Atopic Dermatitis
Conditions
Brief summary
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.
Interventions
DRUGTralokinumab
Tralokinumab is a human recombinant monoclonal antibody of the IgG4 subclass that specifically binds to human IL-13 and blocks interaction with the IL-13 receptors. It is presented as a liquid formulation for subcutaneous (SC) administration.
DRUGPlacebo
Placebo contains the same excipients in the same concentration only lacking tralokinumab.
Sponsors
LEO Pharma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
Neither the subject nor any of the investigator or LEO staff who are involved in the treatment or clinical evaluation and monitoring of the subjects will be aware of the treatment received. The packaging and labelling of the investigational medicinal products (IMPs) will contain no evidence of their identity. Since tralokinumab and placebo are visually distinct and not matched for viscosity, IMP will be handled and administered by a qualified, unblinded health-care professional at the site who will not be involved in the management of trial subjects and who will not perform any of the assessments.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age 18 and above. * Diagnosis of AD as defined by the Hanifin and Rajka (1980) criteria for AD. * History of AD for ≥1 year. * Subjects who have a recent history of inadequate response to treatment with topical medications. * AD involvement of ≥10% body surface area at screening and baseline. * Stable dose of emollient twice daily (or more, as needed) for at least 14 days before randomisation.
Exclusion criteria
* Subjects for whom TCS are medically inadvisable e.g., due to important side effects or safety risks in the opinion of the investigator. * Active dermatologic conditions that may confound the diagnosis of AD. * Use of tanning beds or phototherapy within 6 weeks prior to randomisation. * Treatment with systemic immunosuppressive/immunomodulating drugs and/or systemic corticosteroid within 4 weeks prior to randomisation. * Treatment with TCS, topical calcineurin inhibitors (TCI), or topical phosphodiesterase 4 (PDE-4) inhibitor within 2 weeks prior to randomisation. * Receipt of any marketed biological therapy (i.e. immunoglobulin, anti- immunoglobulin E) including dupilumab or investigational biologic agents within 3 months or 5 half-lives, whichever is longer prior to randomisation. * Active skin infection within 1 week prior to randomisation. * Clinically significant infection within 4 weeks prior to randomisation. * A helminth parasitic infection within 6 months prior to the date informed consent is obtained. * Tuberculosis requiring treatment within the 12 months prior to screening. * Known primary immunodeficiency disorder.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Participants With Investigator's Global Assessment (IGA) Score of 0 (Clear) or 1 (Almost Clear) at Week 16 | 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). |
| Participants Achieving at Least 75% Reduction in Eczema Area and Severity Index (EASI) at Week 16 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Dermatology Life Quality Index (DLQI) Score From Baseline to Week 16 | 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. |
| Frequency of Anti-drug Antibodies (ADA) | 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. |
| Amount of Topical Corticosteroid (TCS) Used Through Week 16 Assuming no TCS Used From the Non-returned Tubes | 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. |
| Amount of Topical Corticosteroid (TCS) Used Through Week 16 Assuming All TCS Used From the Non-returned Tubes | 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. |
| Number of Atopic Dermatitis Flares Through Week 16 | Week 0 to Week 16 | Assessed as appearance of new flares since previous visit. |
| Number of Days Without Topical Treatment Use From Baseline to Week 16 | 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. |
| Participants Achieving at Least 50% Reduction in Eczema Area and Severity Index (EASI) at Week 16 | 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. |
| Reduction of Worst Daily Pruritus Numeric Rating Scale (NRS) (Weekly Average) of at Least 4 From Baseline to Week 16 | 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. |
| Change From Baseline to Week 16 in Eczema Area and Severity Index (EASI) Score | Week 0 to 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. |
| Participants Achieving at Least 50% Reduction in Scoring Atopic Dermatitis (SCORAD) at Week 16 | 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. |
| Participants Achieving at Least 75% Reduction in Scoring Atopic Dermatitis (SCORAD) at Week 16 | 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. |
| Change From Baseline to Week 16 in Worst Daily Pruritus Numeric Rating Scale (NRS) (Weekly Average) | 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. |
| Reduction From Baseline to Week 16 of Dermatology Life Quality Index (DLQI) of at Least 4 Points Among Participants With Baseline DLQI ≥4 | 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. |
| Participants With Investigator's Global Assessment (IGA) Score of 0 (Clear) or 1 (Almost Clear) at Week 32 Among Participants With IGA Score of 0 or 1 at Week 16 After Initial Randomisation to Tralokinumab | Week 32 | IGA is used to evaluate the severity of atopic dermatitis. It is a 5-point score ranging from 0 (clear) to 4 (severe). |
| Participants Achieving at Least 75% Reduction in Eczema Area and Severity Index (EASI) at Week 32 Among Participants Who Had Achieved at Least 75% Reduction in EASI at Week 16 After Initial Randomisation to Tralokinumab | Week 32 | 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. |
| Participants Achieving at Least 90% Reduction in Eczema Area and Severity Index (EASI) at Week 16 | 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. |
| Change in Scoring Atopic Dermatitis (SCORAD) From Baseline to Week 16 | 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. |
Countries
Belgium, Canada, Germany, Netherlands, Poland, Spain, United Kingdom, United States
Participant flow
Pre-assignment details
After the participant gave informed consent, they went through a 2- to 6-week screening period for washout of previous atopic dermatitis medication and disallowed medication. The participant was assigned treatment at Week 0.
Participants by arm
| Arm | Count |
|---|---|
| Tralokinumab Q2W+TCS Participants in the initial treatment period (Week 0 to Week 16) treated with tralokinumab every second week (Q2W) and topical corticosteroid (TCS) as needed.
Participants received a loading dose of 600 mg tralokinumab at Week 0 followed by a dose of 300 mg tralokinumab Q2W from Week 2 to Week 16. | 253 |
| Placebo+TCS Participants in the initial treatment period (Week 0 to Week 16) treated with placebo every second week and topical corticosteroid (TCS) as needed.
