Trial Outcomes & Findings for A Study of Lebrikizumab (LY3650150) in Adult and Adolescent Participants With Moderate-to-Severe Atopic Dermatitis Previously Treated With Dupilumab (NCT NCT05369403)

Last Updated: 2025-03-19

Results Overview

The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - 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 EASI75 responder is defined as a ≥ 75% improvement from baseline in the EASI score.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

86 participants

Primary outcome timeframe

Week 16

Results posted on

2025-03-19

Participant Flow

Results for maximum extended enrollment (ME2) participants will be posted after the study completion.

Participant milestones

Participant milestones
Measure	Lebrikizumab 250 mg Q2W Participants received a 500 milligram (mg) loading dose of Lebrikizumab subcutaneously (SC) once every 2 weeks (Q2W) at baseline and Week 2, followed by 250 mg SC once Q2W until Week 16.	Lebrikizumab 250 mg Q2W to Lebrikizumab 250 mg Q2W Participants who received Lebrikizumab 250 mg SC once Q2W until Week 16 and who did not achieve IGA 0 or 1 (clear or almost clear) or a 75% reduction in the EASI score from baseline (EASI-75) at Week 16 continued to receive 250 mg SC once Q2W until Week 24.	Lebrikizumab 250 mg Q2W to Lebrikizumab 250 mg Q4W Participants who received Lebrikizumab 250 mg SC once Q2W until Week 16 and who achieved IGA 0 or 1 (clear or almost clear) or a 75% reduction in the EASI score from baseline (EASI-75) at Week 16, received 250 mg once every 4 weeks (Q4W) until Week 24.
Treatment Period 1: Week 0 to Week 16 STARTED	86	0	0
Treatment Period 1: Week 0 to Week 16 Received at Least One Dose of Drug	86	0	0
Treatment Period 1: Week 0 to Week 16 Intent-to-Treat (ITT) Population	86	0	0
Treatment Period 1: Week 0 to Week 16 COMPLETED	59	0	0
Treatment Period 1: Week 0 to Week 16 NOT COMPLETED	27	0	0
Treatment Period 2: Weeks 16 to Week 24 STARTED	0	18	41
Treatment Period 2: Weeks 16 to Week 24 COMPLETED	0	15	37
Treatment Period 2: Weeks 16 to Week 24 NOT COMPLETED	0	3	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Lebrikizumab 250 mg Q2W Participants received a 500 milligram (mg) loading dose of Lebrikizumab subcutaneously (SC) once every 2 weeks (Q2W) at baseline and Week 2, followed by 250 mg SC once Q2W until Week 16.	Lebrikizumab 250 mg Q2W to Lebrikizumab 250 mg Q2W Participants who received Lebrikizumab 250 mg SC once Q2W until Week 16 and who did not achieve IGA 0 or 1 (clear or almost clear) or a 75% reduction in the EASI score from baseline (EASI-75) at Week 16 continued to receive 250 mg SC once Q2W until Week 24.	Lebrikizumab 250 mg Q2W to Lebrikizumab 250 mg Q4W Participants who received Lebrikizumab 250 mg SC once Q2W until Week 16 and who achieved IGA 0 or 1 (clear or almost clear) or a 75% reduction in the EASI score from baseline (EASI-75) at Week 16, received 250 mg once every 4 weeks (Q4W) until Week 24.
Treatment Period 1: Week 0 to Week 16 Adverse Event	5	0	0
Treatment Period 1: Week 0 to Week 16 Protocol Deviation	1	0	0
Treatment Period 1: Week 0 to Week 16 Lack of Efficacy	1	0	0
Treatment Period 1: Week 0 to Week 16 Withdrawal by Subject	12	0	0
Treatment Period 1: Week 0 to Week 16 Physician Decision	2	0	0
Treatment Period 1: Week 0 to Week 16 Lost to Follow-up	4	0	0
Treatment Period 1: Week 0 to Week 16 Participant enrolled but didn't meet inclusion criteria 11	1	0	0
Treatment Period 1: Week 0 to Week 16 Participant enrolled but did not meet inclusion criteria 3	1	0	0
Treatment Period 2: Weeks 16 to Week 24 Protocol Deviation	0	1	4
Treatment Period 2: Weeks 16 to Week 24 Withdrawal by Subject	0	1	0
Treatment Period 2: Weeks 16 to Week 24 Lost to Follow-up	0	1	0

Baseline Characteristics

A Study of Lebrikizumab (LY3650150) in Adult and Adolescent Participants With Moderate-to-Severe Atopic Dermatitis Previously Treated With Dupilumab

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Lebrikizumab 250mg Q2W n=86 Participants Participants received a 500 mg loading dose of Lebrikizumab SC once Q2W at baseline and Week 2, followed by 250 mg SC once Q2W until Week 16. Responders who achieved IGA 0 or 1 (clear or almost clear) or a 75% reduction in the EASI score from baseline at Week 16 received 250 mg SC once Q4W until Week 24. Inadequate responders at Week 16 continued to receive 250 mg SC once Q2W until Week 24.
Age, Continuous	46.4 years STANDARD_DEVIATION 20.00 • n=5 Participants
Sex: Female, Male Female	41 Participants n=5 Participants
Sex: Female, Male Male	45 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	15 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	69 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	6 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	22 Participants n=5 Participants
Race (NIH/OMB) White	57 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	86 participants n=5 Participants

PRIMARY outcome

Timeframe: Week 16

Population: ITT population included all enrolled participants according to their planned intervention and had Week 16 EASI 75 data. Observed Cases (OC) analysis is applied here, where analysis is using all the observed data at each time point.

