Evaluation of the Efficacy and Safety of Lebrikizumab (LY... | NCT04178967 | Trialant
NCT04178967
Sponsor
Eli Lilly and Company
Status
Completed
Last Update Posted
May 24, 2023Actual
Enrollment
445Actual
Phase
Phase 3
Conditions
Atopic Dermatitis
Interventions
Lebrikizumab
Placebo
Countries
United States
Bulgaria
Canada
Germany
Mexico
Singapore
Taiwan
Ukraine
Protocol Section
Identification Module
NCT ID
NCT04178967
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
17802
Secondary IDs
ID
Type
Description
Link
2019-002933-12
EudraCT Number
J2T-DM-KGAC
Other Identifier
Eli Lilly and Company
DRM06-AD05
Other Identifier
Dermira, Inc
Brief Title
Evaluation of the Efficacy and Safety of Lebrikizumab (LY3650150) in Moderate to Severe Atopic Dermatitis
Official Title
A Randomized, Double-blind, Placebo Controlled Trial to Evaluate the Efficacy and Safety of Lebrikizumab in Patients With Moderate to Severe Atopic Dermatitis.
Acronym
ADvocate2
Organization
Eli Lilly and CompanyINDUSTRY
Status Module
Record Verification Date
Apr 2023
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Oct 29, 2019Actual
Primary Completion Date
Jul 12, 2021Actual
Completion Date
Apr 28, 2022Actual
First Submitted Date
Nov 25, 2019
First Submission Date that Met QC Criteria
Nov 25, 2019
First Posted Date
Nov 26, 2019Actual
Results Waived
Not provided
Results First Submitted Date
Jul 11, 2022
Results First Submitted that Met QC Criteria
Aug 22, 2022
Results First Posted Date
Sep 16, 2022Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Apr 24, 2023
Last Update Posted Date
May 24, 2023Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Eli Lilly and CompanyINDUSTRY
Collaborators
Name
Class
Dermira, Inc.
INDUSTRY
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
This is a randomized, double-blind, placebo-controlled, parallel-group study which is 52 weeks in duration. The study is designed to confirm the safety and efficacy of lebrikizumab as monotherapy for treatment of moderate-to-severe atopic dermatitis utilizing a 16-week induction treatment period and a 36-week long-term maintenance treatment period.
Detailed Description
Not provided
Conditions Module
Conditions
Atopic Dermatitis
Keywords
Eczema
Dermatitis
Dermatitis, Atopic
Skin Diseases
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 3
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
445Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Placebo
Placebo Comparator
Induction Period (Baseline-Week 16):
Two subcutaneous (SC) injections of Placebo as a loading dose at Baseline and Week 2 followed by a single injection every 2 weeks (Q2W) from Week 4 until Week 14.
Maintenance Period (Week 16-Week 52):
Two placebo SC injections as loading dose on Week 16 and Week 18. One placebo SC injection Q2W until Week 50.
Other: Placebo
Lebrikizumab Q2W
Experimental
Induction Period (Baseline-Week 16):
500 milligram (mg) Lebrikizumab (2 x 250 mg) SC injections as a loading dose at Baseline and Week 2 visits followed by a single 250 mg Lebrikizumab injection Q2W from Week 4 until Week 14.
Maintenance Period (Week 16-Week 52):
One 250 mg Lebrikizumab SC injection and one placebo SC injection as maintenance loading dose on Week 16 and Week 18.
One 250 mg Lebrikizumab SC injection Q2W until Week 50.
Biological: Lebrikizumab
Lebrikizumab Q4W
Experimental
Maintenance Period (Week 16-Week 52):
One 250 mg Lebrikizumab SC injection and one placebo SC injection as maintenance loading dose on Week 16 and two placebo SC injections on Week 18.
One 250 mg Lebrikizumab SC injection Every 4 weeks (Q4W) on Weeks 20, 24, 28, 32, 36, 40, 44, and 48.
One placebo SC injection Q4W on Weeks 22, 26, 30, 34, 38, 42, 46, and 50.
Biological: Lebrikizumab
Other: Placebo
Escape Arm (Lebrikizumab Q2W)
Experimental
Maintenance Period (Week 16-Week 52):
Participants who require topical or systemic rescue treatment for atopic dermatitis during the Induction Period, or are non-responders at Week 16, will be eligible for treatment in an Escape Arm where participants will receive open-label lebrikizumab Q2W from Week 16 through Week 52. In addition, participants who do not maintain an acceptable response during the Maintenance Period (have an EASI score <50% of baseline), will be eligible for the Escape Arm.
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Lebrikizumab
Biological
Subcutaneous injection
Escape Arm (Lebrikizumab Q2W)
Lebrikizumab Q2W
Lebrikizumab Q4W
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Percentage of Participants With an Investigator Global Assessment (IGA) Score of 0 or 1 and a Reduction ≥2 Points From Baseline to Week 16
The IGA measures the investigator's global assessment of the participant's overall severity of their atopic dermatitis (AD), based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification.
Baseline to Week 16
Percentage of Participants Achieving Eczema Area And Severity Index (EASI-75) (≥75% Reduction in EASI Score) From Baseline to Week 16
The EASI assesses objective physician estimates of 2 dimensions of AD - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 to 72 (severe).
The EASI-75 responder is defined as a participant who achieves a ≥ 75% reduction from baseline in the EASI score.
Baseline to Week 16
Secondary Outcomes
Measure
Description
Time Frame
Percentage of Participants With an IGA Score of 0 or 1 and a Reduction ≥2 Points From Baseline to Week 2
The IGA measures the investigator's global assessment of the participant's overall severity of their AD, based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Male or female adults and adolescents (≥12 years and ≥40 kg)
Chronic atopic dermatitis (according to American Academy of Dermatology Consensus Criteria) that has been present for ≥1 year before the screening visit
Eczema Area and Severity Index (EASI) score ≥16 at the baseline visit
Investigator Global Assessment (IGA) score ≥3 (scale of 0 to 4) at the baseline visit
≥10% body surface area (BSA) of atopic dermatitis involvement at the baseline visit
History of inadequate response to treatment with topical medications; or determination that topical treatments are otherwise medically inadvisable
Exclusion Criteria:
Prior treatment with dupilumab or tralokinumab
Treatment with topical corticosteroids, calcineurin inhibitors or phosphodiesterase-4 inhibitors such as crisaborole within 1 week prior to the baseline visit
Treatment with any of the following agents within 4 weeks prior to the baseline visit:
Treatment with the following prior to the baseline visit:
An investigational drug within 8 weeks or within 5 half-lives (if known) of baseline, whichever is longer
Cell-depleting biologics, including to rituximab, within 6 months of baseline
Other biologics within 5 half-lives (if known) or 16 weeks of baseline, whichever is longer
Treatment with a live (attenuated) vaccine within 12 weeks of the baseline visit or planned during the study
Uncontrolled chronic disease that might require bursts of oral corticosteroids, e.g., co-morbid severe uncontrolled asthma
Evidence of active acute or chronic hepatitis
History of human immunodeficiency virus (HIV) infection or positive HIV serology
History of malignancy, including mycosis fungoides, within 5 years before the screening visit, except completely treated in situ carcinoma of the cervix, completely treated and resolved non-metastatic squamous or basal cell carcinoma of the skin
Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed during the study
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
12 Years
Maximum Age
Not provided
Standard Ages
ChildAdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Sher ER, Golant A, de Bruin-Weller M, Carrascosa JM, Mehta V, Bieber T, Dawson Z, Atwater AR, Zhong J, Rodriguez Calleja L, Boguniewicz M. Lebrikizumab is efficacious in adults and adolescents with moderate-to-severe atopic dermatitis regardless of atopic comorbidities. Ann Allergy Asthma Immunol. 2026 May;136(5):565-571. doi: 10.1016/j.anai.2025.12.017. Epub 2025 Dec 21.
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Types
Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame
Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
Access Criteria
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
(Continued) Induction non-responder (i.e.) participants who do not achieve an IGA of 0 or 1 or an EASI-75 at Week 16 and maintenance non-responders (i.e.) those not maintaining an EASI-50 response at week 24, 32, 40, and 48 following week 16 re-randomization were assigned to an Escape Arm and received lebrikizumab 250 mg as open-label treatment Q2W through Week 52.
Recruitment Details
During the Induction period (16-weeks): Participants were randomly assigned to either 250 mg lebrikizumab Q2W or placebo; At week 16, participants who responded to treatment, defined as having an Investigator Global Assessment (IGA) of 0 or 1 or a 75% reduction in Eczema Area and Severity Index (EASI-75) from Baseline to Week 16 entered Maintenance Period and were re-randomized (2:2:1) to: lebrikizumab 250 mg Q2W, lebrikizumab 250 mg Q4W, or placebo (Continued)
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Induction - Placebo
Induction Period (Baseline-Week 16):
Two subcutaneous (SC) injections of Placebo as a loading dose at Baseline and Week 2 followed by a single injection every 2 weeks (Q2W) from Week 4 until Week 14.
Percentage of Participants With an IGA Score of 0 or 1 and a Reduction ≥2 Points From Baseline to Week 4
The IGA measures the investigator's global assessment of the participant's overall severity of their AD, based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification.
Baseline to Week 4
Percentage of Participants With an IGA Score of 0 or 1 and a Reduction ≥2 Points From Baseline to Week 16
The IGA measures the investigator's global assessment of the participant's overall severity of their AD, based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification.
Baseline to Week 16
Percentage of Participants Achieving EASI-90 (≥90% Reduction in EASI Score) From Baseline to Week 16
The EASI assesses objective physician estimates of 2 dimensions of AD - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 to 72 (severe).
The EASI-90 responder is defined as a participant who achieves a ≥ 90% reduction from baseline in the EASI score.
Baseline to Week 16
Percentage Change in Pruritus Numerical Rating Scale (NRS) Score From Baseline to Week 16
Pruritus NRS is an 11-point scale used by participants to rate their worst itch severity over the past 24 hours with 0 indicating "No itch" and 10 indicating "Worst itch imaginable." Least Squares (LS) Mean was calculated using analysis of covariance (ANCOVA) model with treatment and randomization strata (region, disease severity, age) as fixed factors and baseline value as covariate.
Baseline, Week 16
Percentage of Participants With a Pruritus NRS Score of ≥4-points at Baseline Who Achieve a ≥4-point Reduction in Pruritus NRS Score From Baseline to Week 16
Pruritus NRS is an 11-point scale used by participants to rate their worst itch severity over the past 24 hours with 0 indicating "No itch" and 10 indicating "Worst itch imaginable."
Baseline to Week 16
Percentage of Participants With a Pruritus NRS Score of ≥5-points at Baseline Who Achieve a ≥4-point Reduction in Pruritus NRS Score From Baseline to Week 16
Pruritus NRS is an 11-point scale used by participants to rate their worst itch severity over the past 24 hours with 0 indicating "No itch" and 10 indicating "Worst itch imaginable."
Baseline to Week 16
Percentage Change in EASI Score From Baseline to Week 16
The EASI assesses objective physician estimates of 2 dimensions of AD - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 to 72 (severe).
LS Mean was calculated using ANCOVA model with treatment, stratification factors of geographic region, age group, baseline IGA score (IGA 3 versus 4) as fixed factors baseline value as covariate.
Baseline, Week 16
Change From Baseline in Percent Body Surface Area (BSA) at Week 16
The BSA affected by AD will be assessed for 4 separate body regions: head and neck, trunk (including genital region), upper extremities, and lower extremities (including the buttocks). Each body region will be assessed for disease extent ranging from 0% to 100% involvement. BSA was calculated using the participant's palm using the 1% rule, 1 palm was equivalent to 1% with estimates of the number of palms it takes to cover the affected AD area. Maximum number of palms were 10 palms for head and neck (10%), 20 palms for upper extremities (20%), 30 palms for trunk, including axilla and groin (30%), 40 palms for lower extremities, including buttocks (40%). Percent of BSA for a body region was calculated as = total number of palms in a body region * % surface area equivalent to 1 palm. Overall percent BSA of all 4 body regions ranges from 0% to 100 % with higher values representing greater severity of AD.
Baseline, Week 16
Percentage of Participants Achieving EASI-90 From Baseline to Week 4
The EASI assesses objective physician estimates of 2 dimensions of AD - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 to 72 (severe).
The EASI-90 responder is defined as a participant who achieves a ≥ 90% reduction from baseline in the EASI score.
Baseline to Week 4
Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 16
The DLQI is a 10-item, validated questionnaire used to assess the impact of skin disease on the quality of life of an affected person. 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, over the previous week. Response categories include "Not at all," "A little," "A lot," and "Very much," with corresponding scores of 0, 1, 2, and 3 respectively. Questions 3-10 also have an additional response category of "Not relevant" which is scored as "0". Questions are scored from 0 to 3, giving a possible total score range from 0 (no impact of skin disease on quality of life) to 30 (maximum impact on quality of life). A high score is indicative of a poor quality of life.
LS Mean was calculated using the ANCOVA model with treatment, baseline value, and stratification factors of geographic region, age group, baseline IGA (3 versus 4) score as fixed factors.
Baseline, Week 16
Percentage of Participants Achieving ≥4-point Improvement in DLQI From Baseline to Week 16
The DLQI is a 10-item, validated questionnaire used to assess the impact of skin disease on the quality of life of an affected person. 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, over the previous week. Response categories include "Not at all," "A little," "A lot," and "Very much," with corresponding scores of 0, 1, 2, and 3 respectively. Questions 3-10 also have an additional response category of "Not relevant" which is scored as "0". Questions are scored from 0 to 3, giving a possible total score range from 0 (no impact of skin disease on quality of life) to 30 (maximum impact on quality of life). A high score is indicative of a poor quality of life.
