Dermatitis, Atopic, Eczema
Conditions
Keywords
Topical Corticosteroids, Cyclosporine
Brief summary
The main purpose of this study is to evaluate the efficacy of lebrikizumab compared with placebo in participants not adequately controlled with cyclosporine or for whom cyclosporine is not medically advisable up to Week 16.
Interventions
BIOLOGICALLebrikizumab
Lebrikizumab solution for injection administered subcutaneously.
DRUGLebrikizumab-matching Placebo
Matching Placebo solution for injection administered subcutaneously.
Sponsors
Almirall, S.A.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adults and adolescents (aged greater than or equal to (\>=) 12 to \<18 years at the time of Informed Consent Form (ICF)/Informed Assent Form (IAF) and weighing \>=40 kilograms). * Chronic AD that has been present for \>=1 year before the Screening visit. * EASI score \>=16 at the Baseline Visit. * IGA score \>=3 (moderate) (scale of 0 \[clear\] to 4 \[severe\]) at the Baseline visit. * \>=10% BSA of AD involvement at the Baseline visit. * Inadequate response to existing topical medications * Failure to cyclosporine or non-medically advisable to receive/continue receiving cyclosporine * Signed ICF (and informed assent for adolescents as required)
Exclusion criteria
* Treatment with TCS within 1 week before the Baseline visit. * Treatment with topical calcineurin inhibitors, phosphodiesterase-4 inhibitors such as crisaborole, or cannabinoids within 2 week before the Baseline visit. * Treatment with interleukin 4 (IL-4) or interleukin 13 (IL-13) antagonists biological therapies before the Baseline visit. Exception: previous treatment with dupilumab will be allowed in a subset of patients * Treatment with immunosuppressive/immunomodulating drugs, phototherapy and photochemotherapy within 4 weeks before the Baseline visit * Uncontrolled chronic disease that might require bursts of oral corticosteroids * Serious, opportunistic, chronic or recurring infections within 3 months of Screening or before randomization * Current or chronic infection with hepatitis B virus, current infection with hepatitis C virus, known liver cirrhosis and/or chronic hepatitis of any etiology * Known or suspected history of immunosuppression, history of HIV infection or positive HIV serology at Screening * Any clinically significant laboratory test results obtained at the Screening visit * Presence of skin comorbidities that may interfere with study assessments * Have had an important side effect to TCS that would prevent further use.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Double-blind Induction Period: Percentage of Participants Who Achieved Eczema Area and Severity Index (EASI) 75 (>=75% Reduction From Baseline in EASI Score) at Week 16 | At Week 16 | The EASI score is used to measure the severity and extent of atopic dermatitis (AD) and measures erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. The severity of the clinical signs of AD for each of 4 body regions was scored on a 4-point scale: 0=absent, 1=mild, 2=moderate and 3=severe. The area of AD involvement on each of the 4 anatomic regions was assessed as a percentage by body area: 0=no eruption, 1=1% to 9%, 2=10% to 29%, 3=30% to 49%, 4=50% to 60%, 5=70% to 80% and 6=90% to 100%. The composite index with total score ranged from 0 to 72, where higher scores indicates more severe and or extensive disease. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Double-blind Induction Period: Percentage of Participants Who Achieved a 4-point Improvement in Pruritus Numeric Rating Score (NRS) at Week 16 | At Week 16 | The Pruritus NRS is an 11-point scale used by participants to rate their worst pruritus (itch) severity over the past 24 hours, with 0 indicating No itch, and 10 indicating Worst itch imaginable. Higher score indicates more severity. |
| Double-blind Induction Period: Percentage of Participants Who Achieved EASI 75 (>=75% Reduction From Baseline in EASI Score) at Weeks 2, 4, 8, and 12 | At Weeks 2, 4, 8, and12 | The EASI score is used to measure the severity and extent of atopic dermatitis (AD) and measures erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. The severity of the clinical signs of AD for each of 4 body regions was scored on a 4-point scale: 0=absent, 1=mild, 2=moderate and 3=severe. The area of AD involvement on each of the 4 anatomic regions was assessed as a percentage by body area: 0=no eruption, 1=1% to 9%, 2=10% to 29%, 3=30% to 49%, 4=50% to 60%, 5=70% to 80% and 6=90% to 100%. The composite index with total score ranged from 0 to 72, where higher scores indicates more severe and or extensive disease. Percentage of participants who achieved EASI 75 (\>=75% reduction from baseline in EASI score) at Weeks 2, 4, 8, and 12 were reported |
| Double-blind Induction Period: Percentage of Participants Who Achieved EASI 90 (>=90% Reduction From Baseline in EASI Score) at Weeks 2, 4, 8, 12 and 16 | At Weeks 2, 4, 8, 12 and 16 | The EASI score is used to measure the severity and extent of AD and measures erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. The severity of the clinical signs of AD for each of 4 body regions was scored on a 4-point scale: 0=absent, 1=mild, 2=moderate and 3=severe. The area of AD involvement on each of the 4 anatomic regions was assessed as a percentage by body area: 0=no eruption, 1=1% to 9%, 2=10% to 29%, 3=30% to 49%, 4=50% to 60%, 5=70% to 80% and 6=90% to 100%. The composite index with total score ranged from 0 to 72, where higher scores indicates more severe and or extensive disease. |
| Double-blind Induction Period: Percentage of Participants Who Achieved EASI 50 (>=50% Reduction From Baseline in EASI Score) at Weeks 2, 4, 8, 12 and 16 | At Weeks 2, 4, 8, 12 and 16 | The EASI score is used to measure the severity and extent of AD and measures erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. The severity of the clinical signs of AD for each of 4 body regions was scored on a 4-point scale: 0=absent, 1=mild, 2=moderate and 3=severe. The area of AD involvement on each of the 4 anatomic regions was assessed as a percentage by body area: 0=no eruption, 1=1% to 9%, 2=10% to 29%, 3=30% to 49%, 4=50% to 60%, 5=70% to 80% and 6=90% to 100%. The composite index with total score ranged from 0 to 72, where higher scores indicates more severe and or extensive disease. |
| Double-blind Induction Period: Percentage of Participants Who Achieved a 4-point Improvement in Dermatology Life Quality Index (DLQI) at Weeks 2, 4, 8, 12 and 16 | At Weeks 2, 4, 8, 12 and 16 | The DLQI is a 10-item validated questionnaire completed by the participant or caregiver used to assess the impact of skin disease on the participant's quality of life (QoL during the previous week. The 10 questions cover the following topics: symptoms, embarrassment, shopping and home care, clothes, social and leisure, sport, work or study, close relationships, sex, and treatment. Each question was scored on a 4-point scale (ranged from 0 to 3) where, 0 = not at all, 1= a little, 2= a lot, 3= very much, giving a total score ranging from 0 (not at all) to 30 (very much). A high score is indicative of a poor QoL. |
| Double-blind Induction Period: Percentage of Participants Who Achieved a 4-point Improvement in Children's Dermatology Life Quality Index (CDLQI) at Weeks 2, 4, 8, 12 and 16 | At Weeks 2, 4, 8, 12 and 16 | The CDLQI is validated from adolescents younger than age of 16 years, which is based on a set of 10 questions different from those of the DLQI to measure the impact of AD disease on QoL in children during the previous week. Each question is scored as follows: 0=not at all or unanswered, 1 = only a little, 2 = quite a lot and 3 = very much. Question 7 has an added possible response, which was scored as 3. CDLQI equals the sum of the score of each question, ranged from 0 (no impact of skin disease on QoL) to 30 (maximum impact on QoL). Higher scores indicate higher impact on QoL. |
| Double-blind Induction Period: Percentage of Participants Who Achieved a 4- Point Improvement in Skin Pain NRS at Week 16 | At Week 16 | The Skin Pain NRS is an 11-point scale completed by participants to rate their worst skin pain (example, discomfort or soreness) severity over the past 24 hours, with 0 (indicating No pain) and 10 (indicating Worst pain imaginable). Higher scores indicated worse pain. |
| Double-blind Induction Period: Change From Baseline in Body Surface Area (BSA) at Weeks 2, 4, 8, 12 and 16 | Baseline, Weeks 2, 4, 8, 12 and 16 | The BSA assessment estimates the extent of disease or skin involvement with respect to AD and is expressed as a percentage of total body surface. BSA was determined by the Investigator or designee using the participant palm = 1% BSA rule. The participant's palm is measured from the wrist to the proximal interphalangeal and thumb. This higher the BSA %, the more active atopic dermatitis is present. Percent of BSA for a body region = total number of palms in a body region \* % surface area equivalent to 1 palm. Overall percent BSA for an individual is arithmetic mean of % BSA of all 4 body regions and ranges from 0% to 100% with higher values representing greater severity of AD and negative change from baseline indicate no severity. |
| Double-blind Induction Period: Percentage of Participants Who Achieved Investigator Global Assessment (IGA) Score of 0 or 1 and 2-point Improvement at Week 16 | At Week 16 | The IGA is an instrument used to globally rate the severity of the participants AD. It is based on a 5-point scale ranging from 0 (clear), 1 (almost clear), 2 (mild), 3 (moderate) and 4 (severe), and a score is selected using descriptors that best describe the overall appearance of the lesions at a given time point. The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting (minimal, palpable induration and significant induration). Therapeutic response is an IGA score of 0 (clear) or 1 (almost clear). |
| Double-blind Induction Period: Change From Baseline in Pruritus NRS by Week up to Week 16 | Baseline, Weeks 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15 and 16 | The Pruritus NRS is an 11-point scale used by participants to rate their worst pruritus (itch) severity over the past 24 hours, with 0 indicating No itch, and 10 indicating Worst itch imaginable. Higher scores indicated greater severity and negative change from baseline indicate no severity. |
| Double-blind Induction Period: Change From Baseline in the Sleep Loss at Week 16 Using Patient-related Outcome (PRO) by Week up to Week 16 | Baseline, Weeks 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15 and 16 | Sleep loss was assessed by all participants using a PRO instrument. Participants (and if applicable, with help of parents/caregiver if required) rate their sleep on a 5-point Likert scale (with scores ranging from 0 \[not at all\] to 4 \[unable to sleep at all\]). Higher scores indicated a greater impact and worse outcome; therefore, negative change from baseline indicate less impact. |
