Trial Outcomes & Findings for D2212C00002 J-Phase II Study (NCT NCT02036580)
NCT ID: NCT02036580
Last Updated: 2017-02-23
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
37 participants
Primary outcome timeframe
From baseline to Week 48 (treatment-emergent only)
Results posted on
2017-02-23
Participant Flow
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.
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).
Participant milestones
| Measure |
Low Dose
Tralokinumab 400 mg Q4W intravenously dosed for 24 weeks
|
High Dose
Tralokinumab 800 mg Q4W intravenously dosed for 24 weeks
|
Placebo
Placebo Q4W intravenously dosed for 24 weeks
|
|---|---|---|---|
|
Overall Study
STARTED
|
8
|
8
|
4
|
|
Overall Study
COMPLETED
|
7
|
7
|
4
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
0
|
Reasons for withdrawal
| Measure |
Low Dose
Tralokinumab 400 mg Q4W intravenously dosed for 24 weeks
|
High Dose
Tralokinumab 800 mg Q4W intravenously dosed for 24 weeks
|
Placebo
Placebo Q4W intravenously dosed for 24 weeks
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
0
|
|
Overall Study
Adverse Event
|
1
|
0
|
0
|
Baseline Characteristics
D2212C00002 J-Phase II Study
Baseline characteristics by cohort
| Measure |
Low Dose
n=8 Participants
Tralokinumab 400 mg Q4W intravenously dosed for 24 weeks
|
High Dose
n=8 Participants
Tralokinumab 800 mg Q4W intravenously dosed for 24 weeks
|
Placebo
n=4 Participants
Placebo Q4W intravenously dosed for 24 weeks
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
67.0 Years
STANDARD_DEVIATION 7.1 • n=5 Participants
|
65.0 Years
STANDARD_DEVIATION 9.4 • n=7 Participants
|
68.3 Years
STANDARD_DEVIATION 8.5 • n=5 Participants
|
66.5 Years
STANDARD_DEVIATION 8.0 • n=4 Participants
|
|
Gender
Female
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Gender
Male
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: From baseline to Week 48 (treatment-emergent only)Population: Safety population
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.
Outcome measures
| Measure |
Low Dose
n=8 Participants
Tralokinumab 400 mg Q4W intravenously dosed for 24 weeks
|
High Dose
n=8 Participants
Tralokinumab 800 mg Q4W intravenously dosed for 24 weeks
|
Placebo
n=4 Participants
Placebo Q4W intravenously dosed for 24 weeks
|
|---|---|---|---|
|
Safety and Tolerability Primarily Assessed by the Number of Patients With Adverse Events
At lease one adverse events
|
8 Patients
|
7 Patients
|
2 Patients
|
|
Safety and Tolerability Primarily Assessed by the Number of Patients With Adverse Events
At least one IP related adverse event
|
1 Patients
|
2 Patients
|
0 Patients
|
|
Safety and Tolerability Primarily Assessed by the Number of Patients With Adverse Events
At least one adverse event of ≥ grade 3 severity
|
1 Patients
|
0 Patients
|
0 Patients
|
|
Safety and Tolerability Primarily Assessed by the Number of Patients With Adverse Events
Death (grade 5 severity)
|
0 Patients
|
0 Patients
|
0 Patients
|
|
Safety and Tolerability Primarily Assessed by the Number of Patients With Adverse Events
At least one serious adverse event
|
2 Patients
|
1 Patients
|
1 Patients
|
|
Safety and Tolerability Primarily Assessed by the Number of Patients With Adverse Events
At least one serious and ≥ grade 3 severity event
|
0 Patients
|
0 Patients
|
0 Patients
|
|
Safety and Tolerability Primarily Assessed by the Number of Patients With Adverse Events
At least one IP related serious adverse event
|
0 Patients
|
0 Patients
|
0 Patients
|
|
Safety and Tolerability Primarily Assessed by the Number of Patients With Adverse Events
At least one event leading to IP discontinuation
|
2 Patients
|
0 Patients
|
0 Patients
|
SECONDARY outcome
Timeframe: 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)Population: PK population
Serum tralokinumab concentration data will be summarized by treatment group.
