AsthmaPhase 1NCT01592396

A Phase 1, Open-label Study to Investigate the Pharmacokinetics of Tralokinumab (CAT-354) in Adolescents With Asthma

A Phase 1 study testing Tralokinumab 300 mg in people with Asthma, run by MedImmune LLC at 3 sites in Poland.

Completed

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

Trial summary

The pharmacokinetic (PK) profile of tralokinumab (CAT-354) will be studied in adolescent subjects with asthma. Read more about this study

Who is it for?: Ages 12 to 17 years
Conditions the study is for: Asthma
What is being tested?: Tralokinumab 300 mg
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 30 participants
Where: 3 sitesPoland
Study dates: Jun 2012to Jan 2013
Phase: Phase 1
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 17 years
All sexes
No healthy volunteers
Child

Who may be able to join

Age 12-17 years (inclusive)
Weight greater than (>) 30 kilogram (kg)
Asthma for a minimum of 6 months prior to Screening
Effective birth control for both male and female participants in line with protocol details.

Who cannot join

Previously taken tralokinumab (the study drug)
Employee of the clinical study site or any other individuals directly involved with the conduct of the study, or immediate family members of such individuals
Pregnant or breastfeeding women
Current smoker or cessation less than (<) 3 months prior to screening
Known immune deficiency excluding asymptomatic selective immunoglobulin A
History of cancer - Hepatitis B, C or human immunodeficiency virus (HIV) positive
Any disease which may cause complications whilst taking the study drug.

Trial locations and contacts

3 sites in 1 country.

Poland3 sites

Research Site
Gliwice
Research Site
Karpacz
Research Site
Lodz

Other trials in Poland

About this study

Official title: A Phase 1, Open-label Study to Evaluate the Pharmacokinetics of Tralokinumab in Adolescents With Asthma

The pharmacokinetic (PK) profile of tralokinumab (CAT-354) will be studied in adolescent subjects with asthma.

Read the detailed description

Interleukin-13 (IL-13) is a pleiotropic cytokine that promotes inflammation, airways hyper-responsiveness (directly and through recruitment and activation of inflammatory cells), mucus hypersecretion, airway remodeling via fibrosis, increased immunoglobulin E (IgE) synthesis and mast cell activation.Tralokinumab (CAT-354) is a human immunoglobulin G4 (IgG4) anti-IL-13 monoclonal antibody that has been shown to potently and specifically neutralize IL-13 in preclinical models.This study will evaluate the PK profile of a single dose of tralokinumab administered subcutaneously at a dose of 300 mg in adolescent subjects with asthma to be compared with the PK data from completed studies in adults.

Conditions: Asthma
Being tested: Tralokinumab 300 mg
Keywords: Tralokinumab, CAT-354, Asthma
Medical subject headings: Asthma

What participants receive

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

Tralokinumab 300 mgBiological
Also called CAT-354
Participants aged 12 to 14 years and 15 to 17 years will receive a single dose of tralokinumab (CAT-354) 300 mg, subcutaneously on Day 1.

Study groups in NCT01592396
Study group	Role	What they receive
Tralokinumab 300 mg	Experimental	Participants aged 12 to 14 years and 15 to 17 years will receive a single dose of tralokinumab (CAT-354) 300 milligram (mg), subcutaneously on Day 1. Receives: Biological: Tralokinumab 300 mg

What is being measured

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

Time to Reach Maximum Observed Serum Concentration (Tmax)
Measured: 0 (predose), 3, 8 and 24 hours postdose on Day 1; Day 4, 6, 8, 10, 15, 22, 36 and 57
Maximum Observed Serum Concentration (Cmax)
Measured: 0 (predose), 3, 8 and 24 hours postdose on Day 1; Day 4, 6, 8, 10, 15, 22, 36 and 57
Area Under the Concentration-time Curve From Zero to Infinity (AUC [0-infinity])
AUC (0 - infinity) = Area under the serum concentration versus time curve (AUC) from time zero (predose) to extrapolated infinite time (0 - infinity). It is obtained from AUC (0 - t) plus AUC (t - infinity).
Measured: 0 (predose), 3, 8 and 24 hours postdose on Day 1; Day 4, 6, 8, 10, 15, 22, 36 and 57
Area Under the Concentration-Time Curve From Zero to Last Measurable Concentration (AUC [0-t])
Measured: 0 (predose), 3, 8 and 24 hours postdose on Day 1; Day 4, 6, 8, 10, 15, 22, 36 and 57
Terminal Phase Elimination Half Life (t1/2)
Terminal phase elimination half-life is the time measured for the serum concentration to decrease by one half.
Measured: 0 (predose), 3, 8 and 24 hours postdose on Day 1; Day 4, 6, 8, 10, 15, 22, 36 and 57