Outcome measures

Outcome measures
Measure	Lebrikizumab 250mg Q2W n=61 Participants Participants received a 500 mg loading dose of Lebrikizumab SC once Q2W at baseline and Week 2, followed by 250 mg SC once Q2W until Week 16. Responders who achieved IGA 0 or 1 (clear or almost clear) or a 75% reduction in the EASI score from baseline at Week 16 received 250 mg SC once Q4W until Week 24. Inadequate responders at Week 16 continued to receive 250 mg SC once Q2W until Week 24.	Lebrikizumab 250 mg Q2W to Lebrikizumab 250 mg Q4W Participants who received Lebrikizumab 250 mg SC once Q2W until Week 16 and who achieved IGA 0 or 1 (clear or almost clear) or a 75% reduction in the EASI score from baseline (EASI-75) at Week 16, received 250 mg once every 4 weeks (Q4W) until Week 24.
Percentage of Participants Achieving Eczema Area and Severity Index 75 (EASI75) at Week 16	57.4 percentage of participants Interval 46.9 to 67.3	—

SECONDARY outcome

Timeframe: Week 24

Population: Population included all enrolled patients who received at least 1 confirmed dose of 250 mg lebrikizumab during Weeks 0 to 24 of the treatment period and had Week 24 EASI 75 data. OC analysis is applied here, where analysis is using all the observed data at each time point.

Outcome measures

Outcome measures
Measure	Lebrikizumab 250mg Q2W n=16 Participants Participants received a 500 mg loading dose of Lebrikizumab SC once Q2W at baseline and Week 2, followed by 250 mg SC once Q2W until Week 16. Responders who achieved IGA 0 or 1 (clear or almost clear) or a 75% reduction in the EASI score from baseline at Week 16 received 250 mg SC once Q4W until Week 24. Inadequate responders at Week 16 continued to receive 250 mg SC once Q2W until Week 24.	Lebrikizumab 250 mg Q2W to Lebrikizumab 250 mg Q4W n=39 Participants Participants who received Lebrikizumab 250 mg SC once Q2W until Week 16 and who achieved IGA 0 or 1 (clear or almost clear) or a 75% reduction in the EASI score from baseline (EASI-75) at Week 16, received 250 mg once every 4 weeks (Q4W) until Week 24.
Percentage of Participants Achieving EASI 75 at Week 24	31.3 percentage of participants Interval 16.1 to 51.8	71.8 percentage of participants Interval 58.8 to 81.9

SECONDARY outcome

Timeframe: Baseline to Week 16

Population: ITT population included all enrolled participants according to their planned intervention and had Baseline IGA of at least 2. OC analysis is applied here, where analysis is using all the observed data at each time point.

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 the descriptors that best describe the overall appearance of the lesions at a given time point.

Outcome measures

Outcome measures
Measure	Lebrikizumab 250mg Q2W n=62 Participants Participants received a 500 mg loading dose of Lebrikizumab SC once Q2W at baseline and Week 2, followed by 250 mg SC once Q2W until Week 16. Responders who achieved IGA 0 or 1 (clear or almost clear) or a 75% reduction in the EASI score from baseline at Week 16 received 250 mg SC once Q4W until Week 24. Inadequate responders at Week 16 continued to receive 250 mg SC once Q2W until Week 24.	Lebrikizumab 250 mg Q2W to Lebrikizumab 250 mg Q4W Participants who received Lebrikizumab 250 mg SC once Q2W until Week 16 and who achieved IGA 0 or 1 (clear or almost clear) or a 75% reduction in the EASI score from baseline (EASI-75) at Week 16, received 250 mg once every 4 weeks (Q4W) until Week 24.
Percentage of Participants With an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Reduction ≥2 Points From Baseline to Week 16	38.7 percentage of participants Interval 29.2 to 49.2	—

SECONDARY outcome

Timeframe: Baseline to Week 24

Population: Population included all enrolled patients who received at least 1 confirmed dose of 250 mg lebrikizumab during Weeks 0 to 24 of the treatment period and had Week 24 IGA score data. OC analysis is applied here, where analysis is using all the observed data at each time point.

Outcome measures

Outcome measures
Measure	Lebrikizumab 250mg Q2W n=16 Participants Participants received a 500 mg loading dose of Lebrikizumab SC once Q2W at baseline and Week 2, followed by 250 mg SC once Q2W until Week 16. Responders who achieved IGA 0 or 1 (clear or almost clear) or a 75% reduction in the EASI score from baseline at Week 16 received 250 mg SC once Q4W until Week 24. Inadequate responders at Week 16 continued to receive 250 mg SC once Q2W until Week 24.	Lebrikizumab 250 mg Q2W to Lebrikizumab 250 mg Q4W n=39 Participants Participants who received Lebrikizumab 250 mg SC once Q2W until Week 16 and who achieved IGA 0 or 1 (clear or almost clear) or a 75% reduction in the EASI score from baseline (EASI-75) at Week 16, received 250 mg once every 4 weeks (Q4W) until Week 24.
Percentage of Participants With an IGA Score of 0 or 1 and a Reduction ≥2 Points From Baseline to Week 24	12.5 percentage of participants Interval 4.2 to 31.6	48.7 percentage of participants Interval 36.1 to 61.5

SECONDARY outcome

Timeframe: Baseline, Week 16

Population: ITT population included all enrolled participants according to their planned intervention and had Week 16 EASI data. OC analysis is applied here, where analysis is using all the observed data at each time point.

Outcome measures

Outcome measures
Measure	Lebrikizumab 250mg Q2W n=61 Participants Participants received a 500 mg loading dose of Lebrikizumab SC once Q2W at baseline and Week 2, followed by 250 mg SC once Q2W until Week 16. Responders who achieved IGA 0 or 1 (clear or almost clear) or a 75% reduction in the EASI score from baseline at Week 16 received 250 mg SC once Q4W until Week 24. Inadequate responders at Week 16 continued to receive 250 mg SC once Q2W until Week 24.	Lebrikizumab 250 mg Q2W to Lebrikizumab 250 mg Q4W Participants who received Lebrikizumab 250 mg SC once Q2W until Week 16 and who achieved IGA 0 or 1 (clear or almost clear) or a 75% reduction in the EASI score from baseline (EASI-75) at Week 16, received 250 mg once every 4 weeks (Q4W) until Week 24.
Percentage Change From Baseline in EASI Total Score From Baseline to Week 16	-73.3 percentage change Standard Deviation 23.06	—

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: Population included all enrolled patients who received at least 1 confirmed dose of 250 mg lebrikizumab during Weeks 0 to 24 of the treatment period and had EASI score data. OC analysis is applied here, where analysis is using all the observed data at each time point.

