Trial Outcomes & Findings for A Study of (LY3650150) Lebrikizumab to Assess the Safety and Efficacy of Adult and Adolescent Participants With Moderate-to-Severe Atopic Dermatitis and Skin of Color (NCT NCT05372419)

Last Updated: 2026-03-09

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) at each time point. The EASI75 responder is defined as a ≥ 75% improvement from baseline in the EASI score.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

90 participants

Primary outcome timeframe

Week 16

Results posted on

2026-03-09

Participant Flow

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 Investigator Global Assessment (IGA) 0 or 1 (clear or almost clear) or a 75% reduction in the Eczema Area and Severity Index (EASI) score from baseline (EASI-75) at Week 16 continued to receive 250 mg SC once Q2W until Week 24. After Week 24, eligible participants entered the Continued Access Period, receiving the assigned same dose until the product was commercially available in the United States or discontinuation criteria were met.	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 75% reduction in the EASI score from baseline (EASI-75) at Week 16, received 250 mg once every 4 weeks (Q4W) until Week 24. After Week 24, eligible participants entered the Continued Access Period, receiving the assigned same dose until the product was commercially available in the United States or discontinuation criteria were met.
Treatment Period 1: Week 0 to Week 16 STARTED	90	0	0
Treatment Period 1: Week 0 to Week 16 Received at Least 1 Confirmed Dose of 250 mg Lebrikizumab	90	0	0
Treatment Period 1: Week 0 to Week 16 COMPLETED	77	0	0
Treatment Period 1: Week 0 to Week 16 NOT COMPLETED	13	0	0
Treatment Period 2: Week 16 to Week 24 STARTED	0	21	56
Treatment Period 2: Week 16 to Week 24 Received at Least 1 Confirmed Dose of 250 mg Lebrikizumab	0	21	56
Treatment Period 2: Week 16 to Week 24 COMPLETED	0	19	53
Treatment Period 2: Week 16 to Week 24 NOT COMPLETED	0	2	3
Continued Access Period STARTED	0	14	31
Continued Access Period COMPLETED	0	4	8
Continued Access Period NOT COMPLETED	0	10	23

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 Investigator Global Assessment (IGA) 0 or 1 (clear or almost clear) or a 75% reduction in the Eczema Area and Severity Index (EASI) score from baseline (EASI-75) at Week 16 continued to receive 250 mg SC once Q2W until Week 24. After Week 24, eligible participants entered the Continued Access Period, receiving the assigned same dose until the product was commercially available in the United States or discontinuation criteria were met.	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 75% reduction in the EASI score from baseline (EASI-75) at Week 16, received 250 mg once every 4 weeks (Q4W) until Week 24. After Week 24, eligible participants entered the Continued Access Period, receiving the assigned same dose until the product was commercially available in the United States or discontinuation criteria were met.
Treatment Period 1: Week 0 to Week 16 Protocol Deviation	1	0	0
Treatment Period 1: Week 0 to Week 16 Withdrawal by Subject	5	0	0
Treatment Period 1: Week 0 to Week 16 Lost to Follow-up	7	0	0
Treatment Period 2: Week 16 to Week 24 Protocol Deviation	0	0	2
Treatment Period 2: Week 16 to Week 24 Non-compliance with Study Drug	0	1	0
Treatment Period 2: Week 16 to Week 24 Withdrawal by Subject	0	0	1
Treatment Period 2: Week 16 to Week 24 Lack of Efficacy	0	1	0
Continued Access Period Adverse Event	0	1	0
Continued Access Period Protocol Deviation	0	0	3
Continued Access Period Lack of Efficacy	0	1	1
Continued Access Period Withdrawal by Subject	0	0	3
Continued Access Period Lost to Follow-up	0	2	3
Continued Access Period Participant did not transition to commercially available Lebrikizumab	0	6	12
Continued Access Period Participant discontinued participation due to a misunderstanding related to Addendum	0	0	1

Baseline Characteristics

A Study of (LY3650150) Lebrikizumab to Assess the Safety and Efficacy of Adult and Adolescent Participants With Moderate-to-Severe Atopic Dermatitis and Skin of Color