Secondary outcomes (2)

Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between administration of study drug and up to Day 57 that were absent before treatment or that worsened relative to pre-treatment state. Adverse events were summarized together for all participants.
Measured: Day 1 to Day 57
Number of Participants Exhibiting Anti-Drug Antibodies for Tralokinumab at Any Visit
Immunogenicity assessment included determination of anti-drug antibodies to tralokinumab (CAT-354) antibodies in serum samples. Immunogenicity results were summarized together for all participants.
Measured: Day 1 and Day 57

Timeline

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

Jun 2012Jan 2013

First posted7 May 2012 (estimated)
Study startJun 2012
Primary completionJan 2013
Study completionJan 2013

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 AsthmaStudies of the same condition, open and under way.
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 1
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01592396
Sponsor's protocol ID: CD-RI-CAT-354-1054
Other IDs: 2011-005503-33
Status last verified: Jan 2017
First submitted: 25 Apr 2012
Last updated: 6 Mar 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Baverel PG, Jain M, Stelmach I, She D, Agoram B, Sandbach S, Piper E, Kuna P. Pharmacokinetics of tralokinumab in adolescents with asthma: implications for future dosing. Br J Clin Pharmacol. 2015 Dec;80(6):1337-49. doi: 10.1111/bcp.12725. Epub 2015 Oct 1.
PubMed 26182954

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

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All Asthma trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1, Open-label Study to Evaluate the Pharmacokinetics of Tralokinumab in Adolescents With Asthma
ClinicalTrials.gov ID: NCT01592396
Acronym / sponsor ID: CD-RI-CAT-354-1054
Conditions: Asthma
Keywords: Tralokinumab, CAT-354, Asthma
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: MedImmune LLCIndustry (pharma, biotech, devices)
Study start: Jun 2012
Primary completion: Jan 2013 (actual)
Study completion: Jan 2013 (actual)
First posted: 7 May 2012 (estimated)
Results: Posted 20 Jan 2017

Clinical summary

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

The pharmacokinetic (PK) profile of tralokinumab (CAT-354) will be studied in adolescent subjects with asthma.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Tralokinumab 300 mg	Experimental	Biological: Tralokinumab 300 mgParticipants aged 12 to 14 years and 15 to 17 years will receive a single dose of tralokinumab (CAT-354) 300 milligram (mg), subcutaneously on Day 1.

Who may qualify

Ages: 12 to 17 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (4 listed)

Age 12-17 years (inclusive)
Weight greater than (>) 30 kilogram (kg)
Asthma for a minimum of 6 months prior to Screening
Effective birth control for both male and female participants in line with protocol details.

Key exclusion criteria (7 listed)

Previously taken tralokinumab (the study drug)
Employee of the clinical study site or any other individuals directly involved with the conduct of the study, or immediate family members of such individuals
Pregnant or breastfeeding women
Current smoker or cessation less than (<) 3 months prior to screening
Known immune deficiency excluding asymptomatic selective immunoglobulin A

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 300 mgAlso: CAT-354Participants aged 12 to 14 years and 15 to 17 years will receive a single dose of tralokinumab (CAT-354) 300 mg, subcutaneously on Day 1.	Biological	Tralokinumab 300 mg

Primary outcome

Time to Reach Maximum Observed Serum Concentration (Tmax)
Time frame: 0 (predose), 3, 8 and 24 hours postdose on Day 1; Day 4, 6, 8, 10, 15, 22, 36 and 57
Maximum Observed Serum Concentration (Cmax)
Time frame: 0 (predose), 3, 8 and 24 hours postdose on Day 1; Day 4, 6, 8, 10, 15, 22, 36 and 57
Area Under the Concentration-time Curve From Zero to Infinity (AUC [0-infinity])
Time frame: 0 (predose), 3, 8 and 24 hours postdose on Day 1; Day 4, 6, 8, 10, 15, 22, 36 and 57
AUC (0 - infinity) = Area under the serum concentration versus time curve (AUC) from time zero (predose) to extrapolated infinite time (0 - infinity). It is obtained from AUC (0 - t) plus AUC (t - infinity).
Area Under the Concentration-Time Curve From Zero to Last Measurable Concentration (AUC [0-t])
Time frame: 0 (predose), 3, 8 and 24 hours postdose on Day 1; Day 4, 6, 8, 10, 15, 22, 36 and 57
Terminal Phase Elimination Half Life (t1/2)
Time frame: 0 (predose), 3, 8 and 24 hours postdose on Day 1; Day 4, 6, 8, 10, 15, 22, 36 and 57
Terminal phase elimination half-life is the time measured for the serum concentration to decrease by one half.

