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Clinical Trial Results:
A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF LEBRIKIZUMAB IN PATIENTS WITH MODERATE-TO-SEVERE ATOPIC DERMATITIS

Summary
EudraCT number	2019-002932-10
Trial protocol	LT ES PL EE FR LV
Global end of trial date	03 May 2022

Results information
Results version number	v2
This version publication date	21 Aug 2022
First version publication date	06 Jul 2022
Other versions	v1 , v3
Version creation reason	Correction of full data set Corrections to outcome measures per CT.gov Quality Review.

Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information

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Trial information

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Sponsor protocol code

J2T-DM-KGAB, DRM06-AD04

ISRCTN number

US NCT number

NCT04146363

WHO universal trial number (UTN)

Other trial identifiers

Trial Number: 17801

Sponsor organisation name

Eli Lilly and Company

Sponsor organisation address

Lilly Corporate Center, Indianapolis, IN, United States, 46285

Public contact

Available Mon - Fri 9 AM - 5 PM EST, Eli Lilly and Company, 1 877-CTLilly,

Scientific contact

Available Mon - Fri 9 AM - 5 PM EST, Eli Lilly and Company, 1 877-285-4559,

Is trial part of an agreed paediatric investigation plan (PIP)

Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?

Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?

Analysis stage

Interim

Date of interim/final analysis

21 Jun 2021

Is this the analysis of the primary completion data?

Yes

Primary completion date

21 Jun 2021

Global end of trial reached?

Yes

Global end of trial date

03 May 2022

Was the trial ended prematurely?

Main objective of the trial

The primary objective of this study is to evaluate the safety and efficacy of lebrikizumab compared with placebo in participants with moderate-to-severe atopic dermatitis.

Protection of trial subjects

This study was conducted in accordance with International Conference on Harmonization (ICH) Good Clinical Practice, and the principles of the Declaration of Helsinki, in addition to following the laws and regulations of the country or countries in which a study is conducted.

Background therapy

Evidence for comparator

Actual start date of recruitment

24 Sep 2019

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Yes

Number of subjects enrolled per country

Country: Number of subjects enrolled

France: 7

Country: Number of subjects enrolled

Estonia: 8

Country: Number of subjects enrolled

Latvia: 11

Country: Number of subjects enrolled

Lithuania: 18

Country: Number of subjects enrolled

Poland: 81

Country: Number of subjects enrolled

Australia: 39

Country: Number of subjects enrolled

Canada: 23

Country: Number of subjects enrolled

Korea, Republic of: 34

Country: Number of subjects enrolled

United States: 190

Country: Number of subjects enrolled

Spain: 13

Worldwide total number of subjects

424

EEA total number of subjects

138

Number of subjects enrolled per age group

In utero

Preterm newborn - gestational age < 37 wk

Newborns (0-27 days)

Infants and toddlers (28 days-23 months)

Children (2-11 years)

Adolescents (12-17 years)

Adults (18-64 years)

338

From 65 to 84 years

85 years and over

Subject disposition

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Recruitment details

Reported are results for the Induction Period (Baseline to Week16), data for Maintenance Period (Week 16 to Week 52) will be posted at the time of final results reporting.

Screening details

No Text Entered

Period 1 title

Overall Study (overall period)

Is this the baseline period?

Yes

Allocation method

Randomised - controlled

Blinding used

Double blind

Roles blinded

Subject, Investigator, Carer, Assessor

Are arms mutually exclusive

Yes

Placebo

Arm description

Induction Period (Baseline-Week 16): Two subcutaneous (SC) injections of Placebo as a loading dose at Baseline and Week 2 followed by a single injection every 2 weeks (Q2W) from Week 4 until Week 14.

Arm type

Placebo

Investigational medicinal product name

Placebo

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Subcutaneous use

Dosage and administration details

Two subcutaneous (SC) injections of Placebo as a loading dose at Baseline and Week 2 followed by a single injection every 2 weeks (Q2W) from Week 4 until Week 14.

Lebrikizumab Q2W

Arm description

Induction Period (Baseline-Week 16): 500 milligram (mg) Lebrikizumab (2 x 250 mg) SC injections as a loading dose at Baseline and Week 2 visits followed by a single 250 mg Lebrikizumab injection Q2W from Week 4 until Week 14.

Arm type

Experimental

Investigational medicinal product name

Lebrikizumab

Investigational medicinal product code

LY3650150

Other name

Pharmaceutical forms

Injection

Routes of administration

Subcutaneous use

Dosage and administration details

500 milligram (mg) Lebrikizumab (2 x 250 mg) SC injections as a loading dose at Baseline and Week 2 visits followed by a single 250 mg Lebrikizumab injection Q2W from Week 4 until Week 14.

Number of subjects in period 1	Placebo	Lebrikizumab Q2W
Started	141	283
Received at Least One Dose of Study Drug	141	282
Completed	120	263
Not completed	21	20
Started systemic dexamethasone	1	-
Positive quantiferon test	-	1
Adverse event, non-fatal	1	2
Due to Epidemic/Pandemic	1	1
Withdrawal by Subject	6	4
Lost to follow-up	1	4
Lack of efficacy	6	2
Protocol deviation	5	6

Baseline characteristics

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Reporting group title

Placebo

Reporting group description

Induction Period (Baseline-Week 16): Two subcutaneous (SC) injections of Placebo as a loading dose at Baseline and Week 2 followed by a single injection every 2 weeks (Q2W) from Week 4 until Week 14.

Reporting group title

Lebrikizumab Q2W

Reporting group description

Reporting group values	Placebo	Lebrikizumab Q2W	Total
Number of subjects	141	283	424
Age categorical
Units: Subjects
In utero	0	0	0
Preterm newborn infants (gestational age < 37 wks)	0	0	0
Newborns (0-27 days)	0	0	0
Infants and toddlers (28 days-23 months)	0	0	0
Children (2-11 years)	0	0	0
Adolescents (12-17 years)	18	37	55
Adults (18-64 years)	113	225	338
From 65-84 years	10	19	29
85 years and over	0	2	2
Gender categorical
Units: Subjects
Female	73	141	214
Male	68	142	210
Race
Units: Subjects
American Indian or Alaska Native	0	7	7
Asian	31	39	70
Native Hawaiian or Other Pacific Islander	0	2	2
Black or African American	16	33	49
White	93	196	289
More than one race	1	4	5
Unknown or Not Reported	0	2	2
Region of Enrollment
Units: Subjects
Canada	7	16	23
South Korea	13	21	34
Lativa	6	5	11
United States	62	128	190
Poland	25	56	81
Australia	13	26	39
France	0	7	7
Lithuania	7	11	18
Spain	4	9	13
Estonia	4	4	8

End points

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Reporting group title

Placebo

Reporting group description

Induction Period (Baseline-Week 16): Two subcutaneous (SC) injections of Placebo as a loading dose at Baseline and Week 2 followed by a single injection every 2 weeks (Q2W) from Week 4 until Week 14.

Reporting group title

Lebrikizumab Q2W

Reporting group description

Primary: Percentage of Participants With an Investigator Global Assessment (IGA) Score of 0 or 1 and a Reduction ≥2 Points From Baseline to Week 16

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End point title

Percentage of Participants With an Investigator Global Assessment (IGA) Score of 0 or 1 and a Reduction ≥2 Points From Baseline to Week 16

End point description

The IGA measures the investigator's global assessment of the participant's overall severity of their Atopic Dermatitis (AD), based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification. Analysis Population Description (APD): 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. Markov Chain Monte Carlo Multiple Imputation (MCMC-MI) was used to handle missing data.

End point type

Primary

End point timeframe

Baseline to Week 16

End point values	Placebo	Lebrikizumab Q2W
Number of subjects analysed	141	283
Units: Percentage of Participants
number (confidence interval 95%)	12.8 (7.0 to 18.6)	43.0 (37.1 to 49.0)

IGA Baseline to Week 16

Comparison groups

Placebo v Lebrikizumab Q2W

Number of subjects included in analysis

424

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.000001

Method

Cochran-Mantel-Haenszel

Parameter type

Risk difference (RD)

Point estimate

29.6

Confidence interval

level

95%

sides

2-sided

lower limit

21.4

upper limit

37.8

Primary: Percentage of Participants Achieving Eczema Area And Severity Index (EASI-75) (≥75% Reduction in EASI Score) From Baseline to Week 16

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End point title

Percentage of Participants Achieving Eczema Area And Severity Index (EASI-75) (≥75% Reduction in EASI Score) From Baseline to Week 16

End point description

The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent, i.e., percentage of skin affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 (none) to 72 (severe). The EASI-75 responder is defined as a participant who achieves a ≥ 75% improvement from baseline in the EASI score. APD: 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. MCMC-MI was used to handle missing data.

End point type

Primary

End point timeframe

Baseline to Week 16

End point values	Placebo	Lebrikizumab Q2W
Number of subjects analysed	141	283
Units: Percentage of Participants
number (confidence interval 95%)	16.4 (9.8 to 23.0)	59.3 (53.4 to 65.2)

EASI-75

Comparison groups

Placebo v Lebrikizumab Q2W

Number of subjects included in analysis

424

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.000001

Method

Cochran-Mantel-Haenszel

Parameter type

Risk difference (RD)

Point estimate

42.3

Confidence interval

level

95%

sides

2-sided

lower limit

33.5

upper limit

Secondary: Percentage of Participants With an IGA Score of 0 or 1 and a Reduction ≥2 Points From Baseline to Week 2

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End point title

Percentage of Participants With an IGA Score of 0 or 1 and a Reduction ≥2 Points From Baseline to Week 2

End point description

he 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. APD: 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. MCMC-MI was used to handle missing data.

