Trial Outcomes & Findings for Safety and Efficacy of Lebrikizumab (LY3650150) in Combination With Topical Corticosteroid in Moderate-to-Severe Atopic Dermatitis. (NCT NCT04250337)

Last Updated: 2022-05-09

Results Overview

The IGA measures the investigator's global assessment of the participant's overall severity of their AD, based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

228 participants

Primary outcome timeframe

Baseline to Week 16

Results posted on

2022-05-09

Participant Flow

A participant is considered to have completed the study if he/she has completed the last scheduled visit: * For participants continuing into Long-term Extension (LTE), upon completion of week 16 visit and rolling into LTE study * For participants not continuing into LTE, when participant had either week 16 or Early Termination (ET) visit, and safety follow up visit (12 weeks after last study drug administration)

Participant milestones

Participant milestones
Measure	Placebo + Topical Corticosteroid Two placebo subcutaneous (SC) injections as a loading dose at Baseline and Week 2 followed by a single injection of placebo every 2 weeks (Q2W) from Week 4 until Week 14. Topical Corticosteroid (TCS) will be initiated at Baseline in all participants and may be tapered or stopped, or restarted as needed, based on treatment response	Lebrikizumab + Topical Corticosteroid 500 milligram (mg) Lebrikizumab (2 x 250 mg) SC injections as a loading dose at Baseline and Week 2 followed by a single injection of 250 mg Lebrikizumab Q2W from Week 4 until Week 14. TCS will be initiated at Baseline in all participants and may be tapered or stopped, or restarted as needed, based on treatment response.
Overall Study STARTED	75	153
Overall Study Received at Least One Dose of Study Drug	75	153
Overall Study COMPLETED	67	142
Overall Study NOT COMPLETED	8	11

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo + Topical Corticosteroid Two placebo subcutaneous (SC) injections as a loading dose at Baseline and Week 2 followed by a single injection of placebo every 2 weeks (Q2W) from Week 4 until Week 14. Topical Corticosteroid (TCS) will be initiated at Baseline in all participants and may be tapered or stopped, or restarted as needed, based on treatment response	Lebrikizumab + Topical Corticosteroid 500 milligram (mg) Lebrikizumab (2 x 250 mg) SC injections as a loading dose at Baseline and Week 2 followed by a single injection of 250 mg Lebrikizumab Q2W from Week 4 until Week 14. TCS will be initiated at Baseline in all participants and may be tapered or stopped, or restarted as needed, based on treatment response.
Overall Study Adverse Event	0	3
Overall Study Lack of Efficacy	1	3
Overall Study Physician Decision	1	0
Overall Study Protocol Deviation	2	2
Overall Study Withdrawal by Subject	4	3

Baseline Characteristics

Safety and Efficacy of Lebrikizumab (LY3650150) in Combination With Topical Corticosteroid in Moderate-to-Severe Atopic Dermatitis.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo + Topical Corticosteroid n=75 Participants Two placebo SC injections as a loading dose at Baseline and Week 2 followed by a single injection of placebo every Q2W from Week 4 until Week 14. TCS will be initiated at Baseline in all participants and may be tapered or stopped, or restarted as needed, based on treatment response.	Lebrikizumab + Topical Corticosteroid n=153 Participants 500 mg Lebrikizumab (2 x 250 mg) SC injections of lebrikizumab as a loading dose at Baseline and Week 2 followed by a single injection of 250 mg Lebrikizumab Q2W from Week 4 until Week 14. TCS will be initiated at Baseline in all participants and may be tapered or stopped, or restarted as needed, based on treatment response	Total n=228 Participants Total of all reporting groups
Age, Customized 12 - <18	18 Participants n=5 Participants	35 Participants n=7 Participants	53 Participants n=5 Participants
Age, Customized >= 18 - <65	52 Participants n=5 Participants	103 Participants n=7 Participants	155 Participants n=5 Participants
Age, Customized >=65 - <75	5 Participants n=5 Participants	10 Participants n=7 Participants	15 Participants n=5 Participants
Age, Customized >=75	0 Participants n=5 Participants	5 Participants n=7 Participants	5 Participants n=5 Participants
Sex: Female, Male Female	37 Participants n=5 Participants	75 Participants n=7 Participants	112 Participants n=5 Participants
Sex: Female, Male Male	38 Participants n=5 Participants	78 Participants n=7 Participants	116 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	2 Participants n=5 Participants	5 Participants n=7 Participants	7 Participants n=5 Participants
Race (NIH/OMB) Asian	13 Participants n=5 Participants	18 Participants n=7 Participants	31 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) Black or African American	9 Participants n=5 Participants	21 Participants n=7 Participants	30 Participants n=5 Participants
Race (NIH/OMB) White	49 Participants n=5 Participants	96 Participants n=7 Participants	145 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	8 Participants n=7 Participants	9 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Region of Enrollment Canada	8 Participants n=5 Participants	14 Participants n=7 Participants	22 Participants n=5 Participants
Region of Enrollment United States	57 Participants n=5 Participants	111 Participants n=7 Participants	168 Participants n=5 Participants
Region of Enrollment Poland	8 Participants n=5 Participants	19 Participants n=7 Participants	27 Participants n=5 Participants
Region of Enrollment Germany	2 Participants n=5 Participants	9 Participants n=7 Participants	11 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline to Week 16

Population: All randomized participants, even if the participant did not take the assigned treatment, did not receive the correct treatment, or otherwise did not follow the protocol. One investigational site with seventeen participants was excluded from analysis due to Good Clinical Practice (GCP) issues.

Outcome measures

Outcome measures
Measure	Placebo +Topical Corticosteroid n=66 Participants Two placebo SC injections as a loading dose at Baseline and Week 2 followed by a single injection of placebo Q2W from Week 4 until Week 14. TCS will be initiated at Baseline in all participants and may be tapered or stopped, or restarted as needed, based on treatment response.	Lebrikizumab + Topical Corticosteroid n=145 Participants 500 mg Lebrikizumab (2 x 250 mg) SC injections as a loading dose at Baseline and Week 2 followed by a single injection 250 mg Lebrikizumab Q2W from Week 4 until Week 14. TCS will be initiated at Baseline in all participants and may be tapered or stopped, or restarted as needed, based on treatment response.
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.	22.1 percentage of participants Interval 11.6 to 32.7	41.2 percentage of participants Interval 33.0 to 49.4

PRIMARY outcome

Timeframe: Baseline to Week 16

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 EASI responder is defined as a participant who achieves a ≥ 75% improvement from baseline in the EASI score.