Baseline to Week 16
Percentage of Participants With a DLQI Total Score of ≥4-point at Baseline Achieving ≥4-point Improvement in DLQI From Baseline to Week 16
The DLQI is a 10-item, validated questionnaire used to assess the impact of skin disease on the quality of life of an affected person. 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, over the previous week. Response categories include "Not at all," "A little," "A lot," and "Very much," with corresponding scores of 0, 1, 2, and 3 respectively. Questions 3-10 also have an additional response category of "Not relevant" which is scored as "0". Questions are scored from 0 to 3, giving a possible total score range from 0 (no impact of skin disease on quality of life) to 30 (maximum impact on quality of life). A high score is indicative of a poor quality of life.
Baseline to Week 16
Percentage Change in Sleep-loss Score From Baseline to Week 16
Sleep Loss due to interference of itch will be assessed by the participant. Participants rate their interference of itch on sleep based on a 5-point Likert scale [0 (not at all) to 4 (unable to sleep at all)]. Higher scores indicated a greater impact and worse outcome. Assessments will be recorded daily by the participant using an electronic diary. LS Mean was calculated using ANCOVA model with treatment, baseline value, and stratification factors of geographic region, age group, baseline IGA (3 versus 4) score as fixed factors.
Baseline, Week 16
Change From Baseline in Sleep-loss Score at Week 16
Sleep Loss due to interference of itch will be assessed by the participant. Participants rate their interference of itch on sleep based on a 5-point Likert scale [0 (not at all) to 4 (unable to sleep at all)]. Higher scores indicated a greater impact and worse outcome. Assessments will be recorded daily by the participant using an electronic diary. LS Mean was calculated using ANCOVA model with treatment, baseline value, and stratification factors of geographic region, age group, baseline IGA (3 versus 4) score as fixed factors.
Baseline, Week 16
Percentage of Participants With a Sleep-loss Score ≥2 Points at Baseline Who Achieve a ≥2 Points Reduction From Baseline to Week 16
Sleep Loss due to interference of itch will be assessed by the participant. Participants rate their interference of itch on sleep based on a 5-point Likert scale [0 (not at all) to 4 (unable to sleep at all)]. Higher scores indicated a greater impact and worse outcome. Assessments will be recorded daily by the participant using an electronic diary.
Baseline to Week 16
Percentage of Participants With a Pruritus NRS Score of ≥4 Points at Baseline Who Achieve a ≥4-point Reduction From Baseline to Week 1
Pruritus NRS is an 11-point scale used by participants to rate their worst itch severity over the past 24 hours with 0 indicating "No itch" and 10 indicating "Worst itch imaginable."
Baseline to Week 1
Percentage of Participants With a Pruritus NRS Score of ≥4 Points at Baseline Who Achieve a ≥4-point Reduction From Baseline to Week 2
Pruritus NRS is an 11-point scale used by participants to rate their worst itch severity over the past 24 hours with 0 indicating "No itch" and 10 indicating "Worst itch imaginable."
Baseline to Week 2
Percentage of Participants With a Pruritus NRS Score of ≥4 Points at Baseline Who Achieve a ≥4-point Reduction From Baseline to Week 4
Pruritus NRS is an 11-point scale used by participants to rate their worst itch severity over the past 24 hours with 0 indicating "No itch" and 10 indicating "Worst itch imaginable."
Baseline to Week 4
Percentage of Participants With a Pruritus NRS Score of ≥5 Points at Baseline Who Achieve a ≥4-point Reduction From Baseline to Week 1
Pruritus NRS is an 11-point scale used by participants to rate their worst itch severity over the past 24 hours with 0 indicating "No itch" and 10 indicating "Worst itch imaginable."
Baseline to Week 1
Percentage of Participants With a Pruritus NRS Score of ≥5 Points at Baseline Who Achieve a ≥4-point Reduction From Baseline to Week 2
Pruritus NRS is an 11-point scale used by participants to rate their worst itch severity over the past 24 hours with 0 indicating "No itch" and 10 indicating "Worst itch imaginable."
Baseline to Week 2
Percentage of Participants With a Pruritus NRS Score of ≥5 Points at Baseline Who Achieve a ≥4-point Reduction From Baseline to Week 4
Pruritus NRS is an 11-point scale used by participants to rate their worst itch severity over the past 24 hours with 0 indicating "No itch" and 10 indicating "Worst itch imaginable."
Baseline to Week 4
Percentage Change in SCORing Atopic Dermatitis (SCORAD) From Baseline to Week 16
SCORAD is validated tool for assessing the extent and intensity of AD, it consists of 3 components: A=extent of AD as a percentage of each defined body area and reported as sum of all areas, with maximum score of 100%. B=severity of 6 specific symptoms of AD (redness, swelling, oozing/crusting, excoriation, skin thickening/lichenification, dryness) assessed using following scale: none=0, mild=1, moderate=2, or severe=3 for maximum of 18 total points. C=subjective assessment of itch and sleeplessness recorded by participant on visual analog scale (VAS), where 0=no itch/no sleeplessness and 10=worst imaginable itch/sleeplessness with maximum score of 20. SCORAD total score is calculated: A/5+7*B/2+ C to give total score range of 0 to 103, where 0=no disease to 103=severe disease. LS Mean was calculated using ANCOVA model with treatment group and stratification factors of geographic region, age group, baseline IGA (3 versus 4) score as fixed factors and baseline value as covariate.
Baseline, Week 16
Pharmacokinetics (PK): Trough Serum Concentrations of Lebrikizumab in Maintenance Period (C-trough)
C-trough was the concentration of study drug in the blood immediately before the next dose was administered. Trough serum concentration of Lebrikizumab was assessed at predose week 52.
Predose at Week 52
Percentage of Participants From Those Re-randomized Having Achieved EASI-75 at Week 16 Who Continue to Exhibit EASI-75 at Week 52 (EASI-75 Calculated Relative to Baseline EASI Score)
The EASI assesses objective physician estimates of 2 dimensions of AD - disease extent, i.e., percentage of skin affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI-75 score was obtained by weight-averaging these 4 scores and will range from 0 (none) to 72 (severe).
The EASI-75 responder is defined as a participant who achieves a ≥ 75% reduction from baseline in the EASI score.
Baseline to Week 52
Percentage of Participants From Those Re-randomized Having Achieved IGA 0 or 1 and a ≥2-point Improvement From Baseline at Week 16 Who Continue to Exhibit an IGA 0 or 1 and a ≥2-point Improvement From Baseline at Week 52
The IGA measures the investigator's global assessment of the participant's overall severity of their AD, based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification.
Baseline to Week 52
Percentage of Participants From Those With a Pruritus NRS of ≥4-points at Baseline Re-randomized Having Achieved ≥4-point Reduction From Baseline at Week 16 Who Continue to Exhibit ≥4-point Reduction From Baseline at Week 52
Pruritus NRS is an 11-point scale used by participants to rate their worst itch severity over the past 24 hours with 0 indicating "No itch" and 10 indicating "Worst itch imaginable."
Baseline to Week 52
Percentage of Participants From Those With a Pruritus NRS of ≥5-points at Baseline Re-randomized Having Achieved ≥4-point Reduction From Baseline at Week 16 Who Continue to Exhibit ≥4-point Reduction From Baseline at Week 52
Pruritus NRS is an 11-point scale used by participants to rate their worst itch severity over the past 24 hours with 0 indicating "No itch" and 10 indicating "Worst itch imaginable."
Baseline to Week 52
Percentage Change in SCORAD (From Those Re-randomized Having Achieved EASI-75 at Week 16) From Baseline at Week 52
SCORAD is a validated tool for assessing the extent and intensity of AD, it consists of 3 components: A=extent of AD as a percentage of each defined body area and reported as sum of all areas, with maximum score of 100%. B=severity of 6 specific symptoms of AD (redness, swelling, oozing/crusting, excoriation, skin thickening/lichenification, dryness) assessed using following scale: none=0, mild=1, moderate=2, or severe=3 for maximum of 18 total points. C=subjective assessment of itch and sleeplessness recorded by participant on VAS, where 0=no itch/no sleeplessness and 10=worst imaginable itch/sleeplessness with maximum score of 20. SCORAD total score is calculated: A/5+7*B/2+ C to give total score range of 0 to 103, where 0=no disease to 103=severe disease. LS Mean was calculated using ANCOVA model with treatment group and stratification factors of geographic region, age group, baseline IGA (3 versus 4) score as fixed factors and baseline value as covariate.
Baseline, Week 52
Change From Baseline in European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) at Week 16 - Health State Index
The European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) is a is a 2-part questionnaire which measure health status of the participant. The first component (Health state) is a descriptive system of the respondent's health comprised of the following 5 participant-reported dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The responses are used to derive the health state index scores using the United Kingdom (UK) algorithm, with scores ranging from -0.594 to 1, and the United States (US) algorithm, with scores ranging from -0.109 to 1. A higher score indicates better health state.
LS Mean was calculated using the ANCOVA model with treatment and stratification factors of geographic region, age group, baseline IGA (3 versus 4) score as fixed factors and baseline value as covariate.
Baseline, Week 16
Change From Baseline in EQ-5D-5L at Week 16 - Visual Analog Scale (VAS)
The EQ-5D-5L is a 2-part measurement. The second part is assessed using a VAS that ranged from 0 to 100 millimeter (mm), where 0 is the worst health you can imagine and 100 is the best health you can imagine. LS Mean was calculated using the ANCOVA model with treatment and stratification factors of geographic region, age group, baseline IGA (3 versus 4) score as fixed factors and baseline value as covariate.
Baseline, Week 16
Change From Baseline in Patient Oriented Eczema Measure (POEM) at Week 16
POEM is a 7-item, validated, questionnaire used by the participant to assess disease symptoms over the last week. The participant is asked to respond to 7 questions on skin dryness, itching, flaking, cracking, sleep loss, bleeding and weeping. All 7 answers carry equal weight with a total possible score from 0 to 28 (answers scored as: No days=0; 1-2 days = 1; 3-4 days = 2; 5-6 days = 3; everyday = 4). A high score is indicative of a poor quality of life. POEM responses will be captured using an electronic diary and transferred into the clinical database. LS Mean was calculated using MMRM model using treatment, baseline value, visit, the interaction of the baseline value-by-visit, the interaction of treatment by-visit as covariates, geographic region, age group, baseline IGA (3 versus 4) score as fixed.
Baseline, Week 16
Change From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety at Week 16-Adolescents
PROMIS® is a set of person-centered measures that evaluates and monitors physical, mental, and social health in adults and children. Participants ≤17 years will complete pediatric versions for the duration of the study. PROMIS anxiety has 8 questions on Emotion Distress-Anxiety (or Pediatric Anxiety Symptom). Each question has 5 response options with values from 1 to 5. Total raw scores were converted to T-Scores (mean = 50 and a standard deviation = 10) with higher scores representing greater anxiety. LS Mean was calculated using the ANCOVA model with treatment and stratification factors of geographic region, age group, baseline IGA (3 versus 4) score as fixed factors and baseline value as covariate.
Baseline, Week 16
Change From Baseline in PROMIS Anxiety at Week 16 - Adults
PROMIS® is a set of person-centered measures that evaluates and monitors physical, mental, and social health in adults and children. Participants ≤17 years will complete pediatric versions for the duration of the study. PROMIS anxiety has 8 questions on Emotion Distress-Anxiety (or Pediatric Anxiety Symptom). Each question has 5 response options with values from 1 to 5. Total raw scores were converted to T-Scores (mean = 50 and a standard deviation = 10) with higher scores representing greater anxiety. LS Mean was calculated using the ANCOVA model with treatment and stratification factors of geographic region, age group, baseline IGA (3 versus 4) score as fixed factors and baseline value as covariate.
Baseline, Week 16
Change From Baseline in PROMIS Depression at Week 16- Adolescents
PROMIS® is a set of person-centered measures that evaluates and monitors physical, mental, and social health in adults and children. Participants ≤17 years will complete pediatric versions for the duration of the study. PROMIS anxiety has 8 questions on Emotion Distress-Anxiety (or Pediatric Anxiety Symptom). Each question has 5 response options with values from 1 to 5. Total raw scores were converted to T-Scores (mean = 50 and a standard deviation = 10) with higher scores representing greater anxiety. LS Mean was calculated using the ANCOVA model with treatment and stratification factors of geographic region, age group, baseline IGA (3 versus 4) score as fixed factors and baseline value as covariate.
Baseline, Week 16
Change From Baseline in PROMIS Depression at Week 16- Adults
PROMIS® is a set of person-centered measures that evaluates and monitors physical, mental, and social health in adults and children. Participants ≤17 years will complete pediatric versions for the duration of the study. PROMIS anxiety has 8 questions on Emotion Distress-Anxiety (or Pediatric Anxiety Symptom). Each question has 5 response options with values from 1 to 5. Total raw scores were converted to T-Scores (mean = 50 and a standard deviation = 10) with higher scores representing greater anxiety. LS Mean was calculated using the ANCOVA model with treatment and stratification factors of geographic region, age group, baseline IGA (3 versus 4) score as fixed factors and baseline value as covariate.
Baseline, Week 16
Change From Baseline in Asthma Control Questionnaire (ACQ-5) Score at Week 16 in Participants Who Have Self-reported Comorbid Asthma
The ACQ-5 is a five-item, self-completed questionnaire, which is used as a measure of asthma control of a participant. The five questions (concerning nocturnal awakening, waking in the morning, activity limitation, shortness of breath and wheeze) enquire about the frequency and/or severity of symptoms over the previous week. The response options for all these questions range from zero (no impairment/limitation) to six (total impairment/ limitation) scale. The ACQ-5 score is the average of the individual item scores and ranges from 0 (totally controlled) to 6 (severely uncontrolled). Higher scores indicate lower asthma control.
