Trial Outcomes & Findings for Efficacy, Safety, and Pharmacokinetic Profile of Etokimab (ANB020) in Adult Participants With Moderate-to-Severe Atopic Dermatitis (NCT NCT03533751)

Last Updated: 2023-05-24

Results Overview

EASI measures the extent and severity of atopic eczema based on assessments of 4 body regions: head/neck, trunk, upper limbs and lower limbs. For each region the percentage of skin affected and the severity (scored as none \[0\], mild \[1\], moderate \[2\], or severe \[3\]) for symptoms such as redness (erythema), thickness (induration, papulation, and edema), scratching (excoriation), and lichenification (lined skin) are assessed. Total score is calculated by summing the EASI scores of 6 symptoms across 4 body regions. The EASI score ranges from 0 (no disease) to 72 (worse disease).

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

302 participants

Primary outcome timeframe

Baseline and Week 16

Results posted on

2023-05-24

Participant Flow

This study was conducted at 75 centers in the United States, United Kingdom, Canada, Czech Republic, Germany, and Poland. The study enrolled adults with moderate to severe atopic dermatitis (AD). The study included a treatment period of 16 weeks (Week 0 to 16) followed by a safety follow-up for 8 weeks (Week 16 to Week 24).

Participants were equally randomized on Day 1 to one of five treatment groups.

Participant milestones

Participant milestones
Measure	Placebo Participants received matching placebo to etokimab, administered subcutaneously (SC) every 4 weeks (Q4W) for up to 16 weeks.	Etokimab 20 mg SC Q4W Participants received etokimab 20 milligrams (mg) administered SC Q4W for up to 16 weeks.	Etokimab 300 mg / 150 mg SC Q8W Participants received a 300 mg loading dose of etokimab on Day 1 then 150 mg etokimab administered SC every 8 weeks (Q8W) for up to 16 weeks. At Weeks 4 and 12 participants received placebo.	Etokimab 300 mg / 150 mg SC Q4W Participants received a 300 mg loading dose of etokimab on Day 1 then 150 mg etokimab administered SC Q4W for up to 16 weeks.	Etokimab 600 mg / 300 mg SC Q4W Participants received a 600 mg loading dose of etokimab on Day 1 then 300 mg etokimab administered SC Q4W for up to 16 weeks.
Overall Study STARTED	60	61	61	60	60
Overall Study Treated	60	61	59	60	60
Overall Study COMPLETED	41	36	39	40	37
Overall Study NOT COMPLETED	19	25	22	20	23

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Participants received matching placebo to etokimab, administered subcutaneously (SC) every 4 weeks (Q4W) for up to 16 weeks.	Etokimab 20 mg SC Q4W Participants received etokimab 20 milligrams (mg) administered SC Q4W for up to 16 weeks.	Etokimab 300 mg / 150 mg SC Q8W Participants received a 300 mg loading dose of etokimab on Day 1 then 150 mg etokimab administered SC every 8 weeks (Q8W) for up to 16 weeks. At Weeks 4 and 12 participants received placebo.	Etokimab 300 mg / 150 mg SC Q4W Participants received a 300 mg loading dose of etokimab on Day 1 then 150 mg etokimab administered SC Q4W for up to 16 weeks.	Etokimab 600 mg / 300 mg SC Q4W Participants received a 600 mg loading dose of etokimab on Day 1 then 300 mg etokimab administered SC Q4W for up to 16 weeks.
Overall Study Withdrawal by Subject	12	6	11	9	10
Overall Study Adverse Event	4	7	2	4	5
Overall Study Physician Decision	0	2	1	2	1
Overall Study Sponsor Decision	0	0	1	1	0
Overall Study Lost to Follow-up	3	7	6	4	3
Overall Study Use of any excluded/prohibited medications	0	1	0	0	1
Overall Study Other	0	2	1	0	3

