Trial Outcomes & Findings for Phase 2 Study to Evaluate the Efficacy and Safety of Tralokinumab in Adults With Atopic Dermatitis (NCT NCT02347176)
NCT ID: NCT02347176
Last Updated: 2018-05-23
Results Overview
EASI evaluates 4 natural anatomical regions for severity and extent of key disease signs and focuses on the key acute and chronic signs of inflammation (erythema, induration/papulation, excoriation, and lichenification). The maximum total score is 72, with higher values indicating more severe disease. The data presented here is Adjusted mean change after excluding the data from participants who took prohibited medications.
COMPLETED
PHASE2
204 participants
Baseline (Day 1) and Week 12
2018-05-23
Participant Flow
A total of 299 participants participated in the study at 55 sites worldwide, including 24 sites in the United States of America, 8 sites in Germany, 6 sites each in Japan, Poland, and Canada, and 5 sites in Australia.
95 participants were considered screen failures and 204 participants were randomized and treated in the study.
Participant milestones
| Measure |
Placebo
Placebo matched to Tralokinumab was administered subcutaneously to participants once every 2 Weeks (Q2W) for 12 weeks.
|
Tralokinumab Dose 1
Tralokinumab Dose 1 was administered subcutaneously to participants once every 2 Weeks (Q2W) for 12 weeks.
|
Tralokinumab Dose 2
Tralokinumab Dose 2 was administered subcutaneously to participants once every 2 Weeks (Q2W) for 12 weeks.
|
Tralokinumab Dose 3
Tralokinumab Dose 3 was administered subcutaneously to participants once every 2 Weeks (Q2W) for 12 weeks.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
51
|
50
|
51
|
52
|
|
Overall Study
COMPLETED
|
39
|
40
|
43
|
48
|
|
Overall Study
NOT COMPLETED
|
12
|
10
|
8
|
4
|
Reasons for withdrawal
| Measure |
Placebo
Placebo matched to Tralokinumab was administered subcutaneously to participants once every 2 Weeks (Q2W) for 12 weeks.
|
Tralokinumab Dose 1
Tralokinumab Dose 1 was administered subcutaneously to participants once every 2 Weeks (Q2W) for 12 weeks.
|
Tralokinumab Dose 2
Tralokinumab Dose 2 was administered subcutaneously to participants once every 2 Weeks (Q2W) for 12 weeks.
|
Tralokinumab Dose 3
Tralokinumab Dose 3 was administered subcutaneously to participants once every 2 Weeks (Q2W) for 12 weeks.
|
|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
3
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
9
|
5
|
5
|
3
|
|
Overall Study
Other
|
1
|
2
|
2
|
0
|
Baseline Characteristics
Phase 2 Study to Evaluate the Efficacy and Safety of Tralokinumab in Adults With Atopic Dermatitis
Baseline characteristics by cohort
| Measure |
Placebo
n=51 Participants
Placebo matched to Tralokinumab was administered subcutaneously to participants once every 2 Weeks (Q2W) for 12 weeks.
|
Tralokinumab Dose 1
n=50 Participants
Tralokinumab Dose 1 was administered subcutaneously to participants once every 2 Weeks (Q2W) for 12 weeks.
|
Tralokinumab Dose 2
n=51 Participants
Tralokinumab Dose 2 was administered subcutaneously to participants once every 2 Weeks (Q2W) for 12 weeks.
|
Tralokinumab Dose 3
n=52 Participants
Tralokinumab Dose 3 was administered subcutaneously to participants once every 2 Weeks (Q2W) for 12 weeks.