End point type

Secondary

End point timeframe

Baseline to Week 2

End point values	Placebo	Lebrikizumab Q2W
Number of subjects analysed	141	283
Units: Percentage of Participants
number (confidence interval 95%)	0.7 (0.0 to 2.1)	2.5 (0.7 to 4.4)

IGA Baseline to Week 2

Comparison groups

Placebo v Lebrikizumab Q2W

Number of subjects included in analysis

424

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.218644

Method

Cochran-Mantel-Haenszel

Parameter type

Risk difference (RD)

Point estimate

1.7

Confidence interval

level

95%

sides

2-sided

lower limit

-0.6

upper limit

Secondary: Percentage of Participants With an IGA Score of 0 or 1 and a Reduction ≥2 Points From Baseline to Week 4

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End point title

Percentage of Participants With an IGA Score of 0 or 1 and a Reduction ≥2 Points From Baseline to Week 4

End point description

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. APD: 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. MCMC-MI was used to handle missing data.

End point type

Secondary

End point timeframe

Baseline to Week 4

End point values	Placebo	Lebrikizumab Q2W
Number of subjects analysed	141	283
Units: Percentage of Participants
number (confidence interval 95%)	1.0 (-0.8 to 2.8)	10.2 (6.6 to 13.8)

IGA Baseline to Week 4

Comparison groups

Placebo v Lebrikizumab Q2W

Number of subjects included in analysis

424

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.000982

Method

Cochran-Mantel-Haenszel

Parameter type

Risk difference (RD)

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

upper limit

13.1

Secondary: Percentage of Participants With an IGA Score of 0 or 1 and a Reduction ≥2 Points From Baseline to Week 16 in Adults

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End point title

Percentage of Participants With an IGA Score of 0 or 1 and a Reduction ≥2 Points From Baseline to Week 16 in Adults

End point description

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. APD: All randomized, adult participants, even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol. MCMC-MI was used to handle missing data.

End point type

Secondary

End point timeframe

Baseline to Week 16

End point values	Placebo	Lebrikizumab Q2W
Number of subjects analysed	123	246
Units: Percentage of Participants
number (confidence interval 95%)	11.3 (5.4 to 17.3)	42.2 (35.8 to 48.6)

IGA - Adults Baseline to Week 16

Comparison groups

Placebo v Lebrikizumab Q2W

Number of subjects included in analysis

369

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.000001

Method

Cochran-Mantel-Haenszel

Parameter type

Risk difference (RD)

Point estimate

30.7

Confidence interval

level

95%

sides

2-sided

lower limit

upper limit

39.4

Secondary: Percentage of Participants Achieving EASI-90 (≥90% Reduction in EASI Score) From Baseline to Week 16

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End point title

Percentage of Participants Achieving EASI-90 (≥90% Reduction in EASI Score) From Baseline to Week 16

End point description

The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent i.e., percentage of skin affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 (none) to 72 (severe). The EASI-90responder is defined as a participant who achieves a ≥ 90% improvement from baseline in the EASI score. APD: 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. MCMC-MI was used to handle missing data.

End point type

Secondary

End point timeframe

Baseline to Week 16

End point values	Placebo	Lebrikizumab Q2W
Number of subjects analysed	141	283
Units: Percentage of Participants
number (confidence interval 95%)	9.1 (3.9 to 14.3)	38.2 (32.4 to 44.0)

EASI-90

Comparison groups

Placebo v Lebrikizumab Q2W

Number of subjects included in analysis

424

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.000001

Method

Cochran-Mantel-Haenszel

Parameter type

Risk difference (RD)

Point estimate

28.6

Confidence interval

level

95%

sides

2-sided

lower limit

20.9

upper limit

36.3

Secondary: Percent Change in Pruritus Numerical Rating Scale (NRS) Score From Baseline to Week 16

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End point title

Percent Change in Pruritus Numerical Rating Scale (NRS) Score From Baseline to Week 16

End point description

Pruritus NRS is an 11-point scale used by participants to rate their worst itch severity over the past 24 hours with 0 indicating “No itch” and 10 indicating “Worst itch imaginable.” Least Squares (LS) Mean was calculated using analysis of covariance (ANCOVA) model with treatment and randomization strata (region, disease severity, age) as fixed factors and baseline value as covariate. APD: All randomized participants, with a Baseline Pruritus NRS score >0, even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol. MCMC-MI was used to handle missing data.

End point type

Secondary

End point timeframe

Baseline, Week 16

End point values	Placebo	Lebrikizumab Q2W
Number of subjects analysed	136	276
Units: Percent Change
least squares mean (standard error)	-15.24 ± 3.855	-45.75 ± 3.167

Pruritus Numerical Rating Scale (NRS)

Comparison groups

Placebo v Lebrikizumab Q2W

Number of subjects included in analysis

412

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.000001

Method

ANCOVA

Parameter type

LS Mean Difference (Final Values)

Point estimate

-30.51

Confidence interval

level

95%

sides

2-sided

lower limit

-38.2

upper limit

-22.8

Variability estimate

Standard error of the mean

Dispersion value

3.948

Secondary: Percentage of Participants With a Pruritus NRS Score of ≥4-points at Baseline Who Achieve a ≥4-point Reduction in Pruritus NRS Score From Baseline to Week 16

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End point title

Percentage of Participants With a Pruritus NRS Score of ≥4-points at Baseline Who Achieve a ≥4-point Reduction in Pruritus NRS Score From Baseline to Week 16

End point description

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." APD: All randomized participants, with a Baseline Pruritus NRS score ≥4, even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol. MCMC-MI was used to handle missing data.

End point type

Secondary

End point timeframe

Baseline to Week 16

End point values	Placebo	Lebrikizumab Q2W
Number of subjects analysed	130	263
Units: Percentage of Participants
number (confidence interval 95%)	12.7 (6.9 to 18.6)	46.3 (40.2 to 52.5)

Pruritus NRS Score

Comparison groups

Placebo v Lebrikizumab Q2W

Number of subjects included in analysis

393

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.000001

Method

Cochran-Mantel-Haenszel

Parameter type

Risk difference (RD)

Point estimate

33.6

Confidence interval

level

95%

sides

2-sided

lower limit

25.2

upper limit

41.9

Secondary: Percentage of Participants With a Pruritus NRS Score of ≥5-points at Baseline Who Achieve a ≥4-point Reduction in Pruritus NRS Score From Baseline to Week 16

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End point title

Percentage of Participants With a Pruritus NRS Score of ≥5-points at Baseline Who Achieve a ≥4-point Reduction in Pruritus NRS Score From Baseline to Week 16

End point description

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." APD: All randomized participants, with Baseline Pruritus NRS score ≥ 5, even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol. MCMC-MI was used to handle missing data.

End point type

Secondary

End point timeframe

Baseline to Week 16

End point values	Placebo	Lebrikizumab Q2W
Number of subjects analysed	123	141
Units: Percentage of Participants
number (confidence interval 95%)	13.5 (7.3 to 19.6)	49.4 (43.0 to 55.8)

Pruritus NRS Score

Comparison groups

Placebo v Lebrikizumab Q2W

Number of subjects included in analysis

264

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.000001

Method

Cochran-Mantel-Haenszel

Parameter type

Risk difference (RD)

Point estimate

35.7

Confidence interval

level

95%

sides

2-sided

lower limit

upper limit

44.5

Secondary: Percent Change in EASI Score From Baseline to Week 16

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End point title

Percent Change in EASI Score From Baseline to Week 16

End point description

The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent, i.e., percentage of skin affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 to 72 (severe). LS Mean was calculated using ANCOVA model with treatment, stratification factors of geographic region, age group, baseline IGA score (IGA 3 versus 4) as fixed factors baseline value as covariate.

End point type

Secondary

End point timeframe

Baseline, Week 16 APD: 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. MCMC-MI was used to handle missing data.

End point values	Placebo	Lebrikizumab Q2W
Number of subjects analysed	141	283
Units: Percent Change
least squares mean (standard error)	-26.16 ± 4.049	-64.75 ± 3.166

Percent Change in EASI Score

Comparison groups

Placebo v Lebrikizumab Q2W

Number of subjects included in analysis

424

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.000001

Method

ANCOVA

Parameter type

LS Mean Difference (Final Values)

Point estimate

-38.58

Confidence interval

level

95%

sides

2-sided

lower limit

-46.8

upper limit

-30.4

Variability estimate

Standard error of the mean

Dispersion value

4.19

Secondary: Change From Baseline in Percent Body Surface Area (BSA) at Week 16

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End point title

Change From Baseline in Percent Body Surface Area (BSA) at Week 16

End point description

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. MMRM was used to handle all missing data.

End point type

Secondary

End point timeframe

Baseline, Week 16 APD: All randomized participants, with observed BSA data, even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol.