Outcome measures
| Measure |
Low Dose
n=8 Participants
Tralokinumab 400 mg Q4W intravenously dosed for 24 weeks
|
High Dose
n=8 Participants
Tralokinumab 800 mg Q4W intravenously dosed for 24 weeks
|
Placebo
Placebo Q4W intravenously dosed for 24 weeks
|
|---|---|---|---|
|
Serum Tralokinumab Concentration Data
Week 12 (pre-dose)
|
55.1 Microgram per milliliter
Standard Deviation 16.1
|
75.7 Microgram per milliliter
Standard Deviation 41.8
|
—
|
|
Serum Tralokinumab Concentration Data
Week 0 (post-dose)
|
149 Microgram per milliliter
Standard Deviation 64.8
|
313 Microgram per milliliter
Standard Deviation 46.6
|
—
|
|
Serum Tralokinumab Concentration Data
Week 4 (pre-dose)
|
33.9 Microgram per milliliter
Standard Deviation 9.03
|
76.1 Microgram per milliliter
Standard Deviation 32.3
|
—
|
|
Serum Tralokinumab Concentration Data
Week 28
|
61.4 Microgram per milliliter
Standard Deviation 29.1
|
87.5 Microgram per milliliter
Standard Deviation 50.9
|
—
|
|
Serum Tralokinumab Concentration Data
Week 40
|
2.55 Microgram per milliliter
Standard Deviation 2.70
|
2.69 Microgram per milliliter
Standard Deviation 1.72
|
—
|
|
Serum Tralokinumab Concentration Data
Week 48
|
0.515 Microgram per milliliter
Standard Deviation 0.759
|
0.374 Microgram per milliliter
Standard Deviation 0.270
|
—
|
SECONDARY outcome
Timeframe: From baseline to Week 48Population: Safety population
The incidence rate of positive serum antibodies to tralokinumab will be reported.
Outcome measures
| Measure |
Low Dose
n=8 Participants
Tralokinumab 400 mg Q4W intravenously dosed for 24 weeks
|
High Dose
n=8 Participants
Tralokinumab 800 mg Q4W intravenously dosed for 24 weeks
|
Placebo
n=4 Participants
Placebo Q4W intravenously dosed for 24 weeks
|
|---|---|---|---|
|
Immunogenecity
Anti-drug antibody positive at baseline
|
1 Patients
|
0 Patients
|
0 Patients
|
|
Immunogenecity
Anti-drug antibody positive post-baseline
|
0 Patients
|
0 Patients
|
0 Patients
|
Adverse Events
Low Dose
Serious events: 2 serious events
Other events: 8 other events
Deaths: 0 deaths
High Dose
Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Low Dose
n=8 participants at risk
Tralokinumab 400 mg Q4W intravenously dosed for 24 weeks
|
High Dose
n=8 participants at risk
Tralokinumab 800 mg Q4W intravenously dosed for 24 weeks
|
Placebo
n=4 participants at risk
Placebo Q4W intravenously dosed for 24 weeks
|
|---|---|---|---|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/8 • From baseline to Week 48 (treatment-emergent only)
|
12.5%
1/8 • From baseline to Week 48 (treatment-emergent only)
|
0.00%
0/4 • From baseline to Week 48 (treatment-emergent only)
|
|
Hepatobiliary disorders
Bile duct stone
|
12.5%
1/8 • From baseline to Week 48 (treatment-emergent only)
|
0.00%
0/8 • From baseline to Week 48 (treatment-emergent only)
|
0.00%
0/4 • From baseline to Week 48 (treatment-emergent only)
|
|
Infections and infestations
Sinusitis
|
0.00%
0/8 • From baseline to Week 48 (treatment-emergent only)
|
0.00%
0/8 • From baseline to Week 48 (treatment-emergent only)
|
25.0%
1/4 • From baseline to Week 48 (treatment-emergent only)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
12.5%
1/8 • From baseline to Week 48 (treatment-emergent only)
|
0.00%
0/8 • From baseline to Week 48 (treatment-emergent only)
|
0.00%
0/4 • From baseline to Week 48 (treatment-emergent only)
|
Other adverse events
| Measure |
Low Dose
n=8 participants at risk
Tralokinumab 400 mg Q4W intravenously dosed for 24 weeks
|
High Dose
n=8 participants at risk
Tralokinumab 800 mg Q4W intravenously dosed for 24 weeks
|
Placebo
n=4 participants at risk
Placebo Q4W intravenously dosed for 24 weeks
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Eosinophilia
|
12.5%
1/8 • From baseline to Week 48 (treatment-emergent only)
