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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	2019-002933-12
Trial protocol	DE BG IT
Global end of trial date

Results information
Results version number	v1
This version publication date	27 Jul 2022
First version publication date	27 Jul 2022
Other versions	v2

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-KGAC

ISRCTN number

US NCT number

NCT04178967

WHO universal trial number (UTN)

Other trial identifiers

Trial Number: 17802

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)

Yes

EMA paediatric investigation plan number(s)

EMEA-002536-PIP01-18

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

12 Jul 2021

Is this the analysis of the primary completion data?

Global end of trial reached?

Main objective of the trial

This is a randomized, double-blind, placebo-controlled, parallel-group study which is 52 weeks in duration. The study is designed to confirm the safety and efficacy of lebrikizumab as monotherapy for treatment of moderate-to-severe atopic dermatitis utilizing a 16-week induction treatment period and a 36-week long-term maintenance treatment period.

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

29 Oct 2019

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Yes

Number of subjects enrolled per country

Country: Number of subjects enrolled

Canada: 58

Country: Number of subjects enrolled

Singapore: 19

Country: Number of subjects enrolled

United States: 185

Country: Number of subjects enrolled

Taiwan: 60

Country: Number of subjects enrolled

Ukraine: 11

Country: Number of subjects enrolled

Mexico: 9

Country: Number of subjects enrolled

Bulgaria: 22

Country: Number of subjects enrolled

Germany: 81

Worldwide total number of subjects

445

EEA total number of subjects

103

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)

362

From 65 to 84 years

85 years and over

Subject disposition

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Recruitment details

No Text Available

Screening details

Reported are results for the Induction Period (Baseline to Week16), results for Maintenance Period (Week 16 to Week 52) will be posted after study completion. One investigational site with eighteen participants was excluded from analysis due to Good Clinical Practice (GCP) issues.

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. Maintenance Period (Week 16-Week 52): Two placebo SC injections as loading dose on Week 16 and Week 18. One placebo SC injection Q2W until Week 50.

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

Participants received subcutaneous Injection of Placebo.

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. Maintenance Period (Week 16-Week 52): One 250 mg Lebrikizumab SC injection and one placebo SC injection as maintenance loading dose on Week 16 and Week 18. One 250 mg Lebrikizumab SC injection Q2W until Week 50.

Arm type

Experimental

Investigational medicinal product name

Lebrikizumab

Investigational medicinal product code

Other name

LY3650150, DRM06

Pharmaceutical forms

Injection

Routes of administration

Subcutaneous use

Dosage and administration details

Participants received 250 mg of Lebrikizumab administered as subcutaneous injection.

Number of subjects in period 1	Placebo	Lebrikizumab Q2W
Started	150	295
Received at Least One Dose of Study Drug	149	295
Completed	133	273
Not completed	17	22
Consent withdrawn by subject	8	7
Adverse event, non-fatal	4	6
Due to Epidemic/Pandemic	-	1
Lost to follow-up	2	-
Lack of efficacy	3	1
Protocol deviation	-	7

Baseline characteristics

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Reporting group title

Placebo

Reporting group description

Reporting group title

Lebrikizumab Q2W

Reporting group description

Reporting group values	Placebo	Lebrikizumab Q2W	Total
Number of subjects	150	295	445
Age categorical
Units: Subjects
<=18 years	17	33	50
Between 18 and 65 years	123	239	362
>=65 years	10	23	33
Age continuous
Units: years
arithmetic mean (standard deviation)	35.6 ( 17.15 )	36.5 ( 16.64 )	-
Gender categorical
Units: Subjects
Female	79	147	226
Male	71	148	219
Race (NIH/OMB)
Units: Subjects
American Indian or Alaska Native	2	3	5
Asian	44	78	122
Native Hawaiian or Other Pacific Islander	1	2	3
Black or African American	10	26	36
White	89	181	270
More than one race	3	4	7
Unknown or Not Reported	1	1	2
Region of Enrollment
Units: Subjects
Canada	16	42	58
Singapore	8	11	19
United States	64	121	185
Taiwan	21	39	60
Ukraine	3	8	11
Mexico	3	6	9
Bulgaria	7	15	22
Germany	28	53	81

End points

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Reporting group title

Placebo

Reporting group description

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 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. One investigational site with eighteen participants was excluded from analysis due to Good Clinical Practice (GCP) issues. Markov Chain Monte Carlo Multiple Imputation (MCMC-MI) was used to handle missing data.

End point type

Primary

End point timeframe

Baseline to Week 16

End point values	Placebo	Lebrikizumab Q2W
Number of subjects analysed	146	281
Units: percentage of participants
number (confidence interval 95%)	10.9 (5.7 to 16.1)	33.1 (27.4 to 38.8)

IGA Score of 0 or 1

Comparison groups

Placebo v Lebrikizumab Q2W

Number of subjects included in analysis

427

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.000004

Method

Cochran-Mantel-Haenszel

Parameter type

Risk difference (RD)

Point estimate

21.7

Confidence interval

level

95%

sides

2-sided

lower limit

14.1

upper limit

29.4

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 and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 to 72 (severe). 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. One investigational site with eighteen participants was excluded from analysis due to GCP issues. 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	146	281
Units: percentage of participants
number (confidence interval 95%)	18.2 (11.8 to 24.6)	50.8 (44.9 to 56.8)

EASI-75 (≥75% Reduction in EASI Score)

Comparison groups

Placebo v Lebrikizumab Q2W

Number of subjects included in analysis

427

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.000001

Method

Cochran-Mantel-Haenszel

Parameter type

Risk difference (RD)

Point estimate

32.1

Confidence interval

level

95%

sides

2-sided

lower limit

23.2

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

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. One investigational site with eighteen participants was excluded from analysis due to GCP issues. 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	146	281
Units: percentage of participants
number (confidence interval 95%)	0 (0.0 to 0.0)	0.7 (-0.3 to 1.8)

IGA score of 0 or 1

Comparison groups

Placebo v Lebrikizumab Q2W

Number of subjects included in analysis

427

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.305686

Method

Cochran-Mantel-Haenszel

Parameter type

Risk difference (RD)

Point estimate

0.7

Confidence interval

level

95%

sides

2-sided

lower limit

-0.3

upper limit

1.8

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. One investigational site with eighteen participants was excluded from analysis due to GCP issues. 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	146	281
Units: percentage of participants
number (confidence interval 95%)	1.4 (-0.5 to 3.3)	9.0 (5.6 to 12.5)

IGA score of 0 or 1

Comparison groups

Placebo v Lebrikizumab Q2W

Number of subjects included in analysis

427

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.001635

Method

Cochran-Mantel-Haenszel

Parameter type

Risk difference (RD)

Point estimate

8.1

Confidence interval

level

95%

sides

2-sided

lower limit

4.1

upper limit

12.2

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. One investigational site with eighteen participants was excluded from analysis due to GCP issues. 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	129	251
Units: percentage of participants
number (confidence interval 95%)	11.6 (5.9 to 17.2)	31.8 (25.9 to 37.8)