Outcome measures

Outcome measures
Measure	Placebo +Topical Corticosteroid n=66 Participants Two placebo SC injections as a loading dose at Baseline and Week 2 followed by a single injection of placebo Q2W from Week 4 until Week 14. TCS will be initiated at Baseline in all participants and may be tapered or stopped, or restarted as needed, based on treatment response.	Lebrikizumab + Topical Corticosteroid n=145 Participants 500 mg Lebrikizumab (2 x 250 mg) SC injections as a loading dose at Baseline and Week 2 followed by a single injection 250 mg Lebrikizumab Q2W from Week 4 until Week 14. TCS will be initiated at Baseline in all participants and may be tapered or stopped, or restarted as needed, based on treatment response.
Percentage of Participants Achieving Eczema Area and Severity Index (EASI-75) (≥75% Reduction From Baseline in EASI Score) at Week 16	42.2 percentage of participants Interval 30.1 to 54.4	69.5 percentage of participants Interval 61.9 to 77.2

SECONDARY outcome

Timeframe: Baseline to Week 16

Outcome measures

Outcome measures
Measure	Placebo +Topical Corticosteroid n=66 Participants Two placebo SC injections as a loading dose at Baseline and Week 2 followed by a single injection of placebo Q2W from Week 4 until Week 14. TCS will be initiated at Baseline in all participants and may be tapered or stopped, or restarted as needed, based on treatment response.	Lebrikizumab + Topical Corticosteroid n=145 Participants 500 mg Lebrikizumab (2 x 250 mg) SC injections as a loading dose at Baseline and Week 2 followed by a single injection 250 mg Lebrikizumab Q2W from Week 4 until Week 14. TCS will be initiated at Baseline in all participants and may be tapered or stopped, or restarted as needed, based on treatment response.
Percentage of Participants Achieving EASI-90 (≥90% Reduction From Baseline in EASI Score) at Week 16	21.7 percentage of participants Interval 11.4 to 32.0	41.2 percentage of participants Interval 33.0 to 49.3

SECONDARY outcome

Timeframe: Baseline, Week 16

Pruritus NRS is an 11-point scale used by participants to rate their worst itch severity over the past 24 hours with 0 indicating "No itch" and 10 indicating "Worst itch imaginable." Least Squares (LS) Mean was calculated using analysis covariance (ANCOVA) model includes treatment, baseline value, and stratification factors of geographic region, age group, baseline IGA score as fixed factors.

Outcome measures

Outcome measures
Measure	Placebo +Topical Corticosteroid n=63 Participants Two placebo SC injections as a loading dose at Baseline and Week 2 followed by a single injection of placebo Q2W from Week 4 until Week 14. TCS will be initiated at Baseline in all participants and may be tapered or stopped, or restarted as needed, based on treatment response.	Lebrikizumab + Topical Corticosteroid n=139 Participants 500 mg Lebrikizumab (2 x 250 mg) SC injections as a loading dose at Baseline and Week 2 followed by a single injection 250 mg Lebrikizumab Q2W from Week 4 until Week 14. TCS will be initiated at Baseline in all participants and may be tapered or stopped, or restarted as needed, based on treatment response.
Percent Change in Pruritus Numerical Rating Scale (NRS) Score From Baseline to Week 16	-35.47 Percent change Standard Error 6.358	-50.68 Percent change Standard Error 4.546

SECONDARY outcome

Timeframe: Baseline to Week 16

Pruritus NRS is an 11-point scale used by participants to rate their worst itch severity over the past 24 hours with 0 indicating "No itch" and 10 indicating "Worst itch imaginable."

Outcome measures

Outcome measures
Measure	Placebo +Topical Corticosteroid n=57 Participants Two placebo SC injections as a loading dose at Baseline and Week 2 followed by a single injection of placebo Q2W from Week 4 until Week 14. TCS will be initiated at Baseline in all participants and may be tapered or stopped, or restarted as needed, based on treatment response.	Lebrikizumab + Topical Corticosteroid n=130 Participants 500 mg Lebrikizumab (2 x 250 mg) SC injections as a loading dose at Baseline and Week 2 followed by a single injection 250 mg Lebrikizumab Q2W from Week 4 until Week 14. TCS will be initiated at Baseline in all participants and may be tapered or stopped, or restarted as needed, based on treatment response.
Percentage of Participants With a Pruritus NRS of ≥4-Points at Baseline Who Achieve a ≥4-Point Reduction From Baseline to Week 16	31.9 percentage of participants Interval 19.3 to 44.4	50.6 percentage of participants Interval 41.8 to 59.4

SECONDARY outcome

Timeframe: Baseline to Week 16

Pruritus NRS is an 11-point scale used by participants to rate their worst itch severity over the past 24 hours with 0 indicating "No itch" and 10 indicating "Worst itch imaginable."

Outcome measures

Outcome measures
Measure	Placebo +Topical Corticosteroid n=53 Participants Two placebo SC injections as a loading dose at Baseline and Week 2 followed by a single injection of placebo Q2W from Week 4 until Week 14. TCS will be initiated at Baseline in all participants and may be tapered or stopped, or restarted as needed, based on treatment response.	Lebrikizumab + Topical Corticosteroid n=124 Participants 500 mg Lebrikizumab (2 x 250 mg) SC injections as a loading dose at Baseline and Week 2 followed by a single injection 250 mg Lebrikizumab Q2W from Week 4 until Week 14. TCS will be initiated at Baseline in all participants and may be tapered or stopped, or restarted as needed, based on treatment response.
Percentage of Participants With a Pruritus NRS of ≥5-points at Baseline Who Achieve a ≥4-point Reduction From Baseline to Week 16	26.4 percentage of participants Interval 14.5 to 38.3	46.8 percentage of participants Interval 38.0 to 55.6

SECONDARY outcome

Timeframe: Baseline, Week 16

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). LS Mean was calculated using ANCOVA model with treatment, baseline value, and stratification factors of geographic region, age group, baseline IGA score (IGA 3 versus 4) as fixed factors.