|
0.00%
0/8 • From baseline to Week 48 (treatment-emergent only)
|
0.00%
0/4 • From baseline to Week 48 (treatment-emergent only)
|
|
Cardiac disorders
Angina pectoris
|
12.5%
1/8 • From baseline to Week 48 (treatment-emergent only)
|
0.00%
0/8 • From baseline to Week 48 (treatment-emergent only)
|
0.00%
0/4 • From baseline to Week 48 (treatment-emergent only)
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/8 • From baseline to Week 48 (treatment-emergent only)
|
0.00%
0/8 • From baseline to Week 48 (treatment-emergent only)
|
25.0%
1/4 • From baseline to Week 48 (treatment-emergent only)
|
|
Gastrointestinal disorders
Chronic gastritis
|
12.5%
1/8 • From baseline to Week 48 (treatment-emergent only)
|
0.00%
0/8 • From baseline to Week 48 (treatment-emergent only)
|
0.00%
0/4 • From baseline to Week 48 (treatment-emergent only)
|
|
Gastrointestinal disorders
Constipation
|
25.0%
2/8 • From baseline to Week 48 (treatment-emergent only)
|
0.00%
0/8 • From baseline to Week 48 (treatment-emergent only)
|
0.00%
0/4 • From baseline to Week 48 (treatment-emergent only)
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/8 • From baseline to Week 48 (treatment-emergent only)
|
12.5%
1/8 • From baseline to Week 48 (treatment-emergent only)
|
0.00%
0/4 • From baseline to Week 48 (treatment-emergent only)
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/8 • From baseline to Week 48 (treatment-emergent only)
|
0.00%
0/8 • From baseline to Week 48 (treatment-emergent only)
|
25.0%
1/4 • From baseline to Week 48 (treatment-emergent only)
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/8 • From baseline to Week 48 (treatment-emergent only)
|
12.5%
1/8 • From baseline to Week 48 (treatment-emergent only)
|
0.00%
0/4 • From baseline to Week 48 (treatment-emergent only)
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/8 • From baseline to Week 48 (treatment-emergent only)
|
0.00%
0/8 • From baseline to Week 48 (treatment-emergent only)
|
25.0%
1/4 • From baseline to Week 48 (treatment-emergent only)
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/8 • From baseline to Week 48 (treatment-emergent only)
|
12.5%
1/8 • From baseline to Week 48 (treatment-emergent only)
|
0.00%
0/4 • From baseline to Week 48 (treatment-emergent only)
|
|
Gastrointestinal disorders
Large intestine polyp
|
12.5%
1/8 • From baseline to Week 48 (treatment-emergent only)
|
0.00%
0/8 • From baseline to Week 48 (treatment-emergent only)
|
0.00%
0/4 • From baseline to Week 48 (treatment-emergent only)
|
|
Gastrointestinal disorders
Noninfective gingivitis
|
12.5%
1/8 • From baseline to Week 48 (treatment-emergent only)
|
0.00%
0/8 • From baseline to Week 48 (treatment-emergent only)
|
0.00%
0/4 • From baseline to Week 48 (treatment-emergent only)
|
|
General disorders
Influenza like illness
|
0.00%
0/8 • From baseline to Week 48 (treatment-emergent only)
|
12.5%
1/8 • From baseline to Week 48 (treatment-emergent only)
|
0.00%
0/4 • From baseline to Week 48 (treatment-emergent only)
|
|
General disorders
Malaise
|
0.00%
0/8 • From baseline to Week 48 (treatment-emergent only)
|
12.5%
1/8 • From baseline to Week 48 (treatment-emergent only)
|
0.00%
0/4 • From baseline to Week 48 (treatment-emergent only)
|
|
General disorders
Pyrexia
|
12.5%
1/8 • From baseline to Week 48 (treatment-emergent only)
|
0.00%
0/8 • From baseline to Week 48 (treatment-emergent only)
|
0.00%
0/4 • From baseline to Week 48 (treatment-emergent only)
|
|
Hepatobiliary disorders
Bile duct stone
|
12.5%
1/8 • From baseline to Week 48 (treatment-emergent only)
|
0.00%
0/8 • From baseline to Week 48 (treatment-emergent only)
|
0.00%
0/4 • From baseline to Week 48 (treatment-emergent only)
|
|
Hepatobiliary disorders
Cholelithiasis
|
12.5%