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Lebrikizumab 250 mg Q2W n=90 Participants 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.
Age, Continuous	40.7 Years STANDARD_DEVIATION 19.56 • n=68 Participants
Sex: Female, Male Female	39 Participants n=68 Participants
Sex: Female, Male Male	51 Participants n=68 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	19 Participants n=68 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	71 Participants n=68 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=68 Participants
Race (NIH/OMB) American Indian or Alaska Native	6 Participants n=68 Participants
Race (NIH/OMB) Asian	10 Participants n=68 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	4 Participants n=68 Participants
Race (NIH/OMB) Black or African American	70 Participants n=68 Participants
Race (NIH/OMB) White	0 Participants n=68 Participants
Race (NIH/OMB) More than one race	0 Participants n=68 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=68 Participants
Region of Enrollment United States	90 Participants n=68 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 250 mg Q2W n=78 Participants 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 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 Q4W until Week 24.
Percentage of Participants Achieving Eczema Area and Severity Index 75 (≥75% Reduction From Baseline in EASI) at Week 16	69.2 percentage of participants Interval 60.1 to 77.1	—

SECONDARY outcome

Timeframe: Week 24

Population: Population included all enrolled participants who received at least 1 confirmed dose of 250 mg lebrikizumab during Weeks 16 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.

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) at each time point. The EASI75 responder is defined as a ≥ 75% improvement from baseline in the EASI score.

Outcome measures

Outcome measures
Measure	Lebrikizumab 250 mg Q2W n=20 Participants 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 Q4W n=54 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 Q4W until Week 24.
Percentage of Participants Achieving EASI 75 at Week 24	45.0 percentage of participants Interval 28.4 to 62.8	90.7 percentage of participants Interval 82.2 to 95.4

SECONDARY outcome

Timeframe: Baseline to Week 16

Population: The ITT population included all enrolled participants according to their planned intervention and had a baseline IGA score 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 250 mg Q2W n=78 Participants 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 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 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	44.9 percentage of participants Interval 35.9 to 54.2	—

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 baseline IGA score of at least 2. OC analysis is applied here, where analysis is using all the observed data at each time point.

Outcome measures

Outcome measures
Measure	Lebrikizumab 250 mg Q2W n=20 Participants 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 Q4W n=54 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 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	5.0 percentage of participants Interval 1.1 to 19.6	72.2 percentage of participants Interval 61.3 to 81.0

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 250 mg Q2W n=78 Participants 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 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 Q4W until Week 24.
Percentage Change From Baseline in Total EASI Score From Baseline to Week 16	-78.8 percentage change Standard Deviation 25.33	—

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 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 250 mg Q2W n=20 Participants 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 Q4W n=54 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 Q4W until Week 24.
Percentage Change From Baseline in Total EASI Score From Baseline to Week 24	-58.3 percentage change Standard Deviation 35.27	-91.2 percentage change Standard Deviation 10.24

SECONDARY outcome

Timeframe: Baseline, Week 16

Outcome measures

Outcome measures
Measure	Lebrikizumab 250 mg Q2W n=78 Participants 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 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 Q4W until Week 24.
Change From Baseline in Total EASI Score From Baseline to Week 16	-20.2 score on a scale Standard Deviation 11.05	—

SECONDARY outcome

Timeframe: Baseline, Week 24

Outcome measures

Outcome measures
Measure	Lebrikizumab 250 mg Q2W n=20 Participants 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 Q4W n=54 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 Q4W until Week 24.
Change From Baseline in Total EASI Score From Baseline to Week 24	-16.1 score on a scale Standard Deviation 14.23	-22.6 score on a scale Standard Deviation 10.48

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) at each time point. The EASI90 responder is defined as a ≥ 90% improvement from baseline in the EASI score.

Outcome measures

Outcome measures
Measure	Lebrikizumab 250 mg Q2W n=78 Participants 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 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 Q4W until Week 24.
Percentage of Participants Achieving EASI-90 (≥90% Reduction in EASI Score) From Baseline to Week 16	44.9 percentage of participants Interval 35.9 to 54.2	—

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 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) at each time point. The EASI90 responder is defined as a ≥ 90% improvement from baseline in the EASI score.