Participants were administered placebo at Week 0 followed by administration of placebo every second week from Week 2 to Week 16. | 127 |
| Total | 380 |
Baseline characteristics
| Characteristic | Total | Placebo+TCS | Tralokinumab Q2W+TCS |
|---|---|---|---|
| Age at onset of atopic dermatitis | 4.0 years | 2.0 years | 4.0 years |
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 24 Participants | 8 Participants | 16 Participants |
| Age, Categorical Between 18 and 65 years | 356 Participants | 119 Participants | 237 Participants |
| Age, Continuous | 39.1 years STANDARD_DEVIATION 15.2 | 37.7 years STANDARD_DEVIATION 14.8 | 39.8 years STANDARD_DEVIATION 15.3 |
| Body surface area with atopic dermatitis | 48.1 percentage affected STANDARD_DEVIATION 24.2 | 49.0 percentage affected STANDARD_DEVIATION 25.9 | 47.6 percentage affected STANDARD_DEVIATION 23.3 |
| Dermatology Life Quality Index (DLQI) | 17.45 units on a scale STANDARD_DEVIATION 7.09 | 17.19 units on a scale STANDARD_DEVIATION 7.15 | 17.58 units on a scale STANDARD_DEVIATION 7.07 |
| Duration of atopic dermatitis | 28.2 years STANDARD_DEVIATION 16 | 28.7 years STANDARD_DEVIATION 15 | 28.0 years STANDARD_DEVIATION 16.5 |
| Eczema Area and Severity Index (EASI) | 29.35 units on a scale STANDARD_DEVIATION 12.25 | 30.42 units on a scale STANDARD_DEVIATION 12.78 | 28.81 units on a scale STANDARD_DEVIATION 11.97 |
| Investigator's Global Assessment (IGA) Almost clear | 0 Participants | 0 Participants | 0 Participants |
| Investigator's Global Assessment (IGA) Clear | 0 Participants | 0 Participants | 0 Participants |
| Investigator's Global Assessment (IGA) Mild | 0 Participants | 0 Participants | 0 Participants |
| Investigator's Global Assessment (IGA) Missing | 2 Participants | 1 Participants | 1 Participants |
| Investigator's Global Assessment (IGA) Moderate | 202 Participants | 66 Participants | 136 Participants |
| Investigator's Global Assessment (IGA) Severe | 176 Participants | 60 Participants | 116 Participants |
| Race/Ethnicity, Customized Ethnicity Asian | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Ethnicity Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Ethnicity Hispanic or Latino | 34 Participants | 9 Participants | 25 Participants |
| Race/Ethnicity, Customized Ethnicity Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Ethnicity Not Hispanic or Latino | 346 Participants | 118 Participants | 228 Participants |
| Race/Ethnicity, Customized Ethnicity Other | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Ethnicity White | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Race Asian | 41 Participants | 24 Participants | 17 Participants |
| Race/Ethnicity, Customized Race Black or African American | 35 Participants | 12 Participants | 23 Participants |
| Race/Ethnicity, Customized Race Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Race Native Hawaiian or Other Pacific Islander | 2 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Race Not Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Race Other | 14 Participants | 5 Participants | 9 Participants |
| Race/Ethnicity, Customized Race White | 288 Participants | 85 Participants | 203 Participants |
| Region of Enrollment Belgium | 19 Participants | 4 Participants | 15 Participants |
| Region of Enrollment Canada | 60 Participants | 26 Participants | 34 Participants |
| Region of Enrollment Germany | 57 Participants | 15 Participants | 42 Participants |
| Region of Enrollment Netherlands | 16 Participants | 7 Participants | 9 Participants |
| Region of Enrollment Poland | 67 Participants | 19 Participants | 48 Participants |
| Region of Enrollment Spain | 27 Participants | 15 Participants | 12 Participants |
| Region of Enrollment United Kingdom | 34 Participants | 13 Participants | 21 Participants |
| Region of Enrollment United States | 100 Participants | 28 Participants | 72 Participants |
| Scoring Atopic Dermatitis (SCORAD) | 67.59 units on a scale STANDARD_DEVIATION 13.25 | 68.86 units on a scale STANDARD_DEVIATION 13.19 | 66.95 units on a scale STANDARD_DEVIATION 13.26 |
| Sex: Female, Male Female | 171 Participants | 43 Participants | 128 Participants |
| Sex: Female, Male Male | 209 Participants | 84 Participants | 125 Participants |
| Worst Daily Pruritus numeric rating scale (NRS) (weekly average) | 7.74 units on a scale STANDARD_DEVIATION 1.51 | 7.86 units on a scale STANDARD_DEVIATION 1.49 | 7.67 units on a scale STANDARD_DEVIATION 1.51 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk |
|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 252 | 0 / 126 | 0 / 69 | 0 / 69 | 0 / 95 | 0 / 79 | 0 / 41 | 0 / 278 |
| other Total, other adverse events | 118 / 252 | 36 / 126 | 30 / 69 | 24 / 69 | 41 / 95 | 32 / 79 | 12 / 41 | 10 / 278 |
| serious Total, serious adverse events | 2 / 252 | 4 / 126 | 3 / 69 | 0 / 69 | 2 / 95 | 0 / 79 | 1 / 41 | 3 / 278 |
Outcome results
Primary
Participants Achieving at Least 75% Reduction in Eczema Area and Severity Index (EASI) at 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.
Time frame: Week 16
Population: Full analysis set (FAS). Of the 380 participants randomised to initial treatment, 378 were treated. Therefore, the FAS consisted of 378 participants (252 + 126).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Tralokinumab Q2W+TCS | Participants Achieving at Least 75% Reduction in Eczema Area and Severity Index (EASI) at Week 16 | 141 Participants |
| Placebo+TCS | Participants Achieving at Least 75% Reduction in Eczema Area and Severity Index (EASI) at Week 16 | 45 Participants |
Comparison: Participants who achieved at least 75% reduction in EASI at Week 16 were defined as responders. Participants with missing data at Week 16 or who received rescue medication prior to Week 16 were defined as non-responders, independently of their EASI value at Week 16. The null hypothesis of no difference in response rates between tralokinumab Q2W+TCS and placebo+TCS was tested against the 2-sided alternative that there was a difference.p-value: <0.00195% CI: [9.8, 30.6]Cochran-Mantel-Haenszel
Primary
Participants With Investigator's Global Assessment (IGA) Score of 0 (Clear) or 1 (Almost Clear) at 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).
Time frame: Week 16
Population: Full analysis set (FAS). Of the 380 participants randomised to initial treatment, 378 were treated. Therefore, the FAS consisted of 378 participants (252 + 126).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Tralokinumab Q2W+TCS | Participants With Investigator's Global Assessment (IGA) Score of 0 (Clear) or 1 (Almost Clear) at Week 16 | 98 Participants |
| Placebo+TCS | Participants With Investigator's Global Assessment (IGA) Score of 0 (Clear) or 1 (Almost Clear) at Week 16 | 33 Participants |
Comparison: Participants who achieved IGA 0 or 1 at Week 16 were defined as responders. Participants with missing data at Week 16 or who received rescue medication prior to Week 16 were defined as non-responders, independently of their IGA value at Week 16. The null hypothesis of no difference in response rates between tralokinumab Q2W+TCS and placebo+TCS was tested against the 2-sided alternative that there was a difference.p-value: 0.01595% CI: [2.9, 21.9]Cochran-Mantel-Haenszel
Secondary
Amount of Topical Corticosteroid (TCS) Used Through Week 16 Assuming All TCS Used From the Non-returned Tubes
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.