|
Total
n=204 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
39.4 Years
STANDARD_DEVIATION 14.5 • n=93 Participants
|
39.1 Years
STANDARD_DEVIATION 15.1 • n=4 Participants
|
37.1 Years
STANDARD_DEVIATION 14.0 • n=27 Participants
|
35.7 Years
STANDARD_DEVIATION 14.6 • n=483 Participants
|
37.8 Years
STANDARD_DEVIATION 14.5 • n=36 Participants
|
|
Sex: Female, Male
Female
|
29 Participants
n=93 Participants
|
21 Participants
n=4 Participants
|
25 Participants
n=27 Participants
|
19 Participants
n=483 Participants
|
94 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=93 Participants
|
29 Participants
n=4 Participants
|
26 Participants
n=27 Participants
|
33 Participants
n=483 Participants
|
110 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
4 Participants
n=483 Participants
|
11 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
49 Participants
n=93 Participants
|
48 Participants
n=4 Participants
|
48 Participants
n=27 Participants
|
48 Participants
n=483 Participants
|
193 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
1 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Asian
|
10 Participants
n=93 Participants
|
11 Participants
n=4 Participants
|
8 Participants
n=27 Participants
|
16 Participants
n=483 Participants
|
45 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
1 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Black or African American
|
8 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
10 Participants
n=27 Participants
|
7 Participants
n=483 Participants
|
29 Participants
n=36 Participants
|
|
Race (NIH/OMB)
White
|
31 Participants
n=93 Participants
|
33 Participants
n=4 Participants
|
33 Participants
n=27 Participants
|
28 Participants
n=483 Participants
|
125 Participants
n=36 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
3 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
PRIMARY outcome
Timeframe: Baseline (Day 1) and Week 12Population: The intent-to-treat (ITT) population included all randomized and treated participants, grouped according to assigned treatment. Here, the category "Number Analyzed" is number of participants analyzed for this outcome measure.
EASI evaluates 4 natural anatomical regions for severity and extent of key disease signs and focuses on the key acute and chronic signs of inflammation (erythema, induration/papulation, excoriation, and lichenification). The maximum total score is 72, with higher values indicating more severe disease. The data presented here is Adjusted mean change after excluding the data from participants who took prohibited medications.
Outcome measures
| Measure |
Tralokinumab Dose 3
n=52 Participants
Tralokinumab Dose 3 was administered subcutaneously to participants once every 2 Weeks (Q2W) for 12 weeks.
|
Placebo
n=51 Participants
Placebo matched to Tralokinumab was administered subcutaneously to participants once every 2 Weeks (Q2W) for 12 weeks.
|
Tralokinumab Dose 1
n=50 Participants
Tralokinumab Dose 1 was administered subcutaneously to participants once every 2 Weeks (Q2W) for 12 weeks.
|
Tralokinumab Dose 2
n=51 Participants
Tralokinumab Dose 2 was administered subcutaneously to participants once every 2 Weeks (Q2W) for 12 weeks.
|
|---|---|---|---|---|
|
Absolute Change From Baseline in Eczema Area and Severity Index (EASI) Total Score at Week 12
|
-15.72 units on a scale
Standard Error 1.334
|
-10.78 units on a scale
Standard Error 1.398
|
-13.67 units on a scale
Standard Error 1.386
|
-15.14 units on a scale
Standard Error 1.361
|
PRIMARY outcome
Timeframe: Week 12Population: The ITT population included all randomized and treated participants, grouped according to assigned treatment. Here, the category "Number Analyzed" is number of participants analyzed for this outcome measure.
The IGA allows investigators to assess overall disease severity at one given time point and consists of a 6-point severity scale from clear to very severe disease (0 = clear, 1 = almost clear, 2 = mild disease, 3 = moderate disease, 4 = severe disease, and 5 = very severe disease). A participant has IGA response if they achieve a score of 0 (clear) or 1 (almost clear) and at least a 2-grade reduction from baseline.