Outcome measures

Outcome measures
Measure	Lebrikizumab 250mg Q2W n=16 Participants Participants received a 500 mg loading dose of Lebrikizumab SC once Q2W at baseline and Week 2, followed by 250 mg SC once Q2W until Week 16. Responders who achieved IGA 0 or 1 (clear or almost clear) or a 75% reduction in the EASI score from baseline at Week 16 received 250 mg SC once Q4W until Week 24. Inadequate responders at Week 16 continued to receive 250 mg SC once Q2W until Week 24.	Lebrikizumab 250 mg Q2W to Lebrikizumab 250 mg Q4W n=39 Participants Participants who received Lebrikizumab 250 mg SC once Q2W until Week 16 and who achieved IGA 0 or 1 (clear or almost clear) or a 75% reduction in the EASI score from baseline (EASI-75) at Week 16, received 250 mg once every 4 weeks (Q4W) until Week 24.
Percentage Change From Baseline in EASI Score From Baseline to Week 24	-64.6 percentage change Standard Deviation 23.26	-82.4 percentage change Standard Deviation 15.93

SECONDARY outcome

Timeframe: Baseline, Week 16

Outcome measures

Outcome measures
Measure	Lebrikizumab 250mg Q2W n=61 Participants Participants received a 500 mg loading dose of Lebrikizumab SC once Q2W at baseline and Week 2, followed by 250 mg SC once Q2W until Week 16. Responders who achieved IGA 0 or 1 (clear or almost clear) or a 75% reduction in the EASI score from baseline at Week 16 received 250 mg SC once Q4W until Week 24. Inadequate responders at Week 16 continued to receive 250 mg SC once Q2W until Week 24.	Lebrikizumab 250 mg Q2W to Lebrikizumab 250 mg Q4W Participants who received Lebrikizumab 250 mg SC once Q2W until Week 16 and who achieved IGA 0 or 1 (clear or almost clear) or a 75% reduction in the EASI score from baseline (EASI-75) at Week 16, received 250 mg once every 4 weeks (Q4W) until Week 24.
Change From Baseline in EASI Score From Baseline to Week 16	-17.4 score on a scale Standard Deviation 9.34	—

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: Population included all enrolled patients who received at least 1 confirmed dose of 250 mg lebrikizumab during Weeks 0 to 24 of the treatment period and had Week 24 EASI score data. OC analysis is applied here, where analysis is using all the observed data at each time point.

Outcome measures

Outcome measures
Measure	Lebrikizumab 250mg Q2W n=16 Participants Participants received a 500 mg loading dose of Lebrikizumab SC once Q2W at baseline and Week 2, followed by 250 mg SC once Q2W until Week 16. Responders who achieved IGA 0 or 1 (clear or almost clear) or a 75% reduction in the EASI score from baseline at Week 16 received 250 mg SC once Q4W until Week 24. Inadequate responders at Week 16 continued to receive 250 mg SC once Q2W until Week 24.	Lebrikizumab 250 mg Q2W to Lebrikizumab 250 mg Q4W n=39 Participants Participants who received Lebrikizumab 250 mg SC once Q2W until Week 16 and who achieved IGA 0 or 1 (clear or almost clear) or a 75% reduction in the EASI score from baseline (EASI-75) at Week 16, received 250 mg once every 4 weeks (Q4W) until Week 24.
Change From Baseline in EASI Score From Baseline to Week 24	-17.4 score on a scale Standard Deviation 8.90	-19.0 score on a scale Standard Deviation 8.29

SECONDARY outcome

Timeframe: Baseline to Week 16

Population: ITT population included all enrolled participants according to their planned intervention and had Week 16 EASI 90 data. OC analysis is applied here, where analysis is using all the observed data at each time point.

The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - 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 EASI90 responder is defined as a ≥ 90% improvement from baseline in the EASI score.

Outcome measures

Outcome measures
Measure	Lebrikizumab 250mg Q2W n=61 Participants Participants received a 500 mg loading dose of Lebrikizumab SC once Q2W at baseline and Week 2, followed by 250 mg SC once Q2W until Week 16. Responders who achieved IGA 0 or 1 (clear or almost clear) or a 75% reduction in the EASI score from baseline at Week 16 received 250 mg SC once Q4W until Week 24. Inadequate responders at Week 16 continued to receive 250 mg SC once Q2W until Week 24.	Lebrikizumab 250 mg Q2W to Lebrikizumab 250 mg Q4W Participants who received Lebrikizumab 250 mg SC once Q2W until Week 16 and who achieved IGA 0 or 1 (clear or almost clear) or a 75% reduction in the EASI score from baseline (EASI-75) at Week 16, received 250 mg once every 4 weeks (Q4W) until Week 24.
Percentage of Participants Achieving EASI-90 (≥90% Reduction in EASI Score) From Baseline to Week 16	29.5 percentage of participants Interval 20.9 to 39.8	—

SECONDARY outcome

Timeframe: Baseline to Week 24

Population: Population included all enrolled patients who received at least 1 confirmed dose of 250 mg lebrikizumab during Weeks 0 to 24 of the treatment period and had Week 24 EASI 90 data. OC analysis is applied here, where analysis is using all the observed data at each time point.

The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - 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 EASI90 responder is defined as a ≥ 90% improvement from baseline in the EASI score.

