Trial Outcomes & Findings for Efficacy and Safety of Tralokinumab Administered by an Autoinjector in Adults and Adolescents With Moderate to Severe Atopic Dermatitis (INJECZTRA) (NCT NCT05194540)
NCT ID: NCT05194540
Last Updated: 2025-03-11
Results Overview
IGA is an instrument used in clinical trials to rate the severity of the participant's global AD and is based on a 5-point scale ranging from 0 (clear) to 4 (severe)
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
136 participants
Primary outcome timeframe
At Week 16
Results posted on
2025-03-11
Participant Flow
Participant milestones
| Measure |
Tralokinumab Subcutaneous Dosing by an Autoinjector
An initial SC dose of 600 mg tralokinumab at baseline followed by self-administration of a 300 mg dose of tralokinumab every other week for 14 weeks.
Tralokinumab: Tralokinumab is a human recombinant monoclonal antibody of immunoglobulin G4 (IgG4) subclass that specifically binds to human interleukin-13 (IL-13) and blocks interaction with the IL-13 receptors. It is presented as a liquid formulation for subcutaneous administration
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|---|---|
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Overall Study
STARTED
|
136
|
|
Overall Study
COMPLETED
|
117
|
|
Overall Study
NOT COMPLETED
|
19
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Efficacy and Safety of Tralokinumab Administered by an Autoinjector in Adults and Adolescents With Moderate to Severe Atopic Dermatitis (INJECZTRA)
Baseline characteristics by cohort
| Measure |
Tralokinumab Subcutaneous Dosing by an Autoinjector
n=136 Participants
An initial SC dose of 600 mg tralokinumab at baseline followed by self-administration of a 300 mg dose of tralokinumab every other week for 14 weeks.
Tralokinumab: Tralokinumab is a human recombinant monoclonal antibody of immunoglobulin G4 (IgG4) subclass that specifically binds to human interleukin-13 (IL-13) and blocks interaction with the IL-13 receptors. It is presented as a liquid formulation for subcutaneous administration
|
|---|---|
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Age, Continuous
|
36.4 years
STANDARD_DEVIATION 20.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
72 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
64 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
32 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
103 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
14 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
32 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
81 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
136 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At Week 16Population: FAS, full analysis set
IGA is an instrument used in clinical trials to rate the severity of the participant's global AD and is based on a 5-point scale ranging from 0 (clear) to 4 (severe)
Outcome measures
| Measure |
Tralokinumab Subcutaneous Dosing by an Autoinjector
n=136 Participants
An initial SC dose of 600 mg tralokinumab at baseline followed by self-administration of a 300 mg dose of tralokinumab every other week for 14 weeks.
Tralokinumab: Tralokinumab is a human recombinant monoclonal antibody of immunoglobulin G4 (IgG4) subclass that specifically binds to human interleukin-13 (IL-13) and blocks interaction with the IL-13 receptors. It is presented as a liquid formulation for subcutaneous administration
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|---|---|
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Investigator's Global Assessment (IGA) Score of 0 (Clear) or 1 (Almost Clear) at Week 16
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28.7 percentage of subjects
Interval 21.7 to 36.8
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PRIMARY outcome
Timeframe: At Week 16Population: FAS, full analysis set
Eczema Area and Severity Index (EASI) is a validated measure used in clinical practice and clinical trials to assess the severity and extent of AD. EASI is a composite index with scores ranging from 0 to 72, where higher values indicate a more severe or more extensive condition
Outcome measures
| Measure |
Tralokinumab Subcutaneous Dosing by an Autoinjector
n=136 Participants
An initial SC dose of 600 mg tralokinumab at baseline followed by self-administration of a 300 mg dose of tralokinumab every other week for 14 weeks.
Tralokinumab: Tralokinumab is a human recombinant monoclonal antibody of immunoglobulin G4 (IgG4) subclass that specifically binds to human interleukin-13 (IL-13) and blocks interaction with the IL-13 receptors. It is presented as a liquid formulation for subcutaneous administration
|
|---|---|
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At Least 75% Reduction in Eczema Area and Severity Index (EASI75) at Week 16
|
43.4 percentage of subjects
Interval 35.3 to 51.8
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SECONDARY outcome
Timeframe: From Week 0 to Week 16Population: SAF, safety analysis set
An AE will be considered treatment emergent if it started after the first injection of trial drug
Outcome measures
| Measure |
Tralokinumab Subcutaneous Dosing by an Autoinjector
n=136 Participants
An initial SC dose of 600 mg tralokinumab at baseline followed by self-administration of a 300 mg dose of tralokinumab every other week for 14 weeks.