Time frame: Week 1-2 to Week 15-16
Population: Full analysis set. Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Tralokinumab Q2W+TCS | Amount of Topical Corticosteroid (TCS) Used Through Week 16 Assuming All TCS Used From the Non-returned Tubes | Week 1-2 | 40.1 g | Standard Error 3.22 |
| Tralokinumab Q2W+TCS | Amount of Topical Corticosteroid (TCS) Used Through Week 16 Assuming All TCS Used From the Non-returned Tubes | Week 3-4 | 32.4 g | Standard Error 3 |
| Tralokinumab Q2W+TCS | Amount of Topical Corticosteroid (TCS) Used Through Week 16 Assuming All TCS Used From the Non-returned Tubes | Week 5-6 | 29.2 g | Standard Error 2.89 |
| Tralokinumab Q2W+TCS | Amount of Topical Corticosteroid (TCS) Used Through Week 16 Assuming All TCS Used From the Non-returned Tubes | Week 7-8 | 25.2 g | Standard Error 2.89 |
| Tralokinumab Q2W+TCS | Amount of Topical Corticosteroid (TCS) Used Through Week 16 Assuming All TCS Used From the Non-returned Tubes | Week 9-10 | 22.5 g | Standard Error 2.61 |
| Tralokinumab Q2W+TCS | Amount of Topical Corticosteroid (TCS) Used Through Week 16 Assuming All TCS Used From the Non-returned Tubes | Week 11-12 | 16.9 g | Standard Error 2.23 |
| Tralokinumab Q2W+TCS | Amount of Topical Corticosteroid (TCS) Used Through Week 16 Assuming All TCS Used From the Non-returned Tubes | Week 13-14 | 16.6 g | Standard Error 2.22 |
| Tralokinumab Q2W+TCS | Amount of Topical Corticosteroid (TCS) Used Through Week 16 Assuming All TCS Used From the Non-returned Tubes | Week 15-16 | 15.3 g | Standard Error 2.26 |
| Placebo+TCS | Amount of Topical Corticosteroid (TCS) Used Through Week 16 Assuming All TCS Used From the Non-returned Tubes | Week 15-16 | 24.8 g | Standard Error 3.27 |
| Placebo+TCS | Amount of Topical Corticosteroid (TCS) Used Through Week 16 Assuming All TCS Used From the Non-returned Tubes | Week 1-2 | 40.1 g | Standard Error 4.57 |
| Placebo+TCS | Amount of Topical Corticosteroid (TCS) Used Through Week 16 Assuming All TCS Used From the Non-returned Tubes | Week 9-10 | 26.9 g | Standard Error 3.76 |
| Placebo+TCS | Amount of Topical Corticosteroid (TCS) Used Through Week 16 Assuming All TCS Used From the Non-returned Tubes | Week 3-4 | 31.3 g | Standard Error 4.27 |
| Placebo+TCS | Amount of Topical Corticosteroid (TCS) Used Through Week 16 Assuming All TCS Used From the Non-returned Tubes | Week 13-14 | 25.5 g | Standard Error 3.23 |
| Placebo+TCS | Amount of Topical Corticosteroid (TCS) Used Through Week 16 Assuming All TCS Used From the Non-returned Tubes | Week 5-6 | 30.6 g | Standard Error 4.13 |
| Placebo+TCS | Amount of Topical Corticosteroid (TCS) Used Through Week 16 Assuming All TCS Used From the Non-returned Tubes | Week 11-12 | 23.1 g | Standard Error 3.22 |
| Placebo+TCS | Amount of Topical Corticosteroid (TCS) Used Through Week 16 Assuming All TCS Used From the Non-returned Tubes | Week 7-8 | 30.0 g | Standard Error 4.15 |
Comparison: Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included. Results of Week 1-2 are reported below.p-value: 195% CI: [-11, 11]Repeated measurements model
Comparison: Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included. Results of Week 3-4 are reported below.p-value: 0.8395% CI: [-9.1, 11.4]Repeated measurements model
Comparison: Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included. Results of Week 5-6 are reported below.p-value: 0.7895% CI: [-11.3, 8.5]Repeated measurements model
Comparison: Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included. Results of Week 7-8 are reported below.p-value: 0.3495% CI: [-14.8, 5.1]Repeated measurements model
Comparison: Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included. Results of Week 9-10 are reported below.p-value: 0.3495% CI: [-13.4, 4.6]Repeated measurements model
Comparison: Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included. Results of Week 11-12 are reported below.p-value: 0.1195% CI: [-13.9, 1.5]Repeated measurements model
Comparison: Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included. Results of Week 13-14 are reported below.p-value: 0.02495% CI: [-16.6, -1.2]Repeated measurements model
Comparison: Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included. Results of Week 15-16 are reported below.p-value: 0.01795% CI: [-17.3, -1.7]Repeated measurements model
Secondary
Amount of Topical Corticosteroid (TCS) Used Through Week 16 Assuming no TCS Used From the Non-returned Tubes
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.