Outcome measures

Outcome measures
Measure	Lebrikizumab 250mg Q2W n=16 Participants Participants received a 500 mg loading dose of Lebrikizumab SC once Q2W at baseline and Week 2, followed by 250 mg SC once Q2W until Week 16. Responders who achieved IGA 0 or 1 (clear or almost clear) or a 75% reduction in the EASI score from baseline at Week 16 received 250 mg SC once Q4W until Week 24. Inadequate responders at Week 16 continued to receive 250 mg SC once Q2W until Week 24.	Lebrikizumab 250 mg Q2W to Lebrikizumab 250 mg Q4W n=39 Participants Participants who received Lebrikizumab 250 mg SC once Q2W until Week 16 and who achieved IGA 0 or 1 (clear or almost clear) or a 75% reduction in the EASI score from baseline (EASI-75) at Week 16, received 250 mg once every 4 weeks (Q4W) until Week 24.
Percentage of Participants Achieving EASI-90 From Baseline to Week 24	12.5 percentage of participants Interval 4.2 to 31.6	35.9 percentage of participants Interval 24.6 to 49.1

SECONDARY outcome

Timeframe: Baseline to Week 16

Population: ITT population included all enrolled participants according to their planned intervention and had a Baseline Pruritus NRS score of at least 4. OC analysis is applied here, where analysis is using all the observed data at each time point.

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."

Outcome measures

Outcome measures
Measure	Lebrikizumab 250mg Q2W n=47 Participants Participants received a 500 mg loading dose of Lebrikizumab SC once Q2W at baseline and Week 2, followed by 250 mg SC once Q2W until Week 16. Responders who achieved IGA 0 or 1 (clear or almost clear) or a 75% reduction in the EASI score from baseline at Week 16 received 250 mg SC once Q4W until Week 24. Inadequate responders at Week 16 continued to receive 250 mg SC once Q2W until Week 24.	Lebrikizumab 250 mg Q2W to Lebrikizumab 250 mg Q4W Participants who received Lebrikizumab 250 mg SC once Q2W until Week 16 and who achieved IGA 0 or 1 (clear or almost clear) or a 75% reduction in the EASI score from baseline (EASI-75) at Week 16, received 250 mg once every 4 weeks (Q4W) until Week 24.
Percentage of Participants With a Pruritus Numeric Rating Scale (NRS) of ≥4 Points at Baseline Who Achieve at Least 4-point Reduction From Baseline to Week 16	53.2 percentage of participants Interval 41.4 to 64.7	—

SECONDARY outcome

Timeframe: Baseline to Week 24

Population: Population included all enrolled patients who received at least 1 confirmed dose of 250 mg lebrikizumab during Weeks 0 to 24 of the treatment period and had a \>=4-point improvement from baseline in week 24 pruritus NRS score. OC analysis is applied here, where analysis is using all the observed data at each time point.

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."

Outcome measures

Outcome measures
Measure	Lebrikizumab 250mg Q2W n=13 Participants Participants received a 500 mg loading dose of Lebrikizumab SC once Q2W at baseline and Week 2, followed by 250 mg SC once Q2W until Week 16. Responders who achieved IGA 0 or 1 (clear or almost clear) or a 75% reduction in the EASI score from baseline at Week 16 received 250 mg SC once Q4W until Week 24. Inadequate responders at Week 16 continued to receive 250 mg SC once Q2W until Week 24.	Lebrikizumab 250 mg Q2W to Lebrikizumab 250 mg Q4W n=26 Participants Participants who received Lebrikizumab 250 mg SC once Q2W until Week 16 and who achieved IGA 0 or 1 (clear or almost clear) or a 75% reduction in the EASI score from baseline (EASI-75) at Week 16, received 250 mg once every 4 weeks (Q4W) until Week 24.
Percentage of Participants With a Pruritus NRS of ≥4 Points at Baseline Who Achieve at Least 4-point Reduction From Baseline to Week 24	53.8 percentage of participants Interval 32.5 to 73.9	65.4 percentage of participants Interval 49.3 to 78.6

SECONDARY outcome

Timeframe: Baseline to Week 16

Population: ITT population included all enrolled participants according to their planned intervention and had a Baseline Pruritus NRS score of at least 3. OC analysis is applied here, where analysis is using all the observed data at each time point.

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."

Outcome measures

Outcome measures
Measure	Lebrikizumab 250mg Q2W n=48 Participants Participants received a 500 mg loading dose of Lebrikizumab SC once Q2W at baseline and Week 2, followed by 250 mg SC once Q2W until Week 16. Responders who achieved IGA 0 or 1 (clear or almost clear) or a 75% reduction in the EASI score from baseline at Week 16 received 250 mg SC once Q4W until Week 24. Inadequate responders at Week 16 continued to receive 250 mg SC once Q2W until Week 24.	Lebrikizumab 250 mg Q2W to Lebrikizumab 250 mg Q4W Participants who received Lebrikizumab 250 mg SC once Q2W until Week 16 and who achieved IGA 0 or 1 (clear or almost clear) or a 75% reduction in the EASI score from baseline (EASI-75) at Week 16, received 250 mg once every 4 weeks (Q4W) until Week 24.
Percentage of Participants With a Pruritus NRS of ≥3 Points at Baseline Who Achieve at Least 3-point Reduction From Baseline to Week 16	72.9 percentage of participants Interval 61.4 to 82.0	—

SECONDARY outcome

Timeframe: Baseline to Week 24

Population: Population included all enrolled patients who received at least 1 confirmed dose of 250 mg lebrikizumab during Weeks 0 to 24 of the treatment period and had a \>=3-point improvement from baseline in week 24 pruritus NRS score. OC analysis is applied here, where analysis is using all the observed data at each time point.

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."