Outcome measures

Outcome measures
Measure	Placebo +Topical Corticosteroid n=66 Participants Two placebo SC injections as a loading dose at Baseline and Week 2 followed by a single injection of placebo Q2W from Week 4 until Week 14. TCS will be initiated at Baseline in all participants and may be tapered or stopped, or restarted as needed, based on treatment response.	Lebrikizumab + Topical Corticosteroid n=145 Participants 500 mg Lebrikizumab (2 x 250 mg) SC injections as a loading dose at Baseline and Week 2 followed by a single injection 250 mg Lebrikizumab Q2W from Week 4 until Week 14. TCS will be initiated at Baseline in all participants and may be tapered or stopped, or restarted as needed, based on treatment response.
Percent Change in EASI Score From Baseline at Week 16	-53.12 Percent Change Standard Error 5.097	-76.76 Percent Change Standard Error 4.119

SECONDARY outcome

Timeframe: Baseline, Week 16

Population: All randomized participants, even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol. The mixed model repeated measure (MMRM) include treatment, visit, the interaction of treatment by-visit, geographic region, age group, baseline IGA score. One investigational site with seventeen participants was excluded from analysis due to GCP issues.

The BSA affected by AD will be assessed for 4 separate body regions: head and neck, trunk (including genital region), upper extremities, and lower extremities (including the buttocks). Each body region will be assessed for disease extent ranging from 0% to 100% involvement. BSA was calculated using the participant's palm using the 1% rule, 1 palm was equivalent to 1% with estimates of the number of palms it takes to cover the affected AD area. Maximum number of palms were 10 palms for head and neck (10%), 20 palms for upper extremities (20%), 30 palms for trunk, including axilla and groin (30%), 40 palms for lower extremities, including buttocks (40%). Percent of BSA for a body region was calculated as = total number of palms in a body region \* % surface area equivalent to 1 palm. Overall percent BSA of all 4 body regions ranges from 0% to 100 % with higher values representing greater severity of AD.

Outcome measures

Outcome measures
Measure	Placebo +Topical Corticosteroid n=53 Participants Two placebo SC injections as a loading dose at Baseline and Week 2 followed by a single injection of placebo Q2W from Week 4 until Week 14. TCS will be initiated at Baseline in all participants and may be tapered or stopped, or restarted as needed, based on treatment response.	Lebrikizumab + Topical Corticosteroid n=130 Participants 500 mg Lebrikizumab (2 x 250 mg) SC injections as a loading dose at Baseline and Week 2 followed by a single injection 250 mg Lebrikizumab Q2W from Week 4 until Week 14. TCS will be initiated at Baseline in all participants and may be tapered or stopped, or restarted as needed, based on treatment response.
Change From Baseline to Week 16 in Percent Body Surface Area (BSA)	16.92 score on a scale Standard Error 2.287	-29.19 score on a scale Standard Error 1.686

SECONDARY outcome

Timeframe: Baseline to Week 4

Outcome measures

Outcome measures
Measure	Placebo +Topical Corticosteroid n=66 Participants Two placebo SC injections as a loading dose at Baseline and Week 2 followed by a single injection of placebo Q2W from Week 4 until Week 14. TCS will be initiated at Baseline in all participants and may be tapered or stopped, or restarted as needed, based on treatment response.	Lebrikizumab + Topical Corticosteroid n=145 Participants 500 mg Lebrikizumab (2 x 250 mg) SC injections as a loading dose at Baseline and Week 2 followed by a single injection 250 mg Lebrikizumab Q2W from Week 4 until Week 14. TCS will be initiated at Baseline in all participants and may be tapered or stopped, or restarted as needed, based on treatment response.
Percentage of Participants Achieving EASI-90 at Week 4	7.2 percentage of participants Interval 0.5 to 13.8	10.7 percentage of participants Interval 5.6 to 15.8

SECONDARY outcome

Timeframe: Baseline, Week 16

Sleep Loss due to interference of itch will be assessed by the participant. Participants rate their interference of itch on sleep based on a 5-point Likert scale \[0 (not at all) to 4 (unable to sleep at all)\]. Higher scores indicated a greater impact and worse outcome. Assessments will be recorded daily by the participant using an electronic diary. LS Mean was calculated using ANCOVA model with treatment, baseline value, and stratification factors of geographic region, age group, baseline IGA (3 versus 4) score as fixed factors. .

Outcome measures

Outcome measures
Measure	Placebo +Topical Corticosteroid n=62 Participants Two placebo SC injections as a loading dose at Baseline and Week 2 followed by a single injection of placebo Q2W from Week 4 until Week 14. TCS will be initiated at Baseline in all participants and may be tapered or stopped, or restarted as needed, based on treatment response.	Lebrikizumab + Topical Corticosteroid n=134 Participants 500 mg Lebrikizumab (2 x 250 mg) SC injections as a loading dose at Baseline and Week 2 followed by a single injection 250 mg Lebrikizumab Q2W from Week 4 until Week 14. TCS will be initiated at Baseline in all participants and may be tapered or stopped, or restarted as needed, based on treatment response.
Percent Change in Sleep-loss Score From Baseline to Week 16	-36.89 percent change Standard Error 12.217	-57.03 percent change Standard Error 7.939

SECONDARY outcome

Timeframe: Baseline, Week 16

Outcome measures

Outcome measures
Measure	Placebo +Topical Corticosteroid n=63 Participants Two placebo SC injections as a loading dose at Baseline and Week 2 followed by a single injection of placebo Q2W from Week 4 until Week 14. TCS will be initiated at Baseline in all participants and may be tapered or stopped, or restarted as needed, based on treatment response.	Lebrikizumab + Topical Corticosteroid n=139 Participants 500 mg Lebrikizumab (2 x 250 mg) SC injections as a loading dose at Baseline and Week 2 followed by a single injection 250 mg Lebrikizumab Q2W from Week 4 until Week 14. TCS will be initiated at Baseline in all participants and may be tapered or stopped, or restarted as needed, based on treatment response.
Change From Baseline in Sleep-loss Score at Week 16	-0.80 score on a scale Standard Error 0.132	-1.10 score on a scale Standard Error 0.102

SECONDARY outcome

Timeframe: Baseline to Week 4

Population: All randomized participants, with baseline Pruritus NRS score of at least 4, even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol. One investigational site with seventeen participants was excluded from analysis due to GCP issues.