Outcome measures
| Measure |
Tralokinumab Dose 3
n=52 Participants
Tralokinumab Dose 3 was administered subcutaneously to participants once every 2 Weeks (Q2W) for 12 weeks.
|
Placebo
n=51 Participants
Placebo matched to Tralokinumab was administered subcutaneously to participants once every 2 Weeks (Q2W) for 12 weeks.
|
Tralokinumab Dose 1
n=50 Participants
Tralokinumab Dose 1 was administered subcutaneously to participants once every 2 Weeks (Q2W) for 12 weeks.
|
Tralokinumab Dose 2
n=51 Participants
Tralokinumab Dose 2 was administered subcutaneously to participants once every 2 Weeks (Q2W) for 12 weeks.
|
|---|---|---|---|---|
|
Percentage of Participants Achieving Investigator's Global Assessment (IGA) Response of 0 (Clear) or 1 (Almost Clear) and at Least a 2-Grade Reduction From Baseline at Week 12
|
26.7 Percentage of participants
|
11.8 Percentage of participants
|
11.6 Percentage of participants
|
19.5 Percentage of participants
|
SECONDARY outcome
Timeframe: From Study Drug Administration (Day 1) to Week 22Population: As-treated population included all treated participants, grouped according to actual treatment received.
An adverse event (AE) present at baseline that worsened in intensity after administration of investigational product or events absent at baseline that emerged after administration of study drug until Week 22. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening situation (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect in the offspring of a participant who received Tralokinumab. Treatment-emergent adverse events between administration of investigational product and Week 22 that were absent before treatment or that worsened relative to pre-treatment state.
Outcome measures
| Measure |
Tralokinumab Dose 3
n=52 Participants
Tralokinumab Dose 3 was administered subcutaneously to participants once every 2 Weeks (Q2W) for 12 weeks.
|
Placebo
n=51 Participants
Placebo matched to Tralokinumab was administered subcutaneously to participants once every 2 Weeks (Q2W) for 12 weeks.
|
Tralokinumab Dose 1
n=50 Participants
Tralokinumab Dose 1 was administered subcutaneously to participants once every 2 Weeks (Q2W) for 12 weeks.
|
Tralokinumab Dose 2
n=51 Participants
Tralokinumab Dose 2 was administered subcutaneously to participants once every 2 Weeks (Q2W) for 12 weeks.
|
|---|---|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)
TEAEs
|
30 Participants
|
31 Participants
|
36 Participants
|
35 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)
TESAEs
|
0 Participants
|
1 Participants
|
3 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: From Study Drug Administration (Day 1) to Week 22Population: As-treated population included all treated participants, grouped according to actual treatment received.
Vital sign parameters included blood pressure, temperature, pulse rate, and respiratory rate. TEAEs were present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug until Week 22.
Outcome measures
| Measure |
Tralokinumab Dose 3
n=52 Participants
Tralokinumab Dose 3 was administered subcutaneously to participants once every 2 Weeks (Q2W) for 12 weeks.
|
Placebo
n=51 Participants
Placebo matched to Tralokinumab was administered subcutaneously to participants once every 2 Weeks (Q2W) for 12 weeks.
|
Tralokinumab Dose 1
n=50 Participants
Tralokinumab Dose 1 was administered subcutaneously to participants once every 2 Weeks (Q2W) for 12 weeks.
|
Tralokinumab Dose 2
n=51 Participants
Tralokinumab Dose 2 was administered subcutaneously to participants once every 2 Weeks (Q2W) for 12 weeks.
|
|---|---|---|---|---|
|
Number of Participants With Vital Signs and Physical Examination Abnormalities Reported as Treatment Emergent Adverse Events
Blood pressure increased
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Vital Signs and Physical Examination Abnormalities Reported as Treatment Emergent Adverse Events
Pyrexia
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Vital Signs and Physical Examination Abnormalities Reported as Treatment Emergent Adverse Events
Acute coronary syndrome
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Vital Signs and Physical Examination Abnormalities Reported as Treatment Emergent Adverse Events
Angina pectoris
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Vital Signs and Physical Examination Abnormalities Reported as Treatment Emergent Adverse Events
Hypertension
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Vital Signs and Physical Examination Abnormalities Reported as Treatment Emergent Adverse Events
Pallor
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From Study Drug Administration (Day 1) to Week 22Population: As-treated population included all treated participants, grouped according to actual treatment received.