Time frame: Week 1-2 to Week 15-16
Population: Full analysis set. Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Tralokinumab Q2W+TCS | Amount of Topical Corticosteroid (TCS) Used Through Week 16 Assuming no TCS Used From the Non-returned Tubes | Week 1-2 | 29.3 g | Standard Error 2.45 |
| Tralokinumab Q2W+TCS | Amount of Topical Corticosteroid (TCS) Used Through Week 16 Assuming no TCS Used From the Non-returned Tubes | Week 3-4 | 19.7 g | Standard Error 1.86 |
| Tralokinumab Q2W+TCS | Amount of Topical Corticosteroid (TCS) Used Through Week 16 Assuming no TCS Used From the Non-returned Tubes | Week 5-6 | 18.5 g | Standard Error 1.72 |
| Tralokinumab Q2W+TCS | Amount of Topical Corticosteroid (TCS) Used Through Week 16 Assuming no TCS Used From the Non-returned Tubes | Week 7-8 | 17.0 g | Standard Error 2.04 |
| Tralokinumab Q2W+TCS | Amount of Topical Corticosteroid (TCS) Used Through Week 16 Assuming no TCS Used From the Non-returned Tubes | Week 9-10 | 14.8 g | Standard Error 1.66 |
| Tralokinumab Q2W+TCS | Amount of Topical Corticosteroid (TCS) Used Through Week 16 Assuming no TCS Used From the Non-returned Tubes | Week 11-12 | 11.6 g | Standard Error 1.38 |
| Tralokinumab Q2W+TCS | Amount of Topical Corticosteroid (TCS) Used Through Week 16 Assuming no TCS Used From the Non-returned Tubes | Week 13-14 | 12.7 g | Standard Error 1.61 |
| Tralokinumab Q2W+TCS | Amount of Topical Corticosteroid (TCS) Used Through Week 16 Assuming no TCS Used From the Non-returned Tubes | Week 15-16 | 11.6 g | Standard Error 1.57 |
| Placebo+TCS | Amount of Topical Corticosteroid (TCS) Used Through Week 16 Assuming no TCS Used From the Non-returned Tubes | Week 15-16 | 20.2 g | Standard Error 2.27 |
| Placebo+TCS | Amount of Topical Corticosteroid (TCS) Used Through Week 16 Assuming no TCS Used From the Non-returned Tubes | Week 1-2 | 32.8 g | Standard Error 3.47 |
| Placebo+TCS | Amount of Topical Corticosteroid (TCS) Used Through Week 16 Assuming no TCS Used From the Non-returned Tubes | Week 9-10 | 23.9 g | Standard Error 2.38 |
| Placebo+TCS | Amount of Topical Corticosteroid (TCS) Used Through Week 16 Assuming no TCS Used From the Non-returned Tubes | Week 3-4 | 26.6 g | Standard Error 2.66 |
| Placebo+TCS | Amount of Topical Corticosteroid (TCS) Used Through Week 16 Assuming no TCS Used From the Non-returned Tubes | Week 13-14 | 23.0 g | Standard Error 2.33 |
| Placebo+TCS | Amount of Topical Corticosteroid (TCS) Used Through Week 16 Assuming no TCS Used From the Non-returned Tubes | Week 5-6 | 23.2 g | Standard Error 2.46 |
| Placebo+TCS | Amount of Topical Corticosteroid (TCS) Used Through Week 16 Assuming no TCS Used From the Non-returned Tubes | Week 11-12 | 19.6 g | Standard Error 2 |
| Placebo+TCS | Amount of Topical Corticosteroid (TCS) Used Through Week 16 Assuming no TCS Used From the Non-returned Tubes | Week 7-8 | 24.3 g | Standard Error 2.93 |
Comparison: Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included. Results of Week 1-2 are reported below.p-value: 0.4195% CI: [-11.9, 4.9]Repeated measurements model
Comparison: Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included. Results of Week 3-4 are reported below.p-value: 0.03395% CI: [-13.3, -0.6]Repeated measurements model
Comparison: Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included. Results of Week 5-6 are reported below.p-value: 0.1295% CI: [-10.6, 1.2]Repeated measurements model
Comparison: Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included. Results of Week 7-8 are reported below.p-value: 0.04395% CI: [-14.3, -0.2]Repeated measurements model
Comparison: Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included. Results of Week 9-10 are reported below.p-value: 0.00295% CI: [-14.8, -3.4]Repeated measurements model
Comparison: Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included. Results of Week 11-12 are reported below.p-value: 0.00195% CI: [-12.8, -3.2]Repeated measurements model
Comparison: Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included. Results of Week 13-14 are reported below.p-value: <0.00195% CI: [-15.8, -4.7]Repeated measurements model
Comparison: Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included. Results of Week 15-16 are reported below.p-value: 0.00295% CI: [-14.1, -3.2]Repeated measurements model
Secondary
Change From Baseline to Week 16 in Eczema Area and Severity Index (EASI) Score
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.
Time frame: Week 0 to Week 16
Population: Full analysis set. Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Tralokinumab Q2W+TCS | Change From Baseline to Week 16 in Eczema Area and Severity Index (EASI) Score | -21.0 units on a scale | Standard Error 0.67 |
| Placebo+TCS | Change From Baseline to Week 16 in Eczema Area and Severity Index (EASI) Score | -15.6 units on a scale | Standard Error 0.96 |
Comparison: Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included.p-value: <0.00195% CI: [-7.7, -3.1]Repeated measurement model
Secondary
Change From Baseline to Week 16 in Worst Daily Pruritus Numeric Rating Scale (NRS) (Weekly Average)
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.
Time frame: Week 0 to Week 16
Population: Full analysis set. Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Tralokinumab Q2W+TCS | Change From Baseline to Week 16 in Worst Daily Pruritus Numeric Rating Scale (NRS) (Weekly Average) | -4.1 units on a scale | Standard Error 0.15 |
| Placebo+TCS | Change From Baseline to Week 16 in Worst Daily Pruritus Numeric Rating Scale (NRS) (Weekly Average) | -2.9 units on a scale | Standard Error 0.21 |
Comparison: Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included.p-value: <0.00195% CI: [-1.7, -0.7]Repeated measurements model
Secondary
Change in Dermatology Life Quality Index (DLQI) Score From Baseline 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.
Time frame: Week 0 to Week 16
Population: Full analysis set
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Tralokinumab Q2W+TCS | Change in Dermatology Life Quality Index (DLQI) Score From Baseline to Week 16 | -11.7 units on a scale | Standard Error 0.39 |
| Placebo+TCS | Change in Dermatology Life Quality Index (DLQI) Score From Baseline to Week 16 | -8.8 units on a scale | Standard Error 0.56 |
Comparison: Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included.p-value: <0.00195% CI: [-4.3, -1.6]Repeated measurements model
Secondary
Change in Scoring Atopic Dermatitis (SCORAD) From Baseline 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.
Time frame: Week 0 to Week 16
Population: Full analysis set
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Tralokinumab Q2W+TCS | Change in Scoring Atopic Dermatitis (SCORAD) From Baseline to Week 16 | -37.7 units on a scale | Standard Error 1.25 |
| Placebo+TCS | Change in Scoring Atopic Dermatitis (SCORAD) From Baseline to Week 16 | -26.8 units on a scale | Standard Error 1.8 |
Comparison: Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included.p-value: <0.00195% CI: [-15.2, -6.6]Repeated measurements model
Secondary
Frequency of Anti-drug Antibodies (ADA)
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.