The Pruritus NRS is an 11-point scale used by participants to assess 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	Placebo +Topical Corticosteroid n=57 Participants Two placebo SC injections as a loading dose at Baseline and Week 2 followed by a single injection of placebo Q2W from Week 4 until Week 14. TCS will be initiated at Baseline in all participants and may be tapered or stopped, or restarted as needed, based on treatment response.	Lebrikizumab + Topical Corticosteroid n=130 Participants 500 mg Lebrikizumab (2 x 250 mg) SC injections as a loading dose at Baseline and Week 2 followed by a single injection 250 mg Lebrikizumab Q2W from Week 4 until Week 14. TCS will be initiated at Baseline in all participants and may be tapered or stopped, or restarted as needed, based on treatment response.
Percentage of Participants With a Pruritus NRS of ≥4-points at Baseline Who Achieve a ≥4-point Reduction From Baseline to Week 4	9.3 percentage of participants Interval 1.6 to 17.1	23.5 percentage of participants Interval 16.2 to 30.9

SECONDARY outcome

Timeframe: Baseline to Week 2

The Pruritus NRS is an 11-point scale used by participants to assess 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	Placebo +Topical Corticosteroid n=57 Participants Two placebo SC injections as a loading dose at Baseline and Week 2 followed by a single injection of placebo Q2W from Week 4 until Week 14. TCS will be initiated at Baseline in all participants and may be tapered or stopped, or restarted as needed, based on treatment response.	Lebrikizumab + Topical Corticosteroid n=130 Participants 500 mg Lebrikizumab (2 x 250 mg) SC injections as a loading dose at Baseline and Week 2 followed by a single injection 250 mg Lebrikizumab Q2W from Week 4 until Week 14. TCS will be initiated at Baseline in all participants and may be tapered or stopped, or restarted as needed, based on treatment response.
Percentage of Participants With a Pruritus NRS of ≥4-points at Baseline Who Achieve a ≥4-point Reduction From Baseline to Week 2	7.1 percentage of participants Interval 0.4 to 13.8	8.5 percentage of participants Interval 3.7 to 13.3

SECONDARY outcome

Timeframe: Baseline to Week 1

The Pruritus NRS is an 11-point scale used by participants to assess 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	Placebo +Topical Corticosteroid n=57 Participants Two placebo SC injections as a loading dose at Baseline and Week 2 followed by a single injection of placebo Q2W from Week 4 until Week 14. TCS will be initiated at Baseline in all participants and may be tapered or stopped, or restarted as needed, based on treatment response.	Lebrikizumab + Topical Corticosteroid n=130 Participants 500 mg Lebrikizumab (2 x 250 mg) SC injections as a loading dose at Baseline and Week 2 followed by a single injection 250 mg Lebrikizumab Q2W from Week 4 until Week 14. TCS will be initiated at Baseline in all participants and may be tapered or stopped, or restarted as needed, based on treatment response.
Percentage of Participants With a Pruritus NRS of ≥4-points at Baseline Who Achieve a ≥4-point Reduction From Baseline to Week 1	1.8 percentage of participants Interval 0.0 to 5.2	3.8 percentage of participants Interval 0.5 to 7.2

SECONDARY outcome

Timeframe: Baseline to Week 4

Population: All randomized participants, with baseline Pruritus NRS score of at least 5, even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol. One investigational site with seventeen participants was excluded from analysis due to GCP issues.

The Pruritus NRS is an 11-point scale used by participants to assess 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	Placebo +Topical Corticosteroid n=53 Participants Two placebo SC injections as a loading dose at Baseline and Week 2 followed by a single injection of placebo Q2W from Week 4 until Week 14. TCS will be initiated at Baseline in all participants and may be tapered or stopped, or restarted as needed, based on treatment response.	Lebrikizumab + Topical Corticosteroid n=124 Participants 500 mg Lebrikizumab (2 x 250 mg) SC injections as a loading dose at Baseline and Week 2 followed by a single injection 250 mg Lebrikizumab Q2W from Week 4 until Week 14. TCS will be initiated at Baseline in all participants and may be tapered or stopped, or restarted as needed, based on treatment response.
Percentage of Participants With a Pruritus NRS of ≥5-points at Baseline Who Achieve a ≥4-point Reduction From Baseline to Week 4	7.5 percentage of participants Interval 0.4 to 14.7	23.4 percentage of participants Interval 15.9 to 30.8

SECONDARY outcome

Timeframe: Baseline to Week 2

The Pruritus NRS is an 11-point scale used by participants to assess 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	Placebo +Topical Corticosteroid n=53 Participants Two placebo SC injections as a loading dose at Baseline and Week 2 followed by a single injection of placebo Q2W from Week 4 until Week 14. TCS will be initiated at Baseline in all participants and may be tapered or stopped, or restarted as needed, based on treatment response.	Lebrikizumab + Topical Corticosteroid n=124 Participants 500 mg Lebrikizumab (2 x 250 mg) SC injections as a loading dose at Baseline and Week 2 followed by a single injection 250 mg Lebrikizumab Q2W from Week 4 until Week 14. TCS will be initiated at Baseline in all participants and may be tapered or stopped, or restarted as needed, based on treatment response.
Percentage of Participants With a Pruritus NRS of ≥5-points at Baseline Who Achieve a ≥4-point Reduction From Baseline to Week 2	7.5 percentage of participants Interval 0.4 to 14.7	8.9 percentage of participants Interval 3.9 to 13.9