LS Mean was calculated using ANCOVA with treatment, geographic region, age group, baseline IGA (3 versus 4) score as fixed factors and baseline value as covariate.
Baseline, Week 16
Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) at Week 16
The CDLQI questionnaire is designed for use in children (4 to 16 years of age). It consists of 10 items that are grouped into 6 domains: symptoms & feelings, leisure, school or holidays, personal relationships, sleep, & treatment. The scoring of each question is: Very much =3; Quite a lot = 2; Only a little = 1; Not at all = 0. CDLQI total score is calculated by summing all 10 items responses, and has a range of 0 to 30 (higher scores are indicative of greater impairment).
LS Mean was calculated using MMRM model which includes treatment, baseline value, visit, the interaction of the baseline value-by-visit as covariates, the interaction of treatment by-visit, geographic region, age group, and baseline IGA (3 versus 4) score as fixed factors.
Baseline, Week 16
Rogers
Arkansas
72758
United States
Bakersfield Dermatology and Skin Cancer Medical Group
Bakersfield
California
93309
United States
Center For Dermatology Clinical Research, Inc.
Fremont
California
94538
United States
Woodward Centre
Fresno
California
93720
United States
Dermatology Research Associates
Los Angeles
California
90045
United States
LA Universal Research Center, INC
Los Angeles
California
90057
United States
University Clinical Trials, Inc.
San Diego
California
92123
United States
San Luis Dermatology & Laser Clinic
San Luis Obispo
California
93405
United States
Clinical Physiology Associates, Clinical Study Center
Fort Myers
Florida
33916-9452
United States
Direct Helpers Medical Center
Hialeah
Florida
33012
United States
The Community Research of South Florida
Hialeah
Florida
33016
United States
Solutions Through Advanced Research, Inc.
Jacksonville
Florida
32256
United States
Georgia Pollens Clinical Research Centers, Inc
Albany
Georgia
31707
United States
Marietta Dermatology Clinical Research
Marietta
Georgia
30060
United States
Advanced Medical Research
Sandy Springs
Georgia
30328
United States
Arlington Dermatology
Rolling Meadows
Illinois
60008
United States
NorthShore University HealthSystem
Skokie
Illinois
60077
United States
Kansas City Dermatology, PA
Overland Park
Kansas
66215
United States
Meridian Clinical Research
Baton Rouge
Louisiana
70808
United States
ActivMed Practices and Research
Beverly
Massachusetts
01915
United States
Tufts Medical Center
Boston
Massachusetts
02111
United States
Great Lakes Research Group, Inc.
Bay City
Michigan
48706
United States
Clarkston Skin Research
Clarkston
Michigan
48346
United States
Associated Skin Care Specialists
Fridley
Minnesota
55432
United States
Central Dermatology PC
St Louis
Missouri
63117
United States
Forest Hills Dermatology Group
Kew Gardens
New York
11415
United States
OnSite Clinical Solutions
Charlotte
North Carolina
28277
United States
Wilmington Dermatology Center
Wilmington
North Carolina
28405
United States
Dermatology and Skin Surgery Center
Exton
Pennsylvania
19341
United States
DermDOX
Hazleton
Pennsylvania
18201
United States
Peak Research LLC
Upper Saint Clair
Pennsylvania
15241
United States
Dermatology & Laser Center of Charleston
Charleston
South Carolina
29407
United States
Palmetto Clinical Trial Services
Greenville
South Carolina
29601
United States
Arlington Research Center, Inc
Arlington
Texas
76011
United States
Innovate Research, LLC
Fort Worth
Texas
76244
United States
Austin Institute for Clinical Research
Pflugerville
Texas
78660
United States
University of Utah MidValley Dematology
Murray
Utah
84107
United States
Virginia Clinical Research, Inc.
Norfolk
Virginia
23502
United States
Dermatology Associates
Seattle
Washington
98101
United States
DCC Sveti Georgi
Plovdiv
4000
Bulgaria
Diagnostic and Consultation Center 14
Sofia
1408
Bulgaria
Alexandrovska University Hospital
Sofia
1432
Bulgaria
Euro Derma clinic
Sofia
1606
Bulgaria
Military Medical Academy
Sofia
1606
Bulgaria
Medical centre Alitera-Med EOOD
Sofia
1618
Bulgaria
Dr. Chih-ho Hong Medical Inc.
Surrey
British Columbia
V3R 6A7
Canada
Simcoderm Medical & Surgical Dermatology Centre
Barrie
Ontario
L4M 7G1
Canada
Lynderm Research Inc.
Markham
Ontario
L3P1X2
Canada
North York Research Inc.
North York
Ontario
M2M4J5
Canada
Ottawa Allergy Research Corp
Ottawa
Ontario
K1G 6C6
Canada
K. Papp Clinical Research
Waterloo
Ontario
N2J 1C4
Canada
Derma-Study-Center Friedrichshafen GmbH
Friedrichshafen
Baden-Wurttemberg
88045
Germany
Studienzentrum Dr.Beate Schwarz
Langenau
Baden-Wurttemberg
89129
Germany
Hautarztpraxis am Löwenmarkt
Stuttgart
Baden-Wurttemberg
70499
Germany
licca Fachklinik
Augsburg
Bavaria
86179
Germany
Rosenpark Research Geschäftsbereich der Rosenparkklinik GmbH
Darmstadt
Hesse
64283
Germany
Klinikum der Johann Wolfgang Goethe-Universität Frankfurt
Praxis für Ganzheitliche Dermatologie im Ärztehaus
Berlin
13055
Germany
Universitätsklinikum Hamburg
Hamburg
20246
Germany
TFS Trial Form Support GmbH
Hamburg
20537
Germany
Clinica De Enfermedades Cronicas y Procedimientos Especiales
Morelia
Michoacan Morelia
CP 58249
Mexico
Derma Norte del BajÃo, S.C.
Aguascalientes
20130
Mexico
National University Hospital
Singapore
119074
Singapore
Singapore General Hospital
Singapore
169078
Singapore
Kk Women'S and Childrens Hospital
Singapore
229899
Singapore
National Skin Centre NSC
Singapore
308205
Singapore
Kaohsiung Chang Gung Memorial Hospital
Niaosong Dist
Kaohsiung City
833
Taiwan
Kaohsiung Medical University Chung-Ho Institutional Review B
Kaohsiung City
807
Taiwan
Taipei Medical University- Shuang Ho Hospital
New Taipei City
235
Taiwan
Chung Shan Medical University Hospital
Taichung
402
Taiwan
China Medical University Hospital
Taichung
40447
Taiwan
National Taiwan University Hospital
Taipei
10002
Taiwan
Chang Gung Memorial Hospital - Linkou
Taoyuan City
33305
Taiwan
Municipal Healthcare Institution Kharkiv City Dermatoverenologic Dispensary N2
Kharkiv
61038
Ukraine
Rivne Regional Dermatology and Venereology Dispensary
Rivne
39028
Ukraine
Treatment-diagnostic center PE "Asclepius"
Uzhhorod
88002
Ukraine
Community Institution Zaporizhzhya Regional Dermatovenereology Clinical Hospital of Zaporizhzhya Regional Council
Zaporizhzhya
69000
Ukraine
Derived
Silverberg JI, Wollenberg A, Stein Gold L, Yosipovitch G, Lio P, Vestergaard C, Stander S, Carrascosa JM, Gallo G, Casillas M, Ding Y, Yang FE, Pierce E, Agell H, Del Rosso J. Lebrikizumab provides stable skin response with no or minimal fluctuations for up to 2 years in patients with atopic dermatitis. Clin Exp Dermatol. 2026 May 26;51(6):1012-1019. doi: 10.1093/ced/llaf490.
Simpson E, Fernandez-Penas P, de Bruin-Weller M, Lio PA, Chu CY, Ezzedine K, Agell H, Casillas M, Ding Y, Yang FE, Pierce E, Bieber T. Improvement Across Dimensions of Disease with Lebrikizumab Use in Atopic Dermatitis: Two Phase 3, Randomized, Double-Blind, Placebo-Controlled Monotherapy Trials (ADvocate1 and ADvocate2). Adv Ther. 2025 Jan;42(1):132-143. doi: 10.1007/s12325-024-02974-y. Epub 2024 Sep 9.
Silverberg JI, Wollenberg A, Stein Gold L, Del Rosso J, Yosipovitch G, Lio P, Carrascosa JM, Gallo G, Ding Y, Xu Z, Casillas M, Pierce E, Agell H, Stander S. Patients with Moderate-to-Severe Atopic Dermatitis Maintain Stable Response with No or Minimal Fluctuations with 1 Year of Lebrikizumab Treatment. Dermatol Ther (Heidelb). 2024 Aug;14(8):2249-2260. doi: 10.1007/s13555-024-01226-9. Epub 2024 Aug 10.
Yosipovitch G, Lio P, Legat FJ, Chovatiya R, Deleuran M, Pierce E, Casillas M, Ding Y, Yang FE, Bardolet L, Stander S. Stable Response and Sustained Improvement of Itch and Sleep Symptoms in Patients with Atopic Dermatitis Treated with Lebrikizumab over 52 Weeks. Dermatol Ther (Heidelb). 2024 Aug;14(8):2171-2180. doi: 10.1007/s13555-024-01225-w. Epub 2024 Jul 13.
Lio PA, Armstrong A, Gutermuth J, Nosbaum A, Sofen H, Gil EG, Casillas M, Chen S, Sun L, Pierce E, Elmaraghy H, Dawson Z, Torres T. Lebrikizumab Improves Quality of Life and Patient-Reported Symptoms of Anxiety and Depression in Patients with Moderate-to-Severe Atopic Dermatitis. Dermatol Ther (Heidelb). 2024 Jul;14(7):1929-1943. doi: 10.1007/s13555-024-01199-9. Epub 2024 Jun 26.
Simpson EL, de Bruin-Weller M, Hong HC, Staumont-Salle D, Blauvelt A, Eyerich K, Gooderham M, Shahriari M, Mallbris L, Atwater AR, Rueda MJ, Ding Y, Liu Z, Agell H, Silverberg JI. Lebrikizumab Provides Rapid Clinical Responses Across All Eczema Area and Severity Index Body Regions and Clinical Signs in Adolescents and Adults with Moderate-to-Severe Atopic Dermatitis. Dermatol Ther (Heidelb). 2024 May;14(5):1145-1160. doi: 10.1007/s13555-024-01158-4. Epub 2024 May 3.
Soung J, Stander S, Gutermuth J, Pau-Charles I, Dawson Z, Yang FE, Sun L, Pierce E, Elmaraghy H, Stein-Gold L. Lebrikizumab monotherapy impacts on quality of life scores through improved itch and sleep interference in two Phase 3 trials. J Dermatolog Treat. 2024 Dec;35(1):2329240. doi: 10.1080/09546634.2024.2329240. Epub 2024 Apr 28.
Blauvelt A, Thyssen JP, Guttman-Yassky E, Bieber T, Serra-Baldrich E, Simpson E, Rosmarin D, Elmaraghy H, Meskimen E, Natalie CR, Liu Z, Xu C, Pierce E, Morgan-Cox M, Garcia Gil E, Silverberg JI. Efficacy and safety of lebrikizumab in moderate-to-severe atopic dermatitis: 52-week results of two randomized double-blinded placebo-controlled phase III trials. Br J Dermatol. 2023 May 24;188(6):740-748. doi: 10.1093/bjd/ljad022.
Silverberg JI, Guttman-Yassky E, Thaci D, Irvine AD, Stein Gold L, Blauvelt A, Simpson EL, Chu CY, Liu Z, Gontijo Lima R, Pillai SG, Seneschal J; ADvocate1 and ADvocate2 Investigators. Two Phase 3 Trials of Lebrikizumab for Moderate-to-Severe Atopic Dermatitis. N Engl J Med. 2023 Mar 23;388(12):1080-1091. doi: 10.1056/NEJMoa2206714. Epub 2023 Mar 15.
Induction Period (Baseline-Week 16):
500 milligram (mg) Lebrikizumab (2 x 250 mg) SC injections as a loading dose at Baseline and Week 2 visits followed by a single 250 mg Lebrikizumab injection Q2W from Week 4 until Week 14.
Maintenance Primary Population: Maintenance Period (Week 16 to Week 52):
One 250 mg Lebrikizumab SC injection Q2W until Week 50.
To maintain the blind, for participants who received Lebrikizumab in the Induction Period, the maintenance loading dose is:
One 250 mg Lebrikizumab SC injection and one placebo SC injection on Week 16. One 250 mg Lebrikizumab SC injection and one placebo SC injection on Week 18.
FG008
Escape Arm Week 16 - Maintenance Open Label - Placebo Nonresponder/ Lebrikizumab 250 Q2W
Maintenance Escape Period (Week 16 to Week 52):
Blinded loading doses based on prior treatment assignment will be administered, followed by one 250 mg Lebrikizumab SC injection Q2W until Week 50 in an open-label fashion.
For participants who received placebo in the Induction Period, the loading dose is:
Two 250 mg Lebrikizumab SC injection on Week 16. Two 250 mg Lebrikizumab SC injections on Week 18.
For participants who do not maintain an acceptable response during the Maintenance Period and entered the Escape Arm, the loading doses will be administrated at entry and 2 weeks after entry based on the treatment assignment prior to entering escape arm.
Participants who did not achieve an EASI-50 response after 8 weeks in the Escape Arm were terminated from the study.