1/8 • From baseline to Week 48 (treatment-emergent only)
|
0.00%
0/8 • From baseline to Week 48 (treatment-emergent only)
|
0.00%
0/4 • From baseline to Week 48 (treatment-emergent only)
|
|
Infections and infestations
Bronchitis
|
0.00%
0/8 • From baseline to Week 48 (treatment-emergent only)
|
25.0%
2/8 • From baseline to Week 48 (treatment-emergent only)
|
0.00%
0/4 • From baseline to Week 48 (treatment-emergent only)
|
|
Infections and infestations
Cellulitis
|
0.00%
0/8 • From baseline to Week 48 (treatment-emergent only)
|
0.00%
0/8 • From baseline to Week 48 (treatment-emergent only)
|
25.0%
1/4 • From baseline to Week 48 (treatment-emergent only)
|
|
Infections and infestations
Gastroenteritis
|
12.5%
1/8 • From baseline to Week 48 (treatment-emergent only)
|
0.00%
0/8 • From baseline to Week 48 (treatment-emergent only)
|
0.00%
0/4 • From baseline to Week 48 (treatment-emergent only)
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/8 • From baseline to Week 48 (treatment-emergent only)
|
12.5%
1/8 • From baseline to Week 48 (treatment-emergent only)
|
0.00%
0/4 • From baseline to Week 48 (treatment-emergent only)
|
|
Infections and infestations
Influenza
|
0.00%
0/8 • From baseline to Week 48 (treatment-emergent only)
|
25.0%
2/8 • From baseline to Week 48 (treatment-emergent only)
|
0.00%
0/4 • From baseline to Week 48 (treatment-emergent only)
|
|
Infections and infestations
Nasopharyngitis
|
50.0%
4/8 • From baseline to Week 48 (treatment-emergent only)
|
12.5%
1/8 • From baseline to Week 48 (treatment-emergent only)
|
25.0%
1/4 • From baseline to Week 48 (treatment-emergent only)
|
|
Infections and infestations
Pharyngitis
|
12.5%
1/8 • From baseline to Week 48 (treatment-emergent only)
|
0.00%
0/8 • From baseline to Week 48 (treatment-emergent only)
|
0.00%
0/4 • From baseline to Week 48 (treatment-emergent only)
|
|
Infections and infestations
Sinusitis
|
12.5%
1/8 • From baseline to Week 48 (treatment-emergent only)
|
0.00%
0/8 • From baseline to Week 48 (treatment-emergent only)
|
25.0%
1/4 • From baseline to Week 48 (treatment-emergent only)
|
|
Investigations
Blood pressure increased
|
12.5%
1/8 • From baseline to Week 48 (treatment-emergent only)
|
0.00%
0/8 • From baseline to Week 48 (treatment-emergent only)
|
0.00%
0/4 • From baseline to Week 48 (treatment-emergent only)
|
|
Investigations
Weight decreased
|
0.00%
0/8 • From baseline to Week 48 (treatment-emergent only)
|
12.5%
1/8 • From baseline to Week 48 (treatment-emergent only)
|
0.00%
0/4 • From baseline to Week 48 (treatment-emergent only)
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/8 • From baseline to Week 48 (treatment-emergent only)
|
12.5%
1/8 • From baseline to Week 48 (treatment-emergent only)
|
0.00%
0/4 • From baseline to Week 48 (treatment-emergent only)
|
|
Metabolism and nutrition disorders
Decreased appetite
|
12.5%
1/8 • From baseline to Week 48 (treatment-emergent only)
|
37.5%
3/8 • From baseline to Week 48 (treatment-emergent only)
|
25.0%
1/4 • From baseline to Week 48 (treatment-emergent only)
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/8 • From baseline to Week 48 (treatment-emergent only)
|
12.5%
1/8 • From baseline to Week 48 (treatment-emergent only)
|
25.0%
1/4 • From baseline to Week 48 (treatment-emergent only)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
12.5%
1/8 • From baseline to Week 48 (treatment-emergent only)
|
12.5%
1/8 • From baseline to Week 48 (treatment-emergent only)
|
0.00%
0/4 • From baseline to Week 48 (treatment-emergent only)
|
|
Musculoskeletal and connective tissue disorders
Muscle fatigue
|
12.5%
1/8 • From baseline to Week 48 (treatment-emergent only)
|
0.00%
0/8 • From baseline to Week 48 (treatment-emergent only)
|
0.00%