IGA score of 0 or 1

Comparison groups

Placebo v Lebrikizumab Q2W

Number of subjects included in analysis

380

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.000032

Method

Cochran-Mantel-Haenszel

Parameter type

Risk difference (RD)

Point estimate

20.3

Confidence interval

level

95%

sides

2-sided

lower limit

12.2

upper limit

28.5

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

End point type

Secondary

End point timeframe

Baseline to Week 16

End point values	Placebo	Lebrikizumab Q2W
Number of subjects analysed	146	281
Units: percentage of participants
number (confidence interval 95%)	9.4 (4.5 to 14.2)	30.2 (24.7 to 35.7)

EASI-90 (≥90% reduction in EASI score)

Comparison groups

Placebo v Lebrikizumab Q2W

Number of subjects included in analysis

427

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.000009

Method

Cochran-Mantel-Haenszel

Parameter type

Risk difference (RD)

Point estimate

20.3

Confidence interval

level

95%

sides

2-sided

lower limit

12.9

upper limit

27.8

Secondary: Percentage change in Pruritus Numerical Rating Scale (NRS) score from Baseline to Week 16

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End point title

Percentage 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. One investigational site with eighteen participants was excluded from analysis due to GCP issues. 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	146	281
Units: percentage change
least squares mean (standard error)	-8.91 ( 3.908 )	-35.67 ( 3.357 )

Pruritis NRS score

Comparison groups

Placebo v Lebrikizumab Q2W

Number of subjects included in analysis

427

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.000001

Method

ANCOVA

Parameter type

LS Mean Difference (Final Values)

Point estimate

-26.76

Confidence interval

level

95%

sides

2-sided

lower limit

-34.3

upper limit

-19.3

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. One investigational site with eighteen participants was excluded from analysis due to GCP issues. 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	134	253
Units: percentage of participants
number (confidence interval 95%)	11.3 (5.9 to 16.8)	38.3 (32.2 to 44.4)

Pruritus NRS score of ≥4-points

Comparison groups

Placebo v Lebrikizumab Q2W

Number of subjects included in analysis

387

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.000001

Method

Cochran-Mantel-Haenszel

Parameter type

Risk difference (RD)

Point estimate

26.9

Confidence interval

level

95%

sides

2-sided

lower limit

18.7

upper limit

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. One investigational site with eighteen participants was excluded from analysis due to GCP issues. 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	122	234
Units: percentage of participants
number (confidence interval 95%)	11.6 (5.9 to 17.4)	40.0 (33.6 to 46.4)

Pruritus NRS score

Comparison groups

Placebo v Lebrikizumab Q2W

Number of subjects included in analysis

356

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.000001

Method

Cochran-Mantel-Haenszel

Parameter type

Risk difference (RD)

Point estimate

28.1

Confidence interval

level

95%

sides

2-sided

lower limit

19.6

upper limit

36.7

Secondary: Percentage change in EASI score from Baseline to Week 16

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End point title

Percentage change in EASI score from Baseline to Week 16

End point description

End point type

Secondary

End point timeframe

Baseline, Week 16

End point values	Placebo	Lebrikizumab Q2W
Number of subjects analysed	146	281
Units: percent change
least squares mean (standard error)	-28.22 ( 3.873 )	-60.61 ( 3.268 )

EASI score

Comparison groups

Placebo v Lebrikizumab Q2W

Number of subjects included in analysis

427

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.000001

Method

ANCOVA

Parameter type

LS Mean Difference (Final Values)

Point estimate

-32.39

Confidence interval

level

95%

sides

2-sided

lower limit

-39.9

upper limit

-24.9

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. 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. 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. One investigational site with eighteen participants was excluded from analysis due to GCP issue

End point type

Secondary

End point timeframe

Baseline, Week 16

End point values	Placebo	Lebrikizumab Q2W
Number of subjects analysed	77	209
Units: percentage of BSA
least squares mean (standard error)	-13.76 ( 1.926 )	-29.65 ( 1.330 )

Percent BSA

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

Mixed models analysis

Parameter type

LS Mean Difference (Final Values)

Point estimate

-15.88

Confidence interval

level

95%

sides

2-sided

lower limit

-20.04

upper limit

-11.73

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

End point type

Secondary

End point timeframe

Baseline to Week 4

End point values	Placebo	Lebrikizumab Q2W
Number of subjects analysed	146	281
Units: percentage of participants
number (confidence interval 95%)	1.4 (-0.5 to 3.4)	6.4 (3.4 to 9.3)

EASI-90

Comparison groups

Placebo v Lebrikizumab Q2W

Number of subjects included in analysis

427

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.020407

Method

Cochran-Mantel-Haenszel

Parameter type

Risk difference (RD)

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

1.5

upper limit

8.5

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. A high score is indicative of a poor quality of life. 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. One investigational site with eighteen participants was excluded from analysis due to GCP issues. 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	118	218
Units: score on a scale
least squares mean (standard error)	-2.47 ( 1.164 )	-6.99 ( 1.152 )

Dermatology Life Quality Index (DLQI)

Comparison groups

Placebo v Lebrikizumab Q2W

Number of subjects included in analysis

336

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.000001

Method

ANCOVA

Parameter type

LS Mean Difference (Final Values)

Point estimate

-4.52

Confidence interval

level

95%

sides

2-sided

lower limit

-5.9

upper limit

-3.1

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

End point type

Secondary

End point timeframe

Baseline to Week 16

End point values	Placebo	Lebrikizumab Q2W
Number of subjects analysed	118	218
Units: percentage of participants
number (confidence interval 95%)	33.7 (24.9 to 42.6)	63.5 (57.0 to 70.0)

DLQI

Comparison groups

Placebo v Lebrikizumab Q2W

Number of subjects included in analysis

336

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.000001

Method

Cochran-Mantel-Haenszel

Parameter type

Risk difference (RD)

Point estimate

29.9

Confidence interval

level

95%

sides

2-sided

lower limit

19.1

upper limit

40.8

Secondary: Percentage of participants with a DLQI total score of ≥4-point achieving ≥4-point improvement in DLQI from baseline to Week 16

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End point title

Percentage of participants with a DLQI total score of ≥4-point achieving ≥4-point improvement in DLQI from baseline to 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. A high score is indicative of a poor quality of life. 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. One investigational site with eighteen participants was excluded from analysis due to GCP issues. 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	115	215
Units: percentage of participants
number (confidence interval 95%)	34.6 (25.6 to 43.6)	64.4 (57.8 to 70.9)

DLQI

Comparison groups

Placebo v Lebrikizumab Q2W

Number of subjects included in analysis

330

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.000001

Method

Cochran-Mantel-Haenszel

Parameter type

Risk difference (RD)

Point estimate

29.9

Confidence interval

level

95%

sides

2-sided

lower limit

18.9

upper limit

40.9

Secondary: Percentage change in Sleep-loss score from Baseline to Week 16

Top of page

End point title

Percentage 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. One investigational site with eighteen participants was excluded from analysis due to GCP issues. 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	146	281
Units: percent change
least squares mean (standard error)	-11.40 ( 5.420 )	-47.24 ( 4.610 )

Sleep-loss score

Comparison groups

Placebo v Lebrikizumab Q2W

Number of subjects included in analysis

427

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.000001

Method

ANCOVA

Parameter type

LS Mean Difference (Final Values)

Point estimate

-35.84

Confidence interval

level

95%

sides

2-sided

lower limit

-46.2

upper limit

-25.5

Secondary: Change from Baseline in Sleep-loss score at Week 16

Top of page

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, with non-missing baseline Sleep-loss score, even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol. One investigational site with eighteen participants was excluded from analysis due to GCP issues. MCMC-MI was used to handle missing data.