| Double-blind Induction Period: Change From Baseline in Patient-Oriented Eczema Measure (POEM) Total Score at Weeks 4, 8, 12 and 16 | Baseline, Weeks 4, 8, 12 and 16 | The POEM is a 7-item, validated questionnaire completed by the participant (and, if applicable, with help of parents/caregiver if required) to assess disease symptoms. Participants are asked to respond to questions on skin dryness, itching, flaking, cracking, sleep loss, bleeding, and weeping. All answers carry equal weight, with a total possible score ranging from 0 to 28 (answers scored as: No days = 0; 1 to 2 days = 1; 3 to 4 days = 2; 5 to 6 days = 3; every day = 4. Higher scores indicated more severe disease and poor quality of life (QoL); therefore, negative change from baseline indicate improvement in QoL. |
| Double-blind Induction Period: Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at Weeks 2. 4, 8, 12 and 16 | Baseline, Weeks 2, 4, 8, 12 and 16 | The DLQI is a 10-item validated questionnaire completed by the participant or caregiver used to assess the impact of skin disease on the participant's QoL during the previous week. The 10 questions cover the following topics: symptoms, embarrassment, shopping and home care, clothes, social and leisure, sport, work or study, close relationships, sex, and treatment. Each question was scored on a 4-point scale (ranged from 0 to 3) where, 0 = not at all, 1= a little, 2= a lot, 3= very much, giving a total score ranging from 0 (not at all) to 30 (very much). A high score is indicative of a poor QoL and negative change from baseline indicate improvement in QoL. |
| Double-blind Induction Period: Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) at Week 2. 4, 8, 12 and 16 | Baseline, Weeks 2, 4, 8, 12 and 16 | The CDLQI is validated from adolescents younger than age of 16 years, which is based on a set of 10 questions different from those of the DLQI to measure the impact of AD disease on QoL in children during the previous week. Each question is scored as follows: 0=not at all or unanswered, 1 = only a little, 2 = quite a lot and 3 = very much. Question 7 has an added possible response, which was scored as 3. CDLQI equals the sum of the score of each question, ranged from 0 (no impact of skin disease on QoL) to 30 (maximum impact on QoL). Higher scores indicate higher impact on QoL and negative change from baseline indicate low impact on QoL. |
| Double-blind Induction Period: Change From Baseline in Skin Pain NRS by Week up to Week 16 | Baseline, Weeks 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15 and 16 | The Skin Pain NRS is an 11-point scale completed by participants to rate their worst skin pain (example, discomfort or soreness) severity over the past 24 hours, with 0 (indicating No pain) to 10 (indicating Worst pain imaginable). Higher scores indicated worse pain and negative change from baseline indicate no pain. |
| Double-blind Induction Period: Proportion of Topical Corticosteroids (TCS) Medication Free Days | Baseline up to Week 16 | TCS free days proportion = Number of days participant did not take TCS medication / Number of days from Baseline to Week 16 Date or early discontinuation |
| Double-blind Induction Period: Median Time (Days) to TCS-Free Use | Baseline up to Week 16 | Days from first study drug injection to the day participant stopped using all TCS. |
| Double-blind Induction Period: Change From Baseline in Scoring Atopic Dermatitis (SCORAD) at Weeks 8 and 16 | Baseline, Weeks 8 and 16 | SCORAD is a validated clinical tool for assessing the extent and intensity of AD. There are 3 components: A) Surface involvement is assessed as proportion of involved surface area segment by segment by applying the rule of 9s and reported as the sum of all areas, with a score ranging from 0-100. B) Intensity part of the SCORAD consists of 6 items: erythema, oedema, oozing/crusting, excoriation, lichenification, and dryness. Each item graded as: none (0), mild (1), moderate (2), or severe (3). C) Subjective assessment of itch and of sleeplessness is recorded for each symptom using a visual analogue scale (VAS), where 0=no itch (or no sleeplessness) and 10= worst imaginable itch (or sleeplessness), with maximum score of 20. Formula is: A/5+7B/2+C, A: extent (0-100), B: intensity (0-18), C: subjective symptoms (0-20). SCORAD total score ranged from 0 (no disease) to 103 (severe disease). Higher values represent worse outcome and negative change from baseline indicate improvement. |
Countries
Austria, Belgium, France, Germany, Netherlands, Poland, Spain, United Kingdom
Participant flow
Recruitment details
Study was conducted at 54 sites in Austria, Belgium, France, Germany, Italy, Netherlands, Poland, Spain, and United Kingdom. Randomization was stratified by previous use of dupilumab, age (adolescent participants aged \>=12 to \< 18 years comprises 11.8% of the overall population compared to adults aged \>=18 years) and baseline disease severity (IGA 3 vs 4).
Pre-assignment details
A total of 368 participants were screened, of which 331 participants were randomized into 2 treatment arms (Lebrikizumab and Placebo). The study has 2 treatment periods: a 16-week double-blind Induction Period and 36-week open-label Maintenance Period.
Participants by arm
| Arm | Count |
|---|---|
| Double-blind Induction Period: Lebrikizumab +TCS Participants received loading dose of lebrikizumab 500 mg SC injection at Day 1 (Baseline) and Week 2 followed by lebrikizumab 250 mg SC injection Q2W for up to 16 weeks concomitantly with TCS in the double-blind induction period. | 220 |
| Double-blind Induction Period: Placebo +TCS Participants received lebrikizumab-matched placebo SC injection, Q2W for up to 16 weeks concomitantly with TCS in the double-blind induction period. | 111 |
| Total | 331 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Double-blind Induction Period (16-weeks) | Adverse Event | 2 | 2 | 0 | 0 |
| Double-blind Induction Period (16-weeks) | Lost to Follow-up | 2 | 3 | 0 | 0 |
| Double-blind Induction Period (16-weeks) | Other | 0 | 1 | 0 | 0 |
| Double-blind Induction Period (16-weeks) | Physician Decision | 1 | 0 | 0 | 0 |
| Double-blind Induction Period (16-weeks) | Pregnancy | 1 | 0 | 0 | 0 |
| Double-blind Induction Period (16-weeks) | Withdrawal by Subject | 2 | 5 | 0 | 0 |
| Open-label Maintenance Period (36 Weeks) | Adverse Event | 0 | 0 | 7 | 1 |
| Open-label Maintenance Period (36 Weeks) | Lack of Efficacy | 0 | 0 | 6 | 5 |
| Open-label Maintenance Period (36 Weeks) | Lost to Follow-up | 0 | 0 | 4 | 0 |
| Open-label Maintenance Period (36 Weeks) | Protocol Deviation | 0 | 0 | 1 | 0 |
| Open-label Maintenance Period (36 Weeks) | Withdrawal by Subject | 0 | 0 | 14 | 7 |
Baseline characteristics
| Characteristic | Double-blind Induction Period: Placebo +TCS | Total | Double-blind Induction Period: Lebrikizumab +TCS |
|---|---|---|---|
| Age, Continuous | 34.1 Years STANDARD_DEVIATION 15.24 | 33.8 Years STANDARD_DEVIATION 14.96 | 33.7 Years STANDARD_DEVIATION 14.85 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 14 Participants | 28 Participants | 14 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 93 Participants | 290 Participants | 197 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 4 Participants | 13 Participants | 9 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 3 Participants | 4 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 5 Participants | 5 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 2 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 | 2 Participants | 9 Participants | 7 Participants |
| Race (NIH/OMB) White | 104 Participants | 310 Participants | 206 Participants |
| Sex: Female, Male Female | 56 Participants | 156 Participants | 100 Participants |
| Sex: Female, Male Male | 55 Participants | 175 Participants | 120 Participants |
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 / 220 | 0 / 111 | 0 / 212 | 0 / 100 |
| other Total, other adverse events | 84 / 220 | 31 / 111 | 108 / 212 | 48 / 100 |
| serious Total, serious adverse events | 3 / 220 | 1 / 111 | 12 / 212 | 4 / 100 |
Outcome results
Primary
Double-blind Induction Period: Percentage of Participants Who Achieved Eczema Area and Severity Index (EASI) 75 (>=75% Reduction From Baseline in EASI Score) at Week 16
The EASI score is used to measure the severity and extent of atopic dermatitis (AD) and measures erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. The severity of the clinical signs of AD for each of 4 body regions was scored on a 4-point scale: 0=absent, 1=mild, 2=moderate and 3=severe. The area of AD involvement on each of the 4 anatomic regions was assessed as a percentage by body area: 0=no eruption, 1=1% to 9%, 2=10% to 29%, 3=30% to 49%, 4=50% to 60%, 5=70% to 80% and 6=90% to 100%. The composite index with total score ranged from 0 to 72, where higher scores indicates more severe and or extensive disease.
Time frame: At Week 16
Population: FAS included all randomized participants and were analyzed under the treatment group as randomized.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Double-blind Induction Period: Lebrikizumab +TCS | Double-blind Induction Period: Percentage of Participants Who Achieved Eczema Area and Severity Index (EASI) 75 (>=75% Reduction From Baseline in EASI Score) at Week 16 | 68.4 Percentage of participants |
| Double-blind Induction Period: Placebo +TCS | Double-blind Induction Period: Percentage of Participants Who Achieved Eczema Area and Severity Index (EASI) 75 (>=75% Reduction From Baseline in EASI Score) at Week 16 | 40.8 Percentage of participants |
p-value: <0.000195% CI: [15.63, 40.14]Cochran-Mantel-Haenszel
Secondary
Double-blind Induction Period: Change From Baseline in Body Surface Area (BSA) at Weeks 2, 4, 8, 12 and 16
The BSA assessment estimates the extent of disease or skin involvement with respect to AD and is expressed as a percentage of total body surface. BSA was determined by the Investigator or designee using the participant palm = 1% BSA rule. The participant's palm is measured from the wrist to the proximal interphalangeal and thumb. This higher the BSA %, the more active atopic dermatitis is present. Percent of BSA for a body region = total number of palms in a body region \* % surface area equivalent to 1 palm. Overall percent BSA for an individual is arithmetic mean of % BSA of all 4 body regions and ranges from 0% to 100% with higher values representing greater severity of AD and negative change from baseline indicate no severity.