0/4 • From baseline to Week 48 (treatment-emergent only)
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
12.5%
1/8 • From baseline to Week 48 (treatment-emergent only)
|
12.5%
1/8 • From baseline to Week 48 (treatment-emergent only)
|
0.00%
0/4 • From baseline to Week 48 (treatment-emergent only)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid adenoma
|
12.5%
1/8 • From baseline to Week 48 (treatment-emergent only)
|
0.00%
0/8 • From baseline to Week 48 (treatment-emergent only)
|
0.00%
0/4 • From baseline to Week 48 (treatment-emergent only)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
12.5%
1/8 • From baseline to Week 48 (treatment-emergent only)
|
0.00%
0/8 • From baseline to Week 48 (treatment-emergent only)
|
0.00%
0/4 • From baseline to Week 48 (treatment-emergent only)
|
|
Nervous system disorders
Formication
|
0.00%
0/8 • From baseline to Week 48 (treatment-emergent only)
|
12.5%
1/8 • From baseline to Week 48 (treatment-emergent only)
|
0.00%
0/4 • From baseline to Week 48 (treatment-emergent only)
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/8 • From baseline to Week 48 (treatment-emergent only)
|
25.0%
2/8 • From baseline to Week 48 (treatment-emergent only)
|
0.00%
0/4 • From baseline to Week 48 (treatment-emergent only)
|
|
Renal and urinary disorders
Calculus ureteric
|
12.5%
1/8 • From baseline to Week 48 (treatment-emergent only)
|
0.00%
0/8 • From baseline to Week 48 (treatment-emergent only)
|
0.00%
0/4 • From baseline to Week 48 (treatment-emergent only)
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
12.5%
1/8 • From baseline to Week 48 (treatment-emergent only)
|
0.00%
0/8 • From baseline to Week 48 (treatment-emergent only)
|
0.00%
0/4 • From baseline to Week 48 (treatment-emergent only)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/8 • From baseline to Week 48 (treatment-emergent only)
|
12.5%
1/8 • From baseline to Week 48 (treatment-emergent only)
|
25.0%
1/4 • From baseline to Week 48 (treatment-emergent only)
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/8 • From baseline to Week 48 (treatment-emergent only)
|
0.00%
0/8 • From baseline to Week 48 (treatment-emergent only)
|
25.0%
1/4 • From baseline to Week 48 (treatment-emergent only)
|
|
Respiratory, thoracic and mediastinal disorders
Idiopathic pulmonary fibrosis
|
25.0%
2/8 • From baseline to Week 48 (treatment-emergent only)
|
12.5%
1/8 • From baseline to Week 48 (treatment-emergent only)
|
25.0%
1/4 • From baseline to Week 48 (treatment-emergent only)
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/8 • From baseline to Week 48 (treatment-emergent only)
|
0.00%
0/8 • From baseline to Week 48 (treatment-emergent only)
|
25.0%
1/4 • From baseline to Week 48 (treatment-emergent only)
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/8 • From baseline to Week 48 (treatment-emergent only)
|
0.00%
0/8 • From baseline to Week 48 (treatment-emergent only)
|
25.0%
1/4 • From baseline to Week 48 (treatment-emergent only)
|
|
Respiratory, thoracic and mediastinal disorders
Pneumomediastinum
|
0.00%
0/8 • From baseline to Week 48 (treatment-emergent only)
|
12.5%
1/8 • From baseline to Week 48 (treatment-emergent only)
|
0.00%
0/4 • From baseline to Week 48 (treatment-emergent only)
|
|
Vascular disorders
Hypertension
|
12.5%
1/8 • From baseline to Week 48 (treatment-emergent only)
|
0.00%
0/8 • From baseline to Week 48 (treatment-emergent only)
|
0.00%
0/4 • From baseline to Week 48 (treatment-emergent only)
|
|
Vascular disorders
Intermittent claudication
|
0.00%
0/8 • From baseline to Week 48 (treatment-emergent only)
|
12.5%
1/8 • From baseline to Week 48 (treatment-emergent only)
|
0.00%
0/4 • From baseline to Week 48 (treatment-emergent only)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place