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Trial record 1 of 1 for:    D2212C00002 J-Phase II Study
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D2212C00002 J-Phase II Study

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ClinicalTrials.gov Identifier: NCT02036580
Recruitment Status : Completed
First Posted : January 15, 2014
Results First Posted : February 23, 2017
Last Update Posted : February 23, 2017
Sponsor:
Collaborator:
MedImmune LLC
Information provided by (Responsible Party):
AstraZeneca

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Idiopathic Pulmonary Fibrosis
Interventions Biological: tralokinumab cohort 1
Biological: tralokinumab cohort 2
Other: Placebo
Enrollment 37
Recruitment Details

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.

Pre-assignment Details 20 patients were randomized and received at least 1 dose of tralokinumab low dose, high dose, or placebo (tralokinumab low dose group: n=8, tralokinumab high dose group: n=8, placebo group: n=4).
Arm/Group Title Low Dose High Dose Placebo
Hide Arm/Group Description Tralokinumab 400 mg Q4W intravenously dosed for 24 weeks Tralokinumab 800 mg Q4W intravenously dosed for 24 weeks Placebo Q4W intravenously dosed for 24 weeks
Period Title: Overall Study
Started 8 8 4
Completed 7 7 4
Not Completed 1 1 0
Reason Not Completed
Withdrawal by Subject             0             1             0
Adverse Event             1             0             0
Arm/Group Title Low Dose High Dose Placebo Total
Hide Arm/Group Description Tralokinumab 400 mg Q4W intravenously dosed for 24 weeks Tralokinumab 800 mg Q4W intravenously dosed for 24 weeks Placebo Q4W intravenously dosed for 24 weeks Total of all reporting groups
Overall Number of Baseline Participants 8 8 4 20
Hide Baseline Analysis Population Description
Safety population
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 8 participants 8 participants 4 participants 20 participants
67.0  (7.1) 65.0  (9.4) 68.3  (8.5) 66.5  (8.0)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 8 participants 4 participants 20 participants
Female
2
  25.0%
2
  25.0%
0
   0.0%
4
  20.0%
Male
6
  75.0%
6
  75.0%
4
 100.0%
16
  80.0%
1.Primary Outcome
Title Safety and Tolerability Primarily Assessed by the Number of Patients With Adverse Events
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population
Arm/Group Title Low Dose High Dose Placebo
Hide Arm/Group Description:
Tralokinumab 400 mg Q4W intravenously dosed for 24 weeks
Tralokinumab 800 mg Q4W intravenously dosed for 24 weeks
Placebo Q4W intravenously dosed for 24 weeks
Overall Number of Participants Analyzed 8 8 4
Measure Type: Number
Unit of Measure: Patients
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
2.Secondary Outcome
Title Serum Tralokinumab Concentration Data
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
PK population
Arm/Group Title Low Dose High Dose
Hide Arm/Group Description:
Tralokinumab 400 mg Q4W intravenously dosed for 24 weeks
Tralokinumab 800 mg Q4W intravenously dosed for 24 weeks
Overall Number of Participants Analyzed 8 8
Mean (Standard Deviation)
Unit of Measure: Microgram per milliliter
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)
3.Secondary Outcome
Title Immunogenecity
Hide Description The incidence rate of positive serum antibodies to tralokinumab will be reported.
Time Frame From baseline to Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population
Arm/Group Title Low Dose High Dose Placebo
Hide Arm/Group Description:
Tralokinumab 400 mg Q4W intravenously dosed for 24 weeks
Tralokinumab 800 mg Q4W intravenously dosed for 24 weeks
Placebo Q4W intravenously dosed for 24 weeks
Overall Number of Participants Analyzed 8 8 4
Measure Type: Number
Unit of Measure: Patients
Anti-drug antibody positive at baseline 1 0 0
Anti-drug antibody positive post-baseline 0 0 0
Time Frame From baseline to Week 48 (treatment-emergent only)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Low Dose High Dose Placebo
Hide Arm/Group Description Tralokinumab 400 mg Q4W intravenously dosed for 24 weeks Tralokinumab 800 mg Q4W intravenously dosed for 24 weeks Placebo Q4W intravenously dosed for 24 weeks
All-Cause Mortality
Low Dose High Dose Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Low Dose High Dose Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   2/8 (25.00%)   1/8 (12.50%)   1/4 (25.00%) 
Gastrointestinal disorders       
Gastritis  1  0/8 (0.00%)  1/8 (12.50%)  0/4 (0.00%) 