Time frame: Week 0 to Week 16, Week 16 to Week 32
Population: Safety analysis set (378 participants). Data was collected for the treatment groups applicable in each treatment period, i.e. tralokinumab Q2W+TCS and placebo+TCS treatment groups in the initial treatment period and the 5 continuation treatment groups (see table below) in the continuation treatment period.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Tralokinumab Q2W+TCS | Frequency of Anti-drug Antibodies (ADA) | Initial treatment period (Week 0 to Week 16) | Negative | 246 Participants |
| Tralokinumab Q2W+TCS | Frequency of Anti-drug Antibodies (ADA) | Initial treatment period (Week 0 to Week 16) | Perishing | 1 Participants |
| Tralokinumab Q2W+TCS | Frequency of Anti-drug Antibodies (ADA) | Initial treatment period (Week 0 to Week 16) | Positive | 2 Participants |
| Tralokinumab Q2W+TCS | Frequency of Anti-drug Antibodies (ADA) | Initial treatment period (Week 0 to Week 16) | No post-baseline ADA assessment | 3 Participants |
| Tralokinumab Q2W+TCS | Frequency of Anti-drug Antibodies (ADA) | Continuation treatment period (Week 16 to Week 32) | Positive | 0 Participants |
| Tralokinumab Q2W+TCS | Frequency of Anti-drug Antibodies (ADA) | Continuation treatment period (Week 16 to Week 32) | Perishing | 0 Participants |
| Tralokinumab Q2W+TCS | Frequency of Anti-drug Antibodies (ADA) | Continuation treatment period (Week 16 to Week 32) | Negative | 0 Participants |
| Tralokinumab Q2W+TCS | Frequency of Anti-drug Antibodies (ADA) | Continuation treatment period (Week 16 to Week 32) | No post-baseline ADA assessment | 0 Participants |
| Placebo+TCS | Frequency of Anti-drug Antibodies (ADA) | Initial treatment period (Week 0 to Week 16) | Perishing | 0 Participants |
| Placebo+TCS | Frequency of Anti-drug Antibodies (ADA) | Continuation treatment period (Week 16 to Week 32) | No post-baseline ADA assessment | 0 Participants |
| Placebo+TCS | Frequency of Anti-drug Antibodies (ADA) | Initial treatment period (Week 0 to Week 16) | Negative | 123 Participants |
| Placebo+TCS | Frequency of Anti-drug Antibodies (ADA) | Initial treatment period (Week 0 to Week 16) | No post-baseline ADA assessment | 0 Participants |
| Placebo+TCS | Frequency of Anti-drug Antibodies (ADA) | Continuation treatment period (Week 16 to Week 32) | Positive | 0 Participants |
| Placebo+TCS | Frequency of Anti-drug Antibodies (ADA) | Continuation treatment period (Week 16 to Week 32) | Perishing | 0 Participants |
| Placebo+TCS | Frequency of Anti-drug Antibodies (ADA) | Continuation treatment period (Week 16 to Week 32) | Negative | 0 Participants |
| Placebo+TCS | Frequency of Anti-drug Antibodies (ADA) | Initial treatment period (Week 0 to Week 16) | Positive | 3 Participants |
| Continuation Treatment Period - Tralokinumab R/Q2W+TCS | Frequency of Anti-drug Antibodies (ADA) | Initial treatment period (Week 0 to Week 16) | Negative | 0 Participants |
| Continuation Treatment Period - Tralokinumab R/Q2W+TCS | Frequency of Anti-drug Antibodies (ADA) | Continuation treatment period (Week 16 to Week 32) | No post-baseline ADA assessment | 0 Participants |
| Continuation Treatment Period - Tralokinumab R/Q2W+TCS | Frequency of Anti-drug Antibodies (ADA) | Initial treatment period (Week 0 to Week 16) | No post-baseline ADA assessment | 0 Participants |
| Continuation Treatment Period - Tralokinumab R/Q2W+TCS | Frequency of Anti-drug Antibodies (ADA) | Continuation treatment period (Week 16 to Week 32) | Positive | 0 Participants |
| Continuation Treatment Period - Tralokinumab R/Q2W+TCS | Frequency of Anti-drug Antibodies (ADA) | Continuation treatment period (Week 16 to Week 32) | Perishing | 0 Participants |
| Continuation Treatment Period - Tralokinumab R/Q2W+TCS | Frequency of Anti-drug Antibodies (ADA) | Continuation treatment period (Week 16 to Week 32) | Negative | 66 Participants |
| Continuation Treatment Period - Tralokinumab R/Q2W+TCS | Frequency of Anti-drug Antibodies (ADA) | Initial treatment period (Week 0 to Week 16) | Perishing | 0 Participants |
| Continuation Treatment Period - Tralokinumab R/Q2W+TCS | Frequency of Anti-drug Antibodies (ADA) | Initial treatment period (Week 0 to Week 16) | Positive | 0 Participants |
| Continuation Treatment Period - Tralokinumab R/Q4W+TCS | Frequency of Anti-drug Antibodies (ADA) | Initial treatment period (Week 0 to Week 16) | No post-baseline ADA assessment | 0 Participants |
| Continuation Treatment Period - Tralokinumab R/Q4W+TCS | Frequency of Anti-drug Antibodies (ADA) | Continuation treatment period (Week 16 to Week 32) | No post-baseline ADA assessment | 0 Participants |
| Continuation Treatment Period - Tralokinumab R/Q4W+TCS | Frequency of Anti-drug Antibodies (ADA) | Continuation treatment period (Week 16 to Week 32) | Positive | 2 Participants |
| Continuation Treatment Period - Tralokinumab R/Q4W+TCS | Frequency of Anti-drug Antibodies (ADA) | Continuation treatment period (Week 16 to Week 32) | Perishing | 0 Participants |
| Continuation Treatment Period - Tralokinumab R/Q4W+TCS | Frequency of Anti-drug Antibodies (ADA) | Continuation treatment period (Week 16 to Week 32) | Negative | 63 Participants |
| Continuation Treatment Period - Tralokinumab R/Q4W+TCS | Frequency of Anti-drug Antibodies (ADA) | Initial treatment period (Week 0 to Week 16) | Negative | 0 Participants |