End point type

Secondary

End point timeframe

Baseline, Week 16

End point values	Placebo	Lebrikizumab Q2W
Number of subjects analysed	146	281
Units: score on a scale
least squares mean (standard error)	-0.35 ( 0.097 )	-1.02 ( 0.080 )

Sleep-loss score

Comparison groups

Placebo v Lebrikizumab Q2W

Number of subjects included in analysis

427

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.000001

Method

ANCOVA

Parameter type

LS Mean Difference (Final Values)

Point estimate

-0.67

Confidence interval

level

95%

sides

2-sided

lower limit

-0.9

upper limit

-0.5

Secondary: Percentage of participants with a Sleep-loss score ≥2 points at Baseline who achieve a ≥2 points reduction from Baseline to Week 16

Top of page

End point title

Percentage of participants with a Sleep-loss score ≥2 points at Baseline who achieve a ≥2 points reduction 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. 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. One investigational site with eighteen participants was excluded from analysis due to GCP issues. 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	97	161
Units: percentage of participants
number (confidence interval 95%)	7.8 (2.2 to 13.4)	26.5 (19.6 to 33.4)

Sleep-loss score

Comparison groups

Placebo v Lebrikizumab Q2W

Number of subjects included in analysis

258

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.000842

Method

Cochran-Mantel-Haenszel

Parameter type

Risk difference (RD)

Point estimate

17.9

Confidence interval

level

95%

sides

2-sided

lower limit

8.8

upper limit

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. One investigational site with eighteen participants was excluded from analysis due to GCP issues. 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	134	253
Units: percentage of participants
number (confidence interval 95%)	0.0 (0.0 to 0.0)	0.4 (0.0 to 1.2)

Pruritus NRS score

Comparison groups

Placebo v Lebrikizumab Q2W

Number of subjects included in analysis

387

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.469221

Method

Cochran-Mantel-Haenszel

Parameter type

Risk difference (RD)

Point estimate

0.4

Confidence interval

level

95%

sides

2-sided

lower limit

-0.4

upper limit

1.2

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

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 participants, with a Pruritus NRS Score of ≥4 Points at Baseline, even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol. One investigational site with eighteen participants was excluded from analysis due to GCP issues. MCMC-MI was used to handle missing data.

End point type

Secondary

End point timeframe

Baseline to Week 2

End point values	Placebo	Lebrikizumab Q2W
Number of subjects analysed	134	253
Units: percentage of participants
number (confidence interval 95%)	0.7 (0.0 to 2.2)	3.6 (1.3 to 5.8)

Pruritus NRS score

Comparison groups

Placebo v Lebrikizumab Q2W

Number of subjects included in analysis

387

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.118893

Method

Cochran-Mantel-Haenszel

Parameter type

Risk difference (RD)

Point estimate

2.6

Confidence interval

level

95%

sides

2-sided

lower limit

-0.1

upper limit

5.3

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, even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol. One investigational site with eighteen participants was excluded from analysis due to GCP issues. MCMC-MI was used to handle missing data.

End point type

Secondary

End point timeframe

Baseline to Week 4

End point values	Placebo	Lebrikizumab Q2W
Number of subjects analysed	134	253
Units: percentage of participants
number (confidence interval 95%)	3.0 (0.1 to 5.9)	16.8 (12.2 to 21.4)

Pruritus NRS score

Comparison groups

Placebo v Lebrikizumab Q2W

Number of subjects included in analysis

387

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.000216

Method

Cochran-Mantel-Haenszel

Parameter type

Risk difference (RD)

Point estimate

13.2

Confidence interval

level

95%

sides

2-sided

lower limit

7.7

upper limit

18.7

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. One investigational site with eighteen participants was excluded from analysis due to GCP issues. 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	122	234
Units: percentage of participants
number (confidence interval 95%)	0.0 (0.0 to 0.0)	0.4 (0.0 to 1.3)

Pruritus NRS score

Comparison groups

Placebo v Lebrikizumab Q2W

Number of subjects included in analysis

356

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.46816

Method

Cochran-Mantel-Haenszel

Parameter type

Risk difference (RD)

Point estimate

0.4

Confidence interval

level

95%

sides

2-sided

lower limit

-0.4

upper limit

1.3

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. One investigational site with eighteen participants was excluded from analysis due to GCP issues. 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	122	234
Units: percentage of participants
number (confidence interval 95%)	0.8 (0.0 to 2.4)	3.8 (1.4 to 6.3)

Pruritus NRS score

Comparison groups

Placebo v Lebrikizumab Q2W

Number of subjects included in analysis

356

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.121327

Method

Cochran-Mantel-Haenszel

Parameter type

Risk difference (RD)

Point estimate

2.9

Confidence interval

level

95%

sides

2-sided

lower limit

-0.1

upper limit

5.8

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. One investigational site with eighteen participants was excluded from analysis due to GCP issues. 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	122	234
Units: percentage of participants
number (confidence interval 95%)	3.3 (0.1 to 6.5)	18.1 (13.2 to 23.1)

Pruritus NRS score

Comparison groups

Placebo v Lebrikizumab Q2W

Number of subjects included in analysis

356

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.000238

Method

Cochran-Mantel-Haenszel

Parameter type

Risk difference (RD)

Point estimate

14.2

Confidence interval

level

95%

sides

2-sided

lower limit

8.3

upper limit

20.2

Secondary: Percentage Change in SCORing Atopic Dermatitis (SCORAD) from Baseline to Week 16

Top of page

End point title

Percentage 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 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 to give a maximum possible score of 103, where 0 = no disease and 103 = severe disease. 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. One investigational site with eighteen participants was excluded from analysis due to GCP issue.

End point type

Secondary

End point timeframe

Baseline, Week 16

End point values	Placebo	Lebrikizumab Q2W
Number of subjects analysed	146	281
Units: percent change
least squares mean (standard error)	-13.87 ( 3.201 )	-43.85 ( 2.680 )

SCORing Atopic Dermatitis (SCORAD)

Comparison groups

Placebo v Lebrikizumab Q2W

Number of subjects included in analysis

427

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.000001

Method

ANCOVA

Parameter type

LS Mean Difference (Final Values)

Point estimate

-29.98

Confidence interval

level

95%

sides

2-sided

lower limit

-36.16

upper limit

-23.8

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. 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. One investigational site with eighteen participants was excluded from analysis due to GCP issues. Missing Values were imputed using last observation carried forward (LOCF) method.