Baseline Characteristics

The Full Analysis Set included all randomized participants who received at least 1 dose of etokimab or placebo and had Baseline and post-baseline EASI scores. Number of participants with evaluable data were included.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=60 Participants Participants received matching placebo to etokimab, administered SC Q4W for up to 16 weeks.	Etokimab 20 mg SC Q4W n=61 Participants Participants received etokimab 20 mg administered SC Q4W for up to 16 weeks.	Etokimab 300 mg / 150 mg SC Q8W n=59 Participants Participants received a 300 mg loading dose of etokimab on Day 1 then 150 mg etokimab administered SC every 8 weeks (Q8W) for up to 16 weeks. At Weeks 4 and 12 participants received placebo.	Etokimab 300 mg / 150 mg SC Q4W n=60 Participants Participants received a 300 mg loading dose of etokimab on Day 1 then 150 mg etokimab administered SC Q4W for up to 16 weeks.	Etokimab 600 mg / 300 mg SC Q4W n=60 Participants Participants received a 600 mg loading dose of etokimab on Day 1 then 300 mg etokimab administered SC Q4W for up to 16 weeks.	Total n=300 Participants Total of all reporting groups
Age, Continuous	39.5 years STANDARD_DEVIATION 15.92 • n=60 Participants	40.1 years STANDARD_DEVIATION 16.76 • n=61 Participants	39.7 years STANDARD_DEVIATION 14.38 • n=59 Participants	38.9 years STANDARD_DEVIATION 14.61 • n=60 Participants	37.1 years STANDARD_DEVIATION 14.78 • n=60 Participants	39.0 years STANDARD_DEVIATION 15.28 • n=300 Participants
Sex: Female, Male Female	29 Participants n=60 Participants	25 Participants n=61 Participants	36 Participants n=59 Participants	24 Participants n=60 Participants	32 Participants n=60 Participants	146 Participants n=300 Participants
Sex: Female, Male Male	31 Participants n=60 Participants	36 Participants n=61 Participants	23 Participants n=59 Participants	36 Participants n=60 Participants	28 Participants n=60 Participants	154 Participants n=300 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	10 Participants n=60 Participants	11 Participants n=61 Participants	8 Participants n=59 Participants	8 Participants n=60 Participants	7 Participants n=60 Participants	44 Participants n=300 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	50 Participants n=60 Participants	49 Participants n=61 Participants	51 Participants n=59 Participants	50 Participants n=60 Participants	53 Participants n=60 Participants	253 Participants n=300 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=60 Participants	1 Participants n=61 Participants	0 Participants n=59 Participants	2 Participants n=60 Participants	0 Participants n=60 Participants	3 Participants n=300 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	0 Participants n=60 Participants	1 Participants n=61 Participants	0 Participants n=59 Participants	0 Participants n=60 Participants	2 Participants n=60 Participants	3 Participants n=300 Participants
Race/Ethnicity, Customized Asian	5 Participants n=60 Participants	2 Participants n=61 Participants	0 Participants n=59 Participants	0 Participants n=60 Participants	6 Participants n=60 Participants	13 Participants n=300 Participants
Race/Ethnicity, Customized Black or African American	6 Participants n=60 Participants	9 Participants n=61 Participants	10 Participants n=59 Participants	4 Participants n=60 Participants	6 Participants n=60 Participants	35 Participants n=300 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	0 Participants n=60 Participants	0 Participants n=61 Participants	0 Participants n=59 Participants	0 Participants n=60 Participants	0 Participants n=60 Participants	0 Participants n=300 Participants
Race/Ethnicity, Customized White	49 Participants n=60 Participants	48 Participants n=61 Participants	46 Participants n=59 Participants	55 Participants n=60 Participants	45 Participants n=60 Participants	243 Participants n=300 Participants
Race/Ethnicity, Customized Other	0 Participants n=60 Participants	1 Participants n=61 Participants	3 Participants n=59 Participants	1 Participants n=60 Participants	1 Participants n=60 Participants	6 Participants n=300 Participants
Eczema Area and Severity Index (EASI)	26.6 units on a scale STANDARD_DEVIATION 11.45 • n=59 Participants • The Full Analysis Set included all randomized participants who received at least 1 dose of etokimab or placebo and had Baseline and post-baseline EASI scores. Number of participants with evaluable data were included.	29.8 units on a scale STANDARD_DEVIATION 12.08 • n=61 Participants • The Full Analysis Set included all randomized participants who received at least 1 dose of etokimab or placebo and had Baseline and post-baseline EASI scores. Number of participants with evaluable data were included.	27.1 units on a scale STANDARD_DEVIATION 10.38 • n=59 Participants • The Full Analysis Set included all randomized participants who received at least 1 dose of etokimab or placebo and had Baseline and post-baseline EASI scores. Number of participants with evaluable data were included.	32.2 units on a scale STANDARD_DEVIATION 13.06 • n=60 Participants • The Full Analysis Set included all randomized participants who received at least 1 dose of etokimab or placebo and had Baseline and post-baseline EASI scores. Number of participants with evaluable data were included.	29.5 units on a scale STANDARD_DEVIATION 12.19 • n=60 Participants • The Full Analysis Set included all randomized participants who received at least 1 dose of etokimab or placebo and had Baseline and post-baseline EASI scores. Number of participants with evaluable data were included.	29.1 units on a scale STANDARD_DEVIATION 11.92 • n=299 Participants • The Full Analysis Set included all randomized participants who received at least 1 dose of etokimab or placebo and had Baseline and post-baseline EASI scores. Number of participants with evaluable data were included.
Validated Investigator Global Assessment Scale for Atopic Dermatitis (vIGA-AD) Grade 0 (Clear)	0 Participants n=60 Participants	0 Participants n=61 Participants	0 Participants n=59 Participants	0 Participants n=60 Participants	0 Participants n=60 Participants	0 Participants n=300 Participants
Validated Investigator Global Assessment Scale for Atopic Dermatitis (vIGA-AD) Grade 1 (Almost clear)	0 Participants n=60 Participants	0 Participants n=61 Participants	0 Participants n=59 Participants	0 Participants n=60 Participants	0 Participants n=60 Participants	0 Participants n=300 Participants
Validated Investigator Global Assessment Scale for Atopic Dermatitis (vIGA-AD) Grade 2 (Mild)	0 Participants n=60 Participants	0 Participants n=61 Participants	0 Participants n=59 Participants	0 Participants n=60 Participants	0 Participants n=60 Participants	0 Participants n=300 Participants
Validated Investigator Global Assessment Scale for Atopic Dermatitis (vIGA-AD) Grade 3 (Moderate)	49 Participants n=60 Participants	36 Participants n=61 Participants	43 Participants n=59 Participants	43 Participants n=60 Participants	38 Participants n=60 Participants	209 Participants n=300 Participants
Validated Investigator Global Assessment Scale for Atopic Dermatitis (vIGA-AD) Grade 4 (Severe)	10 Participants n=60 Participants	25 Participants n=61 Participants	16 Participants n=59 Participants	17 Participants n=60 Participants	22 Participants n=60 Participants	90 Participants n=300 Participants
Validated Investigator Global Assessment Scale for Atopic Dermatitis (vIGA-AD) Missing	1 Participants n=60 Participants	0 Participants n=61 Participants	0 Participants n=59 Participants	0 Participants n=60 Participants	0 Participants n=60 Participants	1 Participants n=300 Participants