Outcome measures

Outcome measures
Measure	Lebrikizumab 250mg Q2W n=13 Participants Participants received a 500 mg loading dose of Lebrikizumab SC once Q2W at baseline and Week 2, followed by 250 mg SC once Q2W until Week 16. Responders who achieved IGA 0 or 1 (clear or almost clear) or a 75% reduction in the EASI score from baseline at Week 16 received 250 mg SC once Q4W until Week 24. Inadequate responders at Week 16 continued to receive 250 mg SC once Q2W until Week 24.	Lebrikizumab 250 mg Q2W to Lebrikizumab 250 mg Q4W n=27 Participants Participants who received Lebrikizumab 250 mg SC once Q2W until Week 16 and who achieved IGA 0 or 1 (clear or almost clear) or a 75% reduction in the EASI score from baseline (EASI-75) at Week 16, received 250 mg once every 4 weeks (Q4W) until Week 24.
Percentage of Participants With a Pruritus NRS of ≥3 Points at Baseline Who Achieve at Least 3-point Reduction From Baseline to Week 24	76.9 percentage of participants Interval 54.2 to 90.4	77.8 percentage of participants Interval 62.4 to 88.0

SECONDARY outcome

Timeframe: Baseline, Week 16

Population: ITT population included all enrolled participants according to their planned intervention and had week 16 pruritus NRS score. OC analysis is applied here, where analysis is using all the observed data at each time point.

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." Assessments were recorded daily by the participant using an electronic diary.

Outcome measures

Outcome measures
Measure	Lebrikizumab 250mg Q2W n=53 Participants Participants received a 500 mg loading dose of Lebrikizumab SC once Q2W at baseline and Week 2, followed by 250 mg SC once Q2W until Week 16. Responders who achieved IGA 0 or 1 (clear or almost clear) or a 75% reduction in the EASI score from baseline at Week 16 received 250 mg SC once Q4W until Week 24. Inadequate responders at Week 16 continued to receive 250 mg SC once Q2W until Week 24.	Lebrikizumab 250 mg Q2W to Lebrikizumab 250 mg Q4W Participants who received Lebrikizumab 250 mg SC once Q2W until Week 16 and who achieved IGA 0 or 1 (clear or almost clear) or a 75% reduction in the EASI score from baseline (EASI-75) at Week 16, received 250 mg once every 4 weeks (Q4W) until Week 24.
Percentage Change From Baseline in Pruritus NRS Score From Baseline to Week 16	-55.6 percentage change Standard Deviation 41.78	—

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: Population included all enrolled patients who received at least 1 confirmed dose of 250 mg lebrikizumab during Weeks 0 to 24 of the treatment period and had week 24 pruritus NRS score. OC analysis is applied here, where analysis is using all the observed data at each time point.

Outcome measures

Outcome measures
Measure	Lebrikizumab 250mg Q2W n=15 Participants Participants received a 500 mg loading dose of Lebrikizumab SC once Q2W at baseline and Week 2, followed by 250 mg SC once Q2W until Week 16. Responders who achieved IGA 0 or 1 (clear or almost clear) or a 75% reduction in the EASI score from baseline at Week 16 received 250 mg SC once Q4W until Week 24. Inadequate responders at Week 16 continued to receive 250 mg SC once Q2W until Week 24.	Lebrikizumab 250 mg Q2W to Lebrikizumab 250 mg Q4W n=30 Participants Participants who received Lebrikizumab 250 mg SC once Q2W until Week 16 and who achieved IGA 0 or 1 (clear or almost clear) or a 75% reduction in the EASI score from baseline (EASI-75) at Week 16, received 250 mg once every 4 weeks (Q4W) until Week 24.
Percentage Change From Baseline in Pruritus NRS Score From Baseline to Week 24	-30.0 percentage change Standard Deviation 99.07	-62.0 percentage change Standard Deviation 35.74

SECONDARY outcome

Timeframe: Baseline to Week 16

Population: ITT population included all enrolled participants according to their planned intervention and had a baseline Sleep-Loss scale score of at least 2. OC analysis is applied here, where analysis is using all the observed data at each time point.

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.

Outcome measures

Outcome measures
Measure	Lebrikizumab 250mg Q2W n=24 Participants Participants received a 500 mg loading dose of Lebrikizumab SC once Q2W at baseline and Week 2, followed by 250 mg SC once Q2W until Week 16. Responders who achieved IGA 0 or 1 (clear or almost clear) or a 75% reduction in the EASI score from baseline at Week 16 received 250 mg SC once Q4W until Week 24. Inadequate responders at Week 16 continued to receive 250 mg SC once Q2W until Week 24.	Lebrikizumab 250 mg Q2W to Lebrikizumab 250 mg Q4W Participants who received Lebrikizumab 250 mg SC once Q2W until Week 16 and who achieved IGA 0 or 1 (clear or almost clear) or a 75% reduction in the EASI score from baseline (EASI-75) at Week 16, received 250 mg once every 4 weeks (Q4W) until Week 24.
Percentage of Participants With a Sleep-Loss Scale of ≥2 Points at Baseline Who Achieve at Least 2-point Reduction From Baseline to Week 16	41.7 percentage of participants Interval 26.8 to 58.2	—

SECONDARY outcome

Timeframe: Baseline to Week 24

Population: Population included all enrolled patients who received at least 1 confirmed dose of 250 mg lebrikizumab during Weeks 16 to 24 of the treatment period and had a \>=2-point improvement from baseline in week 24 Sleep-Loss scale score. OC analysis is applied here, where analysis is using all the observed data at each time point.

Outcome measures

Outcome measures
Measure	Lebrikizumab 250mg Q2W n=5 Participants Participants received a 500 mg loading dose of Lebrikizumab SC once Q2W at baseline and Week 2, followed by 250 mg SC once Q2W until Week 16. Responders who achieved IGA 0 or 1 (clear or almost clear) or a 75% reduction in the EASI score from baseline at Week 16 received 250 mg SC once Q4W until Week 24. Inadequate responders at Week 16 continued to receive 250 mg SC once Q2W until Week 24.	Lebrikizumab 250 mg Q2W to Lebrikizumab 250 mg Q4W n=14 Participants Participants who received Lebrikizumab 250 mg SC once Q2W until Week 16 and who achieved IGA 0 or 1 (clear or almost clear) or a 75% reduction in the EASI score from baseline (EASI-75) at Week 16, received 250 mg once every 4 weeks (Q4W) until Week 24.
Percentage of Participants With a Sleep-Loss Scale of ≥2 Points at Baseline Who Achieve at Least 2-point Reduction From Baseline to Week 24	40.0 percentage of participants Interval 14.3 to 72.8	42.9 percentage of participants Interval 24.1 to 64.0

SECONDARY outcome

Timeframe: Baseline, Week 16

Population: ITT population included all enrolled participants according to their planned intervention and had week 16 Sleep-Loss scale score. OC analysis is applied here, where analysis is using all the observed data at each time point.