End point type

Secondary

End point timeframe

Baseline, Week 16

End point values	Placebo	Lebrikizumab Q2W
Number of subjects analysed	146	281
Units: score on a scale
least squares mean (standard error)
Health State Index UK	0.04 ( 0.018 )	0.12 ( 0.015 )
Health State Index US	0.03 ( 0.013 )	0.08 ( 0.011 )

EQ-5D-5L

Statistical analysis description

Comparison groups

Placebo v Lebrikizumab Q2W

Number of subjects included in analysis

427

Analysis specification

Pre-specified

Analysis type

superiority ^[1]

P-value

= 0.000011

Method

ANCOVA

Parameter type

LS Mean Difference (Final Values)

Point estimate

0.08

Confidence interval

level

95%

sides

2-sided

lower limit

0.04

upper limit

0.11

Notes
[1] - UK

EQ-5D-5L

Statistical analysis description

Comparison groups

Placebo v Lebrikizumab Q2W

Number of subjects included in analysis

427

Analysis specification

Pre-specified

Analysis type

superiority ^[2]

P-value

= 0.000012

Method

ANCOVA

Parameter type

LS Mean Difference (Final Values)

Point estimate

0.06

Confidence interval

level

95%

sides

2-sided

lower limit

0.03

upper limit

0.08

Notes
[2] - US

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

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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.

End point type

Secondary

End point timeframe

Baseline, Week 16

End point values	Placebo	Lebrikizumab Q2W
Number of subjects analysed	145	277
Units: millimetre(s)
least squares mean (standard error)	5.23 ( 1.578 )	8.97 ( 1.325 )

VAS

Comparison groups

Placebo v Lebrikizumab Q2W

Number of subjects included in analysis

422

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.016649

Method

ANCOVA

Parameter type

LS Mean Difference (Final Values)

Point estimate

3.73

Confidence interval

level

95%

sides

2-sided

lower limit

0.68

upper limit

6.79

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

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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. 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. One investigational site with eighteen participants was excluded from analysis due to GCP issues. MMRM was used to handle all missing data.

End point type

Secondary

End point timeframe

Baseline, Week 16

End point values	Placebo	Lebrikizumab Q2W
Number of subjects analysed	65	184
Units: score on a scale
least squares mean (standard error)	-3.45 ( 0.773 )	-9.55 ( 0.525 )

POEM

Comparison groups

Placebo v Lebrikizumab Q2W

Number of subjects included in analysis

249

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.000001

Method

Mixed models analysis

Parameter type

LS Mean Difference (Final Values)

Point estimate

-6.1

Confidence interval

level

95%

sides

2-sided

lower limit

-7.81

upper limit

-4.39

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

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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 with higher scores indicating greater severity of symptoms. 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. One investigational site with eighteen participants was excluded from analysis due to GCP issues.

End point type

Secondary

End point timeframe

Baseline, Week 16

End point values	Placebo	Lebrikizumab Q2W
Number of subjects analysed	17	30
Units: score on a scale
least squares mean (standard error)	0.12 ( 2.129 )	-2.79 ( 1.550 )

PROMIS

Comparison groups

Placebo v Lebrikizumab Q2W

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.241275

Method

ANCOVA

Parameter type

LS Mean Difference (Final Values)

Point estimate

-2.91

Confidence interval

level

95%

sides

2-sided

lower limit

-7.85

upper limit

2.03

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. Each question has 5 response options with values from 1 to 5. Total raw scores were converted to T-scores with higher scores indicating greater severity of symptoms. LS Mean was calculated using the ANCOVA model with treatment 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, adults participants, with Week 16 PROMIS anxiety data, even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol. One investigational site with eighteen participants was excluded from analysis due to GCP issues.

End point type

Secondary

End point timeframe

Baseline, Week 16

End point values	Placebo	Lebrikizumab Q2W
Number of subjects analysed	129	251
Units: score on a scale
least squares mean (standard error)	-0.43 ( 0.572 )	-3.00 ( 0.416 )

PROMIS

Comparison groups

Placebo v Lebrikizumab Q2W

Number of subjects included in analysis

380

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.241275

Method

ANCOVA

Parameter type

[LS Mean Difference (Final Values)

Point estimate

-2.91

Confidence interval

level

95%

sides

2-sided

lower limit

-7.85

upper limit

2.03

Secondary: Change from Baseline in PROMIS Depression at Week 16- Adolescents

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End point title

Change from Baseline in PROMIS Depression 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. The PROMIS measures will be completed by the participant in the study clinic. PROMIS depression has 8 questions on Emotion Distress-Depression. Each question has 5 response options with values from 1 to 5. Total raw scores were converted to T-scores with higher scores indicating greater severity of symptoms. LS Mean was calculated using the ANCOVA model with treatment 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. One investigational site with eighteen participants was excluded from analysis due to GCP issues. 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	17	30
Units: score on a scale
least squares mean (standard error)	-0.57 ( 2.047 )	-1.67 ( 1.493 )

PROMIS

Comparison groups

Placebo v Lebrikizumab Q2W

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.645132

Method

ANCOVA

Parameter type

LS Mean Difference (Final Values)

Point estimate

-1.1

Confidence interval

level

95%

sides

2-sided

lower limit

-5.86

upper limit

3.67

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. Each question has 5 response options with values from 1 to 5. Total raw scores were converted to T-scores with higher scores indicating greater severity of symptoms. LS Mean was calculated using the ANCOVA model with treatment 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. One investigational site with eighteen participants was excluded from analysis due to GCP issues.

End point type

Secondary

End point timeframe

Baseline, Week 16

End point values	Placebo	Lebrikizumab Q2W
Number of subjects analysed	129	251
Units: score on a scale
least squares mean (standard error)	0.19 ( 0.533 )	-2.38 ( 0.387 )

PROMIS

Comparison groups

Lebrikizumab Q2W v Placebo

Number of subjects included in analysis

380

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.000081

Method

ANCOVA

Parameter type

LS Mean Difference (Final Values)

Point estimate

-2.57

Confidence interval

level

95%

sides

2-sided

lower limit

-3.84

upper limit

-1.3

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 has been shown to reliably measure asthma control and distinguish participants with well-controlled asthma (score ≤0.75 points) from those with uncontrolled asthma (score ≥1.5 points). It consists of 5 questions that are scored on a 7- point Likert scale with a recall period of 1 week. The total ACQ-5 score is the mean score of all questions; a lower score represents better asthma control. LS Mean was calculated using ANCOVA with treatment, 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 follow the protocol. One investigational site with eighteen participants was excluded from analysis due to GCP issues. 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	35	75
Units: score on a scale
least squares mean (standard error)	0.19 ( 0.138 )	0.20 ( 0.106 )

ACQ-5

Comparison groups

Placebo v Lebrikizumab Q2W

Number of subjects included in analysis

110

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.919129

Method

ANCOVA

Parameter type

LS Mean Difference (Final Values)

Point estimate

0.01

Confidence interval

level

95%

sides

2-sided

lower limit

-0.25

upper limit

0.28

Secondary: Change from Baseline in Children's Dermatology Life Quality Index (CDLQI) at Week 16

Top of page

End point title

Change from Baseline in Children's Dermatology Life Quality Index (CDLQI) at Week 16

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). 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. One investigational site with eighteen participants was excluded from analysis due to GCP issues. MMRM was used to handle all missing data.