PRIMARY outcome

Timeframe: Baseline and Week 16

Population: Full Analysis Set. Missing data were imputed using multiple imputation.

Outcome measures

Outcome measures
Measure	Placebo n=60 Participants Participants received matching placebo to etokimab, administered SC Q4W for up to 16 weeks.	Etokimab 20 mg SC Q4W n=61 Participants Participants received etokimab 20 mg administered SC Q4W for up to 16 weeks.	Etokimab 300 mg / 150 mg SC Q8W n=59 Participants Participants received a 300 mg loading dose of etokimab on Day 1 then 150 mg etokimab administered SC every 8 weeks (Q8W) for up to 16 weeks. At Weeks 4 and 12 participants received placebo.	Etokimab 300 mg / 150 mg SC Q4W n=60 Participants Participants received a 300 mg loading dose of etokimab on Day 1 then 150 mg etokimab administered SC Q4W for up to 16 weeks.	Etokimab 600 mg / 300 mg SC Q4W n=60 Participants Participants received a 600 mg loading dose of etokimab on Day 1 then 300 mg etokimab administered SC Q4W for up to 16 weeks.
Percent Change From Baseline to Week 16 in Eczema Area and Severity Index (EASI) Score	-49.38 percent change Standard Error 7.124	-41.63 percent change Standard Error 6.707	-55.70 percent change Standard Error 6.206	-47.40 percent change Standard Error 6.091	-44.56 percent change Standard Error 7.811