Time frame: Baseline, Weeks 2, 4, 8, 12 and 16
Population: FAS included all randomized participants and were analyzed under the treatment group as randomized. Here, Overall number of participants analyzed signifies participants who were evaluable for this outcome measure and number analyzed signifies participants who were evaluable for specified timepoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Double-blind Induction Period: Lebrikizumab +TCS | Double-blind Induction Period: Change From Baseline in Body Surface Area (BSA) at Weeks 2, 4, 8, 12 and 16 | Change at Week 2 | -11.4 Percentage of body surface area | Standard Deviation 15.33 |
| Double-blind Induction Period: Lebrikizumab +TCS | Double-blind Induction Period: Change From Baseline in Body Surface Area (BSA) at Weeks 2, 4, 8, 12 and 16 | Change at Week 12 | -30.6 Percentage of body surface area | Standard Deviation 21.25 |
| Double-blind Induction Period: Lebrikizumab +TCS | Double-blind Induction Period: Change From Baseline in Body Surface Area (BSA) at Weeks 2, 4, 8, 12 and 16 | Change at Week 4 | -19.5 Percentage of body surface area | Standard Deviation 19.22 |
| Double-blind Induction Period: Lebrikizumab +TCS | Double-blind Induction Period: Change From Baseline in Body Surface Area (BSA) at Weeks 2, 4, 8, 12 and 16 | Change at Week 8 | -27.3 Percentage of body surface area | Standard Deviation 20.6 |
| Double-blind Induction Period: Lebrikizumab +TCS | Double-blind Induction Period: Change From Baseline in Body Surface Area (BSA) at Weeks 2, 4, 8, 12 and 16 | Change at Week 16 | -32.5 Percentage of body surface area | Standard Deviation 21.44 |
| Double-blind Induction Period: Placebo +TCS | Double-blind Induction Period: Change From Baseline in Body Surface Area (BSA) at Weeks 2, 4, 8, 12 and 16 | Change at Week 8 | -19.2 Percentage of body surface area | Standard Deviation 17.12 |
| Double-blind Induction Period: Placebo +TCS | Double-blind Induction Period: Change From Baseline in Body Surface Area (BSA) at Weeks 2, 4, 8, 12 and 16 | Change at Week 2 | -10.6 Percentage of body surface area | Standard Deviation 12.04 |
| Double-blind Induction Period: Placebo +TCS | Double-blind Induction Period: Change From Baseline in Body Surface Area (BSA) at Weeks 2, 4, 8, 12 and 16 | Change at Week 12 | -22.5 Percentage of body surface area | Standard Deviation 17.06 |
| Double-blind Induction Period: Placebo +TCS | Double-blind Induction Period: Change From Baseline in Body Surface Area (BSA) at Weeks 2, 4, 8, 12 and 16 | Change at Week 16 | -22.1 Percentage of body surface area | Standard Deviation 18.57 |
| Double-blind Induction Period: Placebo +TCS | Double-blind Induction Period: Change From Baseline in Body Surface Area (BSA) at Weeks 2, 4, 8, 12 and 16 | Change at Week 4 | -15.3 Percentage of body surface area | Standard Deviation 13.77 |
Secondary
Double-blind Induction Period: Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) at Week 2. 4, 8, 12 and 16
The CDLQI is validated from adolescents younger than age of 16 years, which is based on a set of 10 questions different from those of the DLQI to measure the impact of AD disease on QoL in children during the previous week. Each question is scored as follows: 0=not at all or unanswered, 1 = only a little, 2 = quite a lot and 3 = very much. Question 7 has an added possible response, which was scored as 3. CDLQI equals the sum of the score of each question, ranged from 0 (no impact of skin disease on QoL) to 30 (maximum impact on QoL). Higher scores indicate higher impact on QoL and negative change from baseline indicate low impact on QoL.
Time frame: Baseline, Weeks 2, 4, 8, 12 and 16
Population: FAS included all randomized participants and were analyzed under the treatment group as randomized. Here, Overall number of participants analyzed signifies participants who were evaluable for this outcome measure and number analyzed signifies participants who were evaluable for specified timepoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Double-blind Induction Period: Lebrikizumab +TCS | Double-blind Induction Period: Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) at Week 2. 4, 8, 12 and 16 | Change at Week 8 | -6.6 Score on a Scale | Standard Deviation 6.69 |
| Double-blind Induction Period: Lebrikizumab +TCS | Double-blind Induction Period: Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) at Week 2. 4, 8, 12 and 16 | Change at Week 16 | -7.7 Score on a Scale | Standard Deviation 6.91 |
| Double-blind Induction Period: Lebrikizumab +TCS | Double-blind Induction Period: Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) at Week 2. 4, 8, 12 and 16 | Change at Week 12 | -7.7 Score on a Scale | Standard Deviation 7.6 |
| Double-blind Induction Period: Lebrikizumab +TCS | Double-blind Induction Period: Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) at Week 2. 4, 8, 12 and 16 | Change at Week 4 | -5.1 Score on a Scale | Standard Deviation 4.76 |
| Double-blind Induction Period: Lebrikizumab +TCS | Double-blind Induction Period: Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) at Week 2. 4, 8, 12 and 16 | Change at Week 2 | -2.9 Score on a Scale | Standard Deviation 3.41 |
| Double-blind Induction Period: Placebo +TCS | Double-blind Induction Period: Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) at Week 2. 4, 8, 12 and 16 | Change at Week 4 | -4.3 Score on a Scale | Standard Deviation 4.65 |
| Double-blind Induction Period: Placebo +TCS | Double-blind Induction Period: Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) at Week 2. 4, 8, 12 and 16 | Change at Week 2 | -3.6 Score on a Scale | Standard Deviation 3.25 |
| Double-blind Induction Period: Placebo +TCS | Double-blind Induction Period: Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) at Week 2. 4, 8, 12 and 16 | Change at Week 8 | -6.9 Score on a Scale | Standard Deviation 4.82 |
| Double-blind Induction Period: Placebo +TCS | Double-blind Induction Period: Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) at Week 2. 4, 8, 12 and 16 | Change at Week 12 | -7.4 Score on a Scale | Standard Deviation 6.3 |
| Double-blind Induction Period: Placebo +TCS | Double-blind Induction Period: Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) at Week 2. 4, 8, 12 and 16 | Change at Week 16 | -6.8 Score on a Scale | Standard Deviation 5.73 |
Secondary
Double-blind Induction Period: Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at Weeks 2. 4, 8, 12 and 16
The DLQI is a 10-item validated questionnaire completed by the participant or caregiver used to assess the impact of skin disease on the participant's QoL during the previous week. The 10 questions cover the following topics: symptoms, embarrassment, shopping and home care, clothes, social and leisure, sport, work or study, close relationships, sex, and treatment. Each question was scored on a 4-point scale (ranged from 0 to 3) where, 0 = not at all, 1= a little, 2= a lot, 3= very much, giving a total score ranging from 0 (not at all) to 30 (very much). A high score is indicative of a poor QoL and negative change from baseline indicate improvement in QoL.
Time frame: Baseline, Weeks 2, 4, 8, 12 and 16
Population: FAS included all randomized participants and were analyzed under the treatment group as randomized. Here, Overall number of participants analyzed signifies participants who were evaluable for this outcome measure and number analyzed signifies participants who were evaluable for specified timepoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Double-blind Induction Period: Lebrikizumab +TCS | Double-blind Induction Period: Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at Weeks 2. 4, 8, 12 and 16 | Change at Week 2 | -4.6 Score on a Scale | Standard Deviation 5.54 |
| Double-blind Induction Period: Lebrikizumab +TCS | Double-blind Induction Period: Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at Weeks 2. 4, 8, 12 and 16 | Change at Week 8 | -8.3 Score on a Scale | Standard Deviation 7.03 |
| Double-blind Induction Period: Lebrikizumab +TCS | Double-blind Induction Period: Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at Weeks 2. 4, 8, 12 and 16 | Change at Week 12 | -8.7 Score on a Scale | Standard Deviation 7.38 |
| Double-blind Induction Period: Lebrikizumab +TCS | Double-blind Induction Period: Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at Weeks 2. 4, 8, 12 and 16 | Change at Week 16 | -9.5 Score on a Scale | Standard Deviation 7.4 |
| Double-blind Induction Period: Lebrikizumab +TCS | Double-blind Induction Period: Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at Weeks 2. 4, 8, 12 and 16 | Change at Week 4 | -7.1 Score on a Scale | Standard Deviation 6.54 |
| Double-blind Induction Period: Placebo +TCS | Double-blind Induction Period: Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at Weeks 2. 4, 8, 12 and 16 | Change at Week 16 | -8.1 Score on a Scale | Standard Deviation 7.62 |
| Double-blind Induction Period: Placebo +TCS | Double-blind Induction Period: Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at Weeks 2. 4, 8, 12 and 16 | Change at Week 2 | -4.5 Score on a Scale | Standard Deviation 6 |
| Double-blind Induction Period: Placebo +TCS | Double-blind Induction Period: Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at Weeks 2. 4, 8, 12 and 16 | Change at Week 4 | -5.4 Score on a Scale | Standard Deviation 6.86 |
| Double-blind Induction Period: Placebo +TCS | Double-blind Induction Period: Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at Weeks 2. 4, 8, 12 and 16 | Change at Week 12 | -5.9 Score on a Scale | Standard Deviation 7.9 |
| Double-blind Induction Period: Placebo +TCS | Double-blind Induction Period: Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at Weeks 2. 4, 8, 12 and 16 | Change at Week 8 | -5.7 Score on a Scale | Standard Deviation 7.89 |
Secondary
Double-blind Induction Period: Change From Baseline in Patient-Oriented Eczema Measure (POEM) Total Score at Weeks 4, 8, 12 and 16
The POEM is a 7-item, validated questionnaire completed by the participant (and, if applicable, with help of parents/caregiver if required) to assess disease symptoms. Participants are asked to respond to questions on skin dryness, itching, flaking, cracking, sleep loss, bleeding, and weeping. All answers carry equal weight, with a total possible score ranging from 0 to 28 (answers scored as: No days = 0; 1 to 2 days = 1; 3 to 4 days = 2; 5 to 6 days = 3; every day = 4. Higher scores indicated more severe disease and poor quality of life (QoL); therefore, negative change from baseline indicate improvement in QoL.