End point type

Secondary

End point timeframe

Baseline, Week 16

End point values	Placebo	Lebrikizumab Q2W
Number of subjects analysed	4	17
Units: score on a scale
least squares mean (standard error)	-4.13 ( 2.276 )	-7.49 ( 1.120 )

CDLQI

Comparison groups

Placebo v Lebrikizumab Q2W

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.196507

Method

Mixed models analysis

Parameter type

LS Mean Difference (Final Values)

Point estimate

-3.37

Confidence interval

level

95%

sides

2-sided

lower limit

-8.59

upper limit

1.86

Adverse events

Top of page

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

Reporting group title

Placebo

Reporting group description

Serious adverse events	Lebrikizumab 250mg Q2W	Placebo
Total subjects affected by serious adverse events
subjects affected / exposed	2 / 295 (0.68%)	4 / 149 (2.68%)
number of deaths (all causes)	0	1
number of deaths resulting from adverse events	0	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
uterine leiomyoma
alternative dictionary used: MedDRA 24.0
subjects affected / exposed ^[1]	0 / 147 (0.00%)	1 / 78 (1.28%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Injury, poisoning and procedural complications
fibula fracture
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	0 / 295 (0.00%)	1 / 149 (0.67%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
multiple injuries
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	1 / 295 (0.34%)	0 / 149 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
tibia fracture
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	0 / 295 (0.00%)	1 / 149 (0.67%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiac disorders
cardiac failure
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	1 / 295 (0.34%)	0 / 149 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
myocardial infarction
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	0 / 295 (0.00%)	1 / 149 (0.67%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Nervous system disorders
cerebellar syndrome
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	1 / 295 (0.34%)	0 / 149 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Skin and subcutaneous tissue disorders
dermatitis atopic
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	1 / 295 (0.34%)	1 / 149 (0.67%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Infections and infestations
large intestine infection
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	1 / 295 (0.34%)	0 / 149 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0

Notes
[1] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. 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.