SECONDARY outcome

Timeframe: Baseline and Week 16

Population: Full Analysis Set. Participants with missing data were counted as non-responders.

Outcome measures

Outcome measures
Measure	Placebo n=60 Participants Participants received matching placebo to etokimab, administered SC Q4W for up to 16 weeks.	Etokimab 20 mg SC Q4W n=61 Participants Participants received etokimab 20 mg administered SC Q4W for up to 16 weeks.	Etokimab 300 mg / 150 mg SC Q8W n=59 Participants Participants received a 300 mg loading dose of etokimab on Day 1 then 150 mg etokimab administered SC every 8 weeks (Q8W) for up to 16 weeks. At Weeks 4 and 12 participants received placebo.	Etokimab 300 mg / 150 mg SC Q4W n=60 Participants Participants received a 300 mg loading dose of etokimab on Day 1 then 150 mg etokimab administered SC Q4W for up to 16 weeks.	Etokimab 600 mg / 300 mg SC Q4W n=60 Participants Participants received a 600 mg loading dose of etokimab on Day 1 then 300 mg etokimab administered SC Q4W for up to 16 weeks.
Number of Participants With a 50% Reduction From Baseline in Eczema Area and Severity Index Score (EASI 50 Response) at Week 16	21 Participants	19 Participants	27 Participants	21 Participants	18 Participants

SECONDARY outcome

Timeframe: Baseline and Week 16

Population: Full Analysis Set. Participants with missing data were counted as non-responders.

Outcome measures

Outcome measures
Measure	Placebo n=60 Participants Participants received matching placebo to etokimab, administered SC Q4W for up to 16 weeks.	Etokimab 20 mg SC Q4W n=61 Participants Participants received etokimab 20 mg administered SC Q4W for up to 16 weeks.	Etokimab 300 mg / 150 mg SC Q8W n=59 Participants Participants received a 300 mg loading dose of etokimab on Day 1 then 150 mg etokimab administered SC every 8 weeks (Q8W) for up to 16 weeks. At Weeks 4 and 12 participants received placebo.	Etokimab 300 mg / 150 mg SC Q4W n=60 Participants Participants received a 300 mg loading dose of etokimab on Day 1 then 150 mg etokimab administered SC Q4W for up to 16 weeks.	Etokimab 600 mg / 300 mg SC Q4W n=60 Participants Participants received a 600 mg loading dose of etokimab on Day 1 then 300 mg etokimab administered SC Q4W for up to 16 weeks.
Number of Participants With a 75% Reduction From Baseline in Eczema Area and Severity Index Score (EASI 75 Response) at Week 16	10 Participants	10 Participants	14 Participants	12 Participants	11 Participants

SECONDARY outcome

Timeframe: Baseline and Week 16

Population: Full Analysis Set. Participants with missing data were counted as non-responders.

Outcome measures

Outcome measures
Measure	Placebo n=60 Participants Participants received matching placebo to etokimab, administered SC Q4W for up to 16 weeks.	Etokimab 20 mg SC Q4W n=61 Participants Participants received etokimab 20 mg administered SC Q4W for up to 16 weeks.	Etokimab 300 mg / 150 mg SC Q8W n=59 Participants Participants received a 300 mg loading dose of etokimab on Day 1 then 150 mg etokimab administered SC every 8 weeks (Q8W) for up to 16 weeks. At Weeks 4 and 12 participants received placebo.	Etokimab 300 mg / 150 mg SC Q4W n=60 Participants Participants received a 300 mg loading dose of etokimab on Day 1 then 150 mg etokimab administered SC Q4W for up to 16 weeks.	Etokimab 600 mg / 300 mg SC Q4W n=60 Participants Participants received a 600 mg loading dose of etokimab on Day 1 then 300 mg etokimab administered SC Q4W for up to 16 weeks.
Number of Participants With a 90% Reduction From Baseline in Eczema Area and Severity Index Score (EASI 90 Response) at Week 16	3 Participants	5 Participants	7 Participants	7 Participants	2 Participants

SECONDARY outcome

Timeframe: Baseline and Week 16

Population: Full Analysis Set. Participants with missing data were counted as non-responders.