Outcome measures

Outcome measures
Measure	Lebrikizumab 250mg Q2W n=52 Participants Participants received a 500 mg loading dose of Lebrikizumab SC once Q2W at baseline and Week 2, followed by 250 mg SC once Q2W until Week 16. Responders who achieved IGA 0 or 1 (clear or almost clear) or a 75% reduction in the EASI score from baseline at Week 16 received 250 mg SC once Q4W until Week 24. Inadequate responders at Week 16 continued to receive 250 mg SC once Q2W until Week 24.	Lebrikizumab 250 mg Q2W to Lebrikizumab 250 mg Q4W Participants who received Lebrikizumab 250 mg SC once Q2W until Week 16 and who achieved IGA 0 or 1 (clear or almost clear) or a 75% reduction in the EASI score from baseline (EASI-75) at Week 16, received 250 mg once every 4 weeks (Q4W) until Week 24.
Change From Baseline in Sleep-Loss Scale From Baseline to Week 16	-1.0 percentage of participants Standard Deviation 1.00	—

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: Population included all enrolled patients who received at least 1 confirmed dose of 250 mg lebrikizumab during Weeks 0 to 24 of the treatment period and had week 24 Sleep-Loss scale score. OC analysis is applied here, where analysis is using all the observed data at each time point.

Outcome measures

Outcome measures
Measure	Lebrikizumab 250mg Q2W n=15 Participants Participants received a 500 mg loading dose of Lebrikizumab SC once Q2W at baseline and Week 2, followed by 250 mg SC once Q2W until Week 16. Responders who achieved IGA 0 or 1 (clear or almost clear) or a 75% reduction in the EASI score from baseline at Week 16 received 250 mg SC once Q4W until Week 24. Inadequate responders at Week 16 continued to receive 250 mg SC once Q2W until Week 24.	Lebrikizumab 250 mg Q2W to Lebrikizumab 250 mg Q4W n=29 Participants Participants who received Lebrikizumab 250 mg SC once Q2W until Week 16 and who achieved IGA 0 or 1 (clear or almost clear) or a 75% reduction in the EASI score from baseline (EASI-75) at Week 16, received 250 mg once every 4 weeks (Q4W) until Week 24.
Change From Baseline in Sleep-Loss Scale From Baseline to Week 24	-0.7 percentage of participants Standard Deviation 1.07	-1.1 percentage of participants Standard Deviation 0.91

SECONDARY outcome

Timeframe: Baseline, Week 16

Population: ITT population included all enrolled participants according to their planned intervention and had week 16 skin pain NRS score. OC analysis is applied here, where analysis is using all the observed data at each time point.

The Skin Pain NRS is an 11-point scale used by participants to rate their worst level of skin pain over the past 24 hours, with 0 indicating "no pain" and 10 indicating "worst pain imaginable."

Outcome measures

Outcome measures
Measure	Lebrikizumab 250mg Q2W n=51 Participants Participants received a 500 mg loading dose of Lebrikizumab SC once Q2W at baseline and Week 2, followed by 250 mg SC once Q2W until Week 16. Responders who achieved IGA 0 or 1 (clear or almost clear) or a 75% reduction in the EASI score from baseline at Week 16 received 250 mg SC once Q4W until Week 24. Inadequate responders at Week 16 continued to receive 250 mg SC once Q2W until Week 24.	Lebrikizumab 250 mg Q2W to Lebrikizumab 250 mg Q4W Participants who received Lebrikizumab 250 mg SC once Q2W until Week 16 and who achieved IGA 0 or 1 (clear or almost clear) or a 75% reduction in the EASI score from baseline (EASI-75) at Week 16, received 250 mg once every 4 weeks (Q4W) until Week 24.
Change From Baseline in Skin Pain NRS From Baseline to Week 16	-3.2 score on a scale Standard Deviation 2.96	—

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: Population included all enrolled patients who received at least 1 confirmed dose of 250 mg lebrikizumab during Weeks 16 to 24 of the treatment period and had week 24 skin pain NRS score. OC analysis is applied here, where analysis is using all the observed data at each time point.

The Skin Pain NRS is an 11-point scale used by participants to rate their worst level of skin pain over the past 24 hours, with 0 indicating "no pain" and 10 indicating "worst pain imaginable."

Outcome measures

Outcome measures
Measure	Lebrikizumab 250mg Q2W n=15 Participants Participants received a 500 mg loading dose of Lebrikizumab SC once Q2W at baseline and Week 2, followed by 250 mg SC once Q2W until Week 16. Responders who achieved IGA 0 or 1 (clear or almost clear) or a 75% reduction in the EASI score from baseline at Week 16 received 250 mg SC once Q4W until Week 24. Inadequate responders at Week 16 continued to receive 250 mg SC once Q2W until Week 24.	Lebrikizumab 250 mg Q2W to Lebrikizumab 250 mg Q4W n=28 Participants Participants who received Lebrikizumab 250 mg SC once Q2W until Week 16 and who achieved IGA 0 or 1 (clear or almost clear) or a 75% reduction in the EASI score from baseline (EASI-75) at Week 16, received 250 mg once every 4 weeks (Q4W) until Week 24.
Change From Baseline in Skin Pain NRS From Baseline to Week 24	-2.8 score on a scale Standard Deviation 3.51	-3.3 score on a scale Standard Deviation 2.73

SECONDARY outcome

Timeframe: Baseline, Week 16

Population: ITT population included all enrolled participants according to their planned intervention and had week 16 DLQI score. OC analysis is applied here, where analysis is using all the observed data at each time point.