FG009
Escape Arm Week 16 - Maintenance Open Label - Lebrikizumab Nonresponder/ Lebrikizumab 250 Q2W
Maintenance Escape Period (Week 16 to Week 52):
Blinded loading doses based on prior treatment assignment will be administered, followed by one 250 mg Lebrikizumab SC injection Q2W until Week 50 in an open-label fashion.
To maintain the loading dose blind, for participants who received Lebrikizumab in the Induction Period, the loading dose is:
One 250 mg Lebrikizumab SC injection and one placebo on Week16. One 250 mg Lebrikizumab SC injection and one placebo SC injection on Week 18.
For participants who do not maintain an acceptable response during the Maintenance Period and entered the Escape Arm, the loading doses will be administrated at entry and 2 weeks after entry based on the treatment assignment prior to entering escape arm.
Participants who did not achieve an EASI-50 response after 8 weeks in the Escape Arm were terminated from the study.
FG010
Escape Arm Week 24 to 48 - Maintenance Open Label Lebrikizumab 250 Q2W
Escape Arm Week 24 to 48 - Maintenance Open Label Lebrikizumab 250 Q2W.
FG000150 subjects
FG001295 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
Received at Least One Dose of Study Drug
FG000149 subjects
FG001295 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
COMPLETED
FG000133 subjectsCompleted includes Responders n=25; Non responders n=108
FG001273 subjectsCompleted includes Responders n=148; Non responders n=125
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
NOT COMPLETED
FG00017 subjects
FG00122 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
Type
Comment
Reasons
Adverse Event
FG0004 subjects
FG0016 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
Due to Epidemic/Pandemic
FG0001 subjects
FG0014 subjects
FG0020 subjects
FG0030 subjects
FG004
Lack of Efficacy
FG0004 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG004
Protocol Violation
FG0000 subjects
FG0016 subjects
FG0020 subjects
FG0030 subjects
FG004
Withdrawal by Subject
FG0006 subjects
FG0014 subjects
FG0020 subjects
FG0030 subjects
FG004
Lost to Follow-up
FG0002 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Participant Missed Study Visits
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG004
Maintenance Blinded Treatment Period
Type
Comment
Milestone Data
STARTED
FG0000 subjectsParticipants were assigned to this arm only during Induction Period.
FG0010 subjectsParticipants were assigned to this arm only during Induction Period.
FG0025 subjectsOnly those participants who responded to induction placebo or Lebrikizumab at week 16 entered the Maintenance Period.
FG0039 subjectsOnly those participants who responded to induction placebo or Lebrikizumab at week 16 entered the Maintenance Period.
FG00411 subjectsOnly those participants who responded to induction placebo or Lebrikizumab at week 16 entered the Maintenance Period.
FG00530 subjectsOnly those participants who responded to induction placebo or Lebrikizumab at week 16 entered the Maintenance Period.
FG00659 subjectsOnly those participants who responded to induction placebo or Lebrikizumab at week 16 entered the Maintenance Period.
FG00759 subjectsOnly those participants who responded to induction placebo or Lebrikizumab at week 16 entered the Maintenance Period.
FG0080 subjects
FG0090 subjects
FG0100 subjects
Received at Least One Dose of Study Drug
FG0000 subjects
FG0010 subjects
FG0025 subjects
FG0039 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0024 subjects
FG0036 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0033 subjects
FG004
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Maintenance Open Label Escape Arm
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG008108 subjectsOnly those participants who did not respond to induction placebo or Lebrikizumab entered Escape Arm at week 16.
FG009125 subjectsOnly those participants who did not respond to induction placebo or Lebrikizumab entered Escape Arm at week 16.
FG01011 subjectsOnly those participants who did not respond to treatment during maintenance period (i.e.) not maintaining an EASI-50 response at Weeks 24, 32, 40, or 48 were entered.
Received at Least One Dose of Study Drug
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
All randomized participants, even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Placebo
Induction Period (Baseline-Week 16):
Two subcutaneous (SC) injections of Placebo as a loading dose at Baseline and Week 2 followed by a single injection every 2 weeks (Q2W) from Week 4 until Week 14.
BG001
Lebrikizumab Q2W
Induction Period (Baseline-Week 16):
500 milligram (mg) Lebrikizumab (2 x 250 mg) SC injections as a loading dose at Baseline and Week 2 visits followed by a single 250 mg Lebrikizumab injection Q2W from Week 4 until Week 14.
BG002
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG000150
BG001295
BG002445
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Categorical
Count of Participants
Participants
No
Title
Denominators
Categories
Title
Measurements
<=18 years
BG00017
BG00133
BG00250
Between 18 and 65 years
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00035.6± 17.15
BG00136.5± 16.64
BG002
Sex: Female, Male
Count of Participants
Participants
No
Title
Denominators
Categories
Title
Measurements
Female
BG00079
BG001147
BG002
Race (NIH/OMB)
Count of Participants
Participants
No
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0002
BG0013
BG002
Region of Enrollment
Count of Participants
Participants
No
Title
Denominators
Categories
Canada
Title
Measurements
BG00016
BG00142
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Percentage of Participants With an Investigator Global Assessment (IGA) Score of 0 or 1 and a Reduction ≥2 Points From Baseline to Week 16
The IGA measures the investigator's global assessment of the participant's overall severity of their atopic dermatitis (AD), based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification.
All randomized participants, even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol. One investigational site with eighteen participants was excluded from analysis due to Good Clinical Practice (GCP) issues. Markov Chain Monte Carlo Multiple Imputation (MCMC-MI) was used to handle missing data.
Posted
Number
95% Confidence Interval
percentage of participants
Baseline to Week 16
ID
Title
Description
OG000
Placebo
Induction Period (Baseline-Week 16):
Two subcutaneous (SC) injections of Placebo as a loading dose at Baseline and Week 2 followed by a single injection every 2 weeks (Q2W) from Week 4 until Week 14.
OG001
Lebrikizumab Q2W
Induction Period (Baseline-Week 16):
500 milligram (mg) Lebrikizumab (2 x 250 mg) SC injections as a loading dose at Baseline and Week 2 visits followed by a single 250 mg Lebrikizumab injection Q2W from Week 4 until Week 14.
Units
Counts
Participants
OG000146
OG001281
Title
Denominators
Categories
Title
Measurements
OG00010.8(5.7 to 15.9)
OG00133.2(27.5 to 38.9)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Cochran-Mantel-Haenszel
0.000004
Risk Difference (RD)
21.9
2-Sided
95
14.2
29.6
Superiority
Primary
Percentage of Participants Achieving Eczema Area And Severity Index (EASI-75) (≥75% Reduction in EASI Score) From Baseline to Week 16
The EASI assesses objective physician estimates of 2 dimensions of AD - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 to 72 (severe).
The EASI-75 responder is defined as a participant who achieves a ≥ 75% reduction from baseline in the EASI score.
All randomized participants, even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol. One investigational site with eighteen participants was excluded from analysis due to GCP issues. MCMC-MI was used to handle missing data.
Posted
Number
95% Confidence Interval
percentage of participants
Baseline to Week 16
ID
Title
Description
OG000
Placebo
Induction Period (Baseline-Week 16):
Two subcutaneous (SC) injections of Placebo as a loading dose at Baseline and Week 2 followed by a single injection every 2 weeks (Q2W) from Week 4 until Week 14.
OG001
Lebrikizumab Q2W
Secondary
Percentage of Participants With an IGA Score of 0 or 1 and a Reduction ≥2 Points From Baseline to Week 2
The IGA measures the investigator's global assessment of the participant's overall severity of their AD, based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification.
All randomized participants, even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol. One investigational site with eighteen participants was excluded from analysis due to GCP issues. MCMC-MI was used to handle missing data.
Posted
Number
95% Confidence Interval
percentage of participants
Baseline to Week 2
ID
Title
Description
OG000
Placebo
Induction Period (Baseline-Week 16):
Two subcutaneous (SC) injections of Placebo as a loading dose at Baseline and Week 2 followed by a single injection every 2 weeks (Q2W) from Week 4 until Week 14.
OG001
Lebrikizumab Q2W
Induction Period (Baseline-Week 16):
500 milligram (mg) Lebrikizumab (2 x 250 mg) SC injections as a loading dose at Baseline and Week 2 visits followed by a single 250 mg Lebrikizumab injection Q2W from Week 4 until Week 14.
Secondary
Percentage of Participants With an IGA Score of 0 or 1 and a Reduction ≥2 Points From Baseline to Week 4
The IGA measures the investigator's global assessment of the participant's overall severity of their AD, based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification.
All randomized participants, even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol. One investigational site with eighteen participants was excluded from analysis due to GCP issues. MCMC-MI was used to handle missing data.
Posted
Number
95% Confidence Interval
percentage of participants
Baseline to Week 4
ID
Title
Description
OG000
Placebo
Induction Period (Baseline-Week 16):
Two subcutaneous (SC) injections of Placebo as a loading dose at Baseline and Week 2 followed by a single injection every 2 weeks (Q2W) from Week 4 until Week 14.
OG001
Lebrikizumab Q2W
Induction Period (Baseline-Week 16):
500 milligram (mg) Lebrikizumab (2 x 250 mg) SC injections as a loading dose at Baseline and Week 2 visits followed by a single 250 mg Lebrikizumab injection Q2W from Week 4 until Week 14.
Secondary
Percentage of Participants With an IGA Score of 0 or 1 and a Reduction ≥2 Points From Baseline to Week 16
The IGA measures the investigator's global assessment of the participant's overall severity of their AD, based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification.
All randomized participants, even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol. One investigational site with eighteen participants was excluded from analysis due to GCP issues. MCMC-MI was used to handle missing data.
Posted
Number
95% Confidence Interval
percentage of participants
Baseline to Week 16
ID
Title
Description
OG000
Placebo
Induction Period (Baseline-Week 16):
Two subcutaneous (SC) injections of Placebo as a loading dose at Baseline and Week 2 followed by a single injection every 2 weeks (Q2W) from Week 4 until Week 14.
OG001
Lebrikizumab Q2W
Induction Period (Baseline-Week 16):
500 milligram (mg) Lebrikizumab (2 x 250 mg) SC injections as a loading dose at Baseline and Week 2 visits followed by a single 250 mg Lebrikizumab injection Q2W from Week 4 until Week 14.
Secondary
Percentage of Participants Achieving EASI-90 (≥90% Reduction in EASI Score) From Baseline to Week 16
The EASI assesses objective physician estimates of 2 dimensions of AD - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 to 72 (severe).
The EASI-90 responder is defined as a participant who achieves a ≥ 90% reduction from baseline in the EASI score.
All randomized participants, even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol. One investigational site with eighteen participants was excluded from analysis due to GCP issues. MCMC-MI was used to handle missing data.
Posted
Number
95% Confidence Interval
percentage of participants
Baseline to Week 16
ID
Title
Description
OG000
Placebo
Induction Period (Baseline-Week 16):
Two subcutaneous (SC) injections of Placebo as a loading dose at Baseline and Week 2 followed by a single injection every 2 weeks (Q2W) from Week 4 until Week 14.
OG001
Lebrikizumab Q2W
Secondary
Percentage Change in Pruritus Numerical Rating Scale (NRS) Score From Baseline to Week 16
Pruritus NRS is an 11-point scale used by participants to rate their worst itch severity over the past 24 hours with 0 indicating "No itch" and 10 indicating "Worst itch imaginable." Least Squares (LS) Mean was calculated using analysis of covariance (ANCOVA) model with treatment and randomization strata (region, disease severity, age) as fixed factors and baseline value as covariate.
All randomized participants, with a Baseline Pruritus NRS score >0, even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol. One investigational site with eighteen participants was excluded from analysis due to GCP issues. MCMC-MI was used to handle missing data.
Posted
Least Squares Mean
Standard Error
percentage change
Baseline, Week 16
ID
Title
Description
OG000
Placebo
Induction Period (Baseline-Week 16):
Two subcutaneous (SC) injections of Placebo as a loading dose at Baseline and Week 2 followed by a single injection every 2 weeks (Q2W) from Week 4 until Week 14.
OG001
Lebrikizumab Q2W
Induction Period (Baseline-Week 16):
500 milligram (mg) Lebrikizumab (2 x 250 mg) SC injections as a loading dose at Baseline and Week 2 visits followed by a single 250 mg Lebrikizumab injection Q2W from Week 4 until Week 14.
Secondary
Percentage of Participants With a Pruritus NRS Score of ≥4-points at Baseline Who Achieve a ≥4-point Reduction in Pruritus NRS Score From Baseline to Week 16
Pruritus NRS is an 11-point scale used by participants to rate their worst itch severity over the past 24 hours with 0 indicating "No itch" and 10 indicating "Worst itch imaginable."
All randomized participants, with a Baseline Pruritus NRS score ≥4, even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol. One investigational site with eighteen participants was excluded from analysis due to GCP issues. MCMC-MI was used to handle missing data.
Posted
Number
95% Confidence Interval
percentage of participants
Baseline to Week 16
ID
Title
Description
OG000
Placebo
Induction Period (Baseline-Week 16):
Two subcutaneous (SC) injections of Placebo as a loading dose at Baseline and Week 2 followed by a single injection every 2 weeks (Q2W) from Week 4 until Week 14.
OG001
Lebrikizumab Q2W
Induction Period (Baseline-Week 16):
500 milligram (mg) Lebrikizumab (2 x 250 mg) SC injections as a loading dose at Baseline and Week 2 visits followed by a single 250 mg Lebrikizumab injection Q2W from Week 4 until Week 14.