The vIGA-AD is a static 5-point scale to evaluate AD severity globally: 0: Clear - No inflammatory signs of AD (no erythema, no induration/papulation, no lichenification, no oozing/crusting). Postinflammatory hyperpigmentation and/or hypopigmentation may be present 1. Almost clear - Barely perceptible erythema, barely perceptible induration/papulation, and/or minimal lichenification. No oozing or crusting 2. Mild - Slight but definite erythema (pink), slight but definite induration/papulation, and/or slight but definite lichenification. No oozing or crusting 3. Moderate - Clearly perceptible erythema (dull red), clearly perceptible induration/papulation, and/or clearly perceptible lichenification. Oozing and crusting may be present 4. Severe - Marked erythema (deep or bright red), marked induration/papulation, and/or marked lichenification. Disease is widespread in extent. Oozing or crusting may be present. Number of participants with ≥2 points reduction in vIGA-AD is presented.

Outcome measures

Outcome measures
Measure	Placebo n=60 Participants Participants received matching placebo to etokimab, administered SC Q4W for up to 16 weeks.	Etokimab 20 mg SC Q4W n=61 Participants Participants received etokimab 20 mg administered SC Q4W for up to 16 weeks.	Etokimab 300 mg / 150 mg SC Q8W n=59 Participants Participants received a 300 mg loading dose of etokimab on Day 1 then 150 mg etokimab administered SC every 8 weeks (Q8W) for up to 16 weeks. At Weeks 4 and 12 participants received placebo.	Etokimab 300 mg / 150 mg SC Q4W n=60 Participants Participants received a 300 mg loading dose of etokimab on Day 1 then 150 mg etokimab administered SC Q4W for up to 16 weeks.	Etokimab 600 mg / 300 mg SC Q4W n=60 Participants Participants received a 600 mg loading dose of etokimab on Day 1 then 300 mg etokimab administered SC Q4W for up to 16 weeks.
Number of Participants Who Achieved a Reduction of ≥ 2 Points From Baseline in the Validated Investigator's Global Assessment for Atopic Dermatitis (vIGA-AD) at Week 16	8 Participants	7 Participants	8 Participants	10 Participants	9 Participants

SECONDARY outcome

Timeframe: Week 16

Population: Full Analysis Set. Participants with missing data were counted as non-responders.

vIGA-AD is static 5-point scale to evaluate AD severity globally: 0: Clear - No inflammatory signs of AD (no erythema, no induration/papulation, no lichenification, no oozing/crusting). Postinflammatory hyperpigmentation and/or hypopigmentation may be present 1. Almost clear - Barely perceptible erythema, barely perceptible induration/papulation, and/or minimal lichenification. No oozing or crusting 2. Mild - Slight but definite erythema (pink), slight but definite induration/papulation, and/or slight but definite lichenification. No oozing or crusting 3. Moderate - Clearly perceptible erythema (dull red), clearly perceptible induration/papulation, and/or clearly perceptible lichenification. Oozing and crusting may be present 4. Severe - Marked erythema (deep or bright red), marked induration/papulation, and/or marked lichenification. Disease is widespread. Oozing or crusting may be present Participants who achieved vIGA-AD response of 0 (clear) or 1 (almost clear) are reported.