Hepatobiliary disorders       
Bile duct stone  1  1/8 (12.50%)  0/8 (0.00%)  0/4 (0.00%) 
Infections and infestations       
Sinusitis  1  0/8 (0.00%)  0/8 (0.00%)  1/4 (25.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Lung neoplasm malignant  1  1/8 (12.50%)  0/8 (0.00%)  0/4 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA version 18.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Low Dose High Dose Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   8/8 (100.00%)   7/8 (87.50%)   2/4 (50.00%) 
Blood and lymphatic system disorders       
Eosinophilia  1  1/8 (12.50%)  0/8 (0.00%)  0/4 (0.00%) 
Cardiac disorders       
Angina pectoris  1  1/8 (12.50%)  0/8 (0.00%)  0/4 (0.00%) 
Atrial fibrillation  1  0/8 (0.00%)  0/8 (0.00%)  1/4 (25.00%) 
Gastrointestinal disorders       
Chronic gastritis  1  1/8 (12.50%)  0/8 (0.00%)  0/4 (0.00%) 
Constipation  1  2/8 (25.00%)  0/8 (0.00%)  0/4 (0.00%) 
Dental caries  1  0/8 (0.00%)  1/8 (12.50%)  0/4 (0.00%) 
Diarrhoea  1  0/8 (0.00%)  0/8 (0.00%)  1/4 (25.00%) 
Gastritis  1  0/8 (0.00%)  1/8 (12.50%)  0/4 (0.00%) 
Nausea  1  0/8 (0.00%)  0/8 (0.00%)  1/4 (25.00%) 
Toothache  1  0/8 (0.00%)  1/8 (12.50%)  0/4 (0.00%) 
Large intestine polyp  1  1/8 (12.50%)  0/8 (0.00%)  0/4 (0.00%) 
Noninfective gingivitis  1  1/8 (12.50%)  0/8 (0.00%)  0/4 (0.00%) 
General disorders       
Influenza like illness  1  0/8 (0.00%)  1/8 (12.50%)  0/4 (0.00%) 
Malaise  1  0/8 (0.00%)  1/8 (12.50%)  0/4 (0.00%) 
Pyrexia  1  1/8 (12.50%)  0/8 (0.00%)  0/4 (0.00%) 
Hepatobiliary disorders       
Bile duct stone  1  1/8 (12.50%)  0/8 (0.00%)  0/4 (0.00%) 
Cholelithiasis  1  1/8 (12.50%)  0/8 (0.00%)  0/4 (0.00%) 
Infections and infestations       
Bronchitis  1  0/8 (0.00%)  2/8 (25.00%)  0/4 (0.00%) 
Cellulitis  1  0/8 (0.00%)  0/8 (0.00%)  1/4 (25.00%) 
Gastroenteritis  1  1/8 (12.50%)  0/8 (0.00%)  0/4 (0.00%) 
Herpes zoster  1  0/8 (0.00%)  1/8 (12.50%)  0/4 (0.00%) 
Influenza  1  0/8 (0.00%)  2/8 (25.00%)  0/4 (0.00%) 
Nasopharyngitis  1  4/8 (50.00%)  1/8 (12.50%)  1/4 (25.00%) 
Pharyngitis  1  1/8 (12.50%)  0/8 (0.00%)  0/4 (0.00%) 
Sinusitis  1  1/8 (12.50%)  0/8 (0.00%)  1/4 (25.00%) 
Investigations       
Blood pressure increased  1  1/8 (12.50%)  0/8 (0.00%)  0/4 (0.00%) 
Weight decreased  1  0/8 (0.00%)  1/8 (12.50%)  0/4 (0.00%) 
Metabolism and nutrition disorders       
Hypercholesterolaemia  1  0/8 (0.00%)  1/8 (12.50%)  0/4 (0.00%) 
Decreased appetite  1  1/8 (12.50%)  3/8 (37.50%)  1/4 (25.00%) 
Musculoskeletal and connective tissue disorders       
Arthralgia  1  0/8 (0.00%)  1/8 (12.50%)  1/4 (25.00%) 
Back pain  1  1/8 (12.50%)  1/8 (12.50%)  0/4 (0.00%) 
Muscle fatigue  1  1/8 (12.50%)  0/8 (0.00%)  0/4 (0.00%) 
Musculoskeletal chest pain  1  1/8 (12.50%)  1/8 (12.50%)  0/4 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Thyroid adenoma  1  1/8 (12.50%)  0/8 (0.00%)  0/4 (0.00%) 
Lung neoplasm malignant  1  1/8 (12.50%)  0/8 (0.00%)  0/4 (0.00%) 
Nervous system disorders       
Formication  1  0/8 (0.00%)  1/8 (12.50%)  0/4 (0.00%) 
Psychiatric disorders       
Insomnia  1  0/8 (0.00%)  2/8 (25.00%)  0/4 (0.00%) 
Renal and urinary disorders       
Calculus ureteric  1  1/8 (12.50%)  0/8 (0.00%)  0/4 (0.00%) 
Reproductive system and breast disorders       
Benign prostatic hyperplasia  1  1/8 (12.50%)  0/8 (0.00%)  0/4 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Cough  1  0/8 (0.00%)  1/8 (12.50%)  1/4 (25.00%) 
Epistaxis  1  0/8 (0.00%)  0/8 (0.00%)  1/4 (25.00%) 
Idiopathic pulmonary fibrosis  1  2/8 (25.00%)  1/8 (12.50%)  1/4 (25.00%) 
Productive cough  1  0/8 (0.00%)  0/8 (0.00%)  1/4 (25.00%) 
Rhinorrhoea  1  0/8 (0.00%)  0/8 (0.00%)  1/4 (25.00%) 
Pneumomediastinum  1  0/8 (0.00%)  1/8 (12.50%)  0/4 (0.00%) 
Vascular disorders       
Hypertension  1  1/8 (12.50%)  0/8 (0.00%)  0/4 (0.00%) 
Intermittent claudication  1  0/8 (0.00%)  1/8 (12.50%)  0/4 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA version 18.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Clinical Study Information Center
Organization: AstraZeneca
Phone: 1-877-240-9479
EMail: information.center@astrazeneca.com
Layout table for additonal information
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT02036580     History of Changes
Other Study ID Numbers: D2212C00002
First Submitted: January 13, 2014
First Posted: January 15, 2014
Results First Submitted: October 21, 2016
Results First Posted: February 23, 2017
Last Update Posted: February 23, 2017