The DLQI questionnaire designed for participants aged \>=16 years or more 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 and feelings, daily activities, leisure, work and school, personal relationships, 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.

Outcome measures

Outcome measures
Measure	Lebrikizumab 250mg Q2W n=57 Participants Participants received a 500 mg loading dose of Lebrikizumab SC once Q2W at baseline and Week 2, followed by 250 mg SC once Q2W until Week 16. Responders who achieved IGA 0 or 1 (clear or almost clear) or a 75% reduction in the EASI score from baseline at Week 16 received 250 mg SC once Q4W until Week 24. Inadequate responders at Week 16 continued to receive 250 mg SC once Q2W until Week 24.	Lebrikizumab 250 mg Q2W to Lebrikizumab 250 mg Q4W Participants who received Lebrikizumab 250 mg SC once Q2W until Week 16 and who achieved IGA 0 or 1 (clear or almost clear) or a 75% reduction in the EASI score from baseline (EASI-75) at Week 16, received 250 mg once every 4 weeks (Q4W) until Week 24.
Change From Baseline in Dermatology Life Quality Index (DLQI) From Baseline to Week 16	-8.7 score on a scale Standard Deviation 6.98	—

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: Population included all enrolled patients who received at least 1 confirmed dose of 250 mg lebrikizumab during Weeks 16 to 24 of the treatment period and had week 24 DLQI score. OC analysis is applied here, where analysis is using all the observed data at each time point.

The DLQI questionnaire for participants aged 16 and above is a 10-item tool used to assess the impact of skin disease on quality of life. The 10 questions cover topics: symptoms and feelings, daily activities, leisure, work and school, personal relationships, 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 have an additional response category of "not relevant," which is scored as "0." Questions are scored from 0 to 3. Total score ranges from 0 (no impact) to 30 (maximum impact), with higher scores indicating poorer quality of life.

Outcome measures

Outcome measures
Measure	Lebrikizumab 250mg Q2W n=15 Participants Participants received a 500 mg loading dose of Lebrikizumab SC once Q2W at baseline and Week 2, followed by 250 mg SC once Q2W until Week 16. Responders who achieved IGA 0 or 1 (clear or almost clear) or a 75% reduction in the EASI score from baseline at Week 16 received 250 mg SC once Q4W until Week 24. Inadequate responders at Week 16 continued to receive 250 mg SC once Q2W until Week 24.	Lebrikizumab 250 mg Q2W to Lebrikizumab 250 mg Q4W n=35 Participants Participants who received Lebrikizumab 250 mg SC once Q2W until Week 16 and who achieved IGA 0 or 1 (clear or almost clear) or a 75% reduction in the EASI score from baseline (EASI-75) at Week 16, received 250 mg once every 4 weeks (Q4W) until Week 24.
Change From Baseline in DLQI From Baseline to Week 24	-7.5 score on a scale Standard Deviation 7.13	-9.5 score on a scale Standard Deviation 5.83

SECONDARY outcome

Timeframe: Baseline, Week 16

Population: ITT population included all enrolled participants according to their planned intervention and had week 16 CDLQI score. OC analysis is applied here, where analysis is using all the observed data at each time point.

The CDLQI questionnaire designed for participants aged \<16 years and 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).

Outcome measures

Outcome measures
Measure	Lebrikizumab 250mg Q2W n=4 Participants Participants received a 500 mg loading dose of Lebrikizumab SC once Q2W at baseline and Week 2, followed by 250 mg SC once Q2W until Week 16. Responders who achieved IGA 0 or 1 (clear or almost clear) or a 75% reduction in the EASI score from baseline at Week 16 received 250 mg SC once Q4W until Week 24. Inadequate responders at Week 16 continued to receive 250 mg SC once Q2W until Week 24.	Lebrikizumab 250 mg Q2W to Lebrikizumab 250 mg Q4W Participants who received Lebrikizumab 250 mg SC once Q2W until Week 16 and who achieved IGA 0 or 1 (clear or almost clear) or a 75% reduction in the EASI score from baseline (EASI-75) at Week 16, received 250 mg once every 4 weeks (Q4W) until Week 24.
Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) From Baseline to Week 16	-3.0 score on a scale Standard Deviation 7.96	—

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: Population included all enrolled patients who received at least 1 confirmed dose of 250 mg lebrikizumab during Weeks 0 to 24 of the treatment period and had week 24 cDLQI score. OC analysis is applied here, where analysis is using all the observed data at each time point.

Outcome measures

Outcome measures
Measure	Lebrikizumab 250mg Q2W n=1 Participants Participants received a 500 mg loading dose of Lebrikizumab SC once Q2W at baseline and Week 2, followed by 250 mg SC once Q2W until Week 16. Responders who achieved IGA 0 or 1 (clear or almost clear) or a 75% reduction in the EASI score from baseline at Week 16 received 250 mg SC once Q4W until Week 24. Inadequate responders at Week 16 continued to receive 250 mg SC once Q2W until Week 24.	Lebrikizumab 250 mg Q2W to Lebrikizumab 250 mg Q4W n=3 Participants Participants who received Lebrikizumab 250 mg SC once Q2W until Week 16 and who achieved IGA 0 or 1 (clear or almost clear) or a 75% reduction in the EASI score from baseline (EASI-75) at Week 16, received 250 mg once every 4 weeks (Q4W) until Week 24.
Change From Baseline in CDLQI From Baseline to Week 24	-1.0 score on a scale Standard Deviation NA Only 1 participant included in the analysis, therefore standard deviation is not calculable.	-3.3 score on a scale Standard Deviation 9.45

SECONDARY outcome

Timeframe: Baseline, Week 16

Population: ITT population included all enrolled participants according to their planned intervention and had week 16 SCORAD score. OC analysis is applied here, where analysis is using all the observed data at each time point.

