Atopic Dermatitis
Conditions
Brief summary
Primary objective: To evaluate the efficacy of tralokinumab in combination with topical corticosteroids (TCS) compared with 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, health-related quality of life, and health care resource utilisation 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 16 weeks.
Interventions
DRUGTralokinumab
Tralokinumab is a human recombinant monoclonal antibody of the immunoglobulin G4 subclass that specifically binds to human interleukin-13 (IL-13) and blocks the interaction with IL-13 receptors. It is presented as a liquid formulation for subcutaneous administration.
DRUGPlacebo
Placebo contains the same excipients in the same concentration only lacking tralokinumab.
TCS administered as needed.
Sponsors
LEO Pharma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
Neither the trial participant nor any of the investigator or LEO pharma staff who are involved in the treatment or clinical evaluation and monitoring of the participants will be aware of the treatment received. The packaging and labelling of the investigational medicinal product (IMP) 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 healthcare professional at the site who will not be involved in the management of trial participants and who will not perform any of the assessments.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key inclusion criteria: * Japanese subject aged 18 years and above. * Diagnosis of AD as defined by the Hanifin and Rajka (1980) criteria for AD. * History of AD for 1 year or more. * A recent history (within 1 year before screening) of inadequate response to treatment with topical medication. * AD involvement of 10% or more body surface area at screening and at baseline according to component A of SCORAD. * Applied a stable dose of emollient twice daily (or more, as needed) for at least 14 days before randomisation. Key
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 or would interfere with assessment of treatment. * Use of tanning beds or phototherapy within 6 weeks prior to randomisation. * Treatment with systemic immunosuppressive/immunomodulating drugs and/or systemic corticosteroids within 4 weeks prior to randomisation. * Treatment with TCS, topical calcineurin inhibitors, topical phosphodiesterase-4 inhibitors, or topical Janus kinase inhibitors within 2 weeks prior to randomisation. * Receipt of any marketed biological therapy (i.e. immunoglobulin, anti-immunoglobulin E) including dupilumab or investigational biologic agents 3 to 6 months prior to randomisation. * Active skin infections 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 |
|---|---|---|
| Investigator's Global Assessment (IGA) Score of 0 (Clear) or 1 (Almost Clear) at Week 16 | Week 16 | 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). |
| At Least 75% Reduction in Eczema Area and Severity Index (EASI75) at Week 16 | Week 0 to Week 16 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Reduction of Worst Daily Pruritus Numeric Rating Scale (NRS) Score (Weekly Average) of at Least 4 From Baseline to Week 16 | Week 0 to Week 16 | Participants assessed the itch for the past 24 hours using the Worst Daily Pruritus NRS, consisting of 11 points, with 0 indicating 'no itch' and 10 indicating 'worst itch imaginable'. |
| At Least 90% Reduction in EASI (EASI90) at Week 16 | Week 0 to Week 16 | 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. |
| At Least 50% Reduction in EASI (EASI50) at Week 16 | Week 0 to Week 16 | 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. |
| Percentage Change in EASI Score From Baseline to Week 16 | Week 0 to Week 16 | 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. |
| Change in Scoring Atopic Dermatitis (SCORAD) Total Score From Baseline to Week 16 | Week 0 to Week 16 | SCORAD is a validated tool to evaluate the AD disease based on 3 components: * A) The extent of AD lesions. Assessed as percentage of each defined body area and reported as sum of all areas (max score = 100%). * B) The severity of AD lesions. The intensity of 6 specific symptoms on a representative area was assessed using the scale: 0 = none/absent, 1 = mild, 2 = moderate, 3 = severe (max score = 18). * C) Subjective symptoms. The itch and sleeplessness over the last 3 days/nights was recorded for each symptom by the subject on a VAS scale: 0 = no itch or trouble sleeping, 10 = unbearable itch or a lot of trouble sleeping (max score = 20). The SCORAD was calculated as: A/5+7B/2+C. The maximum total score is 103, with higher values indicating more severe disease. |