Secondary
Percentage of Participants With a Pruritus NRS Score of ≥5-points at Baseline Who Achieve a ≥4-point Reduction in Pruritus NRS Score From Baseline to Week 16
Pruritus NRS is an 11-point scale used by participants to rate their worst itch severity over the past 24 hours with 0 indicating "No itch" and 10 indicating "Worst itch imaginable."
All randomized participants, with Baseline Pruritus NRS score ≥ 5, even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol. One investigational site with eighteen participants was excluded from analysis due to GCP issues. MCMC-MI was used to handle missing data.
Posted
Number
95% Confidence Interval
percentage of participants
Baseline to Week 16
ID
Title
Description
OG000
Placebo
Induction Period (Baseline-Week 16):
Two subcutaneous (SC) injections of Placebo as a loading dose at Baseline and Week 2 followed by a single injection every 2 weeks (Q2W) from Week 4 until Week 14.
OG001
Lebrikizumab Q2W
Induction Period (Baseline-Week 16):
500 milligram (mg) Lebrikizumab (2 x 250 mg) SC injections as a loading dose at Baseline and Week 2 visits followed by a single 250 mg Lebrikizumab injection Q2W from Week 4 until Week 14.
Secondary
Percentage Change in EASI Score From Baseline to Week 16
The EASI assesses objective physician estimates of 2 dimensions of AD - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 to 72 (severe).
LS Mean was calculated using ANCOVA model with treatment, stratification factors of geographic region, age group, baseline IGA score (IGA 3 versus 4) as fixed factors baseline value as covariate.
All randomized participants, even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol. One investigational site with eighteen participants was excluded from analysis due to GCP issues. MCMC-MI was used to handle missing data.
Posted
Least Squares Mean
Standard Error
percent change
Baseline, Week 16
ID
Title
Description
OG000
Placebo
Induction Period (Baseline-Week 16):
Two subcutaneous (SC) injections of Placebo as a loading dose at Baseline and Week 2 followed by a single injection every 2 weeks (Q2W) from Week 4 until Week 14.
OG001
Lebrikizumab Q2W
Secondary
Change From Baseline in Percent Body Surface Area (BSA) at Week 16
The BSA affected by AD will be assessed for 4 separate body regions: head and neck, trunk (including genital region), upper extremities, and lower extremities (including the buttocks). Each body region will be assessed for disease extent ranging from 0% to 100% involvement. BSA was calculated using the participant's palm using the 1% rule, 1 palm was equivalent to 1% with estimates of the number of palms it takes to cover the affected AD area. Maximum number of palms were 10 palms for head and neck (10%), 20 palms for upper extremities (20%), 30 palms for trunk, including axilla and groin (30%), 40 palms for lower extremities, including buttocks (40%). Percent of BSA for a body region was calculated as = total number of palms in a body region * % surface area equivalent to 1 palm. Overall percent BSA of all 4 body regions ranges from 0% to 100 % with higher values representing greater severity of AD.
All randomized participants, with observed BSA data, even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol. One investigational site with eighteen participants was excluded from analysis due to GCP issues. The MMRM included treatment, baseline value, visit, the interaction of the baseline value-by-visit, the interaction of treatment by-visit, geographic region, age group, baseline IGA score.
Posted
Least Squares Mean
Standard Error
percentage of BSA
Baseline, Week 16
ID
Title
Description
OG000
Placebo
Induction Period (Baseline-Week 16):
Two subcutaneous (SC) injections of Placebo as a loading dose at Baseline and Week 2 followed by a single injection every 2 weeks (Q2W) from Week 4 until Week 14.
Secondary
Percentage of Participants Achieving EASI-90 From Baseline to Week 4
The EASI assesses objective physician estimates of 2 dimensions of AD - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 to 72 (severe).
The EASI-90 responder is defined as a participant who achieves a ≥ 90% reduction from baseline in the EASI score.
All randomized participants, even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol. One investigational site with eighteen participants was excluded from analysis due to GCP issues. MCMC-MI was used to handle missing data.
Posted
Number
95% Confidence Interval
percentage of participants
Baseline to Week 4
ID
Title
Description
OG000
Placebo
Induction Period (Baseline-Week 16):
Two subcutaneous (SC) injections of Placebo as a loading dose at Baseline and Week 2 followed by a single injection every 2 weeks (Q2W) from Week 4 until Week 14.
OG001
Lebrikizumab Q2W
Secondary
Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 16
The DLQI is a 10-item, validated questionnaire used to assess the impact of skin disease on the quality of life of an affected person. 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, over the previous week. Response categories include "Not at all," "A little," "A lot," and "Very much," with corresponding scores of 0, 1, 2, and 3 respectively. Questions 3-10 also have an additional response category of "Not relevant" which is scored as "0". Questions are scored from 0 to 3, giving a possible total score range from 0 (no impact of skin disease on quality of life) to 30 (maximum impact on quality of life). A high score is indicative of a poor quality of life.
LS Mean was calculated using the ANCOVA model with treatment, baseline value, and stratification factors of geographic region, age group, baseline IGA (3 versus 4) score as fixed factors.
All randomized participants, with non-missing baseline DLQI score, even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol. One investigational site with eighteen participants was excluded from analysis due to GCP issues. MCMC-MI was used to handle missing data.
Posted
Least Squares Mean
Standard Error
score on a scale
Baseline, Week 16
ID
Title
Description
OG000
Placebo
Induction Period (Baseline-Week 16):
Two subcutaneous (SC) injections of Placebo as a loading dose at Baseline and Week 2 followed by a single injection every 2 weeks (Q2W) from Week 4 until Week 14.
Secondary
Percentage of Participants Achieving ≥4-point Improvement in DLQI From Baseline to Week 16
The DLQI is a 10-item, validated questionnaire used to assess the impact of skin disease on the quality of life of an affected person. 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, over the previous week. Response categories include "Not at all," "A little," "A lot," and "Very much," with corresponding scores of 0, 1, 2, and 3 respectively. Questions 3-10 also have an additional response category of "Not relevant" which is scored as "0". Questions are scored from 0 to 3, giving a possible total score range from 0 (no impact of skin disease on quality of life) to 30 (maximum impact on quality of life). A high score is indicative of a poor quality of life.
All randomized participants, with non-missing baseline DLQI score, even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol. One investigational site with eighteen participants was excluded from analysis due to GCP issues. MCMC-MI was used to handle missing data.
Posted
Number
95% Confidence Interval
percentage of participants
Baseline to Week 16
ID
Title
Description
OG000
Placebo
Induction Period (Baseline-Week 16):
Two subcutaneous (SC) injections of Placebo as a loading dose at Baseline and Week 2 followed by a single injection every 2 weeks (Q2W) from Week 4 until Week 14.
OG001
Secondary
Percentage of Participants With a DLQI Total Score of ≥4-point at Baseline Achieving ≥4-point Improvement in DLQI From Baseline to Week 16
The DLQI is a 10-item, validated questionnaire used to assess the impact of skin disease on the quality of life of an affected person. 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, over the previous week. Response categories include "Not at all," "A little," "A lot," and "Very much," with corresponding scores of 0, 1, 2, and 3 respectively. Questions 3-10 also have an additional response category of "Not relevant" which is scored as "0". Questions are scored from 0 to 3, giving a possible total score range from 0 (no impact of skin disease on quality of life) to 30 (maximum impact on quality of life). A high score is indicative of a poor quality of life.
All randomized participants, with a DLQI Total Score of ≥4-point at baseline, even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol. One investigational site with eighteen participants was excluded from analysis due to GCP issues. MCMC-MI was used to handle missing data.
Posted
Number
95% Confidence Interval
percentage of participants
Baseline to Week 16
ID
Title
Description
OG000
Placebo
Induction Period (Baseline-Week 16):
Two subcutaneous (SC) injections of Placebo as a loading dose at Baseline and Week 2 followed by a single injection every 2 weeks (Q2W) from Week 4 until Week 14.
Secondary
Percentage Change in Sleep-loss Score From Baseline to Week 16
Sleep Loss due to interference of itch will be assessed by the participant. Participants rate their interference of itch on sleep based on a 5-point Likert scale [0 (not at all) to 4 (unable to sleep at all)]. Higher scores indicated a greater impact and worse outcome. Assessments will be recorded daily by the participant using an electronic diary. LS Mean was calculated using ANCOVA model with treatment, baseline value, and stratification factors of geographic region, age group, baseline IGA (3 versus 4) score as fixed factors.
All randomized participants, with baseline sleep-loss score >0, even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol. One investigational site with eighteen participants was excluded from analysis due to GCP issues. MCMC-MI was used to handle missing data.
Posted
Least Squares Mean
Standard Error
percent change
Baseline, Week 16
ID
Title
Description
OG000
Placebo
Induction Period (Baseline-Week 16):
Two subcutaneous (SC) injections of Placebo as a loading dose at Baseline and Week 2 followed by a single injection every 2 weeks (Q2W) from Week 4 until Week 14.
OG001
Lebrikizumab Q2W
Induction Period (Baseline-Week 16):
500 milligram (mg) Lebrikizumab (2 x 250 mg) SC injections as a loading dose at Baseline and Week 2 visits followed by a single 250 mg Lebrikizumab injection Q2W from Week 4 until Week 14.
Secondary
Change From Baseline in Sleep-loss Score at Week 16
Sleep Loss due to interference of itch will be assessed by the participant. Participants rate their interference of itch on sleep based on a 5-point Likert scale [0 (not at all) to 4 (unable to sleep at all)]. Higher scores indicated a greater impact and worse outcome. Assessments will be recorded daily by the participant using an electronic diary. LS Mean was calculated using ANCOVA model with treatment, baseline value, and stratification factors of geographic region, age group, baseline IGA (3 versus 4) score as fixed factors.
All randomized participants, with non-missing baseline Sleep-loss score, even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol. One investigational site with eighteen participants was excluded from analysis due to GCP issues. MCMC-MI was used to handle missing data.
Posted
Least Squares Mean
Standard Error
score on a scale
Baseline, Week 16
ID
Title
Description
OG000
Placebo
Induction Period (Baseline-Week 16):
Two subcutaneous (SC) injections of Placebo as a loading dose at Baseline and Week 2 followed by a single injection every 2 weeks (Q2W) from Week 4 until Week 14.
OG001
Lebrikizumab Q2W
Induction Period (Baseline-Week 16):
500 milligram (mg) Lebrikizumab (2 x 250 mg) SC injections as a loading dose at Baseline and Week 2 visits followed by a single 250 mg Lebrikizumab injection Q2W from Week 4 until Week 14.
Secondary
Percentage of Participants With a Sleep-loss Score ≥2 Points at Baseline Who Achieve a ≥2 Points Reduction From Baseline to Week 16
Sleep Loss due to interference of itch will be assessed by the participant. Participants rate their interference of itch on sleep based on a 5-point Likert scale [0 (not at all) to 4 (unable to sleep at all)]. Higher scores indicated a greater impact and worse outcome. Assessments will be recorded daily by the participant using an electronic diary.
All randomized participants, with baseline sleep-loss score ≥2 Points, even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol. One investigational site with eighteen participants was excluded from analysis due to GCP issues. MCMC-MI was used to handle missing data.
Posted
Number
95% Confidence Interval
percentage of participants
Baseline to Week 16
ID
Title
Description
OG000
Placebo
Induction Period (Baseline-Week 16):
Two subcutaneous (SC) injections of Placebo as a loading dose at Baseline and Week 2 followed by a single injection every 2 weeks (Q2W) from Week 4 until Week 14.
OG001
Lebrikizumab Q2W
Induction Period (Baseline-Week 16):
500 milligram (mg) Lebrikizumab (2 x 250 mg) SC injections as a loading dose at Baseline and Week 2 visits followed by a single 250 mg Lebrikizumab injection Q2W from Week 4 until Week 14.
Secondary
Percentage of Participants With a Pruritus NRS Score of ≥4 Points at Baseline Who Achieve a ≥4-point Reduction From Baseline to Week 1
Pruritus NRS is an 11-point scale used by participants to rate their worst itch severity over the past 24 hours with 0 indicating "No itch" and 10 indicating "Worst itch imaginable."
All randomized participants, with a Pruritus NRS Score of ≥4 Points at baseline, even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol. One investigational site with eighteen participants was excluded from analysis due to GCP issues. MCMC-MI was used to handle missing data.
Posted
Number
95% Confidence Interval
percentage of participants
Baseline to Week 1
ID
Title
Description
OG000
Placebo
Induction Period (Baseline-Week 16):
Two subcutaneous (SC) injections of Placebo as a loading dose at Baseline and Week 2 followed by a single injection every 2 weeks (Q2W) from Week 4 until Week 14.
OG001
Lebrikizumab Q2W
Induction Period (Baseline-Week 16):
500 milligram (mg) Lebrikizumab (2 x 250 mg) SC injections as a loading dose at Baseline and Week 2 visits followed by a single 250 mg Lebrikizumab injection Q2W from Week 4 until Week 14.
Secondary
Percentage of Participants With a Pruritus NRS Score of ≥4 Points at Baseline Who Achieve a ≥4-point Reduction From Baseline to Week 2
Pruritus NRS is an 11-point scale used by participants to rate their worst itch severity over the past 24 hours with 0 indicating "No itch" and 10 indicating "Worst itch imaginable."
All randomized participants, with a Pruritus NRS Score of ≥4 Points at Baseline, even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol. One investigational site with eighteen participants was excluded from analysis due to GCP issues. MCMC-MI was used to handle missing data.
Posted
Number
95% Confidence Interval
percentage of participants
Baseline to Week 2
ID
Title
Description
OG000
Placebo
Induction Period (Baseline-Week 16):
Two subcutaneous (SC) injections of Placebo as a loading dose at Baseline and Week 2 followed by a single injection every 2 weeks (Q2W) from Week 4 until Week 14.