An abnormal laboratory finding which required an action or intervention by the investigator, or a finding judged by the investigator to represent a change beyond the range of normal physiologic fluctuation were reported as an adverse event. Treatment-emergent adverse events between administration of investigational product and Week 22 that were absent before treatment or that worsened relative to pre-treatment state. Laboratory evaluations (haematology, serum chemistry and urinalysis) of blood and urine samples were performed.
Outcome measures
| Measure |
Tralokinumab Dose 3
n=52 Participants
Tralokinumab Dose 3 was administered subcutaneously to participants once every 2 Weeks (Q2W) for 12 weeks.
|
Placebo
n=51 Participants
Placebo matched to Tralokinumab was administered subcutaneously to participants once every 2 Weeks (Q2W) for 12 weeks.
|
Tralokinumab Dose 1
n=50 Participants
Tralokinumab Dose 1 was administered subcutaneously to participants once every 2 Weeks (Q2W) for 12 weeks.
|
Tralokinumab Dose 2
n=51 Participants
Tralokinumab Dose 2 was administered subcutaneously to participants once every 2 Weeks (Q2W) for 12 weeks.
|
|---|---|---|---|---|
|
Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment Emergent Adverse Events
Alanine aminotransferase increased
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment Emergent Adverse Events
Anaemia
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment Emergent Adverse Events
Lymphopenia
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment Emergent Adverse Events
Aspartate aminotransferase increased
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment Emergent Adverse Events
Blood alkaline phosphatase increased
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment Emergent Adverse Events
Blood creatinine increased
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment Emergent Adverse Events
Blood immunoglobulin E increased
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment Emergent Adverse Events
Gamma-glutamyltransferase increased
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment Emergent Adverse Events
Hepatic function abnormal
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment Emergent Adverse Events
Hyperbilirubinaemia
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment Emergent Adverse Events
Liver function test abnormal
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment Emergent Adverse Events
Glycosuria
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment Emergent Adverse Events
Leukocyturia
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From Study Drug Administration (Day 1) to Week 22Population: As-treated population included all treated participants, grouped according to actual treatment received.
AEs observed in participants with clinically significant ECG abnormalities were assessed. ECG parameters included heart rate, RR, PR, QRS and QT intervals. Treatment-emergent adverse events between administration of investigational product and Week 22 that were absent before treatment or that worsened relative to pre-treatment state.
Outcome measures
| Measure |
Tralokinumab Dose 3
n=52 Participants
Tralokinumab Dose 3 was administered subcutaneously to participants once every 2 Weeks (Q2W) for 12 weeks.
|
Placebo
n=51 Participants
Placebo matched to Tralokinumab was administered subcutaneously to participants once every 2 Weeks (Q2W) for 12 weeks.
|
Tralokinumab Dose 1
n=50 Participants
Tralokinumab Dose 1 was administered subcutaneously to participants once every 2 Weeks (Q2W) for 12 weeks.
|
Tralokinumab Dose 2
n=51 Participants
Tralokinumab Dose 2 was administered subcutaneously to participants once every 2 Weeks (Q2W) for 12 weeks.
|
|---|---|---|---|---|
|
Number of Participants With Electrocardiogram (ECG) Abnormalities Reported as Treatment Emergent Adverse Events
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Week 12Population: The ITT population included all randomized and treated participants, grouped according to assigned treatment. Here, the category "Number Analyzed" is number of participants analyzed for this outcome measure.
EASI50 responder is defined as a participant who achieves at least a 50% reduction in EASI score from baseline. Data from participants who took prohibited medications were excluded from this analysis and a last observation carried forward (LOCF) analysis was used.