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	155 / 295 (52.54%)	97 / 149 (65.10%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
bowen's disease
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	0 / 295 (0.00%)	1 / 149 (0.67%)
occurrences all number	0	1
fibroadenoma of breast
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	0 / 295 (0.00%)	1 / 149 (0.67%)
occurrences all number	0	1
skin papilloma
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	3 / 295 (1.02%)	0 / 149 (0.00%)
occurrences all number	3	0
squamous cell carcinoma
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	1 / 295 (0.34%)	1 / 149 (0.67%)
occurrences all number	1	1
Vascular disorders
haematoma
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	0 / 295 (0.00%)	1 / 149 (0.67%)
occurrences all number	0	1
hot flush
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	1 / 295 (0.34%)	0 / 149 (0.00%)
occurrences all number	1	0
hypertension
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	2 / 295 (0.68%)	2 / 149 (1.34%)
occurrences all number	2	2
General disorders and administration site conditions
chills
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	1 / 295 (0.34%)	0 / 149 (0.00%)
occurrences all number	1	0
cyst rupture
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	1 / 295 (0.34%)	0 / 149 (0.00%)
occurrences all number	1	0
fatigue
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	3 / 295 (1.02%)	1 / 149 (0.67%)
occurrences all number	3	1
injection site discomfort
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	1 / 295 (0.34%)	0 / 149 (0.00%)
occurrences all number	1	0
injection site erythema
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	2 / 295 (0.68%)	0 / 149 (0.00%)
occurrences all number	3	0
injection site pain
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	3 / 295 (1.02%)	1 / 149 (0.67%)
occurrences all number	4	1
injection site reaction
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	2 / 295 (0.68%)	0 / 149 (0.00%)
occurrences all number	2	0
injection site swelling
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	0 / 295 (0.00%)	1 / 149 (0.67%)
occurrences all number	0	1
malaise
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	0 / 295 (0.00%)	1 / 149 (0.67%)
occurrences all number	0	1
oedema
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	0 / 295 (0.00%)	1 / 149 (0.67%)
occurrences all number	0	1
oedema peripheral
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	0 / 295 (0.00%)	1 / 149 (0.67%)
occurrences all number	0	2
peripheral swelling
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	0 / 295 (0.00%)	1 / 149 (0.67%)
occurrences all number	0	2
swelling
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	0 / 295 (0.00%)	1 / 149 (0.67%)
occurrences all number	0	1
Immune system disorders
allergy to animal
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	1 / 295 (0.34%)	0 / 149 (0.00%)
occurrences all number	1	0
drug hypersensitivity
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	1 / 295 (0.34%)	0 / 149 (0.00%)
occurrences all number	1	0
seasonal allergy
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	3 / 295 (1.02%)	1 / 149 (0.67%)
occurrences all number	4	1
Reproductive system and breast disorders
breast ulceration
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	0 / 295 (0.00%)	1 / 149 (0.67%)
occurrences all number	0	1
heavy menstrual bleeding
alternative dictionary used: MedDRA 24.0
subjects affected / exposed ^[2]	0 / 147 (0.00%)	1 / 78 (1.28%)
occurrences all number	0	1
vulvovaginal dryness
alternative dictionary used: MedDRA 24.0
subjects affected / exposed ^[3]	1 / 147 (0.68%)	0 / 78 (0.00%)
occurrences all number	1	0
Respiratory, thoracic and mediastinal disorders
asthma
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	1 / 295 (0.34%)	0 / 149 (0.00%)
occurrences all number	1	0
cough
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	2 / 295 (0.68%)	0 / 149 (0.00%)
occurrences all number	2	0
dyspnoea
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	0 / 295 (0.00%)	1 / 149 (0.67%)
occurrences all number	0	1
nasal congestion
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	1 / 295 (0.34%)	1 / 149 (0.67%)
occurrences all number	1	1
oropharyngeal pain
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	2 / 295 (0.68%)	1 / 149 (0.67%)
occurrences all number	2	1
rhinitis allergic
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	3 / 295 (1.02%)	1 / 149 (0.67%)
occurrences all number	3	1
sinus congestion
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	1 / 295 (0.34%)	0 / 149 (0.00%)
occurrences all number	1	0
Psychiatric disorders
anxiety
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	0 / 295 (0.00%)	2 / 149 (1.34%)
occurrences all number	0	2
depression
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	0 / 295 (0.00%)	1 / 149 (0.67%)
occurrences all number	0	1
insomnia
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	1 / 295 (0.34%)	1 / 149 (0.67%)
occurrences all number	1	2
middle insomnia
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	1 / 295 (0.34%)	0 / 149 (0.00%)
occurrences all number	1	0
panic attack
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	1 / 295 (0.34%)	0 / 149 (0.00%)
occurrences all number	1	0
sleep disorder
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	0 / 295 (0.00%)	1 / 149 (0.67%)
occurrences all number	0	1
Investigations
blood alkaline phosphatase increased
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	1 / 295 (0.34%)	0 / 149 (0.00%)
occurrences all number	1	0
blood pressure increased
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	1 / 295 (0.34%)	1 / 149 (0.67%)
occurrences all number	1	1
eosinophil count increased
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	2 / 295 (0.68%)	0 / 149 (0.00%)
occurrences all number	2	0
gamma-glutamyltransferase increased
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	1 / 295 (0.34%)	0 / 149 (0.00%)
occurrences all number	1	0
neutrophil count decreased
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	0 / 295 (0.00%)	1 / 149 (0.67%)
occurrences all number	0	1
neutrophil count increased
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	0 / 295 (0.00%)	1 / 149 (0.67%)
occurrences all number	0	1
nitrite urine present
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	1 / 295 (0.34%)	0 / 149 (0.00%)
occurrences all number	1	0
platelet count increased
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	1 / 295 (0.34%)	2 / 149 (1.34%)
occurrences all number	1	2
white blood cell count increased
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	1 / 295 (0.34%)	0 / 149 (0.00%)
occurrences all number	1	0
Injury, poisoning and procedural complications
accident at work
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	1 / 295 (0.34%)	0 / 149 (0.00%)
occurrences all number	1	0
animal bite
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	1 / 295 (0.34%)	0 / 149 (0.00%)
occurrences all number	1	0
clavicle fracture
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	1 / 295 (0.34%)	0 / 149 (0.00%)
occurrences all number	1	0
concussion
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	1 / 295 (0.34%)	1 / 149 (0.67%)
occurrences all number	1	1
contusion
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	0 / 295 (0.00%)	1 / 149 (0.67%)
occurrences all number	0	1
epicondylitis
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	0 / 295 (0.00%)	1 / 149 (0.67%)
occurrences all number	0	1
fall
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	1 / 295 (0.34%)	0 / 149 (0.00%)
occurrences all number	1	0
fibula fracture
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	0 / 295 (0.00%)	1 / 149 (0.67%)
occurrences all number	0	1
hand fracture
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	2 / 295 (0.68%)	0 / 149 (0.00%)
occurrences all number	2	0
injection related reaction
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	0 / 295 (0.00%)	1 / 149 (0.67%)
occurrences all number	0	2
injury corneal
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	1 / 295 (0.34%)	0 / 149 (0.00%)
occurrences all number	1	0
joint dislocation
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	0 / 295 (0.00%)	1 / 149 (0.67%)
occurrences all number	0	1
ligament sprain
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	0 / 295 (0.00%)	1 / 149 (0.67%)
occurrences all number	0	1
limb injury
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	0 / 295 (0.00%)	1 / 149 (0.67%)
occurrences all number	0	1
muscle strain
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	1 / 295 (0.34%)	1 / 149 (0.67%)
occurrences all number	1	1
overdose
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	3 / 295 (1.02%)	1 / 149 (0.67%)
occurrences all number	4	1
post procedural complication
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	0 / 295 (0.00%)	1 / 149 (0.67%)
occurrences all number	0	1
procedural headache
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	0 / 295 (0.00%)	1 / 149 (0.67%)
occurrences all number	0	1
procedural pain
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	0 / 295 (0.00%)	2 / 149 (1.34%)
occurrences all number	0	2
skin abrasion
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	1 / 295 (0.34%)	0 / 149 (0.00%)
occurrences all number	1	0
skin laceration
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	1 / 295 (0.34%)	1 / 149 (0.67%)
occurrences all number	1	1
thermal burn
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	1 / 295 (0.34%)	0 / 149 (0.00%)
occurrences all number	1	0
tibia fracture
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	0 / 295 (0.00%)	1 / 149 (0.67%)
occurrences all number	0	1
vaccination complication
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	2 / 295 (0.68%)	0 / 149 (0.00%)
occurrences all number	3	0
wound dehiscence
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	1 / 295 (0.34%)	0 / 149 (0.00%)
occurrences all number	1	0
wrist fracture
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	1 / 295 (0.34%)	0 / 149 (0.00%)
occurrences all number	1	0
Cardiac disorders
tachycardia
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	1 / 295 (0.34%)	0 / 149 (0.00%)
occurrences all number	1	0
Nervous system disorders
burning sensation
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	0 / 295 (0.00%)	1 / 149 (0.67%)
occurrences all number	0	1
cerebellar syndrome
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	1 / 295 (0.34%)	0 / 149 (0.00%)
occurrences all number	2	0
dizziness
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	4 / 295 (1.36%)	0 / 149 (0.00%)
occurrences all number	4	0
headache
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	15 / 295 (5.08%)	8 / 149 (5.37%)
occurrences all number	17	8
hypoaesthesia
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	1 / 295 (0.34%)	2 / 149 (1.34%)
occurrences all number	1	2
neuralgia
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	1 / 295 (0.34%)	0 / 149 (0.00%)
occurrences all number	1	0
paraesthesia
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	1 / 295 (0.34%)	1 / 149 (0.67%)
occurrences all number	1	1
Blood and lymphatic system disorders
eosinophilia
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	1 / 295 (0.34%)	0 / 149 (0.00%)
occurrences all number	1	0
iron deficiency anaemia
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	1 / 295 (0.34%)	0 / 149 (0.00%)
occurrences all number	1	0
lymphadenitis
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	1 / 295 (0.34%)	0 / 149 (0.00%)
occurrences all number	1	0
lymphadenopathy
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	1 / 295 (0.34%)	0 / 149 (0.00%)
occurrences all number	1	0
lymphocytosis
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	0 / 295 (0.00%)	1 / 149 (0.67%)
occurrences all number	0	1
lymphopenia
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	0 / 295 (0.00%)	1 / 149 (0.67%)
occurrences all number	0	1
Ear and labyrinth disorders
ear discomfort
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	1 / 295 (0.34%)	0 / 149 (0.00%)
occurrences all number	1	0
paraesthesia ear
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	1 / 295 (0.34%)	0 / 149 (0.00%)
occurrences all number	1	0
tinnitus
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	1 / 295 (0.34%)	0 / 149 (0.00%)
occurrences all number	1	0
vertigo
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	1 / 295 (0.34%)	0 / 149 (0.00%)
occurrences all number	1	0
Eye disorders
atopic keratoconjunctivitis
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	2 / 295 (0.68%)	0 / 149 (0.00%)
occurrences all number	3	0
blepharitis
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	2 / 295 (0.68%)	1 / 149 (0.67%)
occurrences all number	3	1
cataract
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	1 / 295 (0.34%)	2 / 149 (1.34%)
occurrences all number	1	2
conjunctivitis allergic
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	6 / 295 (2.03%)	2 / 149 (1.34%)
occurrences all number	6	2
dark circles under eyes
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	0 / 295 (0.00%)	1 / 149 (0.67%)
occurrences all number	0	1
dermatochalasis
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	0 / 295 (0.00%)	1 / 149 (0.67%)
occurrences all number	0	1
dry eye
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	7 / 295 (2.37%)	0 / 149 (0.00%)
occurrences all number	8	0
episcleritis
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	1 / 295 (0.34%)	0 / 149 (0.00%)
occurrences all number	1	0
eye discharge
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	2 / 295 (0.68%)	0 / 149 (0.00%)