OG001
Lebrikizumab Q2W
Induction Period (Baseline-Week 16):
500 milligram (mg) Lebrikizumab (2 x 250 mg) SC injections as a loading dose at Baseline and Week 2 visits followed by a single 250 mg Lebrikizumab injection Q2W from Week 4 until Week 14.
Secondary
Percentage of Participants With a Pruritus NRS Score of ≥4 Points at Baseline Who Achieve a ≥4-point Reduction From Baseline to Week 4
Pruritus NRS is an 11-point scale used by participants to rate their worst itch severity over the past 24 hours with 0 indicating "No itch" and 10 indicating "Worst itch imaginable."
All randomized participants, with a Pruritus NRS Score of ≥4 Points at Baseline, even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol. One investigational site with eighteen participants was excluded from analysis due to GCP issues. MCMC-MI was used to handle missing data.
Posted
Number
95% Confidence Interval
percentage of participants
Baseline to Week 4
ID
Title
Description
OG000
Placebo
Induction Period (Baseline-Week 16):
Two subcutaneous (SC) injections of Placebo as a loading dose at Baseline and Week 2 followed by a single injection every 2 weeks (Q2W) from Week 4 until Week 14.
OG001
Lebrikizumab Q2W
Induction Period (Baseline-Week 16):
500 milligram (mg) Lebrikizumab (2 x 250 mg) SC injections as a loading dose at Baseline and Week 2 visits followed by a single 250 mg Lebrikizumab injection Q2W from Week 4 until Week 14.
Secondary
Percentage of Participants With a Pruritus NRS Score of ≥5 Points at Baseline Who Achieve a ≥4-point Reduction From Baseline to Week 1
Pruritus NRS is an 11-point scale used by participants to rate their worst itch severity over the past 24 hours with 0 indicating "No itch" and 10 indicating "Worst itch imaginable."
All randomized participants, with a Pruritus NRS Score of ≥5 Points at Baseline, even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol. One investigational site with eighteen participants was excluded from analysis due to GCP issues. MCMC-MI was used to handle missing data.
Posted
Number
95% Confidence Interval
percentage of participants
Baseline to Week 1
ID
Title
Description
OG000
Placebo
Induction Period (Baseline-Week 16):
Two subcutaneous (SC) injections of Placebo as a loading dose at Baseline and Week 2 followed by a single injection every 2 weeks (Q2W) from Week 4 until Week 14.
OG001
Lebrikizumab Q2W
Induction Period (Baseline-Week 16):
500 milligram (mg) Lebrikizumab (2 x 250 mg) SC injections as a loading dose at Baseline and Week 2 visits followed by a single 250 mg Lebrikizumab injection Q2W from Week 4 until Week 14.
Secondary
Percentage of Participants With a Pruritus NRS Score of ≥5 Points at Baseline Who Achieve a ≥4-point Reduction From Baseline to Week 2
Pruritus NRS is an 11-point scale used by participants to rate their worst itch severity over the past 24 hours with 0 indicating "No itch" and 10 indicating "Worst itch imaginable."
All randomized participants, with a Pruritus NRS Score of ≥5 Points at Baseline, even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol. One investigational site with eighteen participants was excluded from analysis due to GCP issues. MCMC-MI was used to handle missing data.
Posted
Number
95% Confidence Interval
percentage of participants
Baseline to Week 2
ID
Title
Description
OG000
Placebo
Induction Period (Baseline-Week 16):
Two subcutaneous (SC) injections of Placebo as a loading dose at Baseline and Week 2 followed by a single injection every 2 weeks (Q2W) from Week 4 until Week 14.
OG001
Lebrikizumab Q2W
Induction Period (Baseline-Week 16):
500 milligram (mg) Lebrikizumab (2 x 250 mg) SC injections as a loading dose at Baseline and Week 2 visits followed by a single 250 mg Lebrikizumab injection Q2W from Week 4 until Week 14.
Secondary
Percentage of Participants With a Pruritus NRS Score of ≥5 Points at Baseline Who Achieve a ≥4-point Reduction From Baseline to Week 4
Pruritus NRS is an 11-point scale used by participants to rate their worst itch severity over the past 24 hours with 0 indicating "No itch" and 10 indicating "Worst itch imaginable."
All randomized participants, with a Pruritus NRS Score of ≥5 Points at Baseline, even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol. One investigational site with eighteen participants was excluded from analysis due to GCP issues. MCMC-MI was used to handle missing data.
Posted
Number
95% Confidence Interval
percentage of participants
Baseline to Week 4
ID
Title
Description
OG000
Placebo
Induction Period (Baseline-Week 16):
Two subcutaneous (SC) injections of Placebo as a loading dose at Baseline and Week 2 followed by a single injection every 2 weeks (Q2W) from Week 4 until Week 14.
OG001
Lebrikizumab Q2W
Induction Period (Baseline-Week 16):
500 milligram (mg) Lebrikizumab (2 x 250 mg) SC injections as a loading dose at Baseline and Week 2 visits followed by a single 250 mg Lebrikizumab injection Q2W from Week 4 until Week 14.
Secondary
Percentage Change in SCORing Atopic Dermatitis (SCORAD) From Baseline to Week 16
SCORAD is validated tool for assessing the extent and intensity of AD, it consists of 3 components: A=extent of AD as a percentage of each defined body area and reported as sum of all areas, with maximum score of 100%. B=severity of 6 specific symptoms of AD (redness, swelling, oozing/crusting, excoriation, skin thickening/lichenification, dryness) assessed using following scale: none=0, mild=1, moderate=2, or severe=3 for maximum of 18 total points. C=subjective assessment of itch and sleeplessness recorded by participant on visual analog scale (VAS), where 0=no itch/no sleeplessness and 10=worst imaginable itch/sleeplessness with maximum score of 20. SCORAD total score is calculated: A/5+7*B/2+ C to give total score range of 0 to 103, where 0=no disease to 103=severe disease. LS Mean was calculated using ANCOVA model with treatment group and stratification factors of geographic region, age group, baseline IGA (3 versus 4) score as fixed factors and baseline value as covariate.
All randomized participants, with baseline SCORAD >0, even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol. One investigational site with eighteen participants was excluded from analysis due to GCP issues. Missing Values were imputed using last observation carried forward (LOCF) method.
Posted
Least Squares Mean
Standard Error
percent change
Baseline, Week 16
ID
Title
Description
OG000
Placebo
Induction Period (Baseline-Week 16):
Two subcutaneous (SC) injections of Placebo as a loading dose at Baseline and Week 2 followed by a single injection every 2 weeks (Q2W) from Week 4 until Week 14.
Secondary
Pharmacokinetics (PK): Trough Serum Concentrations of Lebrikizumab in Maintenance Period (C-trough)
C-trough was the concentration of study drug in the blood immediately before the next dose was administered. Trough serum concentration of Lebrikizumab was assessed at predose week 52.
All participants who received 250 mg Q2W or 250 mg Q4W in the Maintenance Period and had evaluable PK data at Week 52. The 250 mg Q2W PK population also includes participants from the Escape Arm (Induction period non-responders and Maintenance Period non-responders who received open-label 250 mg Q2W dosing).
Percentage of Participants From Those Re-randomized Having Achieved EASI-75 at Week 16 Who Continue to Exhibit EASI-75 at Week 52 (EASI-75 Calculated Relative to Baseline EASI Score)
The EASI assesses objective physician estimates of 2 dimensions of AD - disease extent, i.e., percentage of skin affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI-75 score was obtained by weight-averaging these 4 scores and will range from 0 (none) to 72 (severe).
The EASI-75 responder is defined as a participant who achieves a ≥ 75% reduction from baseline in the EASI score.
All participants who were randomized to Lebrikizumab 250 mg Q2W at Baseline Visit and re-randomized to Lebrikizumab 250 mg Q2W, Lebrikizumab 250 mg Q4W or placebo at Week 16 and received at least 1 dose of study treatment during the maintenance period and had evaluable EASI-75 data at week 52.
Percentage of Participants From Those Re-randomized Having Achieved IGA 0 or 1 and a ≥2-point Improvement From Baseline at Week 16 Who Continue to Exhibit an IGA 0 or 1 and a ≥2-point Improvement From Baseline at Week 52
The IGA measures the investigator's global assessment of the participant's overall severity of their AD, based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification.
All participants who were randomized to Lebrikizumab 250 mg Q2W at Baseline Visit and re-randomized to Lebrikizumab 250 mg Q2W, Lebrikizumab 250 mg Q4W or placebo at Week 16 and received at least 1 dose of study treatment during the maintenance period and had evaluable IGA data at week 52.
Percentage of Participants From Those With a Pruritus NRS of ≥4-points at Baseline Re-randomized Having Achieved ≥4-point Reduction From Baseline at Week 16 Who Continue to Exhibit ≥4-point Reduction From Baseline at Week 52
Pruritus NRS is an 11-point scale used by participants to rate their worst itch severity over the past 24 hours with 0 indicating "No itch" and 10 indicating "Worst itch imaginable."
All participants who were randomized to Lebrikizumab 250 mg Q2W at Baseline Visit and re-randomized to Lebrikizumab 250 mg Q2W, Lebrikizumab 250 mg Q4W or placebo at Week 16 and received at least 1 dose of study treatment during the maintenance period and had evaluable data at week 52.
Participants received 250 mg Lebrikizumab administered SC injection Q2W.
Secondary
Percentage of Participants From Those With a Pruritus NRS of ≥5-points at Baseline Re-randomized Having Achieved ≥4-point Reduction From Baseline at Week 16 Who Continue to Exhibit ≥4-point Reduction From Baseline at Week 52
Pruritus NRS is an 11-point scale used by participants to rate their worst itch severity over the past 24 hours with 0 indicating "No itch" and 10 indicating "Worst itch imaginable."
All participants who were randomized to Lebrikizumab 250 mg Q2W at Baseline Visit and re-randomized to Lebrikizumab 250 mg Q2W, Lebrikizumab 250 mg Q4W or placebo at Week 16 and received at least 1 dose of study treatment during the maintenance period and had evaluable data at week 52.
Participants received 250 mg Lebrikizumab administered SC injection Q2W.
Secondary
Percentage Change in SCORAD (From Those Re-randomized Having Achieved EASI-75 at Week 16) From Baseline at Week 52
SCORAD is a validated tool for assessing the extent and intensity of AD, it consists of 3 components: A=extent of AD as a percentage of each defined body area and reported as sum of all areas, with maximum score of 100%. B=severity of 6 specific symptoms of AD (redness, swelling, oozing/crusting, excoriation, skin thickening/lichenification, dryness) assessed using following scale: none=0, mild=1, moderate=2, or severe=3 for maximum of 18 total points. C=subjective assessment of itch and sleeplessness recorded by participant on VAS, where 0=no itch/no sleeplessness and 10=worst imaginable itch/sleeplessness with maximum score of 20. SCORAD total score is calculated: A/5+7*B/2+ C to give total score range of 0 to 103, where 0=no disease to 103=severe disease. LS Mean was calculated using ANCOVA model with treatment group and stratification factors of geographic region, age group, baseline IGA (3 versus 4) score as fixed factors and baseline value as covariate.
All participants who were randomized to Lebrikizumab 250 mg Q2W at Baseline Visit and re-randomized to Lebrikizumab 250 mg Q2W, Lebrikizumab 250 mg Q4W or placebo at Week 16 and received at least 1 dose of study treatment during the maintenance period and had evaluable data at week 52. Missing Values were imputed using LOCF method.
Participants received placebo administered SC injection Q2W
Secondary
Change From Baseline in European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) at Week 16 - Health State Index
The European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) is a is a 2-part questionnaire which measure health status of the participant. The first component (Health state) is a descriptive system of the respondent's health comprised of the following 5 participant-reported dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The responses are used to derive the health state index scores using the United Kingdom (UK) algorithm, with scores ranging from -0.594 to 1, and the United States (US) algorithm, with scores ranging from -0.109 to 1. A higher score indicates better health state.
LS Mean was calculated using the ANCOVA model with treatment and stratification factors of geographic region, age group, baseline IGA (3 versus 4) score as fixed factors and baseline value as covariate.
All randomized participants, with non-missing EQ-5D-5L- Health State Index data at baseline, even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol. One investigational site with eighteen participants was excluded from analysis due to GCP issues. Missing Values were imputed using last observation carried forward (LOCF) method.
Posted
Least Squares Mean
Standard Error
score on a scale
Baseline, Week 16
ID
Title
Description
OG000
Placebo
Induction Period (Baseline-Week 16):
Two subcutaneous (SC) injections of Placebo as a loading dose at Baseline and Week 2 followed by a single injection every 2 weeks (Q2W) from Week 4 until Week 14.
Secondary
Change From Baseline in EQ-5D-5L at Week 16 - Visual Analog Scale (VAS)
The EQ-5D-5L is a 2-part measurement. The second part is assessed using a VAS that ranged from 0 to 100 millimeter (mm), where 0 is the worst health you can imagine and 100 is the best health you can imagine. LS Mean was calculated using the ANCOVA model with treatment and stratification factors of geographic region, age group, baseline IGA (3 versus 4) score as fixed factors and baseline value as covariate.
All randomized participants, with non-missing EQ-5D-5L-VAS data at baseline, even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol. One investigational site with eighteen participants was excluded from analysis due to GCP issues. Missing values were imputed using LOCF method.