Outcome measures
| Measure |
Tralokinumab Dose 3
n=52 Participants
Tralokinumab Dose 3 was administered subcutaneously to participants once every 2 Weeks (Q2W) for 12 weeks.
|
Placebo
n=51 Participants
Placebo matched to Tralokinumab was administered subcutaneously to participants once every 2 Weeks (Q2W) for 12 weeks.
|
Tralokinumab Dose 1
n=50 Participants
Tralokinumab Dose 1 was administered subcutaneously to participants once every 2 Weeks (Q2W) for 12 weeks.
|
Tralokinumab Dose 2
n=51 Participants
Tralokinumab Dose 2 was administered subcutaneously to participants once every 2 Weeks (Q2W) for 12 weeks.
|
|---|---|---|---|---|
|
Adjusted Percentage of Participants Achieving 50 Percent (%) Reduction From Baseline in Eczema Area and Severity Index (EASI) at Week 12
|
73.4 Percentage of participants
|
51.9 Percentage of participants
|
54.3 Percentage of participants
|
67.3 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Week 12Population: The ITT population included all randomized and treated participants, grouped according to assigned treatment. Here, the category "Number Analyzed" is number of participants analyzed for this outcome measure.
The SCORAD is a clinical tool for assessing the severity (that is, extent, intensity) of atopic dermatitis (AD). The tool evaluates the extent and intensity of the AD lesions, along with participant symptoms. The maximum total score is 103, with higher values indicating more severe disease. The data presented here is Adjusted mean change after excluding the data from participants who took prohibited medications.
Outcome measures
| Measure |
Tralokinumab Dose 3
n=52 Participants
Tralokinumab Dose 3 was administered subcutaneously to participants once every 2 Weeks (Q2W) for 12 weeks.
|
Placebo
n=51 Participants
Placebo matched to Tralokinumab was administered subcutaneously to participants once every 2 Weeks (Q2W) for 12 weeks.
|
Tralokinumab Dose 1
n=50 Participants
Tralokinumab Dose 1 was administered subcutaneously to participants once every 2 Weeks (Q2W) for 12 weeks.
|
Tralokinumab Dose 2
n=51 Participants
Tralokinumab Dose 2 was administered subcutaneously to participants once every 2 Weeks (Q2W) for 12 weeks.
|
|---|---|---|---|---|
|
Absolute Change From Baseline in Scoring of Atopic Dermatitis (SCORAD) at Week 12
|
-26.50 units on a scale
Standard Error 2.123
|
-16.67 units on a scale
Standard Error 2.224
|
-21.97 units on a scale
Standard Error 2.204
|
-26.09 units on a scale
Standard Error 2.168
|
SECONDARY outcome
Timeframe: Week 12Population: The ITT population included all randomized and treated participants, grouped according to assigned treatment. Here, the category "Number Analyzed" is number of participants analyzed for this outcome measure.
SCORAD 50 responder is defined as a participant who achieves at least a 50% reduction in SCORAD score from baseline. Data from participants who took prohibited medications were excluded from this analysis and a LOCF analysis was used.
Outcome measures
| Measure |
Tralokinumab Dose 3
n=52 Participants
Tralokinumab Dose 3 was administered subcutaneously to participants once every 2 Weeks (Q2W) for 12 weeks.
|
Placebo
n=51 Participants
Placebo matched to Tralokinumab was administered subcutaneously to participants once every 2 Weeks (Q2W) for 12 weeks.
|
Tralokinumab Dose 1
n=50 Participants
Tralokinumab Dose 1 was administered subcutaneously to participants once every 2 Weeks (Q2W) for 12 weeks.
|
Tralokinumab Dose 2
n=51 Participants
Tralokinumab Dose 2 was administered subcutaneously to participants once every 2 Weeks (Q2W) for 12 weeks.
|
|---|---|---|---|---|
|
Adjusted Percentage of Participants Achieving 50 Percent (%) Reduction From Baseline in SCORAD at Week 12
|
44.1 Percentage of participants
|
19.5 Percentage of participants
|
26.9 Percentage of participants
|
44.2 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Week 12Population: The ITT population included all randomized and treated participants, grouped according to assigned treatment. Here, the category "Number Analyzed" is number of participants analyzed for this outcome measure.
Pruritus assessed using an NRS (0 - 10) with 0= no itch and 10= worst imaginable itch. Daily pruritus assessments were summarized as weekly peak score and a change from baseline in weekly peak score was calculated. The data presented here is Adjusted mean change after excluding the data from participants who took prohibited medications.