occurrences all number	2	0
eye pruritus
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	1 / 295 (0.34%)	0 / 149 (0.00%)
occurrences all number	1	0
eyelid erosion
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	0 / 295 (0.00%)	2 / 149 (1.34%)
occurrences all number	0	2
keratitis
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	1 / 295 (0.34%)	0 / 149 (0.00%)
occurrences all number	2	0
lacrimation increased
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	0 / 295 (0.00%)	1 / 149 (0.67%)
occurrences all number	0	1
ocular hyperaemia
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	1 / 295 (0.34%)	0 / 149 (0.00%)
occurrences all number	1	0
vision blurred
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	1 / 295 (0.34%)	0 / 149 (0.00%)
occurrences all number	1	0
vitreous floaters
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	0 / 295 (0.00%)	1 / 149 (0.67%)
occurrences all number	0	1
Gastrointestinal disorders
abdominal pain
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	1 / 295 (0.34%)	0 / 149 (0.00%)
occurrences all number	1	0
breath odour
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	1 / 295 (0.34%)	0 / 149 (0.00%)
occurrences all number	1	0
constipation
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	0 / 295 (0.00%)	1 / 149 (0.67%)
occurrences all number	0	1
diarrhoea
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	2 / 295 (0.68%)	1 / 149 (0.67%)
occurrences all number	2	1
dyspepsia
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	1 / 295 (0.34%)	1 / 149 (0.67%)
occurrences all number	1	1
flatulence
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	1 / 295 (0.34%)	0 / 149 (0.00%)
occurrences all number	1	0
gastrointestinal inflammation
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	0 / 295 (0.00%)	1 / 149 (0.67%)
occurrences all number	0	1
haematemesis
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	1 / 295 (0.34%)	0 / 149 (0.00%)
occurrences all number	1	0
haemorrhoids
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	1 / 295 (0.34%)	1 / 149 (0.67%)
occurrences all number	1	1
hiatus hernia
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	1 / 295 (0.34%)	0 / 149 (0.00%)
occurrences all number	1	0
inguinal hernia
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	1 / 295 (0.34%)	1 / 149 (0.67%)
occurrences all number	1	1
nausea
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	4 / 295 (1.36%)	1 / 149 (0.67%)
occurrences all number	4	1
toothache
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	0 / 295 (0.00%)	1 / 149 (0.67%)
occurrences all number	0	1
vomiting
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	1 / 295 (0.34%)	0 / 149 (0.00%)
occurrences all number	2	0
Skin and subcutaneous tissue disorders
acne
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	1 / 295 (0.34%)	3 / 149 (2.01%)
occurrences all number	1	3
alopecia
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	2 / 295 (0.68%)	0 / 149 (0.00%)
occurrences all number	2	0
alopecia areata
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	1 / 295 (0.34%)	0 / 149 (0.00%)
occurrences all number	1	0
angioedema
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	0 / 295 (0.00%)	1 / 149 (0.67%)
occurrences all number	0	1
dermatitis
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	2 / 295 (0.68%)	1 / 149 (0.67%)
occurrences all number	2	1
dermatitis atopic
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	27 / 295 (9.15%)	37 / 149 (24.83%)
occurrences all number	30	40
dermatitis contact
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	1 / 295 (0.34%)	2 / 149 (1.34%)
occurrences all number	1	2
dermatitis exfoliative generalised
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	1 / 295 (0.34%)	1 / 149 (0.67%)
occurrences all number	1	1
dermatitis psoriasiform
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	2 / 295 (0.68%)	0 / 149 (0.00%)
occurrences all number	2	0
diffuse alopecia
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	1 / 295 (0.34%)	0 / 149 (0.00%)
occurrences all number	1	0
dyshidrotic eczema
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	0 / 295 (0.00%)	1 / 149 (0.67%)
occurrences all number	0	1
eczema
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	1 / 295 (0.34%)	1 / 149 (0.67%)
occurrences all number	1	1
erythema
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	1 / 295 (0.34%)	0 / 149 (0.00%)
occurrences all number	1	0
hair disorder
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	1 / 295 (0.34%)	0 / 149 (0.00%)
occurrences all number	1	0
night sweats
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	2 / 295 (0.68%)	0 / 149 (0.00%)
occurrences all number	2	0
pityriasis rosea
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	1 / 295 (0.34%)	0 / 149 (0.00%)
occurrences all number	1	0
prurigo
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	0 / 295 (0.00%)	1 / 149 (0.67%)
occurrences all number	0	1
pruritus
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	5 / 295 (1.69%)	1 / 149 (0.67%)
occurrences all number	5	1
rash
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	1 / 295 (0.34%)	0 / 149 (0.00%)
occurrences all number	1	0
rash erythematous
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	0 / 295 (0.00%)	1 / 149 (0.67%)
occurrences all number	0	2
rosacea
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	0 / 295 (0.00%)	1 / 149 (0.67%)
occurrences all number	0	1
seborrhoea
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	1 / 295 (0.34%)	0 / 149 (0.00%)
occurrences all number	1	0
skin fissures
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	1 / 295 (0.34%)	1 / 149 (0.67%)
occurrences all number	1	1
skin lesion inflammation
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	1 / 295 (0.34%)	1 / 149 (0.67%)
occurrences all number	1	1
urticaria
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	2 / 295 (0.68%)	1 / 149 (0.67%)
occurrences all number	3	1
Renal and urinary disorders
bladder disorder
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	1 / 295 (0.34%)	0 / 149 (0.00%)
occurrences all number	1	0
nephrolithiasis
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	0 / 295 (0.00%)	1 / 149 (0.67%)
occurrences all number	0	1
renal pain
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	0 / 295 (0.00%)	1 / 149 (0.67%)
occurrences all number	0	1
Musculoskeletal and connective tissue disorders
arthralgia
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	3 / 295 (1.02%)	1 / 149 (0.67%)
occurrences all number	3	1
arthritis
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	0 / 295 (0.00%)	1 / 149 (0.67%)
occurrences all number	0	1
bursitis
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	0 / 295 (0.00%)	1 / 149 (0.67%)
occurrences all number	0	1
coccydynia
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	1 / 295 (0.34%)	0 / 149 (0.00%)
occurrences all number	1	0
joint swelling
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	0 / 295 (0.00%)	1 / 149 (0.67%)
occurrences all number	0	1
limb discomfort
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	1 / 295 (0.34%)	0 / 149 (0.00%)
occurrences all number	2	0
muscle spasms
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	1 / 295 (0.34%)	0 / 149 (0.00%)
occurrences all number	1	0
pain in extremity
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	1 / 295 (0.34%)	1 / 149 (0.67%)
occurrences all number	1	2
synovial cyst
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	0 / 295 (0.00%)	1 / 149 (0.67%)
occurrences all number	0	1
Infections and infestations
abscess
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	0 / 295 (0.00%)	1 / 149 (0.67%)
occurrences all number	0	1
asymptomatic bacteriuria
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	0 / 295 (0.00%)	1 / 149 (0.67%)
occurrences all number	0	1
body tinea
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	1 / 295 (0.34%)	0 / 149 (0.00%)
occurrences all number	1	0
covid-19
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	2 / 295 (0.68%)	2 / 149 (1.34%)
occurrences all number	2	2
conjunctivitis
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	22 / 295 (7.46%)	3 / 149 (2.01%)
occurrences all number	23	3
conjunctivitis bacterial
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	3 / 295 (1.02%)	0 / 149 (0.00%)
occurrences all number	3	0
cystitis
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	2 / 295 (0.68%)	1 / 149 (0.67%)
occurrences all number	2	1
dermatitis infected
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	0 / 295 (0.00%)	1 / 149 (0.67%)
occurrences all number	0	1
eczema herpeticum
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	0 / 295 (0.00%)	1 / 149 (0.67%)
occurrences all number	0	1
eczema impetiginous
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	0 / 295 (0.00%)	1 / 149 (0.67%)
occurrences all number	0	1
eczema infected
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	1 / 295 (0.34%)	0 / 149 (0.00%)
occurrences all number	2	0
erysipelas
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	1 / 295 (0.34%)	0 / 149 (0.00%)
occurrences all number	1	0
folliculitis
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	1 / 295 (0.34%)	3 / 149 (2.01%)
occurrences all number	1	3
gastroenteritis
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	3 / 295 (1.02%)	1 / 149 (0.67%)
occurrences all number	4	1
genital herpes simplex
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	0 / 295 (0.00%)	1 / 149 (0.67%)
occurrences all number	0	1
herpes dermatitis
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	1 / 295 (0.34%)	1 / 149 (0.67%)
occurrences all number	1	1
herpes simplex
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	2 / 295 (0.68%)	0 / 149 (0.00%)
occurrences all number	3	0
herpes zoster
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	1 / 295 (0.34%)	0 / 149 (0.00%)
occurrences all number	1	0
hordeolum
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	1 / 295 (0.34%)	1 / 149 (0.67%)
occurrences all number	1	1
impetigo
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	0 / 295 (0.00%)	3 / 149 (2.01%)
occurrences all number	0	3
large intestine infection
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	1 / 295 (0.34%)	0 / 149 (0.00%)
occurrences all number	1	0
nasopharyngitis
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	15 / 295 (5.08%)	3 / 149 (2.01%)
occurrences all number	17	3
oral herpes
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	4 / 295 (1.36%)	3 / 149 (2.01%)
occurrences all number	4	3
oral infection
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	1 / 295 (0.34%)	0 / 149 (0.00%)
occurrences all number	1	0
otitis externa
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	1 / 295 (0.34%)	1 / 149 (0.67%)
occurrences all number	1	1
paronychia
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	2 / 295 (0.68%)	0 / 149 (0.00%)
occurrences all number	2	0
pharyngitis
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	0 / 295 (0.00%)	1 / 149 (0.67%)
occurrences all number	0	1
pharyngitis streptococcal
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	0 / 295 (0.00%)	1 / 149 (0.67%)
occurrences all number	0	1
pharyngotonsillitis
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	1 / 295 (0.34%)	0 / 149 (0.00%)
occurrences all number	1	0
post procedural infection
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	0 / 295 (0.00%)	1 / 149 (0.67%)
occurrences all number	0	1
pustule
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	0 / 295 (0.00%)	1 / 149 (0.67%)
occurrences all number	0	1
rhinitis
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	1 / 295 (0.34%)	0 / 149 (0.00%)
occurrences all number	1	0
skin infection
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	1 / 295 (0.34%)	0 / 149 (0.00%)
occurrences all number	2	0
superinfection
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	0 / 295 (0.00%)	1 / 149 (0.67%)
occurrences all number	0	1
tinea infection
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	0 / 295 (0.00%)	1 / 149 (0.67%)
occurrences all number	0	1
tinea pedis
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	1 / 295 (0.34%)	0 / 149 (0.00%)
occurrences all number	1	0
tooth abscess
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	1 / 295 (0.34%)	1 / 149 (0.67%)
occurrences all number	1	1
tooth infection
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	1 / 295 (0.34%)	1 / 149 (0.67%)
occurrences all number	1	1
upper respiratory tract infection
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	0 / 295 (0.00%)	2 / 149 (1.34%)
occurrences all number	0	2
urinary tract infection
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	4 / 295 (1.36%)	1 / 149 (0.67%)
occurrences all number	4	1
viral infection
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	1 / 295 (0.34%)	0 / 149 (0.00%)
occurrences all number	1	0
vulvovaginal candidiasis
alternative dictionary used: MedDRA 24.0
subjects affected / exposed ^[4]	0 / 147 (0.00%)	1 / 78 (1.28%)
occurrences all number	0	1
Metabolism and nutrition disorders
decreased appetite
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	1 / 295 (0.34%)	0 / 149 (0.00%)
occurrences all number	1	0
hypercholesterolaemia
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	0 / 295 (0.00%)	1 / 149 (0.67%)
occurrences all number	0	1
hypoglycaemia
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	0 / 295 (0.00%)	1 / 149 (0.67%)
occurrences all number	0	1
obesity
alternative dictionary used: MedDRA 24.0
subjects affected / exposed	1 / 295 (0.34%)	0 / 149 (0.00%)
occurrences all number	1	0