Outcome measures

Outcome measures
Measure	Lebrikizumab 250 mg Q2W n=20 Participants 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 Q4W n=54 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 Q4W until Week 24.
Percentage of Participants Achieving EASI-90 From Baseline to Week 24	5.0 percentage of participants Interval 1.1 to 19.6	63.0 percentage of participants Interval 51.8 to 72.9

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 250 mg Q2W n=62 Participants 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 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 Q4W until Week 24.
Percentage of Participants With a Pruritus Numeric Rating Scale (NRS) of ≥4 Points at Baseline Who Achieve a 4-point Reduction From Baseline to Week 16	58.1 percentage of participants Interval 47.6 to 67.8	—

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 16 to 24 of the treatment period 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 250 mg Q2W n=15 Participants 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 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 Q4W until Week 24.
Percentage of Participants With a Pruritus NRS of ≥4 Points at Baseline Who Achieve a 4-point Reduction From Baseline to Week 24	40.0 percentage of participants Interval 22.3 to 60.7	68.4 percentage of participants Interval 55.2 to 79.2

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 250 mg Q2W n=65 Participants 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 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 Q4W until Week 24.
Percentage of Participants With a Pruritus NRS ≥3 Points at Baseline Who Achieve at Least 3- Point Reduction From Baseline to Week 16	66.2 percentage of participants Interval 56.0 to 75.0	—

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 16 to 24 of the treatment period 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. Assessments were recorded daily by the participant using an electronic diary.

Outcome measures

Outcome measures
Measure	Lebrikizumab 250 mg Q2W n=16 Participants 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 Q4W n=40 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 Q4W until Week 24.
Percentage of Participants With a Pruritus NRS ≥3 Points at Baseline Who Achieve at Least 3- Point Reduction From Baseline to Week 24	43.8 percentage of participants Interval 25.8 to 63.5	70.0 percentage of participants Interval 57.1 to 80.3

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 250 mg Q2W n=68 Participants 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 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 Q4W until Week 24.
Percentage Change in Pruritus NRS Score From Baseline to Week 16	-58.3 percentage change Standard Deviation 36.03	—

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 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 250 mg Q2W n=16 Participants 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 Q4W n=43 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 Q4W until Week 24.
Percentage Change From Baseline in Pruritus NRS Score From Baseline to Week 24	-45.9 percentage change Standard Deviation 32.23	-63.3 percentage change Standard Deviation 37.97

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 250 mg Q2W n=39 Participants 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 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 Q4W until Week 24.
Percentage of Participants With a Sleep-Loss Scale Score of ≥2 Points at Baseline Who Achieve a 2-point Reduction From Baseline to Week 16	30.8 percentage of participants Interval 20.2 to 43.8	—

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 16 to 24 of the treatment period 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.

Outcome measures

Outcome measures
Measure	Lebrikizumab 250 mg Q2W n=9 Participants 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 Q4W n=24 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 Q4W until Week 24.
Percentage of Participants With a Sleep-Loss Scale Score of ≥2 Points at Baseline Who Achieve a 2-point Reduction From Baseline to Week 24	22.2 percentage of participants Interval 7.6 to 49.6	37.5 percentage of participants Interval 23.3 to 54.2

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 250 mg Q2W n=63 Participants 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 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 Q4W until Week 24.
Percentage Change From Baseline in Sleep-Loss Scale Score From Baseline to Week 16	-54.3 percentage change Standard Deviation 53.52	—

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 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 250 mg Q2W n=15 Participants 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 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 Q4W until Week 24.
Percentage Change From Baseline in Sleep-Loss Scale Score From Baseline to Week 24	-40.9 percentage change Standard Deviation 52.25	-62.9 percentage change Standard Deviation 38.46

SECONDARY outcome

Timeframe: Baseline to Week 16

Population: ITT population included all enrolled participants according to their planned intervention and had a baseline skin pain NRS score of at least 4. 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 250 mg Q2W n=51 Participants 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 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 Q4W until Week 24.
Percentage of Participants With a Skin Pain NRS of ≥4 Points at Baseline Who Achieve a 4-point Reduction From Baseline to Week 16	58.8 percentage of participants Interval 47.3 to 69.4	—

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 baseline skin pain NRS score of at least 4. 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 250 mg Q2W n=13 Participants 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 Q4W n=31 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 Q4W until Week 24.
Percentage of Participants With a Skin Pain NRS of ≥4 Points at Baseline Who Achieve a 4-point Reduction From Baseline to Week 24	38.5 percentage of participants Interval 20.2 to 60.7	71.0 percentage of participants Interval 56.3 to 82.3

SECONDARY outcome

Timeframe: Baseline, Week 16

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

The POEM is a simple, participant-reported, 7-item scale that assesses disease severity in children and adults. Participants respond to questions about the frequency of 7 symptoms (itching, sleep disturbance, bleeding, weeping/oozing, cracking, flaking, and dryness/roughness) over the past week. Response categories include "No days," "1-2 days," "3-4 days," "5-6 days," and "Every day" with corresponding scores of 0, 1, 2, 3, and 4, respectively The sum of the 7 items gives the total POEM score of 0 (absent disease) to 28 (severe disease). High scores are indicative of more severe disease and poor quality of life.