Posted
Least Squares Mean
Standard Error
millimeters (mm)
Baseline, Week 16
ID
Title
Description
OG000
Placebo
Induction Period (Baseline-Week 16):
Two subcutaneous (SC) injections of Placebo as a loading dose at Baseline and Week 2 followed by a single injection every 2 weeks (Q2W) from Week 4 until Week 14.
OG001
Lebrikizumab Q2W
Induction Period (Baseline-Week 16):
500 milligram (mg) Lebrikizumab (2 x 250 mg) SC injections as a loading dose at Baseline and Week 2 visits followed by a single 250 mg Lebrikizumab injection Q2W from Week 4 until Week 14.
Secondary
Change From Baseline in Patient Oriented Eczema Measure (POEM) at Week 16
POEM is a 7-item, validated, questionnaire used by the participant to assess disease symptoms over the last week. The participant is asked to respond to 7 questions on skin dryness, itching, flaking, cracking, sleep loss, bleeding and weeping. All 7 answers carry equal weight with a total possible score from 0 to 28 (answers scored as: No days=0; 1-2 days = 1; 3-4 days = 2; 5-6 days = 3; everyday = 4). A high score is indicative of a poor quality of life. POEM responses will be captured using an electronic diary and transferred into the clinical database. LS Mean was calculated using MMRM model using treatment, baseline value, visit, the interaction of the baseline value-by-visit, the interaction of treatment by-visit as covariates, geographic region, age group, baseline IGA (3 versus 4) score as fixed.
All randomized participants, with observed POEM data, even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol. One investigational site with eighteen participants was excluded from analysis due to GCP issues. MMRM was used to handle all missing data.
Posted
Least Squares Mean
Standard Error
score on a scale
Baseline, Week 16
ID
Title
Description
OG000
Placebo
Induction Period (Baseline-Week 16):
Two subcutaneous (SC) injections of Placebo as a loading dose at Baseline and Week 2 followed by a single injection every 2 weeks (Q2W) from Week 4 until Week 14.
OG001
Lebrikizumab Q2W
Secondary
Change From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety at Week 16-Adolescents
PROMIS® is a set of person-centered measures that evaluates and monitors physical, mental, and social health in adults and children. Participants ≤17 years will complete pediatric versions for the duration of the study. PROMIS anxiety has 8 questions on Emotion Distress-Anxiety (or Pediatric Anxiety Symptom). Each question has 5 response options with values from 1 to 5. Total raw scores were converted to T-Scores (mean = 50 and a standard deviation = 10) with higher scores representing greater anxiety. LS Mean was calculated using the ANCOVA model with treatment and stratification factors of geographic region, age group, baseline IGA (3 versus 4) score as fixed factors and baseline value as covariate.
All randomized, adolescent participants, even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol. One investigational site with eighteen participants was excluded from analysis due to GCP issues. Missing values were imputed using LOCF method.
Posted
Least Squares Mean
Standard Error
T-score
Baseline, Week 16
ID
Title
Description
OG000
Placebo
Induction Period (Baseline-Week 16):
Two subcutaneous (SC) injections of Placebo as a loading dose at Baseline and Week 2 followed by a single injection every 2 weeks (Q2W) from Week 4 until Week 14.
OG001
Lebrikizumab Q2W
Secondary
Change From Baseline in PROMIS Anxiety at Week 16 - Adults
PROMIS® is a set of person-centered measures that evaluates and monitors physical, mental, and social health in adults and children. Participants ≤17 years will complete pediatric versions for the duration of the study. PROMIS anxiety has 8 questions on Emotion Distress-Anxiety (or Pediatric Anxiety Symptom). Each question has 5 response options with values from 1 to 5. Total raw scores were converted to T-Scores (mean = 50 and a standard deviation = 10) with higher scores representing greater anxiety. LS Mean was calculated using the ANCOVA model with treatment and stratification factors of geographic region, age group, baseline IGA (3 versus 4) score as fixed factors and baseline value as covariate.
All randomized, adults participants, with Week 16 PROMIS anxiety data, even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol. One investigational site with eighteen participants was excluded from analysis due to GCP issues. Missing Values were imputed using LOCF method.
Posted
Least Squares Mean
Standard Error
T-score
Baseline, Week 16
ID
Title
Description
OG000
Placebo
Induction Period (Baseline-Week 16):
Two subcutaneous (SC) injections of Placebo as a loading dose at Baseline and Week 2 followed by a single injection every 2 weeks (Q2W) from Week 4 until Week 14.
OG001
Lebrikizumab Q2W
Secondary
Change From Baseline in PROMIS Depression at Week 16- Adolescents
PROMIS® is a set of person-centered measures that evaluates and monitors physical, mental, and social health in adults and children. Participants ≤17 years will complete pediatric versions for the duration of the study. PROMIS anxiety has 8 questions on Emotion Distress-Anxiety (or Pediatric Anxiety Symptom). Each question has 5 response options with values from 1 to 5. Total raw scores were converted to T-Scores (mean = 50 and a standard deviation = 10) with higher scores representing greater anxiety. LS Mean was calculated using the ANCOVA model with treatment and stratification factors of geographic region, age group, baseline IGA (3 versus 4) score as fixed factors and baseline value as covariate.
All randomized, adolescent participants, even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol. One investigational site with eighteen participants was excluded from analysis due to GCP issues. Missing values were imputed using LOCF method.
Posted
Least Squares Mean
Standard Error
T-score
Baseline, Week 16
ID
Title
Description
OG000
Placebo
Induction Period (Baseline-Week 16):
Two subcutaneous (SC) injections of Placebo as a loading dose at Baseline and Week 2 followed by a single injection every 2 weeks (Q2W) from Week 4 until Week 14.
OG001
Lebrikizumab Q2W
Induction Period (Baseline-Week 16):
500 milligram (mg) Lebrikizumab (2 x 250 mg) SC injections as a loading dose at Baseline and Week 2 visits followed by a single 250 mg Lebrikizumab injection Q2W from Week 4 until Week 14.
Secondary
Change From Baseline in PROMIS Depression at Week 16- Adults
PROMIS® is a set of person-centered measures that evaluates and monitors physical, mental, and social health in adults and children. Participants ≤17 years will complete pediatric versions for the duration of the study. PROMIS anxiety has 8 questions on Emotion Distress-Anxiety (or Pediatric Anxiety Symptom). Each question has 5 response options with values from 1 to 5. Total raw scores were converted to T-Scores (mean = 50 and a standard deviation = 10) with higher scores representing greater anxiety. LS Mean was calculated using the ANCOVA model with treatment and stratification factors of geographic region, age group, baseline IGA (3 versus 4) score as fixed factors and baseline value as covariate.
All randomized, adult participants, with Week 16 PROMIS Depression data, even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol. One investigational site with eighteen participants was excluded from analysis due to GCP issues. Missing values were imputed using LOCF method.
Posted
Least Squares Mean
Standard Error
T-score
Baseline, Week 16
ID
Title
Description
OG000
Placebo
Induction Period (Baseline-Week 16):
Two subcutaneous (SC) injections of Placebo as a loading dose at Baseline and Week 2 followed by a single injection every 2 weeks (Q2W) from Week 4 until Week 14.
OG001
Lebrikizumab Q2W
Secondary
Change From Baseline in Asthma Control Questionnaire (ACQ-5) Score at Week 16 in Participants Who Have Self-reported Comorbid Asthma
The ACQ-5 is a five-item, self-completed questionnaire, which is used as a measure of asthma control of a participant. The five questions (concerning nocturnal awakening, waking in the morning, activity limitation, shortness of breath and wheeze) enquire about the frequency and/or severity of symptoms over the previous week. The response options for all these questions range from zero (no impairment/limitation) to six (total impairment/ limitation) scale. The ACQ-5 score is the average of the individual item scores and ranges from 0 (totally controlled) to 6 (severely uncontrolled). Higher scores indicate lower asthma control.
LS Mean was calculated using ANCOVA with treatment, geographic region, age group, baseline IGA (3 versus 4) score as fixed factors and baseline value as covariate.
All randomized participants, with non-missing baseline ACQ-5 score, even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol. One investigational site with eighteen participants was excluded from analysis due to GCP issues. Missing values were imputed using LOCF method.
Posted
Least Squares Mean
Standard Error
score on a scale
Baseline, Week 16
ID
Title
Description
OG000
Placebo
Induction Period (Baseline-Week 16):
Two subcutaneous (SC) injections of Placebo as a loading dose at Baseline and Week 2 followed by a single injection every 2 weeks (Q2W) from Week 4 until Week 14.
OG001
Secondary
Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) at Week 16
The CDLQI questionnaire is designed for use in children (4 to 16 years of age). It consists of 10 items that are grouped into 6 domains: symptoms & feelings, leisure, school or holidays, personal relationships, sleep, & treatment. The scoring of each question is: Very much =3; Quite a lot = 2; Only a little = 1; Not at all = 0. CDLQI total score is calculated by summing all 10 items responses, and has a range of 0 to 30 (higher scores are indicative of greater impairment).
LS Mean was calculated using MMRM model which includes treatment, baseline value, visit, the interaction of the baseline value-by-visit as covariates, the interaction of treatment by-visit, geographic region, age group, and baseline IGA (3 versus 4) score as fixed factors.
All randomized, adolescent participants, with non-missing baseline CDLQI score, even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol. One investigational site with eighteen participants was excluded from analysis due to GCP issues. MMRM was used to handle all missing data.
Posted
Least Squares Mean
Standard Error
score on a scale
Baseline, Week 16
ID
Title
Description
OG000
Placebo
Induction Period (Baseline-Week 16):
Two subcutaneous (SC) injections of Placebo as a loading dose at Baseline and Week 2 followed by a single injection every 2 weeks (Q2W) from Week 4 until Week 14.
OG001
Lebrikizumab Q2W
Time Frame
Baseline up to Week 52
Description
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Induction - Placebo
Induction Period (Baseline-Week 16):
Two subcutaneous (SC) injections of Placebo as a loading dose at Baseline and Week 2 followed by a single injection every 2 weeks (Q2W) from Week 4 until Week 14.
1
149
4
149
97
149
EG001
Induction - Lebrikizumab 250mg Q2W
Induction Period (Baseline-Week 16):
500 milligram (mg) Lebrikizumab (2 x 250 mg) SC injections as a loading dose at Baseline and Week 2 visits followed by a single 250 mg Lebrikizumab injection Q2W from Week 4 until Week 14.
Congenital, Hereditary, and Neonatal Diseases and Abnormalities
D017437
Skin and Connective Tissue Diseases
D017443
Skin Diseases, Eczematous
D006969
Hypersensitivity, Immediate
D006967
Hypersensitivity
D007154
Immune System Diseases
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
C561806
lebrikizumab
Ancestor Terms
Not provided
Browse Leaves
Not provided
Browse Branches
Not provided
0 subjects
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Lost to Follow-up
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BG000123
BG001239
BG002362
>=65 years
BG00010
BG00123
BG00233
36.2
± 16.80
226
Male
BG00071
BG001148
BG002219
5
Asian
BG00044
BG00178
BG002122
Native Hawaiian or Other Pacific Islander
BG0001
BG0012
BG0023
Black or African American
BG00010
BG00126
BG00236
White
BG00089
BG001181
BG002270
More than one race
BG0003
BG0014
BG0027
Unknown or Not Reported
BG0001
BG0011
BG0022
58
Singapore
Title
Measurements
BG0008
BG00111
BG00219
United States
Title
Measurements
BG00064
BG001121
BG002185
Taiwan
Title
Measurements
BG00021
BG00139
BG00260
Ukraine
Title
Measurements
BG0003
BG0018
BG00211
Mexico
Title
Measurements
BG0003
BG0016
BG0029
Bulgaria
Title
Measurements
BG0007
BG00115
BG00222
Germany
Title
Measurements
BG00028
BG00153
BG00281
Induction Period (Baseline-Week 16):
500 milligram (mg) Lebrikizumab (2 x 250 mg) SC injections as a loading dose at Baseline and Week 2 visits followed by a single 250 mg Lebrikizumab injection Q2W from Week 4 until Week 14.
Units
Counts
Participants
OG000146
OG001281
Title
Denominators
Categories
Title
Measurements
OG00018.1(11.7 to 24.5)
OG00152.1(46.1 to 58.0)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Cochran-Mantel-Haenszel
<0.000001
Risk Difference (RD)
33.3
2-Sided
95
24.4
42.2
Superiority
Units
Counts
Participants
OG000146
OG001281
Title
Denominators
Categories
Title
Measurements
OG0000(0.0 to 0.0)
OG0010.7(-0.3 to 1.7)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Cochran-Mantel-Haenszel
0.308463
Risk Difference (RD)
0.7
2-Sided
95
-0.3
1.7
Superiority
Units
Counts
Participants
OG000146
OG001281
Title
Denominators
Categories
Title
Measurements
OG0001.4(0.0 to 3.3)
OG0019.0(5.6 to 12.4)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Cochran-Mantel-Haenszel
0.001607
Risk Difference (RD)
8.1
2-Sided
95
4.1
12.0
Superiority
Units
Counts
Participants
OG000146
OG001281
Title
Denominators
Categories
Title
Measurements
OG00010.8(5.7 to 15.9)
OG00133.2(27.5 to 38.9)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Cochran-Mantel-Haenszel
0.000004
Risk Difference (RD)
21.9
2-Sided
95
14.2
29.6
Superiority
Induction Period (Baseline-Week 16):
500 milligram (mg) Lebrikizumab (2 x 250 mg) SC injections as a loading dose at Baseline and Week 2 visits followed by a single 250 mg Lebrikizumab injection Q2W from Week 4 until Week 14.