Time frame: Baseline, Weeks 4, 8, 12 and 16
Population: FAS included all randomized participants and were analyzed under the treatment group as randomized. Here, Overall number of participants analyzed signifies participants who were evaluable for this outcome measure and number analyzed signifies participants who were evaluable for specified timepoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Double-blind Induction Period: Lebrikizumab +TCS | Double-blind Induction Period: Change From Baseline in Patient-Oriented Eczema Measure (POEM) Total Score at Weeks 4, 8, 12 and 16 | Change at Week 4 | -8.4 Score on a Scale | Standard Deviation 6.82 |
| Double-blind Induction Period: Lebrikizumab +TCS | Double-blind Induction Period: Change From Baseline in Patient-Oriented Eczema Measure (POEM) Total Score at Weeks 4, 8, 12 and 16 | Change at Week 8 | -10.9 Score on a Scale | Standard Deviation 7.45 |
| Double-blind Induction Period: Lebrikizumab +TCS | Double-blind Induction Period: Change From Baseline in Patient-Oriented Eczema Measure (POEM) Total Score at Weeks 4, 8, 12 and 16 | Change at Week 12 | -11.3 Score on a Scale | Standard Deviation 8.08 |
| Double-blind Induction Period: Lebrikizumab +TCS | Double-blind Induction Period: Change From Baseline in Patient-Oriented Eczema Measure (POEM) Total Score at Weeks 4, 8, 12 and 16 | Change at Week 16 | -11.9 Score on a Scale | Standard Deviation 8.01 |
| Double-blind Induction Period: Placebo +TCS | Double-blind Induction Period: Change From Baseline in Patient-Oriented Eczema Measure (POEM) Total Score at Weeks 4, 8, 12 and 16 | Change at Week 16 | -5.8 Score on a Scale | Standard Deviation 7.18 |
| Double-blind Induction Period: Placebo +TCS | Double-blind Induction Period: Change From Baseline in Patient-Oriented Eczema Measure (POEM) Total Score at Weeks 4, 8, 12 and 16 | Change at Week 4 | -4.7 Score on a Scale | Standard Deviation 6.42 |
| Double-blind Induction Period: Placebo +TCS | Double-blind Induction Period: Change From Baseline in Patient-Oriented Eczema Measure (POEM) Total Score at Weeks 4, 8, 12 and 16 | Change at Week 12 | -5.1 Score on a Scale | Standard Deviation 7.25 |
| Double-blind Induction Period: Placebo +TCS | Double-blind Induction Period: Change From Baseline in Patient-Oriented Eczema Measure (POEM) Total Score at Weeks 4, 8, 12 and 16 | Change at Week 8 | -5.2 Score on a Scale | Standard Deviation 6.65 |
Secondary
Double-blind Induction Period: Change From Baseline in Pruritus NRS by Week up to Week 16
The Pruritus NRS is an 11-point scale used by participants to rate their worst pruritus (itch) severity over the past 24 hours, with 0 indicating No itch, and 10 indicating Worst itch imaginable. Higher scores indicated greater severity and negative change from baseline indicate no severity.
Time frame: Baseline, Weeks 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15 and 16
Population: FAS included all randomized participants and were analyzed under the treatment group as randomized. Here, Overall number of participants analyzed signifies participants who were evaluable for this outcome measure and number analyzed signifies participants who were evaluable for specified timepoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Double-blind Induction Period: Lebrikizumab +TCS | Double-blind Induction Period: Change From Baseline in Pruritus NRS by Week up to Week 16 | Change at Week 12 | -3.388 Score on a Scale | Standard Deviation 2.6195 |
| Double-blind Induction Period: Lebrikizumab +TCS | Double-blind Induction Period: Change From Baseline in Pruritus NRS by Week up to Week 16 | Change at Week 16 | -3.476 Score on a Scale | Standard Deviation 2.5453 |
| Double-blind Induction Period: Lebrikizumab +TCS | Double-blind Induction Period: Change From Baseline in Pruritus NRS by Week up to Week 16 | Change at Week 6 | -3.053 Score on a Scale | Standard Deviation 2.3975 |
| Double-blind Induction Period: Lebrikizumab +TCS | Double-blind Induction Period: Change From Baseline in Pruritus NRS by Week up to Week 16 | Change at Week 2 | -1.543 Score on a Scale | Standard Deviation 1.6304 |
| Double-blind Induction Period: Lebrikizumab +TCS | Double-blind Induction Period: Change From Baseline in Pruritus NRS by Week up to Week 16 | Change at Week 13 | -3.326 Score on a Scale | Standard Deviation 2.6697 |
| Double-blind Induction Period: Lebrikizumab +TCS | Double-blind Induction Period: Change From Baseline in Pruritus NRS by Week up to Week 16 | Change at Week 3 | -2.199 Score on a Scale | Standard Deviation 2.096 |
| Double-blind Induction Period: Lebrikizumab +TCS | Double-blind Induction Period: Change From Baseline in Pruritus NRS by Week up to Week 16 | Change at Week 11 | -3.285 Score on a Scale | Standard Deviation 2.5484 |
| Double-blind Induction Period: Lebrikizumab +TCS | Double-blind Induction Period: Change From Baseline in Pruritus NRS by Week up to Week 16 | Change at Week 4 | -2.351 Score on a Scale | Standard Deviation 2.2558 |
| Double-blind Induction Period: Lebrikizumab +TCS | Double-blind Induction Period: Change From Baseline in Pruritus NRS by Week up to Week 16 | Change at Week 14 | -3.313 Score on a Scale | Standard Deviation 2.6843 |
| Double-blind Induction Period: Lebrikizumab +TCS | Double-blind Induction Period: Change From Baseline in Pruritus NRS by Week up to Week 16 | Change at Week 5 | -2.771 Score on a Scale | Standard Deviation 2.4152 |
| Double-blind Induction Period: Lebrikizumab +TCS | Double-blind Induction Period: Change From Baseline in Pruritus NRS by Week up to Week 16 | Change at Week 7 | -3.204 Score on a Scale | Standard Deviation 2.4643 |
| Double-blind Induction Period: Lebrikizumab +TCS | Double-blind Induction Period: Change From Baseline in Pruritus NRS by Week up to Week 16 | Change at Week 10 | -3.245 Score on a Scale | Standard Deviation 2.6101 |
| Double-blind Induction Period: Lebrikizumab +TCS | Double-blind Induction Period: Change From Baseline in Pruritus NRS by Week up to Week 16 | Change at Week 8 | -3.080 Score on a Scale | Standard Deviation 2.4552 |
| Double-blind Induction Period: Lebrikizumab +TCS | Double-blind Induction Period: Change From Baseline in Pruritus NRS by Week up to Week 16 | Change at Week 15 | -3.366 Score on a Scale | Standard Deviation 2.5291 |
| Double-blind Induction Period: Lebrikizumab +TCS | Double-blind Induction Period: Change From Baseline in Pruritus NRS by Week up to Week 16 | Change at Week 9 | -3.283 Score on a Scale | Standard Deviation 2.5105 |
| Double-blind Induction Period: Placebo +TCS | Double-blind Induction Period: Change From Baseline in Pruritus NRS by Week up to Week 16 | Change at Week 15 | -1.938 Score on a Scale | Standard Deviation 2.5245 |
| Double-blind Induction Period: Placebo +TCS | Double-blind Induction Period: Change From Baseline in Pruritus NRS by Week up to Week 16 | Change at Week 6 | -1.711 Score on a Scale | Standard Deviation 2.533 |
| Double-blind Induction Period: Placebo +TCS | Double-blind Induction Period: Change From Baseline in Pruritus NRS by Week up to Week 16 | Change at Week 9 | -1.861 Score on a Scale | Standard Deviation 2.5872 |
| Double-blind Induction Period: Placebo +TCS | Double-blind Induction Period: Change From Baseline in Pruritus NRS by Week up to Week 16 | Change at Week 10 | -1.529 Score on a Scale | Standard Deviation 2.7489 |
| Double-blind Induction Period: Placebo +TCS | Double-blind Induction Period: Change From Baseline in Pruritus NRS by Week up to Week 16 | Change at Week 11 | -1.776 Score on a Scale | Standard Deviation 2.7302 |
| Double-blind Induction Period: Placebo +TCS | Double-blind Induction Period: Change From Baseline in Pruritus NRS by Week up to Week 16 | Change at Week 12 | -1.853 Score on a Scale | Standard Deviation 2.3583 |
| Double-blind Induction Period: Placebo +TCS | Double-blind Induction Period: Change From Baseline in Pruritus NRS by Week up to Week 16 | Change at Week 13 | -2.053 Score on a Scale | Standard Deviation 2.5284 |
| Double-blind Induction Period: Placebo +TCS | Double-blind Induction Period: Change From Baseline in Pruritus NRS by Week up to Week 16 | Change at Week 14 | -1.948 Score on a Scale | Standard Deviation 2.4181 |
| Double-blind Induction Period: Placebo +TCS | Double-blind Induction Period: Change From Baseline in Pruritus NRS by Week up to Week 16 | Change at Week 5 | -1.485 Score on a Scale | Standard Deviation 2.4553 |
| Double-blind Induction Period: Placebo +TCS | Double-blind Induction Period: Change From Baseline in Pruritus NRS by Week up to Week 16 | Change at Week 16 | -2.183 Score on a Scale | Standard Deviation 2.4246 |
| Double-blind Induction Period: Placebo +TCS | Double-blind Induction Period: Change From Baseline in Pruritus NRS by Week up to Week 16 | Change at Week 2 | -1.113 Score on a Scale | Standard Deviation 1.7468 |
| Double-blind Induction Period: Placebo +TCS | Double-blind Induction Period: Change From Baseline in Pruritus NRS by Week up to Week 16 | Change at Week 3 | -1.420 Score on a Scale | Standard Deviation 2.1401 |
| Double-blind Induction Period: Placebo +TCS | Double-blind Induction Period: Change From Baseline in Pruritus NRS by Week up to Week 16 | Change at Week 4 | -1.450 Score on a Scale | Standard Deviation 2.3924 |
| Double-blind Induction Period: Placebo +TCS | Double-blind Induction Period: Change From Baseline in Pruritus NRS by Week up to Week 16 | Change at Week 7 | -1.823 Score on a Scale | Standard Deviation 2.5263 |
| Double-blind Induction Period: Placebo +TCS | Double-blind Induction Period: Change From Baseline in Pruritus NRS by Week up to Week 16 | Change at Week 8 | -1.856 Score on a Scale | Standard Deviation 2.567 |
Secondary
Double-blind Induction Period: Change From Baseline in Scoring Atopic Dermatitis (SCORAD) at Weeks 8 and 16
SCORAD is a validated clinical tool for assessing the extent and intensity of AD. There are 3 components: A) Surface involvement is assessed as proportion of involved surface area segment by segment by applying the rule of 9s and reported as the sum of all areas, with a score ranging from 0-100. B) Intensity part of the SCORAD consists of 6 items: erythema, oedema, oozing/crusting, excoriation, lichenification, and dryness. Each item graded as: none (0), mild (1), moderate (2), or severe (3). C) Subjective assessment of itch and of sleeplessness is recorded for each symptom using a visual analogue scale (VAS), where 0=no itch (or no sleeplessness) and 10= worst imaginable itch (or sleeplessness), with maximum score of 20. Formula is: A/5+7B/2+C, A: extent (0-100), B: intensity (0-18), C: subjective symptoms (0-20). SCORAD total score ranged from 0 (no disease) to 103 (severe disease). Higher values represent worse outcome and negative change from baseline indicate improvement.