End point values	Placebo	Lebrikizumab Q2W
Number of subjects analysed	77	236
Units: percentage of body surface area
least squares mean (standard error)	-11.77 ± 1.856	-30.23 ± 1.310

BSA

Comparison groups

Placebo v Lebrikizumab Q2W

Number of subjects included in analysis

313

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.000001

Method

Mixed models analysis

Parameter type

LS Mean Difference (Final Values)

Point estimate

-18.45

Confidence interval

level

95%

sides

2-sided

lower limit

-22.38

upper limit

-14.53

Variability estimate

Standard error of the mean

Dispersion value

1.995

Secondary: Percentage of Participants Achieving EASI-90 From Baseline to Week 4

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End point title

Percentage of Participants Achieving EASI-90 From Baseline to Week 4

End point description

The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent, i.e., percentage of skin affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 (none) to 72 (severe). The EASI-90 responder is defined as a participant who achieves a ≥ 90% improvement from baseline in the EASI score. APD: 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. MCMC-MI was used to handle missing data.

End point type

Secondary

End point timeframe

Baseline to Week 4

End point values	Placebo	Lebrikizumab Q2W
Number of subjects analysed	141	283
Units: Percentage of Participants
number (confidence interval 95%)	1.8 (-0.7 to 4.3)	12.0 (8.2 to 15.9)

EASI-90

Comparison groups

Placebo v Lebrikizumab Q2W

Number of subjects included in analysis

424

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.000878

Method

Cochran-Mantel-Haenszel

Parameter type

Risk difference (RD)

Point estimate

10.1

Confidence interval

level

95%

sides

2-sided

lower limit

5.5

upper limit

14.8

Secondary: Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 16

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End point title

Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 16

End point description

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.

End point type

Secondary

End point timeframe

Baseline, Week 16 APD: All randomized participants, with non-missing baseline DLQI score, even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol.

End point values	Placebo	Lebrikizumab Q2W
Number of subjects analysed	121 ^[1]	239 ^[2]
Units: Score on a Scale
least squares mean (standard error)	-2.94 ± 1.103	-8.78 ± 1.056

Notes
[1] - MCMC-MI was used to handle missing data.
[2] - MCMC-MI was used to handle missing data.

DLQI

Comparison groups

Placebo v Lebrikizumab Q2W

Number of subjects included in analysis

360

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.000001

Method

ANCOVA

Parameter type

LS Mean Difference (Final Values)

Point estimate

-5.84

Confidence interval

level

95%

sides

2-sided

lower limit

-7.2

upper limit

-4.5

Variability estimate

Standard error of the mean

Dispersion value

0.678

Secondary: Percentage of Participants Achieving ≥4 Point Improvement in DLQI From Baseline to Week 16

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End point title

Percentage of Participants Achieving ≥4 Point Improvement in DLQI From Baseline to Week 16

End point description

he 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. MCMC-MI was used to handle all missing data.

End point type

Secondary

End point timeframe

Baseline to Week 16 APD: All randomized participants, with non-missing baseline DLQI score, even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol.

End point values	Placebo	Lebrikizumab Q2W
Number of subjects analysed	121 ^[3]	239 ^[4]
Units: Percentage of Participants
number (confidence interval 95%)	32.4 (23.8 to 41.1)	71.4 (65.5 to 77.2)

Notes
[3] - MCMC-MI was used to handle missing data.
[4] - MCMC-MI was used to handle missing data.

DLQI

Comparison groups

Placebo v Lebrikizumab Q2W

Number of subjects included in analysis

360

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.000001

Method

Cochran-Mantel-Haenszel

Parameter type

Risk difference (RD)

Point estimate

38.7

Confidence interval

level

95%

sides

2-sided

lower limit

upper limit

49.3

Secondary: Percentage of Participants With a DLQI Total Score of ≥4-point at Baseline Achieving ≥4-point Improvement in DLQI From Baseline to Week 16

Top of page

End point title

Percentage of Participants With a DLQI Total Score of ≥4-point at Baseline Achieving ≥4-point Improvement in DLQI From Baseline to Week 16

End point description

End point type

Secondary

End point timeframe

Baseline to Week 16 APD: All randomized participants, with a DLQI Total Score of ≥4-point at baseline, even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol.

End point values	Placebo	Lebrikizumab Q2W
Number of subjects analysed	116	226
Units: Percentage of Participants
number (confidence interval 95%)	33.8 (24.9 to 42.8)	75.5 (69.8 to 81.2)

No statistical analyses for this end point

Secondary: Percent Change in Sleep-loss Score From Baseline to Week 16

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End point title

Percent Change in Sleep-loss Score From Baseline to Week 16

End point description

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. APD: All randomized participants, with baseline sleep-loss score >0, even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol. MCMC-MI was used to handle missing data.

End point type

Secondary

End point timeframe

Baseline, Week 16

End point values	Placebo	Lebrikizumab Q2W
Number of subjects analysed	132	269
Units: Percent Change
least squares mean (standard error)	-16.34 ± 5.156	-48.61 ± 4.164

Sleep-loss Score

Comparison groups

Placebo v Lebrikizumab Q2W

Number of subjects included in analysis

401

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.000001

Method

ANCOVA

Parameter type

LS Mean Difference (Final Values)

Point estimate

-32.28

Confidence interval

level

95%

sides

2-sided

lower limit

-42.6

upper limit

-22

Variability estimate

Standard error of the mean

Dispersion value

5.242

Secondary: Change From Baseline in Sleep-loss Score at Week 16

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End point title

Change From Baseline in Sleep-loss Score at Week 16

End point description

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. APD: All randomized participants, non-missing baseline Sleep-loss score, even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol. MCMC-MI was used to handle missing data.

End point type

Secondary

End point timeframe

Baseline, Week 16

End point values	Placebo	Lebrikizumab Q2W
Number of subjects analysed	136	276
Units: Score on a Scale
least squares mean (standard error)	-0.39 ± 0.095	-1.14 ± 0.078

No statistical analyses for this end point

Secondary: Percentage of Participants With a Sleep-loss Score ≥2 Points at Baseline Who Achieve a ≥2 Points Reduction From Baseline at Week 16

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End point title

Percentage of Participants With a Sleep-loss Score ≥2 Points at Baseline Who Achieve a ≥2 Points Reduction From Baseline at Week 16

End point description

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. APD: All randomized participants, with baseline sleep-loss score ≥2 Points, even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol. MCMC-MI was used to handle missing data.

End point type

Secondary

End point timeframe

Baseline to Week 16

End point values	Placebo	Lebrikizumab Q2W
Number of subjects analysed	91	195
Units: Percentage of Participants
number (confidence interval 95%)	5.1 (0.3 to 9.9)	38.7 (31.8 to 45.7)

Sleep-loss Score

Comparison groups

Placebo v Lebrikizumab Q2W

Number of subjects included in analysis

286

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.000001

Method

Cochran-Mantel-Haenszel

Parameter type

Risk difference (RD)

Point estimate

33.9

Confidence interval

level

95%

sides

2-sided

lower limit

25.4

upper limit

42.4

Secondary: Percentage of Participants With a Pruritus NRS Score of ≥4 Points at Baseline Who Achieve a ≥4-point Reduction From Baseline to Week 1

Top of page

End point title

Percentage of Participants With a Pruritus NRS Score of ≥4 Points at Baseline Who Achieve a ≥4-point Reduction From Baseline to Week 1

End point description

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." APD: All randomized participants, with a Pruritus NRS Score of ≥4 Points at Baseline, even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol. MCMC-MI was used to handle missing data.

End point type

Secondary

End point timeframe

Baseline to Week 1

End point values	Placebo	Lebrikizumab Q2W
Number of subjects analysed	130	263
Units: Percentage of Participants
number (confidence interval 95%)	0.8 (0.0 to 2.3)	2.3 (0.5 to 4.1)

Pruritus NRS Score

Comparison groups

Placebo v Lebrikizumab Q2W

Number of subjects included in analysis

393

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.275529

Method

Cochran-Mantel-Haenszel

Parameter type

Risk difference (RD)

Point estimate

1.5

Confidence interval

level

95%

sides

2-sided

lower limit

-0.8

upper limit

3.9

Secondary: Percentage of Participants With a Pruritus NRS Score of ≥4 Points at Baseline Who Achieve a ≥4-point Reduction From Baseline to Week 2

Top of page

End point title

Percentage of Participants With a Pruritus NRS Score of ≥4 Points at Baseline Who Achieve a ≥4-point Reduction From Baseline to Week 2

End point description

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." APD: All randomized participant, with a Pruritus NRS Score of ≥4 Points at Baseline, even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol. MCMC-MI was used to handle missing data.

End point type

Secondary

End point timeframe

Baseline to Week 2

End point values	Placebo	Lebrikizumab Q2W
Number of subjects analysed	130	263
Units: Percentage of Participants
number (confidence interval 95%)	0.9 (-0.8 to 2.5)	6.1 (3.2 to 9.1)

Pruritus NRS Score

Comparison groups

Placebo v Lebrikizumab Q2W

Number of subjects included in analysis

393

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.016543

Method

Cochran-Mantel-Haenszel

Parameter type

Risk difference (RD)

Point estimate

5.3

Confidence interval

level

95%

sides

2-sided

lower limit

1.9

upper limit

8.7

Secondary: Percentage of Participants With a Pruritus NRS Score of ≥4 Points at Baseline Who Achieve a ≥4-point Reduction From Baseline to Week 4

Top of page

End point title

Percentage of Participants With a Pruritus NRS Score of ≥4 Points at Baseline Who Achieve a ≥4-point Reduction From Baseline to Week 4

End point description

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." APD: All randomized participants, with a Pruritus NRS Score of ≥4 Points at Baseline, if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol. MCMC-MI was used to handle missing data.