| Change in Eczema-related Sleep NRS Score (Weekly Average) From Baseline to Week 16 | Week 0 to Week 16 | Participants rated how much their eczema interfered with their sleep the last night using an 11-point NRS (0 indicating that it 'did not interfere' and 10 indicating that it 'completely interfered'). |
| Change in Patient-Oriented Eczema Measure (POEM) Score Form Baseline to Week 16 | Week 0 to Week 16 | POEM consists of 7 items, each addressing a specific symptom (itching, sleep, bleeding, weeping, cracking, flaking, and dryness). Participants score how often they have experienced each symptom over the previous week, using a 5-point categorical response scale (0=no days; 1=1 to 2 days; 2=3 to 4 days; 3=5 to 6 days; 4=every day). The total score is the sum of the 7 items (ranging from 0 to 28) and reflects disease-related morbidity; higher scores indicate more severe disease. |
| Number of Treatment-emergent Adverse Events From Baseline to Week 16 Per Subject | Week 0 to Week 16 | Number of events divided by patient years of exposure (= rate). |
| Number of Subjects With Presence of Treatment-emergent Anti-drug Antibodies (ADA) From Baseline to Week 16 | Week 0 to Week 16 | Anti-tralokinumab antibody levels were analyzed using a validated bioanalytical method. Positive treatment-emergent ADA was defined as ADA negative or missing at baseline, and at least one positive post-baseline ADA response. Negative treatment-emergent ADA was defined as ADA negative or missing at baseline, and all post-baseline ADA assessments negative. |
| Change in Worst Daily Pruritus NRS Score (Weekly Average) From Baseline to Week 16 | Week 0 to Week 16 | Participants assessed the itch for the past 24 hours using the Worst Daily Pruritus NRS, consisting of 11 points, with 0 indicating 'no itch' and 10 indicating 'worst itch imaginable'. |
| Change in Dermatology Life Quality Index (DLQI) Score From Baseline to Week 16. | Week 0 to Week 16 | DLQI consists of 10 items addressing the participant's perception of the impact of their skin disease on different aspects of their health-related quality of life over the past week, such as dermatology-related symptoms and feelings, daily activities, leisure, work or school, personal relationships, and the treatment. Each item is scored on a 4-point Likert scale (0=not at all ⁄ not relevant; 1=a little; 2=a lot; 3=very much). The total score is the sum of the 10 items (ranging from 0 to 30), with higher scores indicating poorer health-related quality of life. |
Countries
Japan
Participant flow
Recruitment details
First subject first visit: 27-Oct-2020. Subjects were recruited at 25 sites in Japan.
Pre-assignment details
126 subjects were screened. 20 subjects were screening failures. 106 subjects were included in the trial and randomised 1:1 to tralokinumab+TCS and placebo+TCS. All randomised subjects received at least 1 dose of investigational medicinal product (IMP).
Participants by arm
| Arm | Count |
|---|---|
| Tralokinumab+TCS Treatment period (Week 0 to Week 16): Participants were treated with 300 mg tralokinumab every 2 weeks until Week 14, after a loading dose of 600 mg tralokinumab at Week 0. TCS was applied on the skin as needed. | 53 |
| Placebo+TCS Treatment period (Week 0 to Week 16): Participants received placebo every 2 weeks until Week 14, after a loading dose of placebo at Week 0. TCS was applied on the skin as needed. | 53 |
| Total | 106 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Treatment Period (Week 0 to Week 16) | Premature (before Week 16) discontinuation of IMP | 0 | 1 |
Baseline characteristics
| Characteristic | Tralokinumab+TCS | Total | Placebo+TCS |
|---|---|---|---|
| Age at onset of atopic dermatitis | 3.0 years | 4.0 years | 5.0 years |
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 1 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 52 Participants | 105 Participants | 53 Participants |
| Age, Continuous | 39.0 years STANDARD_DEVIATION 13.7 | 39.0 years STANDARD_DEVIATION 12.9 | 38.9 years STANDARD_DEVIATION 12.1 |
| Body surface area (BSA) with atopic dermatitis | 66.6 percentage of BSA affected STANDARD_DEVIATION 20.7 | 65.5 percentage of BSA affected STANDARD_DEVIATION 19.6 | 64.4 percentage of BSA affected STANDARD_DEVIATION 18.5 |