Time frame: Baseline, Weeks 8 and 16
Population: FAS included all randomized participants and were analyzed under the treatment group as randomized. Here, Overall number of participants analyzed signifies participants who were evaluable for this outcome measure and number analyzed signifies participants who were evaluable for specified time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Double-blind Induction Period: Lebrikizumab +TCS | Double-blind Induction Period: Change From Baseline in Scoring Atopic Dermatitis (SCORAD) at Weeks 8 and 16 | Change at Week 8 | -32.1 Score on a Scale | Standard Deviation 17.9 |
| Double-blind Induction Period: Lebrikizumab +TCS | Double-blind Induction Period: Change From Baseline in Scoring Atopic Dermatitis (SCORAD) at Weeks 8 and 16 | Change at Week 16 | -36.8 Score on a Scale | Standard Deviation 20.4 |
| Double-blind Induction Period: Placebo +TCS | Double-blind Induction Period: Change From Baseline in Scoring Atopic Dermatitis (SCORAD) at Weeks 8 and 16 | Change at Week 8 | -20.0 Score on a Scale | Standard Deviation 18.04 |
| Double-blind Induction Period: Placebo +TCS | Double-blind Induction Period: Change From Baseline in Scoring Atopic Dermatitis (SCORAD) at Weeks 8 and 16 | Change at Week 16 | -23.7 Score on a Scale | Standard Deviation 21.25 |
Secondary
Double-blind Induction Period: Change From Baseline in Skin Pain NRS by Week up to Week 16
The Skin Pain NRS is an 11-point scale completed by participants to rate their worst skin pain (example, discomfort or soreness) severity over the past 24 hours, with 0 (indicating No pain) to 10 (indicating Worst pain imaginable). Higher scores indicated worse pain and negative change from baseline indicate no pain.
Time frame: Baseline, Weeks 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15 and 16
Population: FAS included all randomized participants and were analyzed under the treatment group as randomized. Here, Overall number of participants analyzed signifies participants who were evaluable for this outcome measure and number analyzed signifies participants who were evaluable for specified categories.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Double-blind Induction Period: Lebrikizumab +TCS | Double-blind Induction Period: Change From Baseline in Skin Pain NRS by Week up to Week 16 | Change at Week 11 | -3.116 Score on a Scale | Standard Deviation 2.623 |
| Double-blind Induction Period: Lebrikizumab +TCS | Double-blind Induction Period: Change From Baseline in Skin Pain NRS by Week up to Week 16 | Change at Week 3 | -2.152 Score on a Scale | Standard Deviation 2.1719 |
| Double-blind Induction Period: Lebrikizumab +TCS | Double-blind Induction Period: Change From Baseline in Skin Pain NRS by Week up to Week 16 | Change at Week 9 | -3.017 Score on a Scale | Standard Deviation 2.4897 |
| Double-blind Induction Period: Lebrikizumab +TCS | Double-blind Induction Period: Change From Baseline in Skin Pain NRS by Week up to Week 16 | Change at Week 8 | -2.872 Score on a Scale | Standard Deviation 2.4975 |
| Double-blind Induction Period: Lebrikizumab +TCS | Double-blind Induction Period: Change From Baseline in Skin Pain NRS by Week up to Week 16 | Change at Week 10 | -3.017 Score on a Scale | Standard Deviation 2.6017 |
| Double-blind Induction Period: Lebrikizumab +TCS | Double-blind Induction Period: Change From Baseline in Skin Pain NRS by Week up to Week 16 | Change at Week 4 | -2.308 Score on a Scale | Standard Deviation 2.2457 |
| Double-blind Induction Period: Lebrikizumab +TCS | Double-blind Induction Period: Change From Baseline in Skin Pain NRS by Week up to Week 16 | Change at Week 12 | -3.115 Score on a Scale | Standard Deviation 2.6181 |
| Double-blind Induction Period: Lebrikizumab +TCS | Double-blind Induction Period: Change From Baseline in Skin Pain NRS by Week up to Week 16 | Change at Week 14 | -3.035 Score on a Scale | Standard Deviation 2.6733 |
| Double-blind Induction Period: Lebrikizumab +TCS | Double-blind Induction Period: Change From Baseline in Skin Pain NRS by Week up to Week 16 | Change at Week 13 | -3.140 Score on a Scale | Standard Deviation 2.5568 |
| Double-blind Induction Period: Lebrikizumab +TCS | Double-blind Induction Period: Change From Baseline in Skin Pain NRS by Week up to Week 16 | Change at Week 5 | -2.589 Score on a Scale | Standard Deviation 2.3577 |
| Double-blind Induction Period: Lebrikizumab +TCS | Double-blind Induction Period: Change From Baseline in Skin Pain NRS by Week up to Week 16 | Change at Week 6 | -2.862 Score on a Scale | Standard Deviation 2.4428 |
| Double-blind Induction Period: Lebrikizumab +TCS | Double-blind Induction Period: Change From Baseline in Skin Pain NRS by Week up to Week 16 | Change at Week 15 | -3.138 Score on a Scale | Standard Deviation 2.6062 |
| Double-blind Induction Period: Lebrikizumab +TCS | Double-blind Induction Period: Change From Baseline in Skin Pain NRS by Week up to Week 16 | Change at Week 2 | -1.546 Score on a Scale | Standard Deviation 1.7978 |
| Double-blind Induction Period: Lebrikizumab +TCS | Double-blind Induction Period: Change From Baseline in Skin Pain NRS by Week up to Week 16 | Change at Week 16 | -3.302 Score on a Scale | Standard Deviation 2.5844 |
| Double-blind Induction Period: Lebrikizumab +TCS | Double-blind Induction Period: Change From Baseline in Skin Pain NRS by Week up to Week 16 | Change at Week 7 | -2.886 Score on a Scale | Standard Deviation 2.4473 |
| Double-blind Induction Period: Placebo +TCS | Double-blind Induction Period: Change From Baseline in Skin Pain NRS by Week up to Week 16 | Change at Week 16 | -1.831 Score on a Scale | Standard Deviation 2.5766 |
| Double-blind Induction Period: Placebo +TCS | Double-blind Induction Period: Change From Baseline in Skin Pain NRS by Week up to Week 16 | Change at Week 11 | -1.572 Score on a Scale | Standard Deviation 2.6465 |
| Double-blind Induction Period: Placebo +TCS | Double-blind Induction Period: Change From Baseline in Skin Pain NRS by Week up to Week 16 | Change at Week 2 | -0.905 Score on a Scale | Standard Deviation 1.917 |
| Double-blind Induction Period: Placebo +TCS | Double-blind Induction Period: Change From Baseline in Skin Pain NRS by Week up to Week 16 | Change at Week 3 | -1.316 Score on a Scale | Standard Deviation 2.268 |
| Double-blind Induction Period: Placebo +TCS | Double-blind Induction Period: Change From Baseline in Skin Pain NRS by Week up to Week 16 | Change at Week 4 | -1.271 Score on a Scale | Standard Deviation 2.488 |
| Double-blind Induction Period: Placebo +TCS | Double-blind Induction Period: Change From Baseline in Skin Pain NRS by Week up to Week 16 | Change at Week 6 | -1.309 Score on a Scale | Standard Deviation 2.5079 |
| Double-blind Induction Period: Placebo +TCS | Double-blind Induction Period: Change From Baseline in Skin Pain NRS by Week up to Week 16 | Change at Week 7 | -1.656 Score on a Scale | Standard Deviation 2.4816 |
| Double-blind Induction Period: Placebo +TCS | Double-blind Induction Period: Change From Baseline in Skin Pain NRS by Week up to Week 16 | Change at Week 8 | -1.711 Score on a Scale | Standard Deviation 2.7208 |
| Double-blind Induction Period: Placebo +TCS | Double-blind Induction Period: Change From Baseline in Skin Pain NRS by Week up to Week 16 | Change at Week 9 | -1.598 Score on a Scale | Standard Deviation 2.5693 |
| Double-blind Induction Period: Placebo +TCS | Double-blind Induction Period: Change From Baseline in Skin Pain NRS by Week up to Week 16 | Change at Week 10 | -1.382 Score on a Scale | Standard Deviation 2.7463 |
| Double-blind Induction Period: Placebo +TCS | Double-blind Induction Period: Change From Baseline in Skin Pain NRS by Week up to Week 16 | Change at Week 12 | -1.520 Score on a Scale | Standard Deviation 2.5976 |
| Double-blind Induction Period: Placebo +TCS | Double-blind Induction Period: Change From Baseline in Skin Pain NRS by Week up to Week 16 | Change at Week 13 | -1.788 Score on a Scale | Standard Deviation 2.4726 |
| Double-blind Induction Period: Placebo +TCS | Double-blind Induction Period: Change From Baseline in Skin Pain NRS by Week up to Week 16 | Change at Week 14 | -1.683 Score on a Scale | Standard Deviation 2.4462 |
| Double-blind Induction Period: Placebo +TCS | Double-blind Induction Period: Change From Baseline in Skin Pain NRS by Week up to Week 16 | Change at Week 15 | -1.781 Score on a Scale | Standard Deviation 2.6443 |
| Double-blind Induction Period: Placebo +TCS | Double-blind Induction Period: Change From Baseline in Skin Pain NRS by Week up to Week 16 | Change at Week 5 | -1.333 Score on a Scale | Standard Deviation 2.4462 |
Secondary
Double-blind Induction Period: Change From Baseline in the Sleep Loss at Week 16 Using Patient-related Outcome (PRO) by Week up to Week 16
Sleep loss was assessed by all participants using a PRO instrument. Participants (and if applicable, with help of parents/caregiver if required) rate their sleep on a 5-point Likert scale (with scores ranging from 0 \[not at all\] to 4 \[unable to sleep at all\]). Higher scores indicated a greater impact and worse outcome; therefore, negative change from baseline indicate less impact.