End point type

Secondary

End point timeframe

Baseline to Week 4

End point values	Placebo	Lebrikizumab Q2W
Number of subjects analysed	130	263
Units: Percentage of Participants
number (confidence interval 95%)	2.4 (-0.3 to 5.0)	21.6 (16.6 to 26.6)

Pruritus NRS Score

Comparison groups

Placebo v Lebrikizumab Q2W

Number of subjects included in analysis

393

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.000003

Method

Cochran-Mantel-Haenszel

Parameter type

Risk difference (RD)

Point estimate

19.3

Confidence interval

level

95%

sides

2-sided

lower limit

13.6

upper limit

Secondary: Percentage of Participants With a Pruritus NRS Score of ≥5 Points at Baseline Who Achieve a ≥4-point Reduction From Baseline to Week 1

Top of page

End point title

Percentage of Participants With a Pruritus NRS Score of ≥5 Points at Baseline Who Achieve a ≥4-point Reduction From Baseline to Week 1

End point description

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." APD: All randomized participants, with a Pruritus NRS Score of ≥5 Points at Baseline, even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol. MCMC-MI was used to handle missing data.

End point type

Secondary

End point timeframe

Baseline to Week 1

End point values	Placebo	Lebrikizumab Q2W
Number of subjects analysed	123	244
Units: Percentage of Participants
number (confidence interval 95%)	0.8 (0.0 to 2.4)	2.5 (0.5 to 4.4)

Pruritus NRS Score

Comparison groups

Placebo v Lebrikizumab Q2W

Number of subjects included in analysis

367

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.244105

Method

Cochran-Mantel-Haenszel

Parameter type

Risk difference (RD)

Point estimate

1.8

Confidence interval

level

95%

sides

2-sided

lower limit

-0.8

upper limit

4.3

Secondary: Percentage of Participants With a Pruritus NRS Score of ≥5 Points at Baseline Who Achieve a ≥4-point Reduction From Baseline to Week 2

Top of page

End point title

Percentage of Participants With a Pruritus NRS Score of ≥5 Points at Baseline Who Achieve a ≥4-point Reduction From Baseline to Week 2

End point description

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." APD: All randomized participants, with a Pruritus NRS Score of ≥5 Points at Baseline, even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol. MCMC-MI was used to handle missing data.

End point type

Secondary

End point timeframe

Baseline to Week 2

End point values	Placebo	Lebrikizumab Q2W
Number of subjects analysed	123	244
Units: Percentage of Participants
number (confidence interval 95%)	0.9 (-0.9 to 2.7)	6.6 (3.5 to 9.8)

Pruritus NRS Score

Comparison groups

Placebo v Lebrikizumab Q2W

Number of subjects included in analysis

367

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.014375

Method

Cochran-Mantel-Haenszel

Parameter type

Risk difference (RD)

Point estimate

5.8

Confidence interval

level

95%

sides

2-sided

lower limit

2.2

upper limit

9.5

Secondary: Percentage of Participants With a Pruritus NRS Score of ≥5 Points at Baseline Who Achieve a ≥4-point Reduction From Baseline to Week 4

Top of page

End point title

Percentage of Participants With a Pruritus NRS Score of ≥5 Points at Baseline Who Achieve a ≥4-point Reduction From Baseline to Week 4

End point description

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." APD: All randomized participants, with a Pruritus NRS Score of ≥5 Points at Baseline, even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol. MCMC-MI was used to handle missing data.

End point type

Secondary

End point timeframe

Baseline to Week 4

End point values	Placebo	Lebrikizumab Q2W
Number of subjects analysed	123	244
Units: Percentage of Participants
number (confidence interval 95%)	2.5 (-0.3 to 5.3)	23.2 (17.9 to 28.6)

Pruritus NRS Score

Comparison groups

Placebo v Lebrikizumab Q2W

Number of subjects included in analysis

367

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.000002

Method

Cochran-Mantel-Haenszel

Parameter type

Risk difference (RD)

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

14.9

upper limit

Secondary: Percent Change in SCORing Atopic Dermatitis (SCORAD) From Baseline to Week 16

Top of page

End point title

Percent Change in SCORing Atopic Dermatitis (SCORAD) From Baseline to Week 16

End point description

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 and stratification factors of geographic region, age group, baseline IGA (3 versus 4) score as fixed factors and baseline value as covariate. Missing Values were imputed using LOCF method.

End point type

Secondary

End point timeframe

Baseline, Week 16 APD: All randomized participants, with baseline SCORAD >0, even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol.

End point values	Placebo	Lebrikizumab Q2W
Number of subjects analysed	138	276
Units: Score on a Scale
least squares mean (standard error)	-16.79 ± 3.164	-47.26 ± 2.552

SCORing Atopic Dermatitis

Comparison groups

Placebo v Lebrikizumab Q2W

Number of subjects included in analysis

414

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.000001

Method

ANCOVA

Parameter type

Risk difference (RD)

Point estimate

-30.47

Confidence interval

level

95%

sides

2-sided

lower limit

-36.77

upper limit

-24.17

Secondary: Change From Baseline in European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) at Week 16 - Health State Index

Top of page

End point title

Change From Baseline in European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) at Week 16 - Health State Index

End point description

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 and stratification factors of geographic region, age group, baseline IGA (3 versus 4) score as fixed factors and baseline value as covariate. Missing Values were imputed using last observation carried forward (LOCF) method.

End point type

Secondary

End point timeframe

Baseline, Week 16 APD: All randomized participants, with non-missing EQ-5D-5L data at baseline, even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol.

End point values	Placebo	Lebrikizumab Q2W
Number of subjects analysed	141	282
Units: Score on a Scale
least squares mean (standard error)
Health State Index UK	0.05 ± 0.017	0.19 ± 0.014
Health State Index US	0.03 ± 0.012	0.13 ± 0.010

Health State Index UK

Comparison groups

Placebo v Lebrikizumab Q2W

Number of subjects included in analysis

423

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.000001

Method

ANCOVA

Parameter type

LS Mean Difference (Final Values)

Point estimate

0.14

Confidence interval

level

95%

sides

2-sided

lower limit

0.11

upper limit

0.18

Variability estimate

Standard error of the mean

Dispersion value

0.018

Health State Index US

Comparison groups

Placebo v Lebrikizumab Q2W

Number of subjects included in analysis

423

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.000001

Method

ANCOVA

Parameter type

LS Mean Difference (Final Values)

Point estimate

0.1

Confidence interval

level

95%

sides

2-sided

lower limit

0.08

upper limit

0.13

Variability estimate

Standard error of the mean

Dispersion value

0.013

Secondary: Change From Baseline in EQ-5D-5L at Week 16 - Visual Analog Scale (VAS)

Top of page

End point title

Change From Baseline in EQ-5D-5L at Week 16 - Visual Analog Scale (VAS)

End point description

The EQ-5D-5L is a 2-part measurement. The second part is assessed using a VAS that ranged from 0 to 100 millimeter (mm), where 0 is the worst health you can imagine and 100 is the best health you can imagine. LS Mean was calculated using the ANCOVA model with treatment and stratification factors of geographic region, age group, baseline IGA (3 versus 4) score as fixed factors and baseline value as covariate. APD: All randomized participants, with non-missing EQ-5D-5L data at baseline, even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol. Missing values were imputed using LOCF method.

End point type

Secondary

End point timeframe

Baseline, Week 16

End point values	Placebo	Lebrikizumab Q2W
Number of subjects analysed	141	282
Units: Score on a Scale
least squares mean (standard error)	2.19 ± 1.641	10.48 ± 1.329

EQ-5D-5L VAS

Comparison groups

Placebo v Lebrikizumab Q2W

Number of subjects included in analysis

423

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.000001

Method

ANCOVA

Parameter type

LS Mean Difference (Final Values)

Point estimate

8.29

Confidence interval

level

95%

sides

2-sided

lower limit

5.02

upper limit

11.56

Variability estimate

Standard error of the mean

Dispersion value

1.664

Secondary: Change From Baseline in Patient Oriented Eczema Measure (POEM) at Week 16

Top of page

End point title

Change From Baseline in Patient Oriented Eczema Measure (POEM) at Week 16

End point description

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. MMRM was used to handle all missing data

End point type

Secondary

End point timeframe

Baseline, Week 16 APD: All randomized participants, with observed POEM data, even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol.

End point values	Placebo	Lebrikizumab Q2W
Number of subjects analysed	70	203
Units: Score on a Scale
least squares mean (standard error)	-4.02 ± 0.723	-11.28 ± 0.475

POEM

Comparison groups

Placebo v Lebrikizumab Q2W

Number of subjects included in analysis

273

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.000001

Method

Mixed models analysis

Parameter type

LS Mean Difference (Final Values)

Point estimate

-7.26

Confidence interval

level

95%

sides

2-sided

lower limit

-8.85

upper limit

-5.66

Variability estimate

Standard error of the mean

Dispersion value

0.811

Secondary: Change From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety at Week 16 - Adolescents

Top of page

End point title

Change From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety at Week 16 - Adolescents

End point description

PROMIS® is a set of person-centered measures that evaluates and monitors physical, mental, and social health in adults and children. Participants ≤17 years will complete pediatric versions for the duration of the study. PROMIS anxiety has 8 questions on Emotion Distress-Anxiety (or Pediatric Anxiety Symptom). Each question has 5 response options with values from 1 to 5. Total raw scores were converted to T-Scores (mean = 50 and a standard deviation = 10) with higher scores representing greater anxiety. LS Mean was calculated using the ANCOVA model with treatment and stratification factors of geographic region, age group, baseline IGA (3 versus 4) score as fixed factors and baseline value as covariate. APD: All randomized, adolescent participants, even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol. Missing values were imputed using the LOCF method.