SECONDARY outcome

Timeframe: Baseline to Week 1

The Pruritus NRS is an 11-point scale used by participants to assess 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	Placebo +Topical Corticosteroid n=53 Participants Two placebo SC injections as a loading dose at Baseline and Week 2 followed by a single injection of placebo Q2W from Week 4 until Week 14. TCS will be initiated at Baseline in all participants and may be tapered or stopped, or restarted as needed, based on treatment response.	Lebrikizumab + Topical Corticosteroid n=124 Participants 500 mg Lebrikizumab (2 x 250 mg) SC injections as a loading dose at Baseline and Week 2 followed by a single injection 250 mg Lebrikizumab Q2W from Week 4 until Week 14. TCS will be initiated at Baseline in all participants and may be tapered or stopped, or restarted as needed, based on treatment response.
Percentage of Participants With a Pruritus NRS of ≥5-points at Baseline Who Achieve a ≥4-point Reduction From Baseline to Week 1	1.9 percentage of participants Interval 0.0 to 5.5	4.0 percentage of participants Interval 0.6 to 7.5

SECONDARY outcome

Timeframe: Baseline to Week 16

Number of the total TCS/TCI free days divided by total number of days during the treatment period. The mixed model repeated measures (MMRM) includes treatment, visit, the interaction of treatment by-visit, geographic region, age group, baseline IGA score.

Outcome measures

Outcome measures
Measure	Placebo +Topical Corticosteroid n=53 Participants Two placebo SC injections as a loading dose at Baseline and Week 2 followed by a single injection of placebo Q2W from Week 4 until Week 14. TCS will be initiated at Baseline in all participants and may be tapered or stopped, or restarted as needed, based on treatment response.	Lebrikizumab + Topical Corticosteroid n=131 Participants 500 mg Lebrikizumab (2 x 250 mg) SC injections as a loading dose at Baseline and Week 2 followed by a single injection 250 mg Lebrikizumab Q2W from Week 4 until Week 14. TCS will be initiated at Baseline in all participants and may be tapered or stopped, or restarted as needed, based on treatment response.
Percentage of Topical Corticosteroid (TCS)/Topical Calcineurin Inhibitors (TCI) Free Days From Baseline to Week 16	23.88 Percentage of Days Standard Error 4.823	31.17 Percentage of Days Standard Error 3.512

SECONDARY outcome

Timeframe: Baseline to Week 16

Days from first study drug injection to the day participant stopped using all TCS/TCI (if a participant started and stopped using low or midpotency TCS/TCI multiple times, use the last stop date as the stop date for this participant).

Outcome measures

Outcome measures
Measure	Placebo +Topical Corticosteroid n=66 Participants Two placebo SC injections as a loading dose at Baseline and Week 2 followed by a single injection of placebo Q2W from Week 4 until Week 14. TCS will be initiated at Baseline in all participants and may be tapered or stopped, or restarted as needed, based on treatment response.	Lebrikizumab + Topical Corticosteroid n=145 Participants 500 mg Lebrikizumab (2 x 250 mg) SC injections as a loading dose at Baseline and Week 2 followed by a single injection 250 mg Lebrikizumab Q2W from Week 4 until Week 14. TCS will be initiated at Baseline in all participants and may be tapered or stopped, or restarted as needed, based on treatment response.
Median Time (Days) to TCS/TCI-free Use From Baseline to Week 16	NA days Interval 1.0 to 112.0 Less than 50 % of the participants reached TCS free within treatment window, median was not calculable.	121.0 days Interval 2.0 to 121.0

SECONDARY outcome

Timeframe: Baseline, Week 16

Population: All randomized participants, even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol. One investigational site with seventeen participants was excluded from analysis due to GCP issues. Missing Values were imputed using last observation carried forward (LOCF) method.

The SCORAD index uses the rule of nines to assess disease extent and evaluates 6 clinical characteristics to determine disease severity: (1) erythema, (2) edema/papulation, (3) oozing/crusts, (4) excoriation, (5) lichenification, and (6) dryness on a scale of 0 to 3 (0=absence, 1=mild, 2=moderate, 3=severe). The SCORAD index also assesses subjective symptoms of pruritus and sleep loss with VAS where 0 is no itching or no trouble sleeping and 10 is unbearable itching or a lot of trouble sleeping. These 3 aspects: extent of disease (A: 0-1-2), disease severity (B: 0-18), \& subjective symptoms (C: 0-20) combine using A/5 + 7\*B/2+ C to give a maximum possible score of 103, where 0 = no disease and 103 = severe disease. LS Mean was calculated using the ANCOVA model with treatment group, baseline value, and stratification factors of geographic region, age group, baseline IGA (3 versus 4) score as fixed factors.

Outcome measures

Outcome measures
Measure	Placebo +Topical Corticosteroid n=65 Participants Two placebo SC injections as a loading dose at Baseline and Week 2 followed by a single injection of placebo Q2W from Week 4 until Week 14. TCS will be initiated at Baseline in all participants and may be tapered or stopped, or restarted as needed, based on treatment response.	Lebrikizumab + Topical Corticosteroid n=140 Participants 500 mg Lebrikizumab (2 x 250 mg) SC injections as a loading dose at Baseline and Week 2 followed by a single injection 250 mg Lebrikizumab Q2W from Week 4 until Week 14. TCS will be initiated at Baseline in all participants and may be tapered or stopped, or restarted as needed, based on treatment response.
Percent Change in SCORing Atopic Dermatitis (SCORAD) From Baseline to Week 16	-37.35 percent change Standard Error 4.415	-55.04 percent change Standard Error 3.542

SECONDARY outcome

Timeframe: Baseline, Week 16

The DLQI is a 10-item, validated questionnaire used to assess the impact of skin disease on the quality of life of an affected person. The 10 questions cover the following topics: symptoms, embarrassment, shopping and home care, clothes, social and leisure, sport, work or study, close relationships, sex, and treatment, over the previous week. Response categories include "Not at all," "A little," "A lot," and "Very much," with corresponding scores of 0, 1, 2, and 3 respectively. Questions 3-10 also have an additional response category of "Not relevant" which is scored as "0". Questions are scored from 0 to 3, giving a possible total score range from 0 (no impact of skin disease on quality of life) to 30 (maximum impact on quality of life). A high score is indicative of a poor quality of life. LS Mean was calculated using the ANCOVA model with treatment, baseline value, and stratification factors of geographic region, age group, baseline IGA (3 versus 4) score as fixed factors.