Outcome measures

Outcome measures
Measure	Placebo n=60 Participants Participants received matching placebo to etokimab, administered SC Q4W for up to 16 weeks.	Etokimab 20 mg SC Q4W n=61 Participants Participants received etokimab 20 mg administered SC Q4W for up to 16 weeks.	Etokimab 300 mg / 150 mg SC Q8W n=59 Participants Participants received a 300 mg loading dose of etokimab on Day 1 then 150 mg etokimab administered SC every 8 weeks (Q8W) for up to 16 weeks. At Weeks 4 and 12 participants received placebo.	Etokimab 300 mg / 150 mg SC Q4W n=60 Participants Participants received a 300 mg loading dose of etokimab on Day 1 then 150 mg etokimab administered SC Q4W for up to 16 weeks.	Etokimab 600 mg / 300 mg SC Q4W n=60 Participants Participants received a 600 mg loading dose of etokimab on Day 1 then 300 mg etokimab administered SC Q4W for up to 16 weeks.
Number of Participants Who Achieved a vIGA-AD Response of 0 (Clear) or 1 (Almost Clear) at Week 16	5 Participants	5 Participants	6 Participants	8 Participants	6 Participants

SECONDARY outcome

Timeframe: Baseline and Week 16

Population: Full Analysis Set. Participants with missing data were counted as non-responders.

Participants were asked to rate itch (pruritis) intensity at its worst (peak) during the past 24 hours on an 11-point scale from 0 (no itch) to 10 (worst imaginable itch) in a daily electronic diary. Weekly average was calculated as the average of the 7 days before each visit.

Outcome measures

Outcome measures
Measure	Placebo n=60 Participants Participants received matching placebo to etokimab, administered SC Q4W for up to 16 weeks.	Etokimab 20 mg SC Q4W n=61 Participants Participants received etokimab 20 mg administered SC Q4W for up to 16 weeks.	Etokimab 300 mg / 150 mg SC Q8W n=59 Participants Participants received a 300 mg loading dose of etokimab on Day 1 then 150 mg etokimab administered SC every 8 weeks (Q8W) for up to 16 weeks. At Weeks 4 and 12 participants received placebo.	Etokimab 300 mg / 150 mg SC Q4W n=60 Participants Participants received a 300 mg loading dose of etokimab on Day 1 then 150 mg etokimab administered SC Q4W for up to 16 weeks.	Etokimab 600 mg / 300 mg SC Q4W n=60 Participants Participants received a 600 mg loading dose of etokimab on Day 1 then 300 mg etokimab administered SC Q4W for up to 16 weeks.
Number of Participants Who Achieved a Reduction of ≥ 4 Points From Baseline in Weekly Averaged Peak Numerical Rating Scale (NRS) for Pruritus Score at Week 16	5 Participants	6 Participants	8 Participants	9 Participants	9 Participants

SECONDARY outcome

Timeframe: Baseline and Week 16

Population: Full Analysis Set with available data were analyzed. Missing data were imputed using multiple imputation.

Outcome measures

Outcome measures
Measure	Placebo n=56 Participants Participants received matching placebo to etokimab, administered SC Q4W for up to 16 weeks.	Etokimab 20 mg SC Q4W n=58 Participants Participants received etokimab 20 mg administered SC Q4W for up to 16 weeks.	Etokimab 300 mg / 150 mg SC Q8W n=52 Participants Participants received a 300 mg loading dose of etokimab on Day 1 then 150 mg etokimab administered SC every 8 weeks (Q8W) for up to 16 weeks. At Weeks 4 and 12 participants received placebo.	Etokimab 300 mg / 150 mg SC Q4W n=54 Participants Participants received a 300 mg loading dose of etokimab on Day 1 then 150 mg etokimab administered SC Q4W for up to 16 weeks.	Etokimab 600 mg / 300 mg SC Q4W n=54 Participants Participants received a 600 mg loading dose of etokimab on Day 1 then 300 mg etokimab administered SC Q4W for up to 16 weeks.
Percent Change From Baseline in Peak Weekly Averaged Numerical Rating Scale (NRS) for Pruritus Score at Week 16	-21.13 percent change Standard Error 5.964	-22.30 percent change Standard Error 6.211	-17.69 percent change Standard Error 6.530	-30.39 percent change Standard Error 6.176	-27.18 percent change Standard Error 6.192

SECONDARY outcome

Timeframe: Baseline and Week 16

Population: Full Analysis Set. Missing data were imputed using multiple imputation.