Units
Counts
Participants
OG000146
OG001281
Title
Denominators
Categories
Title
Measurements
OG0009.5(4.6 to 14.3)
OG00130.7(25.2 to 36.2)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Cochran-Mantel-Haenszel
0.000008
Risk Difference (RD)
20.7
2-Sided
95
13.3
28.1
Superiority
Units
Counts
Participants
OG000146
OG001281
Title
Denominators
Categories
Title
Measurements
OG000-9.02± 3.868
OG001-36.56± 3.321
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
ANCOVA
<0.000001
LS Mean Difference (Final Values)
-27.53
2-Sided
95
-34.9
-20.2
Superiority
Units
Counts
Participants
OG000134
OG001253
Title
Denominators
Categories
Title
Measurements
OG00011.5(6.0 to 16.9)
OG00139.8(33.6 to 46.0)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Cochran-Mantel-Haenszel
<0.000001
Risk Difference (RD)
28.3
2-Sided
95
20.0
36.5
Superiority
Units
Counts
Participants
OG000122
OG001234
Title
Denominators
Categories
Title
Measurements
OG00011.8(6.0 to 17.6)
OG00141.6(35.1 to 48.1)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Cochran-Mantel-Haenszel
<0.000001
Risk Difference (RD)
29.7
2-Sided
95
21.0
38.4
Superiority
Induction Period (Baseline-Week 16):
500 milligram (mg) Lebrikizumab (2 x 250 mg) SC injections as a loading dose at Baseline and Week 2 visits followed by a single 250 mg Lebrikizumab injection Q2W from Week 4 until Week 14.
Units
Counts
Participants
OG000146
OG001281
Title
Denominators
Categories
Title
Measurements
OG000-27.96± 3.893
OG001-61.53± 3.300
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
ANCOVA
<0.000001
LS Mean Difference (Final Values)
-33.57
2-Sided
95
-41.2
-26.0
Superiority
OG001
Lebrikizumab Q2W
Induction Period (Baseline-Week 16):
500 milligram (mg) Lebrikizumab (2 x 250 mg) SC injections as a loading dose at Baseline and Week 2 visits followed by a single 250 mg Lebrikizumab injection Q2W from Week 4 until Week 14.
Units
Counts
Participants
OG00077
OG001213
Title
Denominators
Categories
Title
Measurements
OG000-14.0± 1.94
OG001-30.2± 1.33
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Mixed Models Analysis
<0.000001
LS Mean Difference (Final Values)
-16.2
2-Sided
95
-20.3
-12.0
Superiority
Induction Period (Baseline-Week 16):
500 milligram (mg) Lebrikizumab (2 x 250 mg) SC injections as a loading dose at Baseline and Week 2 visits followed by a single 250 mg Lebrikizumab injection Q2W from Week 4 until Week 14.
Units
Counts
Participants
OG000146
OG001281
Title
Denominators
Categories
Title
Measurements
OG0001.5(-0.5 to 3.5)
OG0016.3(3.4 to 9.2)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Cochran-Mantel-Haenszel
0.022921
Risk Difference (RD)
4.9
2-Sided
95
1.4
8.4
Superiority
OG001
Lebrikizumab Q2W
Induction Period (Baseline-Week 16):
500 milligram (mg) Lebrikizumab (2 x 250 mg) SC injections as a loading dose at Baseline and Week 2 visits followed by a single 250 mg Lebrikizumab injection Q2W from Week 4 until Week 14.
Units
Counts
Participants
OG000118
OG001218
Title
Denominators
Categories
Title
Measurements
OG000-2.4± 1.17
OG001-7.3± 1.16
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
ANCOVA
<0.000001
LS Mean Difference (Final Values)
-4.9
2-Sided
95
-6.3
-3.5
Superiority
Lebrikizumab Q2W
Induction Period (Baseline-Week 16):
500 milligram (mg) Lebrikizumab (2 x 250 mg) SC injections as a loading dose at Baseline and Week 2 visits followed by a single 250 mg Lebrikizumab injection Q2W from Week 4 until Week 14.
Units
Counts
Participants
OG000118
OG001218
Title
Denominators
Categories
Title
Measurements
OG00032.8(24.1 to 41.4)
OG00165.4(59.0 to 71.9)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Cochran-Mantel-Haenszel
0.000001
Risk Difference (RD)
32.9
2-Sided
95
22.2
43.6
Superiority
OG001
Lebrikizumab Q2W
Induction Period (Baseline-Week 16):
500 milligram (mg) Lebrikizumab (2 x 250 mg) SC injections as a loading dose at Baseline and Week 2 visits followed by a single 250 mg Lebrikizumab injection Q2W from Week 4 until Week 14.
Units
Counts
Participants
OG000115
OG001215
Title
Denominators
Categories
Title
Measurements
OG00033.6(24.8 to 42.5)
OG00166.3(59.9 to 72.8)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Cochran-Mantel-Haenszel
0.000001
Risk Difference (RD)
33.0
2-Sided
95
22.2
43.8
Superiority
Units
Counts
Participants
OG000146
OG001281
Title
Denominators
Categories
Title
Measurements
OG000-11.29± 5.393
OG001-48.37± 4.590
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
ANCOVA
<0.000001
LS Mean Difference (Final Values)
-37.09
2-Sided
95
-47.4
-26.8
Superiority
Units
Counts
Participants
OG000146
OG001281
Title
Denominators
Categories
Title
Measurements
OG000-0.35± 0.095
OG001-1.05± 0.080
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
ANCOVA
<0.000001
LS Mean Difference (Final Values)
-0.70
2-Sided
95
-0.9
-0.5
Superiority
Units
Counts
Participants
OG00097
OG001161
Title
Denominators
Categories
Title
Measurements
OG0008.2(2.5 to 13.9)
OG00128.0(21.0 to 35.0)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Cochran-Mantel-Haenszel
0.000571
Risk Difference (RD)
18.9
2-Sided
95
9.6
28.1
Superiority
Units
Counts
Participants
OG000134
OG001253
Title
Denominators
Categories
Title
Measurements
OG0000.0(0.0 to 0.0)
OG0010.4(0.0 to 1.2)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Cochran-Mantel-Haenszel
0.469221
Risk Difference (RD)
0.4
2-Sided
95
-0.4
1.2
Superiority
Units
Counts
Participants
OG000134
OG001253
Title
Denominators
Categories
Title
Measurements
OG0000.7(0.0 to 2.2)
OG0013.6(1.3 to 5.9)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Cochran-Mantel-Haenszel
0.113194
Risk Difference (RD)
2.7
2-Sided
95
-0.1
5.4
Superiority
Units
Counts
Participants
OG000134
OG001253
Title
Denominators
Categories
Title
Measurements
OG0003.0(0.1 to 6.0)
OG00116.8(12.2 to 21.4)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Cochran-Mantel-Haenszel
0.000230
Risk Difference (RD)
13.2
2-Sided
95
7.7
18.7
Superiority
Units
Counts
Participants
OG000122
OG001234
Title
Denominators
Categories
Title
Measurements
OG0000.0(0.0 to 0.0)
OG0010.4(0.0 to 1.3)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Cochran-Mantel-Haenszel
0.468160
Risk Difference (RD)
0.4
2-Sided
95
-0.4
1.3
Superiority
Units
Counts
Participants
OG000122
OG001234
Title
Denominators
Categories
Title
Measurements
OG0000.8(0.0 to 2.4)
OG0013.9(1.4 to 6.3)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Cochran-Mantel-Haenszel
0.115770
Risk Difference (RD)
2.9
2-Sided
95
-0.1
5.8
Superiority
Units
Counts
Participants
OG000122
OG001234
Title
Denominators
Categories
Title
Measurements
OG0003.3(0.1 to 6.6)
OG00118.1(13.2 to 23.1)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Cochran-Mantel-Haenszel
0.000252
Risk Difference (RD)
14.2
2-Sided
95
8.2
20.1
Superiority
OG001
Lebrikizumab Q2W
Induction Period (Baseline-Week 16):
500 milligram (mg) Lebrikizumab (2 x 250 mg) SC injections as a loading dose at Baseline and Week 2 visits followed by a single 250 mg Lebrikizumab injection Q2W from Week 4 until Week 14.
Units
Counts
Participants
OG000146
OG001281
Title
Denominators
Categories
Title
Measurements
OG000-13.81± 3.197
OG001-44.57± 2.677
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
ANCOVA
<0.000001
LS Mean Difference (Final Values)
-30.76
2-Sided
95
-36.93
-24.59
Superiority
OG000
51
OG001206
Title
Denominators
Categories
Title
Measurements
OG00046.7± 24.8
OG00190.5± 40.1
Participants received 250 mg Lebrikizumab administered SC injection Q4W.
Participants received 250 mg Lebrikizumab administered SC injection Q2W.
Units
Counts
Participants
OG00027
OG00153
OG00251
Title
Denominators
Categories
Title
Measurements
OG000-67.60± 3.767
OG001-73.89± 2.718
OG002-73.85± 2.764
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
ANCOVA
0.176748
LS Mean Difference (Final Values)
-6.29
2-Sided
95
-15.46
2.87
Superiority
OG000
OG002
ANCOVA
0.183151
LS Mean Difference (Final Values)
-6.25
2-Sided
95
-15.48
2.99
Superiority
OG001
Lebrikizumab Q2W
Induction Period (Baseline-Week 16):
500 milligram (mg) Lebrikizumab (2 x 250 mg) SC injections as a loading dose at Baseline and Week 2 visits followed by a single 250 mg Lebrikizumab injection Q2W from Week 4 until Week 14.
Units
Counts
Participants
OG000146
OG001281
Title
Denominators
Categories
Health State Index UK
Title
Measurements
OG0000.0± 0.02
OG0010.1± 0.02
Health State Index US
Title
Measurements
OG0000.0± 0.01
OG0010.1± 0.01
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
UK
ANCOVA
0.000001
LS Mean Difference (Final Values)
0.1
2-Sided
95
0.1
0.1
Superiority
OG000
OG001
US
ANCOVA
0.000001
LS Mean Difference (Final Values)
0.1
2-Sided
95
0.0
0.1
Superiority
Units
Counts
Participants
OG000145
OG001277
Title
Denominators
Categories
Title
Measurements
OG0005.2± 1.62
OG0019.7± 1.36
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
ANCOVA
0.005304
LS Mean Difference (Final Values)
4.5
2-Sided
95
1.3
7.6
Superiority
Induction Period (Baseline-Week 16):
500 milligram (mg) Lebrikizumab (2 x 250 mg) SC injections as a loading dose at Baseline and Week 2 visits followed by a single 250 mg Lebrikizumab injection Q2W from Week 4 until Week 14.
Units
Counts
Participants
OG00065
OG001184
Title
Denominators
Categories
Title
Measurements
OG000-3.5± 0.77
OG001-9.5± 0.52
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Mixed Models Analysis
<0.000001
LS Mean Difference (Final Values)
-6.0
2-Sided
95
-7.7
-4.3
Superiority
Induction Period (Baseline-Week 16):
500 milligram (mg) Lebrikizumab (2 x 250 mg) SC injections as a loading dose at Baseline and Week 2 visits followed by a single 250 mg Lebrikizumab injection Q2W from Week 4 until Week 14.
Units
Counts
Participants
OG00017
OG00130
Title
Denominators
Categories
Title
Measurements
OG0000.12± 2.129
OG001-2.79± 1.550
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
ANCOVA
0.241275
LS Mean Difference (Final Values)
-2.91
2-Sided
95
-7.85
2.03
Superiority
Induction Period (Baseline-Week 16):
500 milligram (mg) Lebrikizumab (2 x 250 mg) SC injections as a loading dose at Baseline and Week 2 visits followed by a single 250 mg Lebrikizumab injection Q2W from Week 4 until Week 14.
Units
Counts
Participants
OG000128
OG001246
Title
Denominators
Categories
Title
Measurements
OG000-0.45± 0.580
OG001-3.18± 0.422
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
ANCOVA
0.000116
LS Mean Difference (Final Values)
-2.74
2-Sided
95
-4.12
-1.36
Superiority
Units
Counts
Participants
OG00017
OG00130
Title
Denominators
Categories
Title
Measurements
OG000-0.57± 2.047
OG001-1.67± 1.493
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
ANCOVA
0.645132
LS Mean Difference (Final Values)
-1.10
2-Sided
95
-5.86
3.67
Superiority
Induction Period (Baseline-Week 16):
500 milligram (mg) Lebrikizumab (2 x 250 mg) SC injections as a loading dose at Baseline and Week 2 visits followed by a single 250 mg Lebrikizumab injection Q2W from Week 4 until Week 14.
Units
Counts
Participants
OG000128
OG001246
Title
Denominators
Categories
Title
Measurements
OG0000.16± 0.540
OG001-2.59± 0.392
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
ANCOVA
0.000031
LS Mean Difference (Final Values)
-2.75
2-Sided
95
-4.03
-1.47
Superiority
Lebrikizumab Q2W
Induction Period (Baseline-Week 16):
500 milligram (mg) Lebrikizumab (2 x 250 mg) SC injections as a loading dose at Baseline and Week 2 visits followed by a single 250 mg Lebrikizumab injection Q2W from Week 4 until Week 14.
Units
Counts
Participants
OG00035
OG00175
Title
Denominators
Categories
Title
Measurements
OG0000.19± 0.140
OG0010.19± 0.108
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
ANCOVA
0.974417
LS Mean Difference (Final Values)
-0.00
2-Sided
95
-0.27
0.26
Superiority
Induction Period (Baseline-Week 16):
500 milligram (mg) Lebrikizumab (2 x 250 mg) SC injections as a loading dose at Baseline and Week 2 visits followed by a single 250 mg Lebrikizumab injection Q2W from Week 4 until Week 14.