Outcome measures

Outcome measures
Measure	Lebrikizumab 250 mg Q2W n=45 Participants 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 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 Q4W until Week 24.
Change From Baseline in Patient-Oriented Eczema Measure (POEM) From Baseline to Week 16	-10.8 score on a scale Standard Deviation 7.51	—

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 POEM data. OC analysis is applied here, where analysis is using all the observed data at each time point.

Outcome measures

Outcome measures
Measure	Lebrikizumab 250 mg Q2W n=7 Participants 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 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 Q4W until Week 24.
Change From Baseline in POEM From Baseline to Week 24	-2.7 score on a scale Standard Deviation 4.39	-12.6 score on a scale Standard Deviation 6.58

SECONDARY outcome

Timeframe: Baseline, Week 16

Population: The 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 250 mg Q2W n=66 Participants 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 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 Q4W until Week 24.
Change From Baseline in Dermatology Life Quality Index (DLQI) From Baseline to Week 16	-7.4 score on a scale Standard Deviation 6.63	—

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.

Outcome measures

Outcome measures
Measure	Lebrikizumab 250 mg Q2W n=17 Participants 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 Q4W n=48 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 Q4W until Week 24.
Change From Baseline in DLQI From Baseline to Week 24	-6.9 score on a scale Standard Deviation 4.34	-8.1 score on a scale Standard Deviation 7.48

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 250 mg Q2W n=9 Participants 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 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 Q4W until Week 24.
Change From Baseline in Children's Dermatology Life Quality Index (cDLQI) From Baseline to Week 16	-9.4 score on a scale Standard Deviation 8.50	—

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 cDLQI 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 250 mg Q2W n=4 Participants 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 Q4W n=4 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 Q4W until Week 24.
Change From Baseline in cDLQI From Baseline to Week 24	-5.3 score on a scale Standard Deviation 6.40	-14.3 score on a scale Standard Deviation 9.91

SECONDARY outcome

Timeframe: Baseline to Week 16

Population: ITT population included all enrolled participants according to their planned intervention and had baseline DLQI score of at least 4. 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 250 mg Q2W n=60 Participants 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 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 Q4W until Week 24.
Percentage of Participants With a DLQI of ≥4 Points at Baseline Who Achieve a ≥4-point Improvement in DLQI From Baseline to Week 16	71.7 percentage of participants Interval 61.3 to 80.1	—

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 baseline DLQI score of at least 4. OC analysis is applied here, where analysis is using all the observed data at each time point.

Outcome measures

Outcome measures
Measure	Lebrikizumab 250 mg Q2W n=17 Participants 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 Q4W n=42 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 Q4W until Week 24.
Percentage of Participants With a DLQI of ≥4 Points at Baseline Who Achieve a ≥4-point Improvement in DLQI From Baseline to Week 24	70.6 percentage of participants Interval 50.6 to 84.9	73.8 percentage of participants Interval 61.5 to 83.3

Adverse Events

Lebrikizumab 250 mg Q2W

Serious events: 0 serious events

Other events: 23 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: 11 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Lebrikizumab 250 mg Q2W n=90 participants at risk 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.	Lebrikizumab 250 mg Q2W to Q2W n=21 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. After Week 24, eligible participants entered the Continued Access Period, receiving the assigned same dose until the product was commercially available in the United States or discontinuation criteria were met.	Lebrikizumab 250 mg Q2W to Q4W n=56 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. After Week 24, eligible participants entered the Continued Access Period, receiving the assigned same dose until the product was commercially available in the United States or discontinuation criteria were met.
Musculoskeletal and connective tissue disorders Cervical spinal stenosis	0.00% 0/90 • Baseline up to end of follow-up including continued access period (Up to 94 Weeks) All enrolled participants who received at least one confirmed dose of 250 mg lebrikizumab.	0.00% 0/21 • Baseline up to end of follow-up including continued access period (Up to 94 Weeks) All enrolled participants who received at least one confirmed dose of 250 mg lebrikizumab.	1.8% 1/56 • Number of events 1 • Baseline up to end of follow-up including continued access period (Up to 94 Weeks) All enrolled participants who received at least one confirmed dose of 250 mg lebrikizumab.

Other adverse events

Additional Information

Chief Medical Officer

Eli Lilly and Company

Phone: 800- 545-5979

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60