| Continuation Treatment Period - Tralokinumab R/Q4W+TCS | Frequency of Anti-drug Antibodies (ADA) | Initial treatment period (Week 0 to Week 16) | Positive | 0 Participants |
| Continuation Treatment Period - Tralokinumab R/Q4W+TCS | Frequency of Anti-drug Antibodies (ADA) | Initial treatment period (Week 0 to Week 16) | Perishing | 0 Participants |
| Continuation Treatment Period - Tralokinumab NR/Q2W+TCS | Frequency of Anti-drug Antibodies (ADA) | Continuation treatment period (Week 16 to Week 32) | Positive | 0 Participants |
| Continuation Treatment Period - Tralokinumab NR/Q2W+TCS | Frequency of Anti-drug Antibodies (ADA) | Continuation treatment period (Week 16 to Week 32) | No post-baseline ADA assessment | 0 Participants |
| Continuation Treatment Period - Tralokinumab NR/Q2W+TCS | Frequency of Anti-drug Antibodies (ADA) | Continuation treatment period (Week 16 to Week 32) | Perishing | 0 Participants |
| Continuation Treatment Period - Tralokinumab NR/Q2W+TCS | Frequency of Anti-drug Antibodies (ADA) | Continuation treatment period (Week 16 to Week 32) | Negative | 92 Participants |
| Continuation Treatment Period - Tralokinumab NR/Q2W+TCS | Frequency of Anti-drug Antibodies (ADA) | Initial treatment period (Week 0 to Week 16) | No post-baseline ADA assessment | 0 Participants |
| Continuation Treatment Period - Tralokinumab NR/Q2W+TCS | Frequency of Anti-drug Antibodies (ADA) | Initial treatment period (Week 0 to Week 16) | Positive | 0 Participants |
| Continuation Treatment Period - Tralokinumab NR/Q2W+TCS | Frequency of Anti-drug Antibodies (ADA) | Initial treatment period (Week 0 to Week 16) | Perishing | 0 Participants |
| Continuation Treatment Period - Tralokinumab NR/Q2W+TCS | Frequency of Anti-drug Antibodies (ADA) | Initial treatment period (Week 0 to Week 16) | Negative | 0 Participants |
| Continuation Treatment Period - Placebo NR/Tralokinumab Q2W+TCS | Frequency of Anti-drug Antibodies (ADA) | Continuation treatment period (Week 16 to Week 32) | Perishing | 0 Participants |
| Continuation Treatment Period - Placebo NR/Tralokinumab Q2W+TCS | Frequency of Anti-drug Antibodies (ADA) | Continuation treatment period (Week 16 to Week 32) | No post-baseline ADA assessment | 0 Participants |
| Continuation Treatment Period - Placebo NR/Tralokinumab Q2W+TCS | Frequency of Anti-drug Antibodies (ADA) | Continuation treatment period (Week 16 to Week 32) | Negative | 74 Participants |
| Continuation Treatment Period - Placebo NR/Tralokinumab Q2W+TCS | Frequency of Anti-drug Antibodies (ADA) | Continuation treatment period (Week 16 to Week 32) | Positive | 3 Participants |
| Continuation Treatment Period - Placebo NR/Tralokinumab Q2W+TCS | Frequency of Anti-drug Antibodies (ADA) | Initial treatment period (Week 0 to Week 16) | Positive | 0 Participants |
| Continuation Treatment Period - Placebo NR/Tralokinumab Q2W+TCS | Frequency of Anti-drug Antibodies (ADA) | Initial treatment period (Week 0 to Week 16) | Perishing | 0 Participants |
| Continuation Treatment Period - Placebo NR/Tralokinumab Q2W+TCS | Frequency of Anti-drug Antibodies (ADA) | Initial treatment period (Week 0 to Week 16) | Negative | 0 Participants |
| Continuation Treatment Period - Placebo NR/Tralokinumab Q2W+TCS | Frequency of Anti-drug Antibodies (ADA) | Initial treatment period (Week 0 to Week 16) | No post-baseline ADA assessment | 0 Participants |
| Continuation Treatment Period - Placebo R/Placebo+TCS | Frequency of Anti-drug Antibodies (ADA) | Continuation treatment period (Week 16 to Week 32) | Negative | 37 Participants |
| Continuation Treatment Period - Placebo R/Placebo+TCS | Frequency of Anti-drug Antibodies (ADA) | Continuation treatment period (Week 16 to Week 32) | Perishing | 0 Participants |
| Continuation Treatment Period - Placebo R/Placebo+TCS | Frequency of Anti-drug Antibodies (ADA) | Continuation treatment period (Week 16 to Week 32) | No post-baseline ADA assessment | 0 Participants |
| Continuation Treatment Period - Placebo R/Placebo+TCS | Frequency of Anti-drug Antibodies (ADA) | Initial treatment period (Week 0 to Week 16) | Positive | 0 Participants |
| Continuation Treatment Period - Placebo R/Placebo+TCS | Frequency of Anti-drug Antibodies (ADA) | Initial treatment period (Week 0 to Week 16) | Perishing | 0 Participants |
| Continuation Treatment Period - Placebo R/Placebo+TCS | Frequency of Anti-drug Antibodies (ADA) | Initial treatment period (Week 0 to Week 16) | Negative | 0 Participants |
| Continuation Treatment Period - Placebo R/Placebo+TCS | Frequency of Anti-drug Antibodies (ADA) | Initial treatment period (Week 0 to Week 16) | No post-baseline ADA assessment | 0 Participants |
| Continuation Treatment Period - Placebo R/Placebo+TCS | Frequency of Anti-drug Antibodies (ADA) | Continuation treatment period (Week 16 to Week 32) | Positive | 2 Participants |
Secondary
Number of Atopic Dermatitis Flares Through Week 16
Assessed as appearance of new flares since previous visit.
Time frame: Week 0 to Week 16
Population: Full analysis set. All observed data
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tralokinumab Q2W+TCS | Number of Atopic Dermatitis Flares Through Week 16 | 119 number of flares |
| Placebo+TCS | Number of Atopic Dermatitis Flares Through Week 16 | 75 number of flares |
Secondary
Number of Days Without Topical Treatment Use From Baseline 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.