End point type

Secondary

End point timeframe

Baseline, Week 16

End point values	Placebo	Lebrikizumab Q2W
Number of subjects analysed	18	37
Units: Score on a Scale
least squares mean (standard error)	-2.80 ± 2.435	-3.87 ± 1.830

PROMIS Anxiety Adolescents

Comparison groups

Placebo v Lebrikizumab Q2W

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.716224

Method

ANCOVA

Parameter type

LS Mean Difference (Final Values)

Point estimate

-1.07

Confidence interval

level

95%

sides

2-sided

lower limit

-6.93

upper limit

4.8

Variability estimate

Standard error of the mean

Dispersion value

2.917

Secondary: Change From Baseline in PROMIS Depression at Week 16 - Adolescent

Top of page

End point title

Change From Baseline in PROMIS Depression at Week 16 - Adolescent

End point description

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 (mean = 50 and a standard deviation = 10) with higher scores representing greater depression. LS Mean was calculated using the ANCOVA model with treatment and stratification factors of geographic region, age group, baseline IGA (3 versus 4) score as fixed factors and baseline value as covariate. APD: All randomized, adolescent participants, even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol. Missing values were imputed using the LOCF method.

End point type

Secondary

End point timeframe

Baseline, Week 16

End point values	Placebo	Lebrikizumab Q2W
Number of subjects analysed	18	37
Units: Score on a Scale
least squares mean (standard error)	-0.11 ± 2.165	-4.62 ± 1.623

PROMIS Depression Adolescents

Comparison groups

Placebo v Lebrikizumab Q2W

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.089275

Method

ANCOVA

Parameter type

LS Mean Difference (Final Values)

Point estimate

-4.51

Confidence interval

level

95%

sides

2-sided

lower limit

-9.73

upper limit

0.72

Variability estimate

Standard error of the mean

Dispersion value

2.599

Secondary: Change From Baseline in PROMIS Anxiety at Week 16 - Adults

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End point title

Change From Baseline in PROMIS Anxiety at Week 16 - Adults

End point description

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 (or Pediatric Anxiety Symptom). Each question has 5 response options with values from 1 to 5. Total raw scores were converted to T-Scores (mean = 50 and a standard deviation = 10) with higher scores representing greater anxiety. LS Mean was calculated using the ANCOVA model with treatment and stratification factors of geographic region, age group, baseline IGA (3 versus 4) score as fixed factors and baseline value as covariate. APD: All randomized, adult participants, with Week 16 PROMIS anxiety data, even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol. Missing values are imputed with the LOCF method.

End point type

Secondary

End point timeframe

Baseline, Week 16

End point values	Placebo	Lebrikizumab Q2W
Number of subjects analysed	122	244
Units: Score on a Scale
least squares mean (standard error)	-0.62 ± 0.663	-3.99 ± 0.477

PROMIS Anxiety Adults

Comparison groups

Placebo v Lebrikizumab Q2W

Number of subjects included in analysis

366

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.000032

Method

ANCOVA

Parameter type

LS Mean Difference (Final Values)

Point estimate

-3.36

Confidence interval

level

95%

sides

2-sided

lower limit

-4.93

upper limit

-1.79

Variability estimate

Standard error of the mean

Dispersion value

0.799

Secondary: Change From Baseline in PROMIS Depression at Week 16 - Adults

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End point title

Change From Baseline in PROMIS Depression at Week 16 - Adults

End point description

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 (or Pediatric Depressive Symptom). Each question has 5 response options with values from 1 to 5. Total raw scores were converted to T-Scores (mean = 50 and a standard deviation = 10) with higher scores representing greater depression. LS Mean was calculated using the ANCOVA model with treatment and stratification factors of geographic region, age group, baseline IGA (3 versus 4) score as fixed factors and baseline value as covariate. APD: All randomized , adult participants, with Week 16 PROMIS Depression data, even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol. Missing values were imputed using the LOCF method.

End point type

Secondary

End point timeframe

Baseline, Week 16

End point values	Placebo	Lebrikizumab Q2W
Number of subjects analysed	122	244
Units: Score on a Scale
least squares mean (standard error)	-0.40 ± 0.581	-3.16 ± 0.418

PROMIS Depression Adults

Comparison groups

Placebo v Lebrikizumab Q2W

Number of subjects included in analysis

366

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.000096

Method

ANCOVA

Parameter type

LS Mean Difference (Final Values)

Point estimate

-2.76

Confidence interval

level

95%

sides

2-sided

lower limit

-4.13

upper limit

-1.38

Variability estimate

Standard error of the mean

Dispersion value

0.699

Secondary: Change From Baseline in Asthma Control Questionnaire (ACQ-5) Score at Week 16 in Participants Who Have Self-Reported Comorbid Asthma

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End point title

Change From Baseline in Asthma Control Questionnaire (ACQ-5) Score at Week 16 in Participants Who Have Self-Reported Comorbid Asthma

End point description

The ACQ-5 is a five-item, self-completed questionnaire, which is used as a measure of asthma control of a participant. The five questions (concerning nocturnal awakening, waking in the morning, activity limitation, shortness of breath and wheeze) enquire about the frequency and/or severity of symptoms over the previous week. The response options for all these questions range from zero (no impairment/limitation) to six (total impairment/ limitation) scale. The ACQ-5 score is the average of the individual item scores and ranges from 0 (totally controlled) to 6 (severely uncontrolled). Higher scores indicate lower asthma control. LS Mean was calculated using ANCOVA with treatment, geographic region, age group, baseline IGA (3 versus 4) score as fixed factors and baseline value as covariate. APD: All randomized participants, with non-missing baseline ACQ-5 score, even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not f

End point type

Secondary

End point timeframe

Baseline, Week 16

End point values	Placebo	Lebrikizumab Q2W
Number of subjects analysed	51	95
Units: Score on a Scale
least squares mean (standard error)	-0.05 ± 0.118	-0.13 ± 0.096

Asthma Control Questionnaire

Comparison groups

Placebo v Lebrikizumab Q2W

Number of subjects included in analysis

146

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.513146

Method

ANCOVA

Parameter type

LS Mean Difference (Final Values)

Point estimate

-0.08

Confidence interval

level

95%

sides

2-sided

lower limit

-0.32

upper limit

0.16

Variability estimate

Standard error of the mean

Dispersion value

0.122

Secondary: Change From Baseline in Children’s Dermatology Life Quality Index (CDLQI) at Week 16 - Adolescents

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End point title

Change From Baseline in Children’s Dermatology Life Quality Index (CDLQI) at Week 16 - Adolescents

End point description

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. MMRM was used to handle all missing data.

End point type

Secondary

End point timeframe

Baseline, Week 16 APD: All randomized, adolescent participants, with non-missing baseline CDLQI score, even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol.

End point values	Placebo	Lebrikizumab Q2W
Number of subjects analysed	9	26
Units: Score on a Scale
least squares mean (standard error)	-0.99 ± 1.293	-7.96 ± 0.802

Children’s Dermatology Life Quality Index

Comparison groups

Placebo v Lebrikizumab Q2W

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.000069

Method

Mixed models analysis

Parameter type

LS Mean Difference (Final Values)

Point estimate

-6.97

Confidence interval

level

95%

sides

2-sided

lower limit

-10.07

upper limit

-3.87

Variability estimate

Standard error of the mean

Dispersion value

1.52

Adverse events

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Timeframe for reporting adverse events

Baseline up to Week 16

Adverse event reporting additional description

All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.

Assessment type

Systematic

Dictionary name

MedDRA

Dictionary version

24.0

Reporting group title

Lebrikizumab 250mg Q2W

Reporting group description

Induction Period (Baseline-Week 16): Two subcutaneous (SC) injections of Placebo as a loading dose at Baseline and Week 2 followed by a single injection every 2 weeks (Q2W) from Week 4 until Week 14.

Reporting group title

Placebo

Reporting group description

Induction Period (Baseline-Week 16): Two subcutaneous (SC) injections of Placebo as a loading dose at Baseline and Week 2 followed by a single injection every 2 weeks (Q2W) from Week 4 until Week 14.