| Dermatology Life Quality Index (DLQI) | 13.09 score on a scale STANDARD_DEVIATION 6.92 | 13.70 score on a scale STANDARD_DEVIATION 6.65 | 14.30 score on a scale STANDARD_DEVIATION 6.39 |
| Duration of atopic dermatitis | 32.0 years STANDARD_DEVIATION 13 | 31.4 years STANDARD_DEVIATION 13.5 | 30.8 years STANDARD_DEVIATION 14 |
| Eczema Area and Severity Index (EASI) score | 37.12 score on a scale STANDARD_DEVIATION 15.71 | 34.71 score on a scale STANDARD_DEVIATION 14.25 | 32.30 score on a scale STANDARD_DEVIATION 12.32 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 53 Participants | 106 Participants | 53 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| 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) Moderate | 23 Participants | 46 Participants | 23 Participants |
| Investigator's Global Assessment (IGA) Severe | 30 Participants | 60 Participants | 30 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 53 Participants | 106 Participants | 53 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment Japan | 53 Participants | 106 Participants | 53 Participants |
| Scoring Atopic Dermatitis (SCORAD) | 71.72 score on a scale STANDARD_DEVIATION 13.79 | 70.77 score on a scale STANDARD_DEVIATION 13.08 | 69.82 score on a scale STANDARD_DEVIATION 12.39 |
| Sex: Female, Male Female | 17 Participants | 39 Participants | 22 Participants |
| Sex: Female, Male Male | 36 Participants | 67 Participants | 31 Participants |
| Worst Daily Pruritus numeric rating scale (NRS) | 7.60 score on a scale STANDARD_DEVIATION 1.65 | 7.71 score on a scale STANDARD_DEVIATION 1.51 | 7.81 score on a scale STANDARD_DEVIATION 1.37 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 53 | 0 / 53 | 0 / 8 | 0 / 4 |
| other Total, other adverse events | 28 / 53 | 19 / 53 | 2 / 8 | 1 / 4 |
| serious Total, serious adverse events | 0 / 53 | 0 / 53 | 0 / 8 | 0 / 4 |
Outcome results
Primary
At Least 75% Reduction in Eczema Area and Severity Index (EASI75) at Week 16
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.
Time frame: Week 0 to Week 16
Population: Full analysis set: 106 subjects, all randomised and treated.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Tralokinumab+TCS | At Least 75% Reduction in Eczema Area and Severity Index (EASI75) at Week 16 | 38 Participants |
| Placebo+TCS | At Least 75% Reduction in Eczema Area and Severity Index (EASI75) at Week 16 | 30 Participants |
Comparison: Subjects with 75% reduction in EASI were considered responders. Subjects with missing data or subjects who had received rescue medication prior to Week 16 were considered non-responders in the primary analysis of the primary estimand.95% CI: [-2.9, 33]
Primary
Investigator's Global Assessment (IGA) Score of 0 (Clear) or 1 (Almost Clear) at Week 16
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).
Time frame: Week 16
Population: Full analysis set: 106 subjects, all randomised and treated.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Tralokinumab+TCS | Investigator's Global Assessment (IGA) Score of 0 (Clear) or 1 (Almost Clear) at Week 16 | 17 Participants |
| Placebo+TCS | Investigator's Global Assessment (IGA) Score of 0 (Clear) or 1 (Almost Clear) at Week 16 | 14 Participants |
Comparison: Responders were considered those meeting an IGA score of 0 or 1 (clear or almost clear). Subjects with missing data or subjects who had received rescue medication prior to Week 16 were considered non-responders in the primary analysis of the primary estimand.95% CI: [-11.2, 22.5]
Secondary
At Least 50% Reduction in EASI (EASI50) at Week 16
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.
Time frame: Week 0 to Week 16
Population: Full analysis set: 106 subjects, all randomised and treated.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Tralokinumab+TCS | At Least 50% Reduction in EASI (EASI50) at Week 16 | 45 Participants |
| Placebo+TCS | At Least 50% Reduction in EASI (EASI50) at Week 16 | 42 Participants |
Comparison: Subjects with at least 50% reduction in EASI were considered responders. Subjects who had received rescue medication were considered non-responders. Subjects with missing data were imputed as non-responders.95% CI: [-9, 20.3]
Secondary
At Least 90% Reduction in EASI (EASI90) at Week 16
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.