Time frame: Week 1 to Week 16
Population: Full analysis set. Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Tralokinumab Q2W+TCS | Number of Days Without Topical Treatment Use From Baseline to Week 16 | Week 1 | 2.6 days | Standard Error 0.17 |
| Tralokinumab Q2W+TCS | Number of Days Without Topical Treatment Use From Baseline to Week 16 | Week 2 | 3.0 days | Standard Error 0.18 |
| Tralokinumab Q2W+TCS | Number of Days Without Topical Treatment Use From Baseline to Week 16 | Week 3 | 2.9 days | Standard Error 0.17 |
| Tralokinumab Q2W+TCS | Number of Days Without Topical Treatment Use From Baseline to Week 16 | Week 4 | 3.1 days | Standard Error 0.17 |
| Tralokinumab Q2W+TCS | Number of Days Without Topical Treatment Use From Baseline to Week 16 | Week 5 | 3.2 days | Standard Error 0.17 |
| Tralokinumab Q2W+TCS | Number of Days Without Topical Treatment Use From Baseline to Week 16 | Week 6 | 3.1 days | Standard Error 0.18 |
| Tralokinumab Q2W+TCS | Number of Days Without Topical Treatment Use From Baseline to Week 16 | Week 7 | 3.3 days | Standard Error 0.17 |
| Tralokinumab Q2W+TCS | Number of Days Without Topical Treatment Use From Baseline to Week 16 | Week 8 | 3.3 days | Standard Error 0.18 |
| Tralokinumab Q2W+TCS | Number of Days Without Topical Treatment Use From Baseline to Week 16 | Week 9 | 3.6 days | Standard Error 0.17 |
| Tralokinumab Q2W+TCS | Number of Days Without Topical Treatment Use From Baseline to Week 16 | Week 10 | 3.4 days | Standard Error 0.17 |
| Tralokinumab Q2W+TCS | Number of Days Without Topical Treatment Use From Baseline to Week 16 | Week 11 | 3.6 days | Standard Error 0.18 |
| Tralokinumab Q2W+TCS | Number of Days Without Topical Treatment Use From Baseline to Week 16 | Week 12 | 3.4 days | Standard Error 0.18 |
| Tralokinumab Q2W+TCS | Number of Days Without Topical Treatment Use From Baseline to Week 16 | Week 13 | 3.5 days | Standard Error 0.18 |
| Tralokinumab Q2W+TCS | Number of Days Without Topical Treatment Use From Baseline to Week 16 | Week 14 | 3.3 days | Standard Error 0.18 |
| Tralokinumab Q2W+TCS | Number of Days Without Topical Treatment Use From Baseline to Week 16 | Week 15 | 3.5 days | Standard Error 0.18 |
| Tralokinumab Q2W+TCS | Number of Days Without Topical Treatment Use From Baseline to Week 16 | Week 16 | 3.4 days | Standard Error 0.19 |
| Placebo+TCS | Number of Days Without Topical Treatment Use From Baseline to Week 16 | Week 16 | 3.0 days | Standard Error 0.27 |
| Placebo+TCS | Number of Days Without Topical Treatment Use From Baseline to Week 16 | Week 1 | 2.5 days | Standard Error 0.25 |
| Placebo+TCS | Number of Days Without Topical Treatment Use From Baseline to Week 16 | Week 9 | 2.6 days | Standard Error 0.25 |
| Placebo+TCS | Number of Days Without Topical Treatment Use From Baseline to Week 16 | Week 2 | 2.6 days | Standard Error 0.27 |
| Placebo+TCS | Number of Days Without Topical Treatment Use From Baseline to Week 16 | Week 13 | 2.7 days | Standard Error 0.26 |
| Placebo+TCS | Number of Days Without Topical Treatment Use From Baseline to Week 16 | Week 3 | 2.7 days | Standard Error 0.25 |
| Placebo+TCS | Number of Days Without Topical Treatment Use From Baseline to Week 16 | Week 10 | 2.7 days | Standard Error 0.25 |
| Placebo+TCS | Number of Days Without Topical Treatment Use From Baseline to Week 16 | Week 4 | 2.7 days | Standard Error 0.25 |
| Placebo+TCS | Number of Days Without Topical Treatment Use From Baseline to Week 16 | Week 15 | 2.8 days | Standard Error 0.26 |
| Placebo+TCS | Number of Days Without Topical Treatment Use From Baseline to Week 16 | Week 5 | 2.7 days | Standard Error 0.25 |
| Placebo+TCS | Number of Days Without Topical Treatment Use From Baseline to Week 16 | Week 11 | 2.7 days | Standard Error 0.26 |
| Placebo+TCS | Number of Days Without Topical Treatment Use From Baseline to Week 16 | Week 6 | 2.8 days | Standard Error 0.26 |
| Placebo+TCS | Number of Days Without Topical Treatment Use From Baseline to Week 16 | Week 14 | 2.6 days | Standard Error 0.26 |
| Placebo+TCS | Number of Days Without Topical Treatment Use From Baseline to Week 16 | Week 7 | 2.7 days | Standard Error 0.25 |
| Placebo+TCS | Number of Days Without Topical Treatment Use From Baseline to Week 16 | Week 12 | 2.7 days | Standard Error 0.26 |
| Placebo+TCS | Number of Days Without Topical Treatment Use From Baseline to Week 16 | Week 8 | 3.0 days | Standard Error 0.26 |
Comparison: Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included. Results of Week 1 are reported below.p-value: 0.6495% CI: [-0.5, 0.7]Repeated measurements model
Comparison: Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included. Results of Week 2 are reported below.p-value: 0.2695% CI: [-0.3, 1]Repeated measurements model
Comparison: Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included. Results of Week 3 are reported below.p-value: 0.4695% CI: [-0.4, 0.8]Repeated measurements model
Comparison: Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included. Results of Week 4 are reported below.p-value: 0.1695% CI: [-0.2, 1]Repeated measurements model
Comparison: Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included. Results of Week 5 are reported below.p-value: 0.1395% CI: [-0.1, 1.1]Repeated measurements model
Comparison: Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included. Results of Week 6 are reported below.p-value: 0.3895% CI: [-0.3, 0.9]Repeated measurements model
Comparison: Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included. Results of Week 7 are reported below.p-value: 0.0495% CI: [0, 1.2]Repeated measurements model
Comparison: Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included. Results of Week 8 are reported below.p-value: 0.3195% CI: [-0.3, 1]Repeated measurements model
Comparison: Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included. Results of Week 9 are reported below.p-value: 0.00195% CI: [0.4, 1.6]Repeated measurements model
Comparison: Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included. Results of Week 10 are reported below.p-value: 0.02695% CI: [0.1, 1.3]Repeated measurements model
Comparison: Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included. Results of Week 11 are reported below.p-value: 0.00695% CI: [0.2, 1.5]Repeated measurements model]
Comparison: Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included. Results of Week 12 are reported below.p-value: 0.04395% CI: [0, 1.3]Repeated measurements model
Comparison: Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included. Results of Week 13 are reported below.p-value: 0.0195% CI: [0.2, 1.4]Repeated measurements model
Comparison: Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included. Results of Week 14 are reported below.p-value: 0.03795% CI: [0, 1.3]Repeated measurements model
Comparison: Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included. Results of Week 15 are reported below.p-value: 0.04595% CI: [0, 1.3]Repeated measurements model
Comparison: Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included. Results of Week 16 are reported below.p-value: 0.1795% CI: [-0.2, 1.1]Repeated measurements model
Secondary
Participants Achieving at Least 50% Reduction in Eczema Area and Severity Index (EASI) at 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.
Time frame: Week 16
Population: Full analysis set
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Tralokinumab Q2W+TCS | Participants Achieving at Least 50% Reduction in Eczema Area and Severity Index (EASI) at Week 16 | 200 Participants |
| Placebo+TCS | Participants Achieving at Least 50% Reduction in Eczema Area and Severity Index (EASI) at Week 16 | 73 Participants |
Comparison: Participants meeting the endpoint were defined as responders. Participants with missing data at Week 16 or who received rescue medication prior to Week 16 were defined as non-responders, independently of their EASI value at Week 16.p-value: <0.00195% CI: [11.3, 31.3]Cochran-Mantel-Haenszel
Secondary
Participants Achieving at Least 50% Reduction in Scoring Atopic Dermatitis (SCORAD) at 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.