Serious adverse events	Lebrikizumab 250mg Q2W	Placebo
Total subjects affected by serious adverse events
subjects affected / exposed	6 / 282 (2.13%)	1 / 141 (0.71%)
number of deaths (all causes)	0	0
number of deaths resulting from adverse events	0	0
Injury, poisoning and procedural complications
accidental overdose
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	1 / 282 (0.35%)	0 / 141 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiac disorders
myocardial infarction
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	1 / 282 (0.35%)	0 / 141 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Nervous system disorders
carpal tunnel syndrome
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	1 / 282 (0.35%)	0 / 141 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
General disorders and administration site conditions
oedema peripheral
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	1 / 282 (0.35%)	0 / 141 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Musculoskeletal and connective tissue disorders
arthralgia
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	1 / 282 (0.35%)	0 / 141 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
synovitis
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	1 / 282 (0.35%)	0 / 141 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Infections and infestations
cellulitis
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	0 / 282 (0.00%)	1 / 141 (0.71%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
sepsis
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	0 / 282 (0.00%)	1 / 141 (0.71%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0

Frequency threshold for reporting non-serious adverse events: 0%

Non-serious adverse events	Lebrikizumab 250mg Q2W	Placebo
Total subjects affected by non serious adverse events
subjects affected / exposed	126 / 282 (44.68%)	72 / 141 (51.06%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
acrochordon
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	0 / 282 (0.00%)	1 / 141 (0.71%)
occurrences all number	0	2
haemangioma
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	1 / 282 (0.35%)	0 / 141 (0.00%)
occurrences all number	1	0
Vascular disorders
hypertension
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	3 / 282 (1.06%)	1 / 141 (0.71%)
occurrences all number	3	1
peripheral venous disease
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	1 / 282 (0.35%)	0 / 141 (0.00%)
occurrences all number	1	0
General disorders and administration site conditions
administration site reaction
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	1 / 282 (0.35%)	0 / 141 (0.00%)
occurrences all number	1	0
asthenia
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	1 / 282 (0.35%)	0 / 141 (0.00%)
occurrences all number	2	0
chest discomfort
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	0 / 282 (0.00%)	1 / 141 (0.71%)
occurrences all number	0	1
chills
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	0 / 282 (0.00%)	1 / 141 (0.71%)
occurrences all number	0	2
fatigue
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	2 / 282 (0.71%)	1 / 141 (0.71%)
occurrences all number	2	1
hyperthermia
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	1 / 282 (0.35%)	0 / 141 (0.00%)
occurrences all number	1	0
injection site bruising
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	0 / 282 (0.00%)	1 / 141 (0.71%)
occurrences all number	0	1
injection site erythema
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	1 / 282 (0.35%)	0 / 141 (0.00%)
occurrences all number	1	0
injection site pain
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	1 / 282 (0.35%)	2 / 141 (1.42%)
occurrences all number	2	4
injection site reaction
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	1 / 282 (0.35%)	0 / 141 (0.00%)
occurrences all number	3	0
oedema peripheral
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	3 / 282 (1.06%)	0 / 141 (0.00%)
occurrences all number	4	0
pyrexia
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	1 / 282 (0.35%)	0 / 141 (0.00%)
occurrences all number	1	0
Immune system disorders
food allergy
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	0 / 282 (0.00%)	1 / 141 (0.71%)
occurrences all number	0	1
hypersensitivity
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	1 / 282 (0.35%)	0 / 141 (0.00%)
occurrences all number	1	0
Reproductive system and breast disorders
dysmenorrhoea
alternative dictionary used: MedDRA 24.0
subjects affected / exposed ^[1]	3 / 141 (2.13%)	0 / 73 (0.00%)
occurrences all number	5	0
heavy menstrual bleeding
alternative dictionary used: MedDRA 24.0
subjects affected / exposed ^[2]	1 / 141 (0.71%)	0 / 73 (0.00%)
occurrences all number	1	0
Respiratory, thoracic and mediastinal disorders
asthma
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	3 / 282 (1.06%)	0 / 141 (0.00%)
occurrences all number	3	0
chronic obstructive pulmonary disease
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	1 / 282 (0.35%)	0 / 141 (0.00%)
occurrences all number	1	0
cough
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	1 / 282 (0.35%)	1 / 141 (0.71%)
occurrences all number	1	1
dyspnoea
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	0 / 282 (0.00%)	1 / 141 (0.71%)
occurrences all number	0	1
nasal congestion
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	1 / 282 (0.35%)	0 / 141 (0.00%)
occurrences all number	1	0
oropharyngeal pain
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	1 / 282 (0.35%)	0 / 141 (0.00%)
occurrences all number	1	0
pneumonia aspiration
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	1 / 282 (0.35%)	0 / 141 (0.00%)
occurrences all number	1	0
rhinitis allergic
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	2 / 282 (0.71%)	0 / 141 (0.00%)
occurrences all number	2	0
rhinorrhoea
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	0 / 282 (0.00%)	1 / 141 (0.71%)
occurrences all number	0	1
sleep apnoea syndrome
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	0 / 282 (0.00%)	1 / 141 (0.71%)
occurrences all number	0	1
Psychiatric disorders
anxiety
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	4 / 282 (1.42%)	0 / 141 (0.00%)
occurrences all number	6	0
attention deficit hyperactivity disorder
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	0 / 282 (0.00%)	1 / 141 (0.71%)
occurrences all number	0	1
depression
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	2 / 282 (0.71%)	1 / 141 (0.71%)
occurrences all number	2	1
insomnia
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	1 / 282 (0.35%)	1 / 141 (0.71%)
occurrences all number	1	1
persistent depressive disorder
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	0 / 282 (0.00%)	1 / 141 (0.71%)
occurrences all number	0	1
stress
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	0 / 282 (0.00%)	1 / 141 (0.71%)
occurrences all number	0	1
Investigations
blood lactate dehydrogenase increased
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	0 / 282 (0.00%)	1 / 141 (0.71%)
occurrences all number	0	1
blood pressure increased
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	0 / 282 (0.00%)	1 / 141 (0.71%)
occurrences all number	0	1
eosinophil count increased
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	0 / 282 (0.00%)	1 / 141 (0.71%)
occurrences all number	0	1
hepatic enzyme increased
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	1 / 282 (0.35%)	0 / 141 (0.00%)
occurrences all number	1	0
neutrophil count decreased
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	1 / 282 (0.35%)	0 / 141 (0.00%)
occurrences all number	1	0
neutrophil count increased
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	0 / 282 (0.00%)	1 / 141 (0.71%)
occurrences all number	0	1
platelet count increased
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	0 / 282 (0.00%)	1 / 141 (0.71%)
occurrences all number	0	1
Injury, poisoning and procedural complications
back injury
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	1 / 282 (0.35%)	0 / 141 (0.00%)
occurrences all number	1	0
contusion
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	0 / 282 (0.00%)	1 / 141 (0.71%)
occurrences all number	0	1
head injury
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	1 / 282 (0.35%)	0 / 141 (0.00%)
occurrences all number	1	0
ligament sprain
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	1 / 282 (0.35%)	0 / 141 (0.00%)
occurrences all number	1	0
meniscus injury
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	1 / 282 (0.35%)	0 / 141 (0.00%)
occurrences all number	1	0
muscle strain
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	1 / 282 (0.35%)	0 / 141 (0.00%)
occurrences all number	1	0
overdose
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	1 / 282 (0.35%)	0 / 141 (0.00%)
occurrences all number	1	0
post procedural inflammation
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	0 / 282 (0.00%)	1 / 141 (0.71%)
occurrences all number	0	1
sunburn
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	0 / 282 (0.00%)	1 / 141 (0.71%)
occurrences all number	0	1
tooth injury
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	1 / 282 (0.35%)	0 / 141 (0.00%)
occurrences all number	1	0
Cardiac disorders
angina pectoris
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	1 / 282 (0.35%)	0 / 141 (0.00%)
occurrences all number	1	0
palpitations
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	0 / 282 (0.00%)	1 / 141 (0.71%)
occurrences all number	0	1
Nervous system disorders
dizziness
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	2 / 282 (0.71%)	1 / 141 (0.71%)
occurrences all number	5	1
dysgeusia
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	0 / 282 (0.00%)	1 / 141 (0.71%)
occurrences all number	0	1
epilepsy
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	1 / 282 (0.35%)	0 / 141 (0.00%)
occurrences all number	1	0
headache
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	9 / 282 (3.19%)	2 / 141 (1.42%)
occurrences all number	10	2
hypersomnia
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	1 / 282 (0.35%)	0 / 141 (0.00%)
occurrences all number	1	0
post herpetic neuralgia
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	1 / 282 (0.35%)	0 / 141 (0.00%)
occurrences all number	1	0
radiculopathy
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	1 / 282 (0.35%)	0 / 141 (0.00%)
occurrences all number	1	0
seizure
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	0 / 282 (0.00%)	1 / 141 (0.71%)
occurrences all number	0	1
syncope
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	0 / 282 (0.00%)	1 / 141 (0.71%)
occurrences all number	0	1
Blood and lymphatic system disorders
anaemia
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	1 / 282 (0.35%)	0 / 141 (0.00%)
occurrences all number	1	0
eosinophilia
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	1 / 282 (0.35%)	2 / 141 (1.42%)
occurrences all number	1	2
erythropenia
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	1 / 282 (0.35%)	0 / 141 (0.00%)
occurrences all number	1	0
iron deficiency anaemia
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	1 / 282 (0.35%)	0 / 141 (0.00%)
occurrences all number	1	0
lymphopenia
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	1 / 282 (0.35%)	0 / 141 (0.00%)