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.

Outcome measures

Outcome measures
Measure	Lebrikizumab 250mg Q2W n=61 Participants Participants received a 500 mg loading dose of Lebrikizumab SC once Q2W at baseline and Week 2, followed by 250 mg SC once Q2W until Week 16. Responders who achieved IGA 0 or 1 (clear or almost clear) or a 75% reduction in the EASI score from baseline at Week 16 received 250 mg SC once Q4W until Week 24. Inadequate responders at Week 16 continued to receive 250 mg SC once Q2W until Week 24.	Lebrikizumab 250 mg Q2W to Lebrikizumab 250 mg Q4W Participants who received Lebrikizumab 250 mg SC once Q2W until Week 16 and who achieved IGA 0 or 1 (clear or almost clear) or a 75% reduction in the EASI score from baseline (EASI-75) at Week 16, received 250 mg once every 4 weeks (Q4W) until Week 24.
Percentage Change From Baseline in SCORing Atopic Dermatitis (SCORAD) From Baseline to Week 16	-55.7 percentage change Standard Deviation 22.46	—

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: Population included all enrolled patients who received at least 1 confirmed dose of 250 mg lebrikizumab during Weeks 16 to 24 of the treatment period and had week 24 SCORAD score. OC analysis is applied here, where analysis is using all the observed data at each time point.

SCORAD is a validated tool for assessing the extent and intensity of AD. It consists of three components: A) the extent of AD as a percentage of each body area, with a maximum score of 100%; B) the severity of six specific symptoms (redness, swelling, oozing/crusting, excoriation, skin thickening/lichenification, dryness) rated from 0 (none) to 3 (severe) for a maximum of 18 points; and C) the subjective assessment of itch and sleeplessness on a visual analog scale (VAS) from 0 (no itch/sleeplessness) to 10 (worst imaginable itch/sleeplessness) with a maximum score of 20. The total SCORAD score is calculated as A/5 + 7\*B/2 + C, ranging from 0 (no disease) to 103 (severe disease).

Outcome measures

Outcome measures
Measure	Lebrikizumab 250mg Q2W n=16 Participants Participants received a 500 mg loading dose of Lebrikizumab SC once Q2W at baseline and Week 2, followed by 250 mg SC once Q2W until Week 16. Responders who achieved IGA 0 or 1 (clear or almost clear) or a 75% reduction in the EASI score from baseline at Week 16 received 250 mg SC once Q4W until Week 24. Inadequate responders at Week 16 continued to receive 250 mg SC once Q2W until Week 24.	Lebrikizumab 250 mg Q2W to Lebrikizumab 250 mg Q4W n=38 Participants Participants who received Lebrikizumab 250 mg SC once Q2W until Week 16 and who achieved IGA 0 or 1 (clear or almost clear) or a 75% reduction in the EASI score from baseline (EASI-75) at Week 16, received 250 mg once every 4 weeks (Q4W) until Week 24.
Percentage Change From Baseline in SCORAD From Baseline to Week 24	-47.4 percentage change Standard Deviation 27.07	-60.1 percentage change Standard Deviation 23.51

Adverse Events

Lebrikizumab 250 mg Q2W

Serious events: 1 serious events

Other events: 38 other events

Deaths: 0 deaths

Lebrikizumab 250 mg Q2W to Q2W

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Lebrikizumab 250 mg Q2W to Q4W

Serious events: 1 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Lebrikizumab 250 mg Q2W n=86 participants at risk Participants received 500 milligram (mg) loading dose of Lebrikizumab subcutaneously (SC) once every 2 weeks (Q2W) at baseline and Week 2, followed by 250 mg SC once Q2W until Week 16.	Lebrikizumab 250 mg Q2W to Q2W n=18 participants at risk Participants who received Lebrikizumab 250 mg SC once Q2W until Week 16 and who did not achieve IGA 0 or 1 (clear or almost clear) or a 75% reduction in the EASI score from baseline (EASI-75) at Week 16, continued to receive 250 mg SC once Q2W until Week 24.	Lebrikizumab 250 mg Q2W to Q4W n=41 participants at risk Participants who received Lebrikizumab 250 mg SC once Q2W until Week 16 and who achieved IGA 0 or 1 (clear or almost clear) or a 75% reduction in the EASI score from baseline (EASI-75) at Week 16, received 250 mg once every 4 weeks (Q4W) until Week 24.
Nervous system disorders Cerebral vascular occlusion	0.00% 0/86 • Baseline Up To 24 Weeks AE data from the safety follow-up period and the continuous access period will be reported during the final results posting. All enrolled participants who received at least one confirmed dose of 250 mg lebrikizumab.	0.00% 0/18 • Baseline Up To 24 Weeks AE data from the safety follow-up period and the continuous access period will be reported during the final results posting. All enrolled participants who received at least one confirmed dose of 250 mg lebrikizumab.	2.4% 1/41 • Number of events 1 • Baseline Up To 24 Weeks AE data from the safety follow-up period and the continuous access period will be reported during the final results posting. All enrolled participants who received at least one confirmed dose of 250 mg lebrikizumab.
Skin and subcutaneous tissue disorders Rash morbilliform	1.2% 1/86 • Number of events 1 • Baseline Up To 24 Weeks AE data from the safety follow-up period and the continuous access period will be reported during the final results posting. All enrolled participants who received at least one confirmed dose of 250 mg lebrikizumab.	0.00% 0/18 • Baseline Up To 24 Weeks AE data from the safety follow-up period and the continuous access period will be reported during the final results posting. All enrolled participants who received at least one confirmed dose of 250 mg lebrikizumab.	0.00% 0/41 • Baseline Up To 24 Weeks AE data from the safety follow-up period and the continuous access period will be reported during the final results posting. All enrolled participants who received at least one confirmed dose of 250 mg lebrikizumab.

Other adverse events

Additional Information

Chief Medical Officer

Phone: 800- 545-5979

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60