A Phase 2 interventional study of tralokinumab cohort 1 and tralokinumab cohort 2 in Idiopathic Pulmonary Fibrosis, sponsored by AstraZeneca. Completed at 5 sites in Japan. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2017-02-23.
Sponsored by AstraZeneca · Phase 2, Interventional, and Treatment
The purpose of the study is to evaluate the safety and tolerability of multiple-doses of tralokinumab in Japanese patients with Idiopathic Pulmonary Fibrosis.
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.
680 studies on the registry are indexed under Pulmonary Fibrosis; 119 are open to participants now.
This study's enrollment of 37 is below the median of 50 across 419 interventional studies indexed under Pulmonary Fibrosis.
Browse Pulmonary Fibrosis studies →AstraZeneca is the lead sponsor of 3,429 studies on the registry; 270 are open to participants now.
Of its 357 completed or terminated interventional studies of FDA-regulated products, 173 (48%) have results posted.
Counted across the registry records on this site, refreshed daily.
Mild to moderate IPF to include all of the following at Visit 1
Exclusion Criteria:
Investigational product Tralokinumab
Biological: tralokinumab cohort 1
Investigational product Tralokinumab
Biological: tralokinumab cohort 2
Placebo
Other: Placebo
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 is a human recombinant monoclonal antibody (MAb) of the subclass that specifically binds human IL-13, blocking interactions with the IL-13 receptor
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.
Time frame: From baseline to Week 48 (treatment-emergent only)
Serum Tralokinumab Concentration Data
Serum tralokinumab concentration data will be summarized by treatment group.
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
The incidence rate of positive serum antibodies to tralokinumab will be reported.
Time frame: From baseline to Week 48
A total of 37 patients were screened at 5 centres in Japan, and 20 patients were randomized and received at least 1 dose of tralokinumab low dose, high dose, or placebo. The first patient entered the study on 24 January 2014 and the last patient last visit was on 19 November 2015.
| Milestone | Low Dose | High Dose | Placebo |
|---|---|---|---|
| Started | 8 | 8 | 4 |
| Completed | 7 | 7 | 4 |
| Not completed | 1 | 1 | 0 |
| Withdrew: Withdrawal by subject | 0 | 1 | 0 |
| Withdrew: Adverse event | 1 | 0 | 0 |
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.
| Patients | Low Dose | High Dose | Placebo |
|---|---|---|---|
| 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 |
Serum tralokinumab concentration data will be summarized by treatment group.
| Microgram per milliliter | Low Dose | High Dose |
|---|---|---|
| Week 0 (post-dose) | 149 ± 64.8 | 313 ± 46.6 |
| Week 4 (pre-dose) | 33.9 ± 9.03 | 76.1 ± 32.3 |
| Week 12 (pre-dose) | 55.1 ± 16.1 | 75.7 ± 41.8 |
| Week 28 | 61.4 ± 29.1 | 87.5 ± 50.9 |
| Week 40 | 2.55 ± 2.70 | 2.69 ± 1.72 |
| Week 48 | 0.515 ± 0.759 | 0.374 ± 0.270 |
The incidence rate of positive serum antibodies to tralokinumab will be reported.
| Patients | Low Dose | High Dose | Placebo |
|---|---|---|---|
| Anti-drug antibody positive at baseline | 1 | 0 | 0 |
| Anti-drug antibody positive post-baseline | 0 | 0 | 0 |
Collected over From baseline to Week 48 (treatment-emergent only). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Low Dose | — | 2/8 (25%) | 8/8 (100%) |
| High Dose | — | 1/8 (12.5%) | 7/8 (87.5%) |
| Placebo | — | 1/4 (25%) | 2/4 (50%) |
| Event | Low Dose | High Dose | Placebo |
|---|---|---|---|
| SinusitisInfections and infestations | 0/8 | 0/8 | 1/4 |
| GastritisGastrointestinal disorders | 0/8 | 1/8 | 0/4 |
| Bile duct stoneHepatobiliary disorders | 1/8 | 0/8 | 0/4 |
| Lung neoplasm malignantNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/8 | 0/8 | 0/4 |
| Event | Low Dose | High Dose | Placebo |
|---|---|---|---|
| NasopharyngitisInfections and infestations | 4/8 | 1/8 | 1/4 |
| Decreased appetiteMetabolism and nutrition disorders | 1/8 | 3/8 | 1/4 |
| Atrial fibrillationCardiac disorders | 0/8 | 0/8 | 1/4 |
| ConstipationGastrointestinal disorders | 2/8 | 0/8 | 0/4 |
| DiarrhoeaGastrointestinal disorders | 0/8 | 0/8 | 1/4 |
| NauseaGastrointestinal disorders | 0/8 | 0/8 | 1/4 |
| BronchitisInfections and infestations | 0/8 | 2/8 | 0/4 |
| CellulitisInfections and infestations | 0/8 | 0/8 | 1/4 |
| InfluenzaInfections and infestations | 0/8 | 2/8 | 0/4 |
| SinusitisInfections and infestations | 1/8 | 0/8 | 1/4 |
Safety population
| Age, Continuous(Years) | Low Dose | High Dose | Placebo | Total |
|---|---|---|---|---|
| Mean | 67.0 ± 7.1 | 65.0 ± 9.4 | 68.3 ± 8.5 | 66.5 ± 8.0 |
| Gender(Participants) | Low Dose | High Dose | Placebo | Total |
|---|---|---|---|---|
| Female | 2 | 2 | 0 | 4 |
| Male | 6 | 6 | 4 | 16 |
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