occurrences all number	1	0
thrombocytopenia
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	2 / 282 (0.71%)	0 / 141 (0.00%)
occurrences all number	2	0
Eye disorders
blepharitis
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	3 / 282 (1.06%)	0 / 141 (0.00%)
occurrences all number	3	0
chalazion
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	2 / 282 (0.71%)	0 / 141 (0.00%)
occurrences all number	2	0
conjunctival hyperaemia
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	1 / 282 (0.35%)	0 / 141 (0.00%)
occurrences all number	1	0
conjunctivitis allergic
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	6 / 282 (2.13%)	1 / 141 (0.71%)
occurrences all number	6	1
dry eye
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	1 / 282 (0.35%)	2 / 141 (1.42%)
occurrences all number	1	2
eye irritation
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	2 / 282 (0.71%)	0 / 141 (0.00%)
occurrences all number	2	0
eyelids pruritus
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	1 / 282 (0.35%)	0 / 141 (0.00%)
occurrences all number	1	0
eye pruritus
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	1 / 282 (0.35%)	0 / 141 (0.00%)
occurrences all number	1	0
keratoconus
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	0 / 282 (0.00%)	1 / 141 (0.71%)
occurrences all number	0	1
keratitis
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	0 / 282 (0.00%)	1 / 141 (0.71%)
occurrences all number	0	1
pupils unequal
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	1 / 282 (0.35%)	0 / 141 (0.00%)
occurrences all number	1	0
vernal keratoconjunctivitis
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	1 / 282 (0.35%)	0 / 141 (0.00%)
occurrences all number	1	0
vision blurred
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	1 / 282 (0.35%)	0 / 141 (0.00%)
occurrences all number	1	0
visual impairment
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	1 / 282 (0.35%)	0 / 141 (0.00%)
occurrences all number	1	0
Gastrointestinal disorders
abdominal pain
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	1 / 282 (0.35%)	0 / 141 (0.00%)
occurrences all number	1	0
anal haemorrhage
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	0 / 282 (0.00%)	1 / 141 (0.71%)
occurrences all number	0	1
gastric polyps
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	0 / 282 (0.00%)	1 / 141 (0.71%)
occurrences all number	0	1
gastrointestinal inflammation
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	0 / 282 (0.00%)	1 / 141 (0.71%)
occurrences all number	0	1
nausea
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	0 / 282 (0.00%)	2 / 141 (1.42%)
occurrences all number	0	2
odynophagia
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	0 / 282 (0.00%)	1 / 141 (0.71%)
occurrences all number	0	1
toothache
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	1 / 282 (0.35%)	1 / 141 (0.71%)
occurrences all number	1	1
vomiting
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	1 / 282 (0.35%)	1 / 141 (0.71%)
occurrences all number	1	1
Hepatobiliary disorders
non-alcoholic steatohepatitis
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	1 / 282 (0.35%)	0 / 141 (0.00%)
occurrences all number	1	0
Skin and subcutaneous tissue disorders
dermal cyst
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	1 / 282 (0.35%)	0 / 141 (0.00%)
occurrences all number	1	0
dermatitis atopic
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	15 / 282 (5.32%)	28 / 141 (19.86%)
occurrences all number	16	31
dermatitis contact
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	0 / 282 (0.00%)	1 / 141 (0.71%)
occurrences all number	0	1
drug eruption
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	1 / 282 (0.35%)	0 / 141 (0.00%)
occurrences all number	1	0
dyshidrotic eczema
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	0 / 282 (0.00%)	1 / 141 (0.71%)
occurrences all number	0	1
eczema
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	1 / 282 (0.35%)	0 / 141 (0.00%)
occurrences all number	1	0
milia
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	0 / 282 (0.00%)	1 / 141 (0.71%)
occurrences all number	0	1
pruritus
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	3 / 282 (1.06%)	6 / 141 (4.26%)
occurrences all number	3	7
rash
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	1 / 282 (0.35%)	0 / 141 (0.00%)
occurrences all number	1	0
seborrhoea
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	1 / 282 (0.35%)	0 / 141 (0.00%)
occurrences all number	1	0
seborrhoeic dermatitis
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	2 / 282 (0.71%)	1 / 141 (0.71%)
occurrences all number	2	1
skin burning sensation
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	1 / 282 (0.35%)	0 / 141 (0.00%)
occurrences all number	1	0
solar dermatitis
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	0 / 282 (0.00%)	1 / 141 (0.71%)
occurrences all number	0	1
Renal and urinary disorders
cystitis noninfective
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	1 / 282 (0.35%)	0 / 141 (0.00%)
occurrences all number	1	0
nephrolithiasis
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	0 / 282 (0.00%)	1 / 141 (0.71%)
occurrences all number	0	1
Endocrine disorders
hyperparathyroidism secondary
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	0 / 282 (0.00%)	1 / 141 (0.71%)
occurrences all number	0	1
Musculoskeletal and connective tissue disorders
arthralgia
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	1 / 282 (0.35%)	0 / 141 (0.00%)
occurrences all number	1	0
back pain
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	2 / 282 (0.71%)	1 / 141 (0.71%)
occurrences all number	2	1
bursitis
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	1 / 282 (0.35%)	1 / 141 (0.71%)
occurrences all number	1	1
muscle twitching
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	1 / 282 (0.35%)	0 / 141 (0.00%)
occurrences all number	1	0
musculoskeletal chest pain
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	1 / 282 (0.35%)	0 / 141 (0.00%)
occurrences all number	1	0
musculoskeletal stiffness
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	1 / 282 (0.35%)	0 / 141 (0.00%)
occurrences all number	1	0
myalgia
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	0 / 282 (0.00%)	1 / 141 (0.71%)
occurrences all number	0	2
pain in extremity
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	1 / 282 (0.35%)	0 / 141 (0.00%)
occurrences all number	1	0
Infections and infestations
abscess neck
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	0 / 282 (0.00%)	1 / 141 (0.71%)
occurrences all number	0	1
bacterial vaginosis
alternative dictionary used: MedDRA 24.0
subjects affected / exposed ^[3]	1 / 141 (0.71%)	0 / 73 (0.00%)
occurrences all number	1	0
bronchitis
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	2 / 282 (0.71%)	0 / 141 (0.00%)
occurrences all number	2	0
covid-19
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	5 / 282 (1.77%)	3 / 141 (2.13%)
occurrences all number	5	3
cellulitis
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	0 / 282 (0.00%)	1 / 141 (0.71%)
occurrences all number	0	1
conjunctivitis
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	21 / 282 (7.45%)	4 / 141 (2.84%)
occurrences all number	22	4
ear infection
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	0 / 282 (0.00%)	1 / 141 (0.71%)
occurrences all number	0	1
ecthyma
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	0 / 282 (0.00%)	1 / 141 (0.71%)
occurrences all number	0	1
eczema herpeticum
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	0 / 282 (0.00%)	1 / 141 (0.71%)
occurrences all number	0	1
folliculitis
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	3 / 282 (1.06%)	1 / 141 (0.71%)
occurrences all number	3	1
furuncle
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	0 / 282 (0.00%)	2 / 141 (1.42%)
occurrences all number	0	3
gastroenteritis
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	2 / 282 (0.71%)	0 / 141 (0.00%)
occurrences all number	3	0
gastroenteritis viral
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	2 / 282 (0.71%)	0 / 141 (0.00%)
occurrences all number	2	0
helicobacter infection
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	1 / 282 (0.35%)	0 / 141 (0.00%)
occurrences all number	1	0
herpes zoster
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	1 / 282 (0.35%)	0 / 141 (0.00%)
occurrences all number	1	0
impetigo
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	4 / 282 (1.42%)	2 / 141 (1.42%)
occurrences all number	4	2
infection
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	0 / 282 (0.00%)	1 / 141 (0.71%)
occurrences all number	0	1
influenza
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	1 / 282 (0.35%)	0 / 141 (0.00%)
occurrences all number	1	0
lower respiratory tract infection
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	1 / 282 (0.35%)	0 / 141 (0.00%)
occurrences all number	1	0
nasopharyngitis
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	11 / 282 (3.90%)	3 / 141 (2.13%)
occurrences all number	11	3
oral herpes
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	9 / 282 (3.19%)	5 / 141 (3.55%)
occurrences all number	9	10
paronychia
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	1 / 282 (0.35%)	0 / 141 (0.00%)
occurrences all number	1	0
pharyngitis
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	0 / 282 (0.00%)	1 / 141 (0.71%)
occurrences all number	0	1
skin infection
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	1 / 282 (0.35%)	1 / 141 (0.71%)
occurrences all number	1	1
tinea capitis
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	1 / 282 (0.35%)	0 / 141 (0.00%)
occurrences all number	1	0
tonsillitis
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	1 / 282 (0.35%)	2 / 141 (1.42%)
occurrences all number	1	2
tooth abscess
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	0 / 282 (0.00%)	1 / 141 (0.71%)
occurrences all number	0	1
upper respiratory tract infection
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	1 / 282 (0.35%)	3 / 141 (2.13%)
occurrences all number	1	4
urinary tract infection
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	1 / 282 (0.35%)	1 / 141 (0.71%)
occurrences all number	1	1
vaginal infection
alternative dictionary used: MedDRA 24.0
subjects affected / exposed ^[4]	0 / 141 (0.00%)	1 / 73 (1.37%)
occurrences all number	0	1
viral upper respiratory tract infection
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	0 / 282 (0.00%)	1 / 141 (0.71%)
occurrences all number	0	1
vulvovaginal candidiasis
alternative dictionary used: MedDRA 24.0
subjects affected / exposed ^[5]	2 / 141 (1.42%)	0 / 73 (0.00%)
occurrences all number	2	0
Metabolism and nutrition disorders
decreased appetite
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	0 / 282 (0.00%)	1 / 141 (0.71%)
occurrences all number	0	1
dehydration
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	1 / 282 (0.35%)	0 / 141 (0.00%)
occurrences all number	1	0
hyperlipidaemia
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	1 / 282 (0.35%)	0 / 141 (0.00%)
occurrences all number	1	0
vitamin d deficiency
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	0 / 282 (0.00%)	1 / 141 (0.71%)
occurrences all number	0	1