Outcome measures

Outcome measures
Measure	Placebo +Topical Corticosteroid n=51 Participants Two placebo SC injections as a loading dose at Baseline and Week 2 followed by a single injection of placebo Q2W from Week 4 until Week 14. TCS will be initiated at Baseline in all participants and may be tapered or stopped, or restarted as needed, based on treatment response.	Lebrikizumab + Topical Corticosteroid n=109 Participants 500 mg Lebrikizumab (2 x 250 mg) SC injections as a loading dose at Baseline and Week 2 followed by a single injection 250 mg Lebrikizumab Q2W from Week 4 until Week 14. TCS will be initiated at Baseline in all participants and may be tapered or stopped, or restarted as needed, based on treatment response.
Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 16	-6.46 score on a scale Standard Error 1.855	-9.79 score on a scale Standard Error 1.815

SECONDARY outcome

Timeframe: Baseline to Week 16

Outcome measures

Outcome measures
Measure	Placebo +Topical Corticosteroid n=48 Participants Two placebo SC injections as a loading dose at Baseline and Week 2 followed by a single injection of placebo Q2W from Week 4 until Week 14. TCS will be initiated at Baseline in all participants and may be tapered or stopped, or restarted as needed, based on treatment response.	Lebrikizumab + Topical Corticosteroid n=105 Participants 500 mg Lebrikizumab (2 x 250 mg) SC injections as a loading dose at Baseline and Week 2 followed by a single injection 250 mg Lebrikizumab Q2W from Week 4 until Week 14. TCS will be initiated at Baseline in all participants and may be tapered or stopped, or restarted as needed, based on treatment response.
Percentage of Participants With a DLQI Score ≥4 Points at Baseline Who Achieve a ≥4 Points	58.7 percentage of participants Interval 44.1 to 73.2	77.4 percentage of participants Interval 69.3 to 85.5

SECONDARY outcome

Timeframe: Baseline, Week 16

Population: All randomized participants, even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol. One investigational site with seventeen participants was excluded from analysis due to GCP issues. Missing values were imputed using LOCF method.

The EQ-5D-5L is a 2-part measurement. The first part is comprised of the following 5 participant-reported dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The responses are used to derive the health state index scores using the United Kingdom (UK) algorithm, with scores ranging from -0.594 to 1, and the United States (US) algorithm, with scores ranging from -0.109 to 1, with higher score indicating better health state. LS Mean was calculated using the ANCOVA model with treatment, baseline value, and stratification factors of geographic region, age group, baseline IGA (3 versus 4) score as fixed factors.

Outcome measures

Outcome measures
Measure	Placebo +Topical Corticosteroid n=66 Participants Two placebo SC injections as a loading dose at Baseline and Week 2 followed by a single injection of placebo Q2W from Week 4 until Week 14. TCS will be initiated at Baseline in all participants and may be tapered or stopped, or restarted as needed, based on treatment response.	Lebrikizumab + Topical Corticosteroid n=143 Participants 500 mg Lebrikizumab (2 x 250 mg) SC injections as a loading dose at Baseline and Week 2 followed by a single injection 250 mg Lebrikizumab Q2W from Week 4 until Week 14. TCS will be initiated at Baseline in all participants and may be tapered or stopped, or restarted as needed, based on treatment response.
Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) at Week 16 Health State Index Health State Index UK	0.05 score on a scale Standard Error 0.025	0.15 score on a scale Standard Error 0.019
Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) at Week 16 Health State Index Health State Index US	0.03 score on a scale Standard Error 0.018	0.10 score on a scale Standard Error 0.014

SECONDARY outcome

Timeframe: Baseline, Week 16

Population: All randomized participants, even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol. One investigational site with seventeen participants was excluded from analysis due to GCP issues. Missing values were imputed using LOCF method.

The EQ-5D-5L is a 2-part measurement. The second part is assessed using a VAS that ranged from 0 to 100 millimeter (mm), where 0 is the worst health you can imagine and 100 is the best health you can imagine. LS Mean was calculated using the ANCOVA model with treatment, baseline value, and stratification factors of geographic region, age group, baseline IGA (3 versus 4) score as fixed factors.

Outcome measures

Outcome measures
Measure	Placebo +Topical Corticosteroid n=65 Participants Two placebo SC injections as a loading dose at Baseline and Week 2 followed by a single injection of placebo Q2W from Week 4 until Week 14. TCS will be initiated at Baseline in all participants and may be tapered or stopped, or restarted as needed, based on treatment response.	Lebrikizumab + Topical Corticosteroid n=143 Participants 500 mg Lebrikizumab (2 x 250 mg) SC injections as a loading dose at Baseline and Week 2 followed by a single injection 250 mg Lebrikizumab Q2W from Week 4 until Week 14. TCS will be initiated at Baseline in all participants and may be tapered or stopped, or restarted as needed, based on treatment response.
Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) at Week 16 Visual Analog Score (VAS)	6.51 millimeters (mm) Standard Error 2.364	10.13 millimeters (mm) Standard Error 1.831

SECONDARY outcome

Timeframe: Baseline, Week 16

POEM is a 7-item, validated, questionnaire used by the participant to assess disease symptoms over the last week. The participant is asked to respond to 7 questions on skin dryness, itching, flaking, cracking, sleep loss, bleeding and weeping. All 7 answers carry equal weight with a total possible score from 0 to 28 (answers scored as: No days=0; 1- 2 days = 1; 3-4 days = 2; 5-6 days = 3; everyday = 4). A high score is indicative of a poor quality of life. POEM responses will be captured using an electronic diary and transferred into the clinical database. LS Mean was calculated using MMRM model using treatment, baseline value, visit, the interaction of the baseline value-by-visit, the interaction of treatment by-visit as covariates, geographic region, age group, baseline IGA (3 versus 4) score as fixed.