Notes
[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.

More information

Top of page

Were there any global substantial amendments to the protocol? Yes

20 May 2020

Revised to align with FDA and EU received recommendations and regulations, to add more clarifications and ensuring consistencies between different sections, and to be consistent across the Phase 3 studies of Lebrikizumab in atopic dermatitis.

Were there any global interruptions to the trial? No

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

One investigational site with eighteen participants was excluded from analysis due to GCP issues.

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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: Percentage change in Pruritus Numerical Rating Scale (NRS) score from Baseline to Week 16

Secondary: Percentage 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: Percentage change in EASI score from Baseline to Week 16

Secondary: Percentage 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 achieving ≥4-point improvement in DLQI from baseline to Week 16

Secondary: Percentage of participants with a DLQI total score of ≥4-point achieving ≥4-point improvement in DLQI from baseline to Week 16

Secondary: Percentage change in Sleep-loss score from Baseline to Week 16

Secondary: Percentage 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 to Week 16

Secondary: Percentage of participants with a Sleep-loss score ≥2 points at Baseline who achieve a ≥2 points reduction 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 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: Percentage Change in SCORing Atopic Dermatitis (SCORAD) from Baseline to Week 16

Secondary: Percentage 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 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- Adolescents

Secondary: Change from Baseline in PROMIS Depression at Week 16- Adolescents

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

Secondary: Change from Baseline in Children's Dermatology Life Quality Index (CDLQI) at Week 16

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