Time frame: Week 0 to Week 16
Population: Full analysis set: 106 subjects, all randomised and treated.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Tralokinumab+TCS | At Least 90% Reduction in EASI (EASI90) at Week 16 | 24 Participants |
| Placebo+TCS | At Least 90% Reduction in EASI (EASI90) at Week 16 | 16 Participants |
Comparison: Subjects with a reduction of 90% in EASI were considered responders. Subjects who had received rescue medication were considered non-responders. Subjects with missing data were imputed as non-responders.95% CI: [-3, 33.2]
Secondary
Change in Dermatology Life Quality Index (DLQI) Score From Baseline to Week 16.
DLQI consists of 10 items addressing the participant's perception of the impact of their skin disease on different aspects of their health-related quality of life over the past week, such as dermatology-related symptoms and feelings, daily activities, leisure, work or school, personal relationships, and the treatment. Each item is scored on a 4-point Likert scale (0=not at all ⁄ not relevant; 1=a little; 2=a lot; 3=very much). The total score is the sum of the 10 items (ranging from 0 to 30), with higher scores indicating poorer health-related quality of life.
Time frame: Week 0 to Week 16
Population: Full analysis set: 106 subjects, all randomised and treated.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Tralokinumab+TCS | Change in Dermatology Life Quality Index (DLQI) Score From Baseline to Week 16. | -10.0 change in score on a scale | Standard Error 0.56 |
| Placebo+TCS | Change in Dermatology Life Quality Index (DLQI) Score From Baseline to Week 16. | -8.8 change in score on a scale | Standard Error 0.56 |
95% CI: [-2.7, 0.5]
Secondary
Change in Eczema-related Sleep NRS Score (Weekly Average) From Baseline to Week 16
Participants rated how much their eczema interfered with their sleep the last night using an 11-point NRS (0 indicating that it 'did not interfere' and 10 indicating that it 'completely interfered').
Time frame: Week 0 to Week 16
Population: Full analysis set: 106 subjects, all randomised and treated.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Tralokinumab+TCS | Change in Eczema-related Sleep NRS Score (Weekly Average) From Baseline to Week 16 | -4.2 change in score on a scale | Standard Error 0.25 |
| Placebo+TCS | Change in Eczema-related Sleep NRS Score (Weekly Average) From Baseline to Week 16 | -4.1 change in score on a scale | Standard Error 0.26 |
95% CI: [-0.9, 0.6]
Secondary
Change in Patient-Oriented Eczema Measure (POEM) Score Form Baseline to Week 16
POEM consists of 7 items, each addressing a specific symptom (itching, sleep, bleeding, weeping, cracking, flaking, and dryness). Participants score how often they have experienced each symptom over the previous week, using a 5-point categorical response scale (0=no days; 1=1 to 2 days; 2=3 to 4 days; 3=5 to 6 days; 4=every day). The total score is the sum of the 7 items (ranging from 0 to 28) and reflects disease-related morbidity; higher scores indicate more severe disease.
Time frame: Week 0 to Week 16
Population: Full analysis set: 106 subjects, all randomised and treated.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Tralokinumab+TCS | Change in Patient-Oriented Eczema Measure (POEM) Score Form Baseline to Week 16 | -14.4 change in score on a scale | Standard Error 0.82 |
| Placebo+TCS | Change in Patient-Oriented Eczema Measure (POEM) Score Form Baseline to Week 16 | -11.2 change in score on a scale | Standard Error 0.83 |
95% CI: [-5.6, -0.9]
Secondary
Change in Scoring Atopic Dermatitis (SCORAD) Total Score From Baseline to Week 16
SCORAD is a validated tool to evaluate the AD disease based on 3 components: * A) The extent of AD lesions. Assessed as percentage of each defined body area and reported as sum of all areas (max score = 100%). * B) The severity of AD lesions. The intensity of 6 specific symptoms on a representative area was assessed using the scale: 0 = none/absent, 1 = mild, 2 = moderate, 3 = severe (max score = 18). * C) Subjective symptoms. The itch and sleeplessness over the last 3 days/nights was recorded for each symptom by the subject on a VAS scale: 0 = no itch or trouble sleeping, 10 = unbearable itch or a lot of trouble sleeping (max score = 20). The SCORAD was calculated as: A/5+7B/2+C. The maximum total score is 103, with higher values indicating more severe disease.