Outcome measures

Outcome measures
Measure	Placebo +Topical Corticosteroid n=40 Participants Two placebo SC injections as a loading dose at Baseline and Week 2 followed by a single injection of placebo Q2W from Week 4 until Week 14. TCS will be initiated at Baseline in all participants and may be tapered or stopped, or restarted as needed, based on treatment response.	Lebrikizumab + Topical Corticosteroid n=101 Participants 500 mg Lebrikizumab (2 x 250 mg) SC injections as a loading dose at Baseline and Week 2 followed by a single injection 250 mg Lebrikizumab Q2W from Week 4 until Week 14. TCS will be initiated at Baseline in all participants and may be tapered or stopped, or restarted as needed, based on treatment response.
Change From Baseline in Patient Oriented Eczema Measure (POEM) at Week 16	-6.24 score on a scale Standard Error 1.038	-10.23 score on a scale Standard Error 0.727

SECONDARY outcome

Timeframe: Baseline, Week 16

Population: All randomized participants, even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol. One investigational site with seventeen participants was excluded from analysis due to GCP issues. Missing values were imputed with the LOCF method.

PROMIS is a set of person-centered measures that evaluates and monitors physical, mental, and social health in adults and children. The PROMIS measures will be completed by the participant in the study clinic. PROMIS anxiety has 8 questions on Emotion Distress-Anxiety. Each question has 5 response options with values from 1 to 5. Total raw scores were converted to T-scores with higher scores indicating greater severity of symptoms. LS Mean was calculated using the ANCOVA model with treatment, baseline value, and stratification factors of geographic region, age group, baseline IGA (3 versus 4) score as fixed factors.

Outcome measures

Outcome measures
Measure	Placebo +Topical Corticosteroid n=43 Participants Two placebo SC injections as a loading dose at Baseline and Week 2 followed by a single injection of placebo Q2W from Week 4 until Week 14. TCS will be initiated at Baseline in all participants and may be tapered or stopped, or restarted as needed, based on treatment response.	Lebrikizumab + Topical Corticosteroid n=101 Participants 500 mg Lebrikizumab (2 x 250 mg) SC injections as a loading dose at Baseline and Week 2 followed by a single injection 250 mg Lebrikizumab Q2W from Week 4 until Week 14. TCS will be initiated at Baseline in all participants and may be tapered or stopped, or restarted as needed, based on treatment response.
Change From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety at Week 16 - Adults	-1.08 score on a scale Standard Error 1.367	-1.88 score on a scale Standard Error 1.027

SECONDARY outcome

Timeframe: Baseline, Week 16

Population: All randomized participants, even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol. One investigational site with seventeen participants was excluded from analysis due to GCP issues. Missing values were imputed with the LOCF method.

PROMIS is a set of person-centered measures that evaluates and monitors physical, mental, and social health in adults and children. The PROMIS measures will be completed by the participant in the study clinic. PROMIS depression has 8 questions on Emotion Distress-Depression. Each question has 5 response options with values from 1 to 5. Total raw scores were converted to T-scores with higher scores indicating greater severity of symptoms. LS Mean was calculated using the ANCOVA model with treatment, baseline value, and stratification factors of geographic region, age group, baseline IGA (3 versus 4) score as fixed factors.

Outcome measures

Outcome measures
Measure	Placebo +Topical Corticosteroid n=43 Participants Two placebo SC injections as a loading dose at Baseline and Week 2 followed by a single injection of placebo Q2W from Week 4 until Week 14. TCS will be initiated at Baseline in all participants and may be tapered or stopped, or restarted as needed, based on treatment response.	Lebrikizumab + Topical Corticosteroid n=101 Participants 500 mg Lebrikizumab (2 x 250 mg) SC injections as a loading dose at Baseline and Week 2 followed by a single injection 250 mg Lebrikizumab Q2W from Week 4 until Week 14. TCS will be initiated at Baseline in all participants and may be tapered or stopped, or restarted as needed, based on treatment response.
Change From Baseline in PROMIS Depression at Week 16 - Adults	-1.21 score on a scale Standard Error 1.098	-1.38 score on a scale Standard Error 0.834

SECONDARY outcome

Timeframe: Baseline, Week 16

Population: All randomized participants, even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol. One investigational site with seventeen participants was excluded from analysis due to GCP issues. Missing values were imputed using the LOCF method.

PROMIS® is a set of person-centered measures that evaluates and monitors physical, mental, and social health in adults and children. Participants ≤17 years will complete pediatric versions for the duration of the study. PROMIS anxiety has 8 questions on Emotion Distress-Anxiety (or Pediatric Anxiety Symptom). Each question has 5 response options with values from 1 to 5. Total raw scores were converted to T-scores with higher scores indicating greater severity of symptoms. LS Mean was calculated using the ANCOVA model with treatment, baseline value, and stratification factors of geographic region, age group, baseline IGA (3 versus 4) score as fixed factors.

Outcome measures

Outcome measures
Measure	Placebo +Topical Corticosteroid n=13 Participants Two placebo SC injections as a loading dose at Baseline and Week 2 followed by a single injection of placebo Q2W from Week 4 until Week 14. TCS will be initiated at Baseline in all participants and may be tapered or stopped, or restarted as needed, based on treatment response.	Lebrikizumab + Topical Corticosteroid n=31 Participants 500 mg Lebrikizumab (2 x 250 mg) SC injections as a loading dose at Baseline and Week 2 followed by a single injection 250 mg Lebrikizumab Q2W from Week 4 until Week 14. TCS will be initiated at Baseline in all participants and may be tapered or stopped, or restarted as needed, based on treatment response.
Change From Baseline in PROMIS Anxiety at Week 16 - Pediatrics	-4.92 score on a scale Standard Error 2.333	-1.46 score on a scale Standard Error 1.732

SECONDARY outcome

Timeframe: Baseline, Week 16

Population: All randomized participants, even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol. One investigational site with seventeen participants was excluded from analysis due to GCP issues. Missing values were imputed using the LOCF method.

PROMIS® is a set of person-centered measures that evaluates and monitors physical, mental, and social health in adults and children. Participants ≤17 years will complete pediatric versions for the duration of the study. PROMIS depression has 8 questions on Emotion Distress-Depression (or Pediatric Depressive Symptom). Each question has 5 response options with values from 1 to 5. Total raw scores were converted to T-scores with higher scores indicating greater severity of symptoms. LS Mean was calculated using the ANCOVA model with treatment, baseline value, and stratification factors of geographic region, age group, baseline IGA (3 versus 4) score as fixed factors.