Outcome measures
| Measure |
Tralokinumab Dose 3
n=52 Participants
Tralokinumab Dose 3 was administered subcutaneously to participants once every 2 Weeks (Q2W) for 12 weeks.
|
Placebo
n=51 Participants
Placebo matched to Tralokinumab was administered subcutaneously to participants once every 2 Weeks (Q2W) for 12 weeks.
|
Tralokinumab Dose 1
n=50 Participants
Tralokinumab Dose 1 was administered subcutaneously to participants once every 2 Weeks (Q2W) for 12 weeks.
|
Tralokinumab Dose 2
n=51 Participants
Tralokinumab Dose 2 was administered subcutaneously to participants once every 2 Weeks (Q2W) for 12 weeks.
|
|---|---|---|---|---|
|
Change From Baseline in Pruritus Numeric Rating Scale (NRS) (7-day Mean Score) at Week 12
|
-2.17 units on a scale
Standard Error 0.256
|
-1.03 units on a scale
Standard Error 0.270
|
-1.80 units on a scale
Standard Error 0.266
|
-1.59 units on a scale
Standard Error 0.260
|
Adverse Events
Placebo
Tralokinumab Dose 1
Tralokinumab Dose 2
Tralokinumab Dose 3
Serious adverse events
| Measure |
Placebo
n=51 participants at risk
Placebo matched to Tralokinumab was administered subcutaneously to participants once every 2 Weeks (Q2W) for 12 weeks.
|
Tralokinumab Dose 1
n=50 participants at risk
Tralokinumab Dose 1 was administered subcutaneously to participants once every 2 Weeks (Q2W) for 12 weeks.
|
Tralokinumab Dose 2
n=51 participants at risk
Tralokinumab Dose 2 was administered subcutaneously to participants once every 2 Weeks (Q2W) for 12 weeks.
|
Tralokinumab Dose 3
n=52 participants at risk
Tralokinumab Dose 3 was administered subcutaneously to participants once every 2 Weeks (Q2W) for 12 weeks.
|
|---|---|---|---|---|
|
Cardiac disorders
Angina pectoris
|
2.0%
1/51 • Number of events 1 • From Study Drug Administration (Day 1) to Week 22
|
0.00%
0/50 • From Study Drug Administration (Day 1) to Week 22
|
0.00%
0/51 • From Study Drug Administration (Day 1) to Week 22
|
0.00%
0/52 • From Study Drug Administration (Day 1) to Week 22
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/51 • From Study Drug Administration (Day 1) to Week 22
|
2.0%
1/50 • Number of events 1 • From Study Drug Administration (Day 1) to Week 22
|
0.00%
0/51 • From Study Drug Administration (Day 1) to Week 22
|
0.00%
0/52 • From Study Drug Administration (Day 1) to Week 22
|
|
General disorders
Death
|
0.00%
0/51 • From Study Drug Administration (Day 1) to Week 22
|
2.0%
1/50 • Number of events 1 • From Study Drug Administration (Day 1) to Week 22
|
0.00%
0/51 • From Study Drug Administration (Day 1) to Week 22
|
0.00%
0/52 • From Study Drug Administration (Day 1) to Week 22
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/51 • From Study Drug Administration (Day 1) to Week 22
|
2.0%
1/50 • Number of events 1 • From Study Drug Administration (Day 1) to Week 22
|
0.00%
0/51 • From Study Drug Administration (Day 1) to Week 22
|
0.00%
0/52 • From Study Drug Administration (Day 1) to Week 22
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.00%
0/51 • From Study Drug Administration (Day 1) to Week 22
|
2.0%
1/50 • Number of events 1 • From Study Drug Administration (Day 1) to Week 22
|
0.00%
0/51 • From Study Drug Administration (Day 1) to Week 22
|
0.00%
0/52 • From Study Drug Administration (Day 1) to Week 22
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.00%
0/51 • From Study Drug Administration (Day 1) to Week 22
|
0.00%
0/50 • From Study Drug Administration (Day 1) to Week 22
|
2.0%
1/51 • Number of events 1 • From Study Drug Administration (Day 1) to Week 22
|
0.00%
0/52 • From Study Drug Administration (Day 1) to Week 22
|
|
Reproductive system and breast disorders
Uterine polyp
|
0.00%
0/51 • From Study Drug Administration (Day 1) to Week 22
|
0.00%
0/50 • From Study Drug Administration (Day 1) to Week 22
|
2.0%
1/51 • Number of events 1 • From Study Drug Administration (Day 1) to Week 22
|
0.00%
0/52 • From Study Drug Administration (Day 1) to Week 22
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/51 • From Study Drug Administration (Day 1) to Week 22
|
0.00%
0/50 • From Study Drug Administration (Day 1) to Week 22
|
2.0%
1/51 • Number of events 1 • From Study Drug Administration (Day 1) to Week 22
|
0.00%
0/52 • From Study Drug Administration (Day 1) to Week 22
|
Other adverse events
| Measure |
Placebo
n=51 participants at risk
Placebo matched to Tralokinumab was administered subcutaneously to participants once every 2 Weeks (Q2W) for 12 weeks.