Time frame: Week 16
Population: Full analysis set
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Tralokinumab Q2W+TCS | Participants Achieving at Least 50% Reduction in Scoring Atopic Dermatitis (SCORAD) at Week 16 | 154 Participants |
| Placebo+TCS | Participants Achieving at Least 50% Reduction in Scoring Atopic Dermatitis (SCORAD) at Week 16 | 48 Participants |
Comparison: Partcipants meeting the endpoint were defined as responders. Participants with missing data at Week 16 or who received rescue medication prior to Week 16 were defined as non-responders, independently of their SCORAD value at Week 16.p-value: <0.00195% CI: [12.4, 33.3]Cochran-Mantel-Haenszel
Secondary
Participants Achieving at Least 75% Reduction in Eczema Area and Severity Index (EASI) at Week 32 Among Participants Who Had Achieved at Least 75% Reduction in EASI at Week 16 After Initial Randomisation to Tralokinumab
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.
Time frame: Week 32
Population: Participants in the continuation treatment analysis set treated with tralokinumab Q2W+TCS in the initial treatment period and who achieved at least 75% reduction in EASI at Week 16 without rescue medication. Participants who received rescue medication prior to Week 32 or with missing data at Week 32 were not included in the analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Tralokinumab Q2W+TCS | Participants Achieving at Least 75% Reduction in Eczema Area and Severity Index (EASI) at Week 32 Among Participants Who Had Achieved at Least 75% Reduction in EASI at Week 16 After Initial Randomisation to Tralokinumab | 62 Participants |
| Placebo+TCS | Participants Achieving at Least 75% Reduction in Eczema Area and Severity Index (EASI) at Week 32 Among Participants Who Had Achieved at Least 75% Reduction in EASI at Week 16 After Initial Randomisation to Tralokinumab | 59 Participants |
Secondary
Participants Achieving at Least 75% Reduction in Scoring Atopic Dermatitis (SCORAD) at 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.
Time frame: Week 16
Population: Full analysis set
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Tralokinumab Q2W+TCS | Participants Achieving at Least 75% Reduction in Scoring Atopic Dermatitis (SCORAD) at Week 16 | 60 Participants |
| Placebo+TCS | Participants Achieving at Least 75% Reduction in Scoring Atopic Dermatitis (SCORAD) at Week 16 | 16 Participants |
Comparison: Participants meeting the endpoint were defined as responders. Participants with missing data at Week 16 or who received rescue medication prior to Week 16 were defined as non-responders, independently of their SCORAD value at Week 16.p-value: 0.01295% CI: [3.2, 19]Cochran-Mantel-Haenszel
Secondary
Participants Achieving at Least 90% Reduction in Eczema Area and Severity Index (EASI) at 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.
Time frame: Week 16
Population: Full analysis set
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Tralokinumab Q2W+TCS | Participants Achieving at Least 90% Reduction in Eczema Area and Severity Index (EASI) at Week 16 | 83 Participants |
| Placebo+TCS | Participants Achieving at Least 90% Reduction in Eczema Area and Severity Index (EASI) at Week 16 | 27 Participants |
Comparison: Participants meeting the endpoint were defined as responders. Participants with missing data at Week 16 or who received rescue medication prior to Week 16 were defined as non-responders, independently of their EASI value at Week 16.p-value: 0.02295% CI: [2.1, 20.7]Cochran-Mantel-Haenszel
Secondary
Participants With Investigator's Global Assessment (IGA) Score of 0 (Clear) or 1 (Almost Clear) at Week 32 Among Participants With IGA Score of 0 or 1 at Week 16 After Initial Randomisation to Tralokinumab
IGA is used to evaluate the severity of atopic dermatitis. It is a 5-point score ranging from 0 (clear) to 4 (severe).
Time frame: Week 32
Population: Participants in the continuation treatment analysis set treated with tralokinumab Q2W+TCS in the initial treatment period and who achieved IGA score of 0 or 1 at Week 16 without rescue medication. Participants who received rescue medication prior to Week 32 or with missing data at Week 32 were not included in the analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Tralokinumab Q2W+TCS | Participants With Investigator's Global Assessment (IGA) Score of 0 (Clear) or 1 (Almost Clear) at Week 32 Among Participants With IGA Score of 0 or 1 at Week 16 After Initial Randomisation to Tralokinumab | 43 Participants |
| Placebo+TCS | Participants With Investigator's Global Assessment (IGA) Score of 0 (Clear) or 1 (Almost Clear) at Week 32 Among Participants With IGA Score of 0 or 1 at Week 16 After Initial Randomisation to Tralokinumab | 38 Participants |
Secondary
Reduction From Baseline to Week 16 of Dermatology Life Quality Index (DLQI) of at Least 4 Points Among Participants With Baseline DLQI ≥4
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.
Time frame: Week 0 to Week 16
Population: Participants in the full analysis set with DLQI of at least 4 at baseline (Week 0).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Tralokinumab Q2W+TCS | Reduction From Baseline to Week 16 of Dermatology Life Quality Index (DLQI) of at Least 4 Points Among Participants With Baseline DLQI ≥4 | 207 Participants |
| Placebo+TCS | Reduction From Baseline to Week 16 of Dermatology Life Quality Index (DLQI) of at Least 4 Points Among Participants With Baseline DLQI ≥4 | 81 Participants |
Comparison: Participants meeting the endpoint were defined as responders. Participants with missing data at Week 16 or who received rescue medication prior to Week 16 were defined as non-responders, independently of their DLQI value at Week 16.p-value: <0.00195% CI: [8, 27.1]Cochran-Mantel-Haenszel
Secondary
Reduction of Worst Daily Pruritus Numeric Rating Scale (NRS) (Weekly Average) of at Least 4 From Baseline 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.
Time frame: Week 0 to Week 16
Population: Participants in the full analysis set with a Worst Daily Pruritus NRS (weekly average) of at least 4 at baseline (Week 0).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Tralokinumab Q2W+TCS | Reduction of Worst Daily Pruritus Numeric Rating Scale (NRS) (Weekly Average) of at Least 4 From Baseline to Week 16 | 113 Participants |
| Placebo+TCS | Reduction of Worst Daily Pruritus Numeric Rating Scale (NRS) (Weekly Average) of at Least 4 From Baseline to Week 16 | 43 Participants |
Comparison: Participants meeting the endpoint were defined as responders. Participants with missing data at Week 16 or who received rescue medication prior to Week 16 were defined as non-responders, independently of their Worst daily Pruritus NRS value at Week 16.p-value: 0.03795% CI: [0.9, 21.6]Cochran-Mantel-Haenszel