Notes
[1] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
Justification: Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
[2] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
Justification: Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
[3] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
Justification: Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
[4] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
Justification: Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
[5] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
Justification: Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.

More information

Top of page

Were there any global substantial amendments to the protocol? Yes

16 Oct 2019

• Clarification of primary, co-primary and secondary endpoints to be analyzed for the FDA and EMEA • Updated inclusion criterion 10 for contraceptive use after last dose of study drug (increased from 17 to 18 weeks) • Added inclusion criterion 11 to require male patients to use an effective method of contraception if sexually active with a female of child-bearing potential. • Other minor clarifications and editorial changes.

20 May 2020

• Added hormone testing to adolescent patients • Removed requirement for TB screening serology at screening visit. • Added PK sample at Week 4 • Clarifications on analysis timing, study procedures and protocol wording.

Were there any global interruptions to the trial? Yes

Date	Interruption	Restart date
24 Mar 2020	Global enrollment hold on new patient screening and enrollment.	28 May 2020

Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.

None reported

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Clinical trials

Clinical Trial Results: A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF LEBRIKIZUMAB IN PATIENTS WITH MODERATE-TO-SEVERE ATOPIC DERMATITIS

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Percentage of Participants With an Investigator Global Assessment (IGA) Score of 0 or 1 and a Reduction ≥2 Points From Baseline to Week 16

Primary: Percentage of Participants With an Investigator Global Assessment (IGA) Score of 0 or 1 and a Reduction ≥2 Points From Baseline to Week 16

Primary: Percentage of Participants Achieving Eczema Area And Severity Index (EASI-75) (≥75% Reduction in EASI Score) From Baseline to Week 16

Primary: Percentage of Participants Achieving Eczema Area And Severity Index (EASI-75) (≥75% Reduction in EASI Score) From Baseline to Week 16

Secondary: Percentage of Participants With an IGA Score of 0 or 1 and a Reduction ≥2 Points From Baseline to Week 2

Secondary: Percentage of Participants With an IGA Score of 0 or 1 and a Reduction ≥2 Points From Baseline to Week 2

Secondary: Percentage of Participants With an IGA Score of 0 or 1 and a Reduction ≥2 Points From Baseline to Week 4

Secondary: Percentage of Participants With an IGA Score of 0 or 1 and a Reduction ≥2 Points From Baseline to Week 4

Secondary: Percentage of Participants With an IGA Score of 0 or 1 and a Reduction ≥2 Points From Baseline to Week 16 in Adults

Secondary: Percentage of Participants With an IGA Score of 0 or 1 and a Reduction ≥2 Points From Baseline to Week 16 in Adults

Secondary: Percentage of Participants Achieving EASI-90 (≥90% Reduction in EASI Score) From Baseline to Week 16

Secondary: Percentage of Participants Achieving EASI-90 (≥90% Reduction in EASI Score) From Baseline to Week 16

Secondary: Percent Change in Pruritus Numerical Rating Scale (NRS) Score From Baseline to Week 16

Secondary: Percent Change in Pruritus Numerical Rating Scale (NRS) Score From Baseline to Week 16

Secondary: Percentage of Participants With a Pruritus NRS Score of ≥4-points at Baseline Who Achieve a ≥4-point Reduction in Pruritus NRS Score From Baseline to Week 16

Secondary: Percentage of Participants With a Pruritus NRS Score of ≥4-points at Baseline Who Achieve a ≥4-point Reduction in Pruritus NRS Score From Baseline to Week 16

Secondary: Percentage of Participants With a Pruritus NRS Score of ≥5-points at Baseline Who Achieve a ≥4-point Reduction in Pruritus NRS Score From Baseline to Week 16

Secondary: Percentage of Participants With a Pruritus NRS Score of ≥5-points at Baseline Who Achieve a ≥4-point Reduction in Pruritus NRS Score From Baseline to Week 16

Secondary: Percent Change in EASI Score From Baseline to Week 16

Secondary: Percent Change in EASI Score From Baseline to Week 16

Secondary: Change From Baseline in Percent Body Surface Area (BSA) at Week 16

Secondary: Change From Baseline in Percent Body Surface Area (BSA) at Week 16

Secondary: Percentage of Participants Achieving EASI-90 From Baseline to Week 4

Secondary: Percentage of Participants Achieving EASI-90 From Baseline to Week 4

Secondary: Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 16

Secondary: Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 16

Secondary: Percentage of Participants Achieving ≥4 Point Improvement in DLQI From Baseline to Week 16

Secondary: Percentage of Participants Achieving ≥4 Point Improvement in DLQI From Baseline to Week 16

Secondary: Percentage of Participants With a DLQI Total Score of ≥4-point at Baseline Achieving ≥4-point Improvement in DLQI From Baseline to Week 16

Secondary: Percentage of Participants With a DLQI Total Score of ≥4-point at Baseline Achieving ≥4-point Improvement in DLQI From Baseline to Week 16

Secondary: Percent Change in Sleep-loss Score From Baseline to Week 16

Secondary: Percent Change in Sleep-loss Score From Baseline to Week 16

Secondary: Change From Baseline in Sleep-loss Score at Week 16

Secondary: Change From Baseline in Sleep-loss Score at Week 16

Secondary: Percentage of Participants With a Sleep-loss Score ≥2 Points at Baseline Who Achieve a ≥2 Points Reduction From Baseline at Week 16

Secondary: Percentage of Participants With a Sleep-loss Score ≥2 Points at Baseline Who Achieve a ≥2 Points Reduction From Baseline at Week 16

Secondary: Percentage of Participants With a Pruritus NRS Score of ≥4 Points at Baseline Who Achieve a ≥4-point Reduction From Baseline to Week 1

Secondary: Percentage of Participants With a Pruritus NRS Score of ≥4 Points at Baseline Who Achieve a ≥4-point Reduction From Baseline to Week 1

Secondary: Percentage of Participants With a Pruritus NRS Score of ≥4 Points at Baseline Who Achieve a ≥4-point Reduction From Baseline to Week 2

Secondary: Percentage of Participants With a Pruritus NRS Score of ≥4 Points at Baseline Who Achieve a ≥4-point Reduction From Baseline to Week 2

Secondary: Percentage of Participants With a Pruritus NRS Score of ≥4 Points at Baseline Who Achieve a ≥4-point Reduction From Baseline to Week 4

Secondary: Percentage of Participants With a Pruritus NRS Score of ≥4 Points at Baseline Who Achieve a ≥4-point Reduction From Baseline to Week 4

Secondary: Percentage of Participants With a Pruritus NRS Score of ≥5 Points at Baseline Who Achieve a ≥4-point Reduction From Baseline to Week 1

Secondary: Percentage of Participants With a Pruritus NRS Score of ≥5 Points at Baseline Who Achieve a ≥4-point Reduction From Baseline to Week 1

Secondary: Percentage of Participants With a Pruritus NRS Score of ≥5 Points at Baseline Who Achieve a ≥4-point Reduction From Baseline to Week 2

Secondary: Percentage of Participants With a Pruritus NRS Score of ≥5 Points at Baseline Who Achieve a ≥4-point Reduction From Baseline to Week 2

Secondary: Percentage of Participants With a Pruritus NRS Score of ≥5 Points at Baseline Who Achieve a ≥4-point Reduction From Baseline to Week 4

Secondary: Percentage of Participants With a Pruritus NRS Score of ≥5 Points at Baseline Who Achieve a ≥4-point Reduction From Baseline to Week 4

Secondary: Percent Change in SCORing Atopic Dermatitis (SCORAD) From Baseline to Week 16

Secondary: Percent Change in SCORing Atopic Dermatitis (SCORAD) From Baseline to Week 16

Secondary: Change From Baseline in European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) at Week 16 - Health State Index

Secondary: Change From Baseline in European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) at Week 16 - Health State Index

Secondary: Change From Baseline in EQ-5D-5L at Week 16 - Visual Analog Scale (VAS)

Secondary: Change From Baseline in EQ-5D-5L at Week 16 - Visual Analog Scale (VAS)

Secondary: Change From Baseline in Patient Oriented Eczema Measure (POEM) at Week 16

Secondary: Change From Baseline in Patient Oriented Eczema Measure (POEM) at Week 16

Secondary: Change From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety at Week 16 - Adolescents

Secondary: Change From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety at Week 16 - Adolescents

Secondary: Change From Baseline in PROMIS Depression at Week 16 - Adolescent

Secondary: Change From Baseline in PROMIS Depression at Week 16 - Adolescent

Secondary: Change From Baseline in PROMIS Anxiety at Week 16 - Adults

Secondary: Change From Baseline in PROMIS Anxiety at Week 16 - Adults

Secondary: Change From Baseline in PROMIS Depression at Week 16 - Adults

Secondary: Change From Baseline in PROMIS Depression at Week 16 - Adults

Secondary: Change From Baseline in Asthma Control Questionnaire (ACQ-5) Score at Week 16 in Participants Who Have Self-Reported Comorbid Asthma

Secondary: Change From Baseline in Asthma Control Questionnaire (ACQ-5) Score at Week 16 in Participants Who Have Self-Reported Comorbid Asthma

Secondary: Change From Baseline in Children’s Dermatology Life Quality Index (CDLQI) at Week 16 - Adolescents

Secondary: Change From Baseline in Children’s Dermatology Life Quality Index (CDLQI) at Week 16 - Adolescents

Adverse events

Adverse events

Clinical Trial Results:
A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF LEBRIKIZUMAB IN PATIENTS WITH MODERATE-TO-SEVERE ATOPIC DERMATITIS