SCORAD is a clinical tool used to assess the extent and severity of eczema (SCORing Atopic Dermatitis). The extent is assessed using the rule of 9 to calculate the affected area (A) as extent of disease (0 \[no disease\]-102 \[worst disease\]). The intensity part of the SCORAD (B) consists of 6 items: erythema, oedema/papulation, excoriations, lichenification, oozing/crusts and dryness, each graded on a scale from 0 (none) to 3 (severe), for a total score of 0 (none) to 18 (severe intensity). Subjective items (C) include daily pruritus and sleeplessness, each scored on a visual analogue scale (VAS) from 0 to 10 (itch: 0 \[no itch\] to 10 \[worst imaginable itch\] and sleeplessness: 0 \[no sleeplessness\] to 10 \[worst imaginable sleeplessness\]) (total score 0-20). SCORAD is calculated as A/5 + 7B/2 + C, and ranges from 0 (no AD present) to 103.4 (worst).

Outcome measures

Outcome measures
Measure	Placebo n=60 Participants Participants received matching placebo to etokimab, administered SC Q4W for up to 16 weeks.	Etokimab 20 mg SC Q4W n=61 Participants Participants received etokimab 20 mg administered SC Q4W for up to 16 weeks.	Etokimab 300 mg / 150 mg SC Q8W n=59 Participants Participants received a 300 mg loading dose of etokimab on Day 1 then 150 mg etokimab administered SC every 8 weeks (Q8W) for up to 16 weeks. At Weeks 4 and 12 participants received placebo.	Etokimab 300 mg / 150 mg SC Q4W n=60 Participants Participants received a 300 mg loading dose of etokimab on Day 1 then 150 mg etokimab administered SC Q4W for up to 16 weeks.	Etokimab 600 mg / 300 mg SC Q4W n=60 Participants Participants received a 600 mg loading dose of etokimab on Day 1 then 300 mg etokimab administered SC Q4W for up to 16 weeks.
Percent Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Score at Week 16	-37.99 percent change Standard Error 4.764	-31.42 percent change Standard Error 4.605	-39.22 percent change Standard Error 4.294	-35.48 percent change Standard Error 4.401	-31.23 percent change Standard Error 4.927

SECONDARY outcome

Timeframe: Baseline and Week 16

Population: Full Analysis Set with available data were analyzed. Missing data were imputed using multiple imputation.

The DLQI is a 10-item validated questionnaire used to assess the impact of AD disease symptoms and treatment on quality of life (QoL). It consists of 10 questions evaluating impact of skin diseases on different aspects of a participant's QoL over the prior week, including symptoms and feelings, daily activities, leisure, work or school, personal relationships, and the side effects of treatment. Each item is scored on a 4-point scale (0 = not at all/not relevant; 1 = a little; 2 = a lot; and 3 = very much). Item scores are added to provide a total score, ranging from 0 to 30, with higher scores indicating greater impairment of QoL. A negative change from Baseline indicates improvement.

Outcome measures

Outcome measures
Measure	Placebo n=60 Participants Participants received matching placebo to etokimab, administered SC Q4W for up to 16 weeks.	Etokimab 20 mg SC Q4W n=61 Participants Participants received etokimab 20 mg administered SC Q4W for up to 16 weeks.	Etokimab 300 mg / 150 mg SC Q8W n=59 Participants Participants received a 300 mg loading dose of etokimab on Day 1 then 150 mg etokimab administered SC every 8 weeks (Q8W) for up to 16 weeks. At Weeks 4 and 12 participants received placebo.	Etokimab 300 mg / 150 mg SC Q4W n=59 Participants Participants received a 300 mg loading dose of etokimab on Day 1 then 150 mg etokimab administered SC Q4W for up to 16 weeks.	Etokimab 600 mg / 300 mg SC Q4W n=60 Participants Participants received a 600 mg loading dose of etokimab on Day 1 then 300 mg etokimab administered SC Q4W for up to 16 weeks.
Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Week 16	-5.61 units on a scale Standard Error 0.946	-5.35 units on a scale Standard Error 0.966	-6.52 units on a scale Standard Error 0.945	-6.05 units on a scale Standard Error 0.945	-5.18 units on a scale Standard Error 1.036