Time frame: Baseline, Weeks 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15 and 16
Population: FAS included all randomized participants and were analyzed under the treatment group as randomized. Here, Overall number of participants analyzed signifies participants who were evaluable for this outcome measure and number analyzed signifies participants who were evaluable for specified timepoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Double-blind Induction Period: Lebrikizumab +TCS | Double-blind Induction Period: Change From Baseline in the Sleep Loss at Week 16 Using Patient-related Outcome (PRO) by Week up to Week 16 | Change at Week 8 | -0.974 Score on a Scale | Standard Deviation 0.9941 |
| Double-blind Induction Period: Lebrikizumab +TCS | Double-blind Induction Period: Change From Baseline in the Sleep Loss at Week 16 Using Patient-related Outcome (PRO) by Week up to Week 16 | Change at Week 16 | -1.201 Score on a Scale | Standard Deviation 0.9775 |
| Double-blind Induction Period: Lebrikizumab +TCS | Double-blind Induction Period: Change From Baseline in the Sleep Loss at Week 16 Using Patient-related Outcome (PRO) by Week up to Week 16 | Change at Week 9 | -1.052 Score on a Scale | Standard Deviation 0.9352 |
| Double-blind Induction Period: Lebrikizumab +TCS | Double-blind Induction Period: Change From Baseline in the Sleep Loss at Week 16 Using Patient-related Outcome (PRO) by Week up to Week 16 | Change at Week 13 | -1.069 Score on a Scale | Standard Deviation 0.9776 |
| Double-blind Induction Period: Lebrikizumab +TCS | Double-blind Induction Period: Change From Baseline in the Sleep Loss at Week 16 Using Patient-related Outcome (PRO) by Week up to Week 16 | Change at Week 14 | -1.072 Score on a Scale | Standard Deviation 1.0446 |
| Double-blind Induction Period: Lebrikizumab +TCS | Double-blind Induction Period: Change From Baseline in the Sleep Loss at Week 16 Using Patient-related Outcome (PRO) by Week up to Week 16 | Change at Week 15 | -1.096 Score on a Scale | Standard Deviation 0.9819 |
| Double-blind Induction Period: Lebrikizumab +TCS | Double-blind Induction Period: Change From Baseline in the Sleep Loss at Week 16 Using Patient-related Outcome (PRO) by Week up to Week 16 | Change at Week 5 | -0.942 Score on a Scale | Standard Deviation 0.9646 |
| Double-blind Induction Period: Lebrikizumab +TCS | Double-blind Induction Period: Change From Baseline in the Sleep Loss at Week 16 Using Patient-related Outcome (PRO) by Week up to Week 16 | Change at Week 2 | -0.603 Score on a Scale | Standard Deviation 0.6985 |
| Double-blind Induction Period: Lebrikizumab +TCS | Double-blind Induction Period: Change From Baseline in the Sleep Loss at Week 16 Using Patient-related Outcome (PRO) by Week up to Week 16 | Change at Week 10 | -1.091 Score on a Scale | Standard Deviation 0.9624 |
| Double-blind Induction Period: Lebrikizumab +TCS | Double-blind Induction Period: Change From Baseline in the Sleep Loss at Week 16 Using Patient-related Outcome (PRO) by Week up to Week 16 | Change at Week 3 | -0.816 Score on a Scale | Standard Deviation 0.8809 |
| Double-blind Induction Period: Lebrikizumab +TCS | Double-blind Induction Period: Change From Baseline in the Sleep Loss at Week 16 Using Patient-related Outcome (PRO) by Week up to Week 16 | Change at Week 4 | -0.875 Score on a Scale | Standard Deviation 0.9387 |
| Double-blind Induction Period: Lebrikizumab +TCS | Double-blind Induction Period: Change From Baseline in the Sleep Loss at Week 16 Using Patient-related Outcome (PRO) by Week up to Week 16 | Change at Week 7 | -1.038 Score on a Scale | Standard Deviation 0.9388 |
| Double-blind Induction Period: Lebrikizumab +TCS | Double-blind Induction Period: Change From Baseline in the Sleep Loss at Week 16 Using Patient-related Outcome (PRO) by Week up to Week 16 | Change at Week 11 | -1.040 Score on a Scale | Standard Deviation 0.9966 |
| Double-blind Induction Period: Lebrikizumab +TCS | Double-blind Induction Period: Change From Baseline in the Sleep Loss at Week 16 Using Patient-related Outcome (PRO) by Week up to Week 16 | Change at Week 6 | -0.998 Score on a Scale | Standard Deviation 0.9088 |
| Double-blind Induction Period: Lebrikizumab +TCS | Double-blind Induction Period: Change From Baseline in the Sleep Loss at Week 16 Using Patient-related Outcome (PRO) by Week up to Week 16 | Change at Week 12 | -1.123 Score on a Scale | Standard Deviation 1.0281 |
| Double-blind Induction Period: Placebo +TCS | Double-blind Induction Period: Change From Baseline in the Sleep Loss at Week 16 Using Patient-related Outcome (PRO) by Week up to Week 16 | Change at Week 14 | -0.809 Score on a Scale | Standard Deviation 1.0751 |
| Double-blind Induction Period: Placebo +TCS | Double-blind Induction Period: Change From Baseline in the Sleep Loss at Week 16 Using Patient-related Outcome (PRO) by Week up to Week 16 | Change at Week 4 | -0.577 Score on a Scale | Standard Deviation 1.0885 |
| Double-blind Induction Period: Placebo +TCS | Double-blind Induction Period: Change From Baseline in the Sleep Loss at Week 16 Using Patient-related Outcome (PRO) by Week up to Week 16 | Change at Week 5 | -0.607 Score on a Scale | Standard Deviation 1.1342 |
| Double-blind Induction Period: Placebo +TCS | Double-blind Induction Period: Change From Baseline in the Sleep Loss at Week 16 Using Patient-related Outcome (PRO) by Week up to Week 16 | Change at Week 6 | -0.613 Score on a Scale | Standard Deviation 1.0641 |
| Double-blind Induction Period: Placebo +TCS | Double-blind Induction Period: Change From Baseline in the Sleep Loss at Week 16 Using Patient-related Outcome (PRO) by Week up to Week 16 | Change at Week 7 | -0.661 Score on a Scale | Standard Deviation 1.1119 |
| Double-blind Induction Period: Placebo +TCS | Double-blind Induction Period: Change From Baseline in the Sleep Loss at Week 16 Using Patient-related Outcome (PRO) by Week up to Week 16 | Change at Week 9 | -0.668 Score on a Scale | Standard Deviation 1.0604 |
| Double-blind Induction Period: Placebo +TCS | Double-blind Induction Period: Change From Baseline in the Sleep Loss at Week 16 Using Patient-related Outcome (PRO) by Week up to Week 16 | Change at Week 10 | -0.560 Score on a Scale | Standard Deviation 1.1349 |
| Double-blind Induction Period: Placebo +TCS | Double-blind Induction Period: Change From Baseline in the Sleep Loss at Week 16 Using Patient-related Outcome (PRO) by Week up to Week 16 | Change at Week 13 | -0.797 Score on a Scale | Standard Deviation 1.1037 |
| Double-blind Induction Period: Placebo +TCS | Double-blind Induction Period: Change From Baseline in the Sleep Loss at Week 16 Using Patient-related Outcome (PRO) by Week up to Week 16 | Change at Week 3 | -0.673 Score on a Scale | Standard Deviation 1.0262 |
| Double-blind Induction Period: Placebo +TCS | Double-blind Induction Period: Change From Baseline in the Sleep Loss at Week 16 Using Patient-related Outcome (PRO) by Week up to Week 16 | Change at Week 16 | -0.857 Score on a Scale | Standard Deviation 1.0615 |
| Double-blind Induction Period: Placebo +TCS | Double-blind Induction Period: Change From Baseline in the Sleep Loss at Week 16 Using Patient-related Outcome (PRO) by Week up to Week 16 | Change at Week 15 | -0.756 Score on a Scale | Standard Deviation 1.0891 |
| Double-blind Induction Period: Placebo +TCS | Double-blind Induction Period: Change From Baseline in the Sleep Loss at Week 16 Using Patient-related Outcome (PRO) by Week up to Week 16 | Change at Week 2 | -0.493 Score on a Scale | Standard Deviation 0.8407 |
| Double-blind Induction Period: Placebo +TCS | Double-blind Induction Period: Change From Baseline in the Sleep Loss at Week 16 Using Patient-related Outcome (PRO) by Week up to Week 16 | Change at Week 12 | -0.721 Score on a Scale | Standard Deviation 1.0768 |
| Double-blind Induction Period: Placebo +TCS | Double-blind Induction Period: Change From Baseline in the Sleep Loss at Week 16 Using Patient-related Outcome (PRO) by Week up to Week 16 | Change at Week 8 | -0.708 Score on a Scale | Standard Deviation 1.15 |
| Double-blind Induction Period: Placebo +TCS | Double-blind Induction Period: Change From Baseline in the Sleep Loss at Week 16 Using Patient-related Outcome (PRO) by Week up to Week 16 | Change at Week 11 | -0.676 Score on a Scale | Standard Deviation 1.0938 |
Secondary
Double-blind Induction Period: Median Time (Days) to TCS-Free Use
Days from first study drug injection to the day participant stopped using all TCS.
Time frame: Baseline up to Week 16
Population: FAS included all randomized participants and were analyzed under the treatment group as randomized.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Double-blind Induction Period: Lebrikizumab +TCS | Double-blind Induction Period: Median Time (Days) to TCS-Free Use | NA Days |
| Double-blind Induction Period: Placebo +TCS | Double-blind Induction Period: Median Time (Days) to TCS-Free Use | NA Days |
Secondary
Double-blind Induction Period: Percentage of Participants Who Achieved a 4-point Improvement in Children's Dermatology Life Quality Index (CDLQI) at Weeks 2, 4, 8, 12 and 16
The CDLQI is validated from adolescents younger than age of 16 years, which is based on a set of 10 questions different from those of the DLQI to measure the impact of AD disease on QoL in children during the previous week. Each question is scored as follows: 0=not at all or unanswered, 1 = only a little, 2 = quite a lot and 3 = very much. Question 7 has an added possible response, which was scored as 3. CDLQI equals the sum of the score of each question, ranged from 0 (no impact of skin disease on QoL) to 30 (maximum impact on QoL). Higher scores indicate higher impact on QoL.
