18 and older, any sex, with Atopic Dermatitis. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Participants With Investigator's Global Assessment (IGA) Score of 0 (Clear) or 1 (Almost Clear) at Week 16Primary· Week 16
IGA is used to evaluate the severity of atopic dermatitis. It is a 5-point score ranging from 0 (clear) to 4 (severe).
Group
Value
95% CI
Tralokinumab Q2W+TCS
98
Placebo+TCS
33
Participants Achieving at Least 75% Reduction in Eczema Area and Severity Index (EASI) at Week 16Primary· Week 16
EASI is used to evaluate the extent and severity of atopic dermatitis. It is a composite score ranging from 0 to 72 with a higher score indicating a more extensive and/or severe condition.
Group
Value
95% CI
Tralokinumab Q2W+TCS
141
Placebo+TCS
45
Reduction of Worst Daily Pruritus Numeric Rating Scale (NRS) (Weekly Average) of at Least 4 From Baseline to Week 16Secondary· Week 0 to Week 16
Worst Daily Pruritus NRS is used by the participant to evaluate their worst itch severity over the past 24 hours. The score ranges from 0 ('no itch') to 10 ('worst itch imaginable') on an 11-point scale.
Group
Value
95% CI
Tralokinumab Q2W+TCS
113
Placebo+TCS
43
Change in Scoring Atopic Dermatitis (SCORAD) From Baseline to Week 16Secondary· Week 0 to Week 16
SCORAD is used to evaluate the extent and severity of atopic dermatitis as well as subjective symptoms. The score ranges from 0 to 103 with a higher score indicating a more extensive and/or severe condition.
Group
Value
95% CI
Tralokinumab Q2W+TCS
-37.7
± 1.25
Placebo+TCS
-26.8
± 1.80
Change in Dermatology Life Quality Index (DLQI) Score From Baseline to Week 16Secondary· Week 0 to Week 16
DLQI is used by the participant to evaluate the impact of their condition on 10 different aspects of health-related quality of life (HRQoL) over the last week. Each item is scored on a 4-point Likert scale ranging from 0 (not at all/not relevant) to 3 (very much). The total score which is the sum of the 10 items ranges from 0 to 30, with a higher score indicating a poorer HRQoL.
Group
Value
95% CI
Tralokinumab Q2W+TCS
-11.7
± 0.39
Placebo+TCS
-8.8
± 0.56
Frequency of Anti-drug Antibodies (ADA)Secondary· Week 0 to Week 16, Week 16 to Week 32
Presence of ADA from Week 0 to Week 32 was measured. Data were reported in the following categories: positive (presence of ADA at baseline and/or presence of ADA at at least 1 post-baseline assessment), perishing (presence of ADA at baseline and absence of ADA at all post-baseline assessments), negative (absence of ADA at all assessments), no post-baseline ADA assessment. Perishing ADAs were not assessed in the continuation treatment period.
Initial treatment period (Week 0 to Week 16)
Group
Value
95% CI
Initial Treatment Period - Tralokinumab Q2W+TCS
2
Initial Treatment Period - Placebo+TCS
3
Continuation Treatment Period - Tralokinumab R/Q2W+TCS
0
Continuation Treatment Period - Tralokinumab R/Q4W+TCS
0
Continuation Treatment Period - Tralokinumab NR/Q2W+TCS
0
Continuation Treatment Period - Placebo NR/Tralokinumab Q2W+TCS
0
Continuation Treatment Period - Placebo R/Placebo+TCS
0
Initial Treatment Period - Tralokinumab Q2W+TCS
1
Initial Treatment Period - Placebo+TCS
0
Continuation Treatment Period - Tralokinumab R/Q2W+TCS
0
Continuation Treatment Period - Tralokinumab R/Q4W+TCS
0
Continuation Treatment Period - Tralokinumab NR/Q2W+TCS
0
Continuation Treatment Period - Placebo NR/Tralokinumab Q2W+TCS
0
Continuation Treatment Period - Placebo R/Placebo+TCS
0
Initial Treatment Period - Tralokinumab Q2W+TCS
246
Initial Treatment Period - Placebo+TCS
123