2 secondary outcomes

Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
Time frame: Day 1 to Day 57
Number of Participants Exhibiting Anti-Drug Antibodies for Tralokinumab at Any Visit
Time frame: Day 1 and Day 57

Results and safety

Results posted to the registry on 20 Jan 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
Tralokinumab 300 mg (Participants Aged 12-14 Years) - Cohort 1	10	10
Tralokinumab 300 mg (Participants Aged 15-17 Years) - Cohort 2	10	10

Primary outcome: Time to Reach Maximum Observed Serum Concentration (Tmax)

Time frame: 0 (predose), 3, 8 and 24 hours postdose on Day 1; Day 4, 6, 8, 10, 15, 22, 36 and 57. Median (Full Range). Unit: days

Measure	Tralokinumab 300 mg (Participants Aged 12-14 Years) - Cohort 1 n = 10	Tralokinumab 300mg (Participants Aged 15-17 Years) - Cohort 2 n = 10
Value	5.2 ((3.0-9.1))	6.1 (2.9-9.0)

Population analysed: Pharmacokinetic (PK) population included all participants who received the investigational product and had at least 1 detectable post dosing tralokinumab (CAT-354) serum concentration.

Primary outcome: Maximum Observed Serum Concentration (Cmax)

Time frame: 0 (predose), 3, 8 and 24 hours postdose on Day 1; Day 4, 6, 8, 10, 15, 22, 36 and 57. Mean (Standard Deviation). Unit: microgram per milliliter (mcg/mL)

Measure	Tralokinumab 300 mg (Participants Aged 12-14 Years) - Cohort 1 n = 10	Tralokinumab 300mg (Participants Aged 15-17 Years) - Cohort 2 n = 10
Value	57.0 (21.7)	50.6 (16.2)

Population analysed: PK population included all participants who received the investigational product and had at least 1 detectable post dosing tralokinumab (CAT-354) serum concentration.

Primary outcome: Area Under the Concentration-time Curve From Zero to Infinity (AUC [0-infinity])

Time frame: 0 (predose), 3, 8 and 24 hours postdose on Day 1; Day 4, 6, 8, 10, 15, 22, 36 and 57. Mean (Standard Deviation). Unit: (microgram*day)/milliliter (mcg*day/mL)

Measure	Tralokinumab 300 mg (Participants Aged 12-14 Years) - Cohort 1 n = 10	Tralokinumab 300mg (Participants Aged 15-17 Years) - Cohort 2 n = 10
Value	1916.0 (806.3)	1721.1 (568.5)

Population analysed: PK population included all participants who received the investigational product and had at least 1 detectable post dosing tralokinumab (CAT-354) serum concentration.

Primary outcome: Area Under the Concentration-Time Curve From Zero to Last Measurable Concentration (AUC [0-t])

Time frame: 0 (predose), 3, 8 and 24 hours postdose on Day 1; Day 4, 6, 8, 10, 15, 22, 36 and 57. Mean (Standard Deviation). Unit: mcg*day/mL

Measure	Tralokinumab 300 mg (Participants Aged 12-14 Years) - Cohort 1 n = 10	Tralokinumab 300mg (Participants Aged 15-17 Years) - Cohort 2 n = 10
Value	1561.4 (614.9)	1384.6 (421.6)

Population analysed: PK population included all participants who received the investigational product and had at least 1 detectable post dosing tralokinumab (CAT-354) serum concentration.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Day 1 to Day 57. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Tralokinumab 300 mg	0 of 20 (0%)	6 of 20 (30%)	Not reported

Limitations and caveats (from the sponsor): Dose-normalized AUC(0-infinity) and dose-normalized Cmax were not evaluated as they were not relevant for single-dose study.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 26182954Baverel PG, Jain M, Stelmach I, She D, Agoram B, Sandbach S, Piper E, Kuna P. Pharmacokinetics of tralokinumab in adolescents with asthma: implications for future dosing. Br J Clin Pharmacol. 2015 Dec;80(6):1337-49. doi: 10.1111/bcp.12725. Epub 2015 Oct 1.
CD-RI-CAT-354-1054 Statistical Analysis PlanLink provided by the sponsor.
CD-RI-CAT-354-1054 Redacted 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.

Edward Piper, MBBS study director

MedImmune Ltd

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

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Tralokinumab 300 mg in people with Asthma, run by MedImmune LLC at 3 sites in Poland.

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 4 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: finished, as of the sponsor's last update on 6 Mar 2017. 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 Poland. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 20 Jan 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?

Time to Reach Maximum Observed Serum Concentration (Tmax) (time frame: 0 (predose), 3, 8 and 24 hours postdose on Day 1; Day 4, 6, 8, 10, 15, 22, 36 and 57). 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 NCT01592396, 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 Mar 2017.