Outcome measures

Outcome measures
Measure	Placebo +Topical Corticosteroid n=13 Participants Two placebo SC injections as a loading dose at Baseline and Week 2 followed by a single injection of placebo Q2W from Week 4 until Week 14. TCS will be initiated at Baseline in all participants and may be tapered or stopped, or restarted as needed, based on treatment response.	Lebrikizumab + Topical Corticosteroid n=31 Participants 500 mg Lebrikizumab (2 x 250 mg) SC injections as a loading dose at Baseline and Week 2 followed by a single injection 250 mg Lebrikizumab Q2W from Week 4 until Week 14. TCS will be initiated at Baseline in all participants and may be tapered or stopped, or restarted as needed, based on treatment response.
Change From Baseline in PROMIS Depression at Week 16 - Pediatrics	-6.43 score on a scale Standard Error 2.536	-2.01 score on a scale Standard Error 1.916

SECONDARY outcome

Timeframe: Baseline, Week 16

Population: All randomized participants, even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol. One investigational site with seventeen participants was excluded from analysis due to GCP issues. Missing values were imputed with the LOCF method.

The ACQ-5 has been shown to reliably measure asthma control and distinguish participants with well-controlled asthma (score ≤0.75 points) from those with uncontrolled asthma (score ≥1.5 points). It consists of 5 questions that are scored on a 7- point Likert scale with a recall period of 1 week. The total ACQ-5 score is the mean score of all questions; a lower score represents better asthma control. LS Mean was calculated using ANCOVA with treatment, baseline value, geographic region, age group, baseline IGA (3 versus 4) score as fixed factors.

Outcome measures

Outcome measures
Measure	Placebo +Topical Corticosteroid n=14 Participants Two placebo SC injections as a loading dose at Baseline and Week 2 followed by a single injection of placebo Q2W from Week 4 until Week 14. TCS will be initiated at Baseline in all participants and may be tapered or stopped, or restarted as needed, based on treatment response.	Lebrikizumab + Topical Corticosteroid n=38 Participants 500 mg Lebrikizumab (2 x 250 mg) SC injections as a loading dose at Baseline and Week 2 followed by a single injection 250 mg Lebrikizumab Q2W from Week 4 until Week 14. TCS will be initiated at Baseline in all participants and may be tapered or stopped, or restarted as needed, based on treatment response.
Change From Baseline in Asthma Control Questionnaire (ACQ-5) Score at Week 16 in Participants Who Have Self-reported Comorbid Asthma	0.12 score on a scale Standard Error 0.116	0.13 score on a scale Standard Error 0.076

SECONDARY outcome

Timeframe: Baseline, Week 16

The CDLQI questionnaire is designed for use in children (4 to 16 years of age). It consists of 10 items that are grouped into 6 domains: symptoms \& feelings, leisure, school or holidays, personal relationships, sleep, \& treatment. The scoring of each question is: Very much =3; Quite a lot = 2; Only a little = 1; Not at all = 0. CDLQI total score is calculated by summing all 10 items responses, and has a range of 0 to 30 (higher scores are indicative of greater impairment). LS Mean was calculated using MMRM model which includes treatment, baseline value, visit, the interaction of the baseline value-by-visit as covariates, the interaction of treatment by-visit, geographic region, age group, and baseline IGA (3 versus 4) score as fixed factors.

Outcome measures

Outcome measures
Measure	Placebo +Topical Corticosteroid n=11 Participants Two placebo SC injections as a loading dose at Baseline and Week 2 followed by a single injection of placebo Q2W from Week 4 until Week 14. TCS will be initiated at Baseline in all participants and may be tapered or stopped, or restarted as needed, based on treatment response.	Lebrikizumab + Topical Corticosteroid n=24 Participants 500 mg Lebrikizumab (2 x 250 mg) SC injections as a loading dose at Baseline and Week 2 followed by a single injection 250 mg Lebrikizumab Q2W from Week 4 until Week 14. TCS will be initiated at Baseline in all participants and may be tapered or stopped, or restarted as needed, based on treatment response.
Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) at Week 16	-4.71 score on a scale Standard Error 1.170	-9.33 score on a scale Standard Error 0.887

Adverse Events

Placebo +Topical Corticosteroid

Serious events: 1 serious events

Other events: 26 other events

Deaths: 0 deaths

Lebrikizumab + Topical Corticosteroid

Serious events: 2 serious events

Other events: 66 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Placebo +Topical Corticosteroid n=75 participants at risk Two placebo SC injections as a loading dose at Baseline and Week 2 followed by a single injection of placebo Q2W from Week 4 until Week 14. Topical corticosteroid (TCS) will be initiated at Baseline in all participants and may be tapered or stopped, or restarted as needed, based on treatment response.	Lebrikizumab + Topical Corticosteroid n=153 participants at risk 500 mg Lebrikizumab (2 x 250 mg) subcutaneous (SC) injections as a loading dose at Baseline and Week 2 followed by a single injection of 250 mg Lebrikizumab every 2 weeks (Q2W) from Week 4 until Week 14. Topical corticosteroid (TCS) will be initiated at Baseline in all participants and may be tapered or stopped, or restarted as needed, based on treatment response.
Cardiac disorders Sinus node dysfunction	0.00% 0/75 • Baseline up to Week 28 All randomized participants who received at least 1 dose of study treatment.	0.65% 1/153 • Number of events 1 • Baseline up to Week 28 All randomized participants who received at least 1 dose of study treatment.
Injury, poisoning and procedural complications Fall	0.00% 0/75 • Baseline up to Week 28 All randomized participants who received at least 1 dose of study treatment.	0.65% 1/153 • Number of events 1 • Baseline up to Week 28 All randomized participants who received at least 1 dose of study treatment.
Metabolism and nutrition disorders Dehydration	1.3% 1/75 • Number of events 1 • Baseline up to Week 28 All randomized participants who received at least 1 dose of study treatment.	0.00% 0/153 • Baseline up to Week 28 All randomized participants who received at least 1 dose of study treatment.
Renal and urinary disorders Acute kidney injury	1.3% 1/75 • Number of events 1 • Baseline up to Week 28 All randomized participants who received at least 1 dose of study treatment.	0.00% 0/153 • Baseline up to Week 28 All randomized participants who received at least 1 dose of study treatment.

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