Tralokinumab: Tralokinumab is a human recombinant monoclonal antibody of immunoglobulin G4 (IgG4) subclass that specifically binds to human interleukin-13 (IL-13) and blocks interaction with the IL-13 receptors. It is presented as a liquid formulation for subcutaneous administration
|
|---|---|
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Number of Treatment-emergent Adverse Events (AEs) From Baseline to Week 16
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86 events
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SECONDARY outcome
Timeframe: From Week 0 to Week 16Population: SAF, safety analysis set
Serum samples for determination of presence or absence of ADA will be analysed using a validated bioanalytical method
Outcome measures
| Measure |
Tralokinumab Subcutaneous Dosing by an Autoinjector
n=136 Participants
An initial SC dose of 600 mg tralokinumab at baseline followed by self-administration of a 300 mg dose of tralokinumab every other week for 14 weeks.
Tralokinumab: Tralokinumab is a human recombinant monoclonal antibody of immunoglobulin G4 (IgG4) subclass that specifically binds to human interleukin-13 (IL-13) and blocks interaction with the IL-13 receptors. It is presented as a liquid formulation for subcutaneous administration
|
|---|---|
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Presence of Treatment-emergent Anti-drug Antibodies (ADA) From Baseline to Week 16
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0 participants
|
Adverse Events
Tralokinumab+TCS Initial Treatment Period Week 0 to Week 16
Serious events: 0 serious events
Other events: 24 other events
Deaths: 0 deaths
Safety Follow-Up Week 16 to Week 20
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Tralokinumab+TCS Initial Treatment Period Week 0 to Week 16
n=136 participants at risk
Tralokinumab+TCS (N=136)
|
Safety Follow-Up Week 16 to Week 20
n=131 participants at risk
Safety Follow-Up (N=131)
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|---|---|---|
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General disorders
Injection site pain
|
2.2%
3/136 • Number of events 3 • Initial Treatment Period: Week 0 to week 16, Safety Follow- Up Period: Week 16 to Week 20.
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0.00%
0/131 • Initial Treatment Period: Week 0 to week 16, Safety Follow- Up Period: Week 16 to Week 20.
|
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General disorders
Injection site reaction
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5.9%
8/136 • Number of events 10 • Initial Treatment Period: Week 0 to week 16, Safety Follow- Up Period: Week 16 to Week 20.
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0.00%
0/131 • Initial Treatment Period: Week 0 to week 16, Safety Follow- Up Period: Week 16 to Week 20.
|
|
Infections and infestations
COVID-19
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2.2%
3/136 • Number of events 3 • Initial Treatment Period: Week 0 to week 16, Safety Follow- Up Period: Week 16 to Week 20.
|
0.00%
0/131 • Initial Treatment Period: Week 0 to week 16, Safety Follow- Up Period: Week 16 to Week 20.
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|
Infections and infestations
Conjunctivitis
|
2.9%
4/136 • Number of events 4 • Initial Treatment Period: Week 0 to week 16, Safety Follow- Up Period: Week 16 to Week 20.
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0.00%
0/131 • Initial Treatment Period: Week 0 to week 16, Safety Follow- Up Period: Week 16 to Week 20.
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|
Infections and infestations
Dermatitis infected
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2.2%
3/136 • Number of events 3 • Initial Treatment Period: Week 0 to week 16, Safety Follow- Up Period: Week 16 to Week 20.
|
0.00%
0/131 • Initial Treatment Period: Week 0 to week 16, Safety Follow- Up Period: Week 16 to Week 20.
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
4.4%
6/136 • Number of events 6 • Initial Treatment Period: Week 0 to week 16, Safety Follow- Up Period: Week 16 to Week 20.
|
0.00%
0/131 • Initial Treatment Period: Week 0 to week 16, Safety Follow- Up Period: Week 16 to Week 20.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The sponsor seeks publication of all clinical trials in peer-reviewed journals within 12 months after completion or termination of the clinical trial, regardless of whether the findings are positive or negative. If no publication is submitted by the sponsor within these 12 months, the investigator has the right to publish the results from clinical trial generated by him/herself.
- Publication restrictions are in place
Restriction type: OTHER