Time frame: At Weeks 2, 4, 8, 12 and 16
Population: FAS included all randomized participants with Baseline Score \>= 4. Here, Overall number of participants analyzed signifies participants who were evaluable for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Double-blind Induction Period: Lebrikizumab +TCS | Double-blind Induction Period: Percentage of Participants Who Achieved a 4-point Improvement in Children's Dermatology Life Quality Index (CDLQI) at Weeks 2, 4, 8, 12 and 16 | At Week 4 | 68.2 Percentage of participants |
| Double-blind Induction Period: Lebrikizumab +TCS | Double-blind Induction Period: Percentage of Participants Who Achieved a 4-point Improvement in Children's Dermatology Life Quality Index (CDLQI) at Weeks 2, 4, 8, 12 and 16 | At Week 12 | 95.5 Percentage of participants |
| Double-blind Induction Period: Lebrikizumab +TCS | Double-blind Induction Period: Percentage of Participants Who Achieved a 4-point Improvement in Children's Dermatology Life Quality Index (CDLQI) at Weeks 2, 4, 8, 12 and 16 | At Week 16 | 93.1 Percentage of participants |
| Double-blind Induction Period: Lebrikizumab +TCS | Double-blind Induction Period: Percentage of Participants Who Achieved a 4-point Improvement in Children's Dermatology Life Quality Index (CDLQI) at Weeks 2, 4, 8, 12 and 16 | At Week 2 | 90.9 Percentage of participants |
| Double-blind Induction Period: Lebrikizumab +TCS | Double-blind Induction Period: Percentage of Participants Who Achieved a 4-point Improvement in Children's Dermatology Life Quality Index (CDLQI) at Weeks 2, 4, 8, 12 and 16 | At Week 8 | 90.9 Percentage of participants |
| Double-blind Induction Period: Placebo +TCS | Double-blind Induction Period: Percentage of Participants Who Achieved a 4-point Improvement in Children's Dermatology Life Quality Index (CDLQI) at Weeks 2, 4, 8, 12 and 16 | At Week 2 | 100 Percentage of participants |
| Double-blind Induction Period: Placebo +TCS | Double-blind Induction Period: Percentage of Participants Who Achieved a 4-point Improvement in Children's Dermatology Life Quality Index (CDLQI) at Weeks 2, 4, 8, 12 and 16 | At Week 8 | 100 Percentage of participants |
| Double-blind Induction Period: Placebo +TCS | Double-blind Induction Period: Percentage of Participants Who Achieved a 4-point Improvement in Children's Dermatology Life Quality Index (CDLQI) at Weeks 2, 4, 8, 12 and 16 | At Week 4 | 62.5 Percentage of participants |
| Double-blind Induction Period: Placebo +TCS | Double-blind Induction Period: Percentage of Participants Who Achieved a 4-point Improvement in Children's Dermatology Life Quality Index (CDLQI) at Weeks 2, 4, 8, 12 and 16 | At Week 16 | 100 Percentage of participants |
| Double-blind Induction Period: Placebo +TCS | Double-blind Induction Period: Percentage of Participants Who Achieved a 4-point Improvement in Children's Dermatology Life Quality Index (CDLQI) at Weeks 2, 4, 8, 12 and 16 | At Week 12 | 100 Percentage of participants |
Secondary
Double-blind Induction Period: Percentage of Participants Who Achieved a 4-point Improvement in Dermatology Life Quality Index (DLQI) at Weeks 2, 4, 8, 12 and 16
The DLQI is a 10-item validated questionnaire completed by the participant or caregiver used to assess the impact of skin disease on the participant's quality of life (QoL during the previous week. The 10 questions cover the following topics: symptoms, embarrassment, shopping and home care, clothes, social and leisure, sport, work or study, close relationships, sex, and treatment. Each question was scored on a 4-point scale (ranged from 0 to 3) where, 0 = not at all, 1= a little, 2= a lot, 3= very much, giving a total score ranging from 0 (not at all) to 30 (very much). A high score is indicative of a poor QoL.
Time frame: At Weeks 2, 4, 8, 12 and 16
Population: FAS included all randomized participants with Baseline DLQI score of \>=4. Here, Overall number of participants analyzed signifies participants who were evaluable for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Double-blind Induction Period: Lebrikizumab +TCS | Double-blind Induction Period: Percentage of Participants Who Achieved a 4-point Improvement in Dermatology Life Quality Index (DLQI) at Weeks 2, 4, 8, 12 and 16 | At Week 4 | 66.1 Percentage of participants |
| Double-blind Induction Period: Lebrikizumab +TCS | Double-blind Induction Period: Percentage of Participants Who Achieved a 4-point Improvement in Dermatology Life Quality Index (DLQI) at Weeks 2, 4, 8, 12 and 16 | At Week 16 | 78.0 Percentage of participants |
| Double-blind Induction Period: Lebrikizumab +TCS | Double-blind Induction Period: Percentage of Participants Who Achieved a 4-point Improvement in Dermatology Life Quality Index (DLQI) at Weeks 2, 4, 8, 12 and 16 | At Week 12 | 73.1 Percentage of participants |
| Double-blind Induction Period: Lebrikizumab +TCS | Double-blind Induction Period: Percentage of Participants Who Achieved a 4-point Improvement in Dermatology Life Quality Index (DLQI) at Weeks 2, 4, 8, 12 and 16 | At Week 8 | 70.5 Percentage of participants |
| Double-blind Induction Period: Lebrikizumab +TCS | Double-blind Induction Period: Percentage of Participants Who Achieved a 4-point Improvement in Dermatology Life Quality Index (DLQI) at Weeks 2, 4, 8, 12 and 16 | At Week 2 | 52.8 Percentage of participants |
| Double-blind Induction Period: Placebo +TCS | Double-blind Induction Period: Percentage of Participants Who Achieved a 4-point Improvement in Dermatology Life Quality Index (DLQI) at Weeks 2, 4, 8, 12 and 16 | At Week 8 | 56.1 Percentage of participants |
| Double-blind Induction Period: Placebo +TCS | Double-blind Induction Period: Percentage of Participants Who Achieved a 4-point Improvement in Dermatology Life Quality Index (DLQI) at Weeks 2, 4, 8, 12 and 16 | At Week 2 | 57.1 Percentage of participants |
| Double-blind Induction Period: Placebo +TCS | Double-blind Induction Period: Percentage of Participants Who Achieved a 4-point Improvement in Dermatology Life Quality Index (DLQI) at Weeks 2, 4, 8, 12 and 16 | At Week 4 | 61.9 Percentage of participants |
| Double-blind Induction Period: Placebo +TCS | Double-blind Induction Period: Percentage of Participants Who Achieved a 4-point Improvement in Dermatology Life Quality Index (DLQI) at Weeks 2, 4, 8, 12 and 16 | At Week 12 | 59.6 Percentage of participants |
| Double-blind Induction Period: Placebo +TCS | Double-blind Induction Period: Percentage of Participants Who Achieved a 4-point Improvement in Dermatology Life Quality Index (DLQI) at Weeks 2, 4, 8, 12 and 16 | At Week 16 | 69.6 Percentage of participants |
Secondary
Double-blind Induction Period: Percentage of Participants Who Achieved a 4-point Improvement in Pruritus Numeric Rating Score (NRS) at Week 16
The Pruritus NRS is an 11-point scale used by participants to rate their worst pruritus (itch) severity over the past 24 hours, with 0 indicating No itch, and 10 indicating Worst itch imaginable. Higher score indicates more severity.
Time frame: At Week 16
Population: FAS included all randomized participants with the Baseline score \>=4. Here, Overall number of participants analyzed signifies participants who were evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Double-blind Induction Period: Lebrikizumab +TCS | Double-blind Induction Period: Percentage of Participants Who Achieved a 4-point Improvement in Pruritus Numeric Rating Score (NRS) at Week 16 | 49.9 Percentage of participants |
| Double-blind Induction Period: Placebo +TCS | Double-blind Induction Period: Percentage of Participants Who Achieved a 4-point Improvement in Pruritus Numeric Rating Score (NRS) at Week 16 | 29.7 Percentage of participants |
p-value: 0.011495% CI: [5.47, 30.83]Cochran-Mantel-Haenszel
Secondary
Double-blind Induction Period: Percentage of Participants Who Achieved a 4- Point Improvement in Skin Pain NRS at Week 16
The Skin Pain NRS is an 11-point scale completed by participants to rate their worst skin pain (example, discomfort or soreness) severity over the past 24 hours, with 0 (indicating No pain) and 10 (indicating Worst pain imaginable). Higher scores indicated worse pain.
Time frame: At Week 16
Population: FAS included all randomized participants with Baseline Score \>= 4. Here, Overall number of participants analyzed signifies participants who were evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Double-blind Induction Period: Lebrikizumab +TCS | Double-blind Induction Period: Percentage of Participants Who Achieved a 4- Point Improvement in Skin Pain NRS at Week 16 | 51.6 Percentage of participants |
| Double-blind Induction Period: Placebo +TCS | Double-blind Induction Period: Percentage of Participants Who Achieved a 4- Point Improvement in Skin Pain NRS at Week 16 | 27.5 Percentage of participants |
Secondary
Double-blind Induction Period: Percentage of Participants Who Achieved EASI 50 (>=50% Reduction From Baseline in EASI Score) at Weeks 2, 4, 8, 12 and 16
The EASI score is used to measure the severity and extent of AD and measures erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. The severity of the clinical signs of AD for each of 4 body regions was scored on a 4-point scale: 0=absent, 1=mild, 2=moderate and 3=severe. The area of AD involvement on each of the 4 anatomic regions was assessed as a percentage by body area: 0=no eruption, 1=1% to 9%, 2=10% to 29%, 3=30% to 49%, 4=50% to 60%, 5=70% to 80% and 6=90% to 100%. The composite index with total score ranged from 0 to 72, where higher scores indicates more severe and or extensive disease.