Continuation Treatment Period - Tralokinumab R/Q2W+TCS
0
Continuation Treatment Period - Tralokinumab R/Q4W+TCS
0
Continuation Treatment Period - Tralokinumab NR/Q2W+TCS
0
Continuation Treatment Period - Placebo NR/Tralokinumab Q2W+TCS
0
Continuation Treatment Period - Placebo R/Placebo+TCS
0
Initial Treatment Period - Tralokinumab Q2W+TCS
3
Initial Treatment Period - Placebo+TCS
0
Continuation Treatment Period - Tralokinumab R/Q2W+TCS
0
Continuation Treatment Period - Tralokinumab R/Q4W+TCS
0
Continuation Treatment Period - Tralokinumab NR/Q2W+TCS
0
Continuation Treatment Period - Placebo NR/Tralokinumab Q2W+TCS
0
Continuation Treatment Period - Placebo R/Placebo+TCS
0
Continuation treatment period (Week 16 to Week 32)
Group
Value
95% CI
Initial Treatment Period - Tralokinumab Q2W+TCS
0
Initial Treatment Period - Placebo+TCS
0
Continuation Treatment Period - Tralokinumab R/Q2W+TCS
0
Continuation Treatment Period - Tralokinumab R/Q4W+TCS
2
Continuation Treatment Period - Tralokinumab NR/Q2W+TCS
0
Continuation Treatment Period - Placebo NR/Tralokinumab Q2W+TCS
3
Continuation Treatment Period - Placebo R/Placebo+TCS
2
Initial Treatment Period - Tralokinumab Q2W+TCS
0
Initial Treatment Period - Placebo+TCS
0
Continuation Treatment Period - Tralokinumab R/Q2W+TCS
0
Continuation Treatment Period - Tralokinumab R/Q4W+TCS
0
Continuation Treatment Period - Tralokinumab NR/Q2W+TCS
0
Continuation Treatment Period - Placebo NR/Tralokinumab Q2W+TCS
0
Continuation Treatment Period - Placebo R/Placebo+TCS
0
Initial Treatment Period - Tralokinumab Q2W+TCS
0
Initial Treatment Period - Placebo+TCS
0
Continuation Treatment Period - Tralokinumab R/Q2W+TCS
66
Continuation Treatment Period - Tralokinumab R/Q4W+TCS
63
Continuation Treatment Period - Tralokinumab NR/Q2W+TCS
92
Continuation Treatment Period - Placebo NR/Tralokinumab Q2W+TCS
74
Continuation Treatment Period - Placebo R/Placebo+TCS
37
Initial Treatment Period - Tralokinumab Q2W+TCS
0
Initial Treatment Period - Placebo+TCS
0
Continuation Treatment Period - Tralokinumab R/Q2W+TCS
0
Continuation Treatment Period - Tralokinumab R/Q4W+TCS
0
Continuation Treatment Period - Tralokinumab NR/Q2W+TCS
0
Continuation Treatment Period - Placebo NR/Tralokinumab Q2W+TCS
0
Continuation Treatment Period - Placebo R/Placebo+TCS
0
Amount of Topical Corticosteroid (TCS) Used Through Week 16 Assuming no TCS Used From the Non-returned TubesSecondary· Week 1-2 to Week 15-16
Assessed as the amount of TCS weighed from previous visits, assuming no TCS was used from the non-returned tubes. Measurements were collected as TCS weight (g) between the visits.
Week 1-2
Group
Value
95% CI
Tralokinumab Q2W+TCS
29.3
± 2.45
Placebo+TCS
32.8
± 3.47
Week 3-4
Group
Value
95% CI
Tralokinumab Q2W+TCS
19.7
± 1.86
Placebo+TCS
26.6
± 2.66
Week 5-6
Group
Value
95% CI
Tralokinumab Q2W+TCS
18.5
± 1.72
Placebo+TCS
23.2
± 2.46
Week 7-8
Group
Value
95% CI
Tralokinumab Q2W+TCS
17.0
± 2.04
Placebo+TCS
24.3
± 2.93
Week 9-10
Group
Value
95% CI
Tralokinumab Q2W+TCS
14.8
± 1.66
Placebo+TCS
23.9
± 2.38
Week 11-12
Group
Value
95% CI
Tralokinumab Q2W+TCS
11.6
± 1.38
Placebo+TCS
19.6
± 2.00
Week 13-14
Group
Value
95% CI
Tralokinumab Q2W+TCS
12.7
± 1.61
Placebo+TCS
23.0
± 2.33
Week 15-16
Group
Value
95% CI
Tralokinumab Q2W+TCS
11.6
± 1.57
Placebo+TCS
20.2
± 2.27
Amount of Topical Corticosteroid (TCS) Used Through Week 16 Assuming All TCS Used From the Non-returned TubesSecondary· Week 1-2 to Week 15-16
Assessed as the amount of TCS weighed from previous visits, assuming all TCS was used from the non-returned tubes. Measurements were collected as TCS weight (g) between the visits.