|
Tralokinumab Dose 1
n=50 participants at risk
Tralokinumab Dose 1 was administered subcutaneously to participants once every 2 Weeks (Q2W) for 12 weeks.
|
Tralokinumab Dose 2
n=51 participants at risk
Tralokinumab Dose 2 was administered subcutaneously to participants once every 2 Weeks (Q2W) for 12 weeks.
|
Tralokinumab Dose 3
n=52 participants at risk
Tralokinumab Dose 3 was administered subcutaneously to participants once every 2 Weeks (Q2W) for 12 weeks.
|
|---|---|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
11.8%
6/51 • Number of events 9 • From Study Drug Administration (Day 1) to Week 22
|
22.0%
11/50 • Number of events 12 • From Study Drug Administration (Day 1) to Week 22
|
15.7%
8/51 • Number of events 9 • From Study Drug Administration (Day 1) to Week 22
|
25.0%
13/52 • Number of events 20 • From Study Drug Administration (Day 1) to Week 22
|
|
Infections and infestations
Sinusitis
|
2.0%
1/51 • Number of events 1 • From Study Drug Administration (Day 1) to Week 22
|
2.0%
1/50 • Number of events 1 • From Study Drug Administration (Day 1) to Week 22
|
3.9%
2/51 • Number of events 2 • From Study Drug Administration (Day 1) to Week 22
|
5.8%
3/52 • Number of events 3 • From Study Drug Administration (Day 1) to Week 22
|
|
Infections and infestations
Upper respiratory tract infection
|
9.8%
5/51 • Number of events 6 • From Study Drug Administration (Day 1) to Week 22
|
10.0%
5/50 • Number of events 7 • From Study Drug Administration (Day 1) to Week 22
|
11.8%
6/51 • Number of events 9 • From Study Drug Administration (Day 1) to Week 22
|
7.7%
4/52 • Number of events 6 • From Study Drug Administration (Day 1) to Week 22
|
|
Nervous system disorders
Headache
|
3.9%
2/51 • Number of events 3 • From Study Drug Administration (Day 1) to Week 22
|
6.0%
3/50 • Number of events 6 • From Study Drug Administration (Day 1) to Week 22
|
7.8%
4/51 • Number of events 4 • From Study Drug Administration (Day 1) to Week 22
|
7.7%
4/52 • Number of events 4 • From Study Drug Administration (Day 1) to Week 22
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
7.8%
4/51 • Number of events 5 • From Study Drug Administration (Day 1) to Week 22
|
6.0%
3/50 • Number of events 3 • From Study Drug Administration (Day 1) to Week 22
|
5.9%
3/51 • Number of events 4 • From Study Drug Administration (Day 1) to Week 22
|
5.8%
3/52 • Number of events 4 • From Study Drug Administration (Day 1) to Week 22
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee MedImmune has 60 days to review results communications prior to public release and may delete information that compromises on-going studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it being understood that results shall be published regardless of outcome.
- Publication restrictions are in place
Restriction type: OTHER