Time frame: Week 0 to Week 16
Population: Full analysis set: 106 subjects, all randomised and treated.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Tralokinumab+TCS | Change in Scoring Atopic Dermatitis (SCORAD) Total Score From Baseline to Week 16 | -44.1 change in score on a scale | Standard Error 2.61 |
| Placebo+TCS | Change in Scoring Atopic Dermatitis (SCORAD) Total Score From Baseline to Week 16 | -39.0 change in score on a scale | Standard Error 2.61 |
95% CI: [-12.4, 2.3]
Secondary
Change in Worst Daily Pruritus NRS Score (Weekly Average) From Baseline to Week 16
Participants assessed the itch for the past 24 hours using the Worst Daily Pruritus NRS, consisting of 11 points, with 0 indicating 'no itch' and 10 indicating 'worst itch imaginable'.
Time frame: Week 0 to Week 16
Population: Full analysis set:106 subjects, all randomised and treated.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Tralokinumab+TCS | Change in Worst Daily Pruritus NRS Score (Weekly Average) From Baseline to Week 16 | -4.6 change in score on a scale | Standard Error 0.26 |
| Placebo+TCS | Change in Worst Daily Pruritus NRS Score (Weekly Average) From Baseline to Week 16 | -4.6 change in score on a scale | Standard Error 0.27 |
95% CI: [-0.7, 0.8]
Secondary
Number of Subjects With Presence of Treatment-emergent Anti-drug Antibodies (ADA) From Baseline to Week 16
Anti-tralokinumab antibody levels were analyzed using a validated bioanalytical method. Positive treatment-emergent ADA was defined as ADA negative or missing at baseline, and at least one positive post-baseline ADA response. Negative treatment-emergent ADA was defined as ADA negative or missing at baseline, and all post-baseline ADA assessments negative.
Time frame: Week 0 to Week 16
Population: Safety analysis set. Included all subjects exposed to IMP at least 1 time.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tralokinumab+TCS | Number of Subjects With Presence of Treatment-emergent Anti-drug Antibodies (ADA) From Baseline to Week 16 | 0 participants with treatment-emergent ADA |
| Placebo+TCS | Number of Subjects With Presence of Treatment-emergent Anti-drug Antibodies (ADA) From Baseline to Week 16 | 0 participants with treatment-emergent ADA |
Secondary
Number of Treatment-emergent Adverse Events From Baseline to Week 16 Per Subject
Number of events divided by patient years of exposure (= rate).
Time frame: Week 0 to Week 16
Population: Safety analysis set: 106 subjects. Included all subjects exposed to IMP at least 1 time.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tralokinumab+TCS | Number of Treatment-emergent Adverse Events From Baseline to Week 16 Per Subject | 605.9 events per patient year of exposure |
| Placebo+TCS | Number of Treatment-emergent Adverse Events From Baseline to Week 16 Per Subject | 332.8 events per patient year of exposure |
Secondary
Percentage Change in EASI Score From Baseline to Week 16
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.
Time frame: Week 0 to Week 16
Population: Full analysis set: 106 subjects, all randomised and treated.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Tralokinumab+TCS | Percentage Change in EASI Score From Baseline to Week 16 | -77.8 percentage change in score on a scale | Standard Error 3.7 |
| Placebo+TCS | Percentage Change in EASI Score From Baseline to Week 16 | -73.5 percentage change in score on a scale | Standard Error 3.76 |
95% CI: [-14.9, 6.3]
Secondary
Reduction of Worst Daily Pruritus Numeric Rating Scale (NRS) Score (Weekly Average) of at Least 4 From Baseline to Week 16
Participants assessed the itch for the past 24 hours using the Worst Daily Pruritus NRS, consisting of 11 points, with 0 indicating 'no itch' and 10 indicating 'worst itch imaginable'.
Time frame: Week 0 to Week 16
Population: Full analysis set: 106 subjects, all randomised and treated.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Tralokinumab+TCS | Reduction of Worst Daily Pruritus Numeric Rating Scale (NRS) Score (Weekly Average) of at Least 4 From Baseline to Week 16 | 34 Participants |
| Placebo+TCS | Reduction of Worst Daily Pruritus Numeric Rating Scale (NRS) Score (Weekly Average) of at Least 4 From Baseline to Week 16 | 36 Participants |
Comparison: Subjects with at least a reduction of 4 in the worst daily pruritus NRS score were considered responders. Subjects who had received rescue medication were considered non-responders. Subjects with missing data at Week 16 were imputed as non-responders.95% CI: [-21.7, 14.2]