Time frame: At Weeks 2, 4, 8, 12 and 16
Population: FAS included all randomized participants and were analyzed under the treatment group as randomized.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Double-blind Induction Period: Lebrikizumab +TCS | Double-blind Induction Period: Percentage of Participants Who Achieved EASI 50 (>=50% Reduction From Baseline in EASI Score) at Weeks 2, 4, 8, 12 and 16 | At Week 2 | 30.8 Percentage of participants |
| Double-blind Induction Period: Lebrikizumab +TCS | Double-blind Induction Period: Percentage of Participants Who Achieved EASI 50 (>=50% Reduction From Baseline in EASI Score) at Weeks 2, 4, 8, 12 and 16 | At Week 4 | 58.9 Percentage of participants |
| Double-blind Induction Period: Lebrikizumab +TCS | Double-blind Induction Period: Percentage of Participants Who Achieved EASI 50 (>=50% Reduction From Baseline in EASI Score) at Weeks 2, 4, 8, 12 and 16 | At Week 8 | 75.2 Percentage of participants |
| Double-blind Induction Period: Lebrikizumab +TCS | Double-blind Induction Period: Percentage of Participants Who Achieved EASI 50 (>=50% Reduction From Baseline in EASI Score) at Weeks 2, 4, 8, 12 and 16 | At Week 12 | 80.3 Percentage of participants |
| Double-blind Induction Period: Lebrikizumab +TCS | Double-blind Induction Period: Percentage of Participants Who Achieved EASI 50 (>=50% Reduction From Baseline in EASI Score) at Weeks 2, 4, 8, 12 and 16 | At Week 16 | 82.6 Percentage of participants |
| Double-blind Induction Period: Placebo +TCS | Double-blind Induction Period: Percentage of Participants Who Achieved EASI 50 (>=50% Reduction From Baseline in EASI Score) at Weeks 2, 4, 8, 12 and 16 | At Week 16 | 65.3 Percentage of participants |
| Double-blind Induction Period: Placebo +TCS | Double-blind Induction Period: Percentage of Participants Who Achieved EASI 50 (>=50% Reduction From Baseline in EASI Score) at Weeks 2, 4, 8, 12 and 16 | At Week 12 | 68.0 Percentage of participants |
| Double-blind Induction Period: Placebo +TCS | Double-blind Induction Period: Percentage of Participants Who Achieved EASI 50 (>=50% Reduction From Baseline in EASI Score) at Weeks 2, 4, 8, 12 and 16 | At Week 4 | 46.0 Percentage of participants |
| Double-blind Induction Period: Placebo +TCS | Double-blind Induction Period: Percentage of Participants Who Achieved EASI 50 (>=50% Reduction From Baseline in EASI Score) at Weeks 2, 4, 8, 12 and 16 | At Week 2 | 23.4 Percentage of participants |
| Double-blind Induction Period: Placebo +TCS | Double-blind Induction Period: Percentage of Participants Who Achieved EASI 50 (>=50% Reduction From Baseline in EASI Score) at Weeks 2, 4, 8, 12 and 16 | At Week 8 | 59.3 Percentage of participants |
Secondary
Double-blind Induction Period: Percentage of Participants Who Achieved EASI 75 (>=75% Reduction From Baseline in EASI Score) at Weeks 2, 4, 8, and 12
The EASI score is used to measure the severity and extent of atopic dermatitis (AD) and measures erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. The severity of the clinical signs of AD for each of 4 body regions was scored on a 4-point scale: 0=absent, 1=mild, 2=moderate and 3=severe. The area of AD involvement on each of the 4 anatomic regions was assessed as a percentage by body area: 0=no eruption, 1=1% to 9%, 2=10% to 29%, 3=30% to 49%, 4=50% to 60%, 5=70% to 80% and 6=90% to 100%. The composite index with total score ranged from 0 to 72, where higher scores indicates more severe and or extensive disease. Percentage of participants who achieved EASI 75 (\>=75% reduction from baseline in EASI score) at Weeks 2, 4, 8, and 12 were reported
Time frame: At Weeks 2, 4, 8, and12
Population: FAS included all randomized participants and were analyzed under the treatment group as randomized.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Double-blind Induction Period: Lebrikizumab +TCS | Double-blind Induction Period: Percentage of Participants Who Achieved EASI 75 (>=75% Reduction From Baseline in EASI Score) at Weeks 2, 4, 8, and 12 | At Week 2 | 9.7 Percentage of participants |
| Double-blind Induction Period: Lebrikizumab +TCS | Double-blind Induction Period: Percentage of Participants Who Achieved EASI 75 (>=75% Reduction From Baseline in EASI Score) at Weeks 2, 4, 8, and 12 | At Week 8 | 54.9 Percentage of participants |
| Double-blind Induction Period: Lebrikizumab +TCS | Double-blind Induction Period: Percentage of Participants Who Achieved EASI 75 (>=75% Reduction From Baseline in EASI Score) at Weeks 2, 4, 8, and 12 | At Week 4 | 28.3 Percentage of participants |
| Double-blind Induction Period: Lebrikizumab +TCS | Double-blind Induction Period: Percentage of Participants Who Achieved EASI 75 (>=75% Reduction From Baseline in EASI Score) at Weeks 2, 4, 8, and 12 | At Week 12 | 64.9 Percentage of participants |
| Double-blind Induction Period: Placebo +TCS | Double-blind Induction Period: Percentage of Participants Who Achieved EASI 75 (>=75% Reduction From Baseline in EASI Score) at Weeks 2, 4, 8, and 12 | At Week 4 | 19.2 Percentage of participants |
| Double-blind Induction Period: Placebo +TCS | Double-blind Induction Period: Percentage of Participants Who Achieved EASI 75 (>=75% Reduction From Baseline in EASI Score) at Weeks 2, 4, 8, and 12 | At Week 2 | 6.3 Percentage of participants |
| Double-blind Induction Period: Placebo +TCS | Double-blind Induction Period: Percentage of Participants Who Achieved EASI 75 (>=75% Reduction From Baseline in EASI Score) at Weeks 2, 4, 8, and 12 | At Week 12 | 41.1 Percentage of participants |
| Double-blind Induction Period: Placebo +TCS | Double-blind Induction Period: Percentage of Participants Who Achieved EASI 75 (>=75% Reduction From Baseline in EASI Score) at Weeks 2, 4, 8, and 12 | At Week 8 | 31.5 Percentage of participants |
Secondary
Double-blind Induction Period: Percentage of Participants Who Achieved EASI 90 (>=90% Reduction From Baseline in EASI Score) at Weeks 2, 4, 8, 12 and 16
The EASI score is used to measure the severity and extent of AD and measures erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. The severity of the clinical signs of AD for each of 4 body regions was scored on a 4-point scale: 0=absent, 1=mild, 2=moderate and 3=severe. The area of AD involvement on each of the 4 anatomic regions was assessed as a percentage by body area: 0=no eruption, 1=1% to 9%, 2=10% to 29%, 3=30% to 49%, 4=50% to 60%, 5=70% to 80% and 6=90% to 100%. The composite index with total score ranged from 0 to 72, where higher scores indicates more severe and or extensive disease.
Time frame: At Weeks 2, 4, 8, 12 and 16
Population: FAS included all randomized participants and were analyzed under the treatment group as randomized.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Double-blind Induction Period: Lebrikizumab +TCS | Double-blind Induction Period: Percentage of Participants Who Achieved EASI 90 (>=90% Reduction From Baseline in EASI Score) at Weeks 2, 4, 8, 12 and 16 | At Week 4 | 15.8 Percentage of participants |
| Double-blind Induction Period: Lebrikizumab +TCS | Double-blind Induction Period: Percentage of Participants Who Achieved EASI 90 (>=90% Reduction From Baseline in EASI Score) at Weeks 2, 4, 8, 12 and 16 | At Week 12 | 42.1 Percentage of participants |
| Double-blind Induction Period: Lebrikizumab +TCS | Double-blind Induction Period: Percentage of Participants Who Achieved EASI 90 (>=90% Reduction From Baseline in EASI Score) at Weeks 2, 4, 8, 12 and 16 | At Week 8 | 28.9 Percentage of participants |
| Double-blind Induction Period: Lebrikizumab +TCS | Double-blind Induction Period: Percentage of Participants Who Achieved EASI 90 (>=90% Reduction From Baseline in EASI Score) at Weeks 2, 4, 8, 12 and 16 | At Week 16 | 42.9 Percentage of participants |
| Double-blind Induction Period: Lebrikizumab +TCS | Double-blind Induction Period: Percentage of Participants Who Achieved EASI 90 (>=90% Reduction From Baseline in EASI Score) at Weeks 2, 4, 8, 12 and 16 | At Week 2 | 1.5 Percentage of participants |
| Double-blind Induction Period: Placebo +TCS | Double-blind Induction Period: Percentage of Participants Who Achieved EASI 90 (>=90% Reduction From Baseline in EASI Score) at Weeks 2, 4, 8, 12 and 16 | At Week 16 | 20.8 Percentage of participants |
| Double-blind Induction Period: Placebo +TCS | Double-blind Induction Period: Percentage of Participants Who Achieved EASI 90 (>=90% Reduction From Baseline in EASI Score) at Weeks 2, 4, 8, 12 and 16 | At Week 2 | 0.9 Percentage of participants |
| Double-blind Induction Period: Placebo +TCS | Double-blind Induction Period: Percentage of Participants Who Achieved EASI 90 (>=90% Reduction From Baseline in EASI Score) at Weeks 2, 4, 8, 12 and 16 | At Week 4 | 6.4 Percentage of participants |
| Double-blind Induction Period: Placebo +TCS | Double-blind Induction Period: Percentage of Participants Who Achieved EASI 90 (>=90% Reduction From Baseline in EASI Score) at Weeks 2, 4, 8, 12 and 16 | At Week 8 | 10.6 Percentage of participants |
| Double-blind Induction Period: Placebo +TCS | Double-blind Induction Period: Percentage of Participants Who Achieved EASI 90 (>=90% Reduction From Baseline in EASI Score) at Weeks 2, 4, 8, 12 and 16 | At Week 12 | 21.0 Percentage of participants |
Secondary
Double-blind Induction Period: Percentage of Participants Who Achieved Investigator Global Assessment (IGA) Score of 0 or 1 and 2-point Improvement at Week 16
The IGA is an instrument used to globally rate the severity of the participants AD. It is based on a 5-point scale ranging from 0 (clear), 1 (almost clear), 2 (mild), 3 (moderate) and 4 (severe), and a score is selected using descriptors that best describe the overall appearance of the lesions at a given time point. The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting (minimal, palpable induration and significant induration). Therapeutic response is an IGA score of 0 (clear) or 1 (almost clear).
Time frame: At Week 16
Population: FAS included all randomized participants and were analyzed under the treatment group as randomized.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Double-blind Induction Period: Lebrikizumab +TCS | Double-blind Induction Period: Percentage of Participants Who Achieved Investigator Global Assessment (IGA) Score of 0 or 1 and 2-point Improvement at Week 16 | 42.0 Percentage of participants |
| Double-blind Induction Period: Placebo +TCS | Double-blind Induction Period: Percentage of Participants Who Achieved Investigator Global Assessment (IGA) Score of 0 or 1 and 2-point Improvement at Week 16 | 24.5 Percentage of participants |
p-value: 0.005295% CI: [7.03, 28.57]Cochran-Mantel-Haenszel
Secondary
Double-blind Induction Period: Proportion of Topical Corticosteroids (TCS) Medication Free Days
TCS free days proportion = Number of days participant did not take TCS medication / Number of days from Baseline to Week 16 Date or early discontinuation
Time frame: Baseline up to Week 16
Population: FAS included all randomized participants and were analyzed under the treatment group as randomized.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Double-blind Induction Period: Lebrikizumab +TCS | Double-blind Induction Period: Proportion of Topical Corticosteroids (TCS) Medication Free Days | 0.224 Proportion of Days | Standard Deviation 0.3491 |
| Double-blind Induction Period: Placebo +TCS | Double-blind Induction Period: Proportion of Topical Corticosteroids (TCS) Medication Free Days | 0.151 Proportion of Days | Standard Deviation 0.3032 |