pulmonary Fibrosis (IPF)
Idiopathic Pulmonary Fibrosis (IPF)

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.

Joseph M Parker, MD study director

MedImmune LLC

5 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing tralokinumab cohort 1 and tralokinumab cohort 2 in people with Idiopathic Pulmonary Fibrosis, run by AstraZeneca at 5 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 6 inclusion and 6 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: finished, as of the sponsor's last update on 23 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 23 Feb 2017). 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?

Safety and Tolerability Primarily Assessed by the Number of Patients With Adverse Events (time frame: From baseline to Week 48 (treatment-emergent only)). 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 NCT02036580.

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 23 Feb 2017.