Week 1-2
Group
Value
95% CI
Tralokinumab Q2W+TCS
40.1
± 3.22
Placebo+TCS
40.1
± 4.57
Week 3-4
Group
Value
95% CI
Tralokinumab Q2W+TCS
32.4
± 3.00
Placebo+TCS
31.3
± 4.27
Week 5-6
Group
Value
95% CI
Tralokinumab Q2W+TCS
29.2
± 2.89
Placebo+TCS
30.6
± 4.13
Week 7-8
Group
Value
95% CI
Tralokinumab Q2W+TCS
25.2
± 2.89
Placebo+TCS
30.0
± 4.15
Week 9-10
Group
Value
95% CI
Tralokinumab Q2W+TCS
22.5
± 2.61
Placebo+TCS
26.9
± 3.76
Week 11-12
Group
Value
95% CI
Tralokinumab Q2W+TCS
16.9
± 2.23
Placebo+TCS
23.1
± 3.22
Week 13-14
Group
Value
95% CI
Tralokinumab Q2W+TCS
16.6
± 2.22
Placebo+TCS
25.5
± 3.23
Week 15-16
Group
Value
95% CI
Tralokinumab Q2W+TCS
15.3
± 2.26
Placebo+TCS
24.8
± 3.27
Number of Atopic Dermatitis Flares Through Week 16Secondary· Week 0 to Week 16
Assessed as appearance of new flares since previous visit.
Group
Value
95% CI
Tralokinumab Q2W+TCS
119
Placebo+TCS
75
Number of Days Without Topical Treatment Use From Baseline to Week 16Secondary· Week 1 to Week 16
Participants assessed their use of topical treatment over the past 24 hours using a response scale ('yes', 'no'). Measurements of number of days per week were used in the analysis.
Week 1
Group
Value
95% CI
Tralokinumab Q2W+TCS
2.6
± 0.17
Placebo+TCS
2.5
± 0.25
Week 2
Group
Value
95% CI
Tralokinumab Q2W+TCS
3.0
± 0.18
Placebo+TCS
2.6
± 0.27
Week 3
Group
Value
95% CI
Tralokinumab Q2W+TCS
2.9
± 0.17
Placebo+TCS
2.7
± 0.25
Week 4
Group
Value
95% CI
Tralokinumab Q2W+TCS
3.1
± 0.17
Placebo+TCS
2.7
± 0.25
Week 5
Group
Value
95% CI
Tralokinumab Q2W+TCS
3.2
± 0.17
Placebo+TCS
2.7
± 0.25
Week 6
Group
Value
95% CI
Tralokinumab Q2W+TCS
3.1
± 0.18
Placebo+TCS
2.8
± 0.26
Week 7
Group
Value
95% CI
Tralokinumab Q2W+TCS
3.3
± 0.17
Placebo+TCS
2.7
± 0.25
Week 8
Group
Value
95% CI
Tralokinumab Q2W+TCS
3.3
± 0.18
Placebo+TCS
3.0
± 0.26
Participants Achieving at Least 50% Reduction in Eczema Area and Severity Index (EASI) at Week 16Secondary· Week 16
EASI is used to evaluate the extent and severity of atopic dermatitis. It is a composite score ranging from 0 to 72 with a higher score indicating a more extensive and/or severe condition.
Group
Value
95% CI
Tralokinumab Q2W+TCS
200
Placebo+TCS
73
Participants Achieving at Least 90% Reduction in Eczema Area and Severity Index (EASI) at Week 16Secondary· Week 16
EASI is used to evaluate the extent and severity of atopic dermatitis. It is a composite score ranging from 0 to 72 with a higher score indicating a more extensive and/or severe condition.
Group
Value
95% CI
Tralokinumab Q2W+TCS
83
Placebo+TCS
27
Adverse events — posted to ClinicalTrials.gov
Time frame: Initial treatment period (Week 0 to Week 16), continuation treatment period (Week 16 to Week 32), safety follow-up (Week 32 to Week 46)..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Primary objective:
To demonstrate that tralokinumab in combination with topical corticosteroids (TCS) is superior to placebo in combination with TCS in treating moderate-to-severe atopic dermatitis (AD).
Secondary objectives:
To evaluate the efficacy of tralokinumab in combination with TCS on severity and extent of AD, itch, and health-related quality of life compared with placebo in combination with TCS.
To assess the safety of tralokinumab in combination with TCS when used to treat moderate-to-severe AD for 32 weeks.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07352566 — Utilization of a Microdevice for Psoriasis and Atopic Dermatitis
· Phase 4
· not yet recruiting
NCT05958407 — A 32-week Trial to Evaluate the Efficacy and Safety of Tralokinumab in Subjects With Moderate-to-severe Atopic Hand Ecze
· Phase 3
· completed
NCT05938478 — Monitoring Pregnancy and Infant Outcomes Following Tralokinumab Exposure During Pregnancy in the US and Canada - PROTECT
· recruiting
NCT05388760 — Tralokinumab Monotherapy for Children With Moderate-to-severe Atopic Dermatitis - TRAPEDS 1 (TRAlokinumab PEDiatric Tria
· Phase 2
· active not recruiting
NCT05194540 — Efficacy and Safety of Tralokinumab Administered by an Autoinjector in Adults and Adolescents With Moderate to Severe At
· Phase 3
· completed
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by LEO Pharma
Last refreshed: 11 March 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03363854.