SECONDARY outcome

Timeframe: From first dose to Week 24

Population: Safety Analysis Set

An AE is any untoward medical occurrence in a clinical trial participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. A treatment-emergent adverse event (TEAE) is any AE that started or worsened in severity on or after the date and time of the study drug administration. A serious adverse event (SAE) is as any untoward medical occurrence that, at any dose: * Resulted in death; * Was life-threatening; * Required inpatient hospitalization or prolongation of existing hospitalization; * Resulted in persistent disability/incapacity; * Was a congenital anomaly/birth defect.

Outcome measures

Outcome measures
Measure	Placebo n=60 Participants Participants received matching placebo to etokimab, administered SC Q4W for up to 16 weeks.	Etokimab 20 mg SC Q4W n=61 Participants Participants received etokimab 20 mg administered SC Q4W for up to 16 weeks.	Etokimab 300 mg / 150 mg SC Q8W n=59 Participants Participants received a 300 mg loading dose of etokimab on Day 1 then 150 mg etokimab administered SC every 8 weeks (Q8W) for up to 16 weeks. At Weeks 4 and 12 participants received placebo.	Etokimab 300 mg / 150 mg SC Q4W n=60 Participants Participants received a 300 mg loading dose of etokimab on Day 1 then 150 mg etokimab administered SC Q4W for up to 16 weeks.	Etokimab 600 mg / 300 mg SC Q4W n=60 Participants Participants received a 600 mg loading dose of etokimab on Day 1 then 300 mg etokimab administered SC Q4W for up to 16 weeks.
Number of Participants Who Experienced an Adverse Event (AE) Any TEAE	38 Participants	40 Participants	41 Participants	42 Participants	43 Participants
Number of Participants Who Experienced an Adverse Event (AE) Serious TEAE	1 Participants	2 Participants	3 Participants	3 Participants	3 Participants

Adverse Events

Placebo

Serious events: 1 serious events

Other events: 24 other events

Deaths: 0 deaths

Etokimab 20 mg SC Q4W

Serious events: 2 serious events

Other events: 22 other events

Deaths: 0 deaths

Etokimab 300 mg / 150 mg SC Q8W

Serious events: 3 serious events

Other events: 23 other events

Deaths: 0 deaths

Etokimab 300 mg / 150 mg SC Q4W

Serious events: 3 serious events

Other events: 18 other events

Deaths: 0 deaths

Etokimab 600 mg / 300 mg SC Q4W

Serious events: 3 serious events

Other events: 26 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Placebo n=60 participants at risk Participants received matching placebo to etokimab, administered SC Q4W for up to 16 weeks.	Etokimab 20 mg SC Q4W n=61 participants at risk Participants received etokimab 20 mg administered SC Q4W for up to 16 weeks.	Etokimab 300 mg / 150 mg SC Q8W n=59 participants at risk Participants received a 300 mg loading dose of etokimab on Day 1 then 150 mg etokimab administered SC every 8 weeks (Q8W) for up to 16 weeks. At Weeks 4 and 12 participants received placebo.	Etokimab 300 mg / 150 mg SC Q4W n=60 participants at risk Participants received a 300 mg loading dose of etokimab on Day 1 then 150 mg etokimab administered SC Q4W for up to 16 weeks.	Etokimab 600 mg / 300 mg SC Q4W n=60 participants at risk Participants received a 600 mg loading dose of etokimab on Day 1 then 300 mg etokimab administered SC Q4W for up to 16 weeks.
Surgical and medical procedures Hysterectomy	1.7% 1/60 • Number of events 1 • From first dose to Week 24 Safety Analysis Set	0.00% 0/61 • From first dose to Week 24 Safety Analysis Set	0.00% 0/59 • From first dose to Week 24 Safety Analysis Set	0.00% 0/60 • From first dose to Week 24 Safety Analysis Set	0.00% 0/60 • From first dose to Week 24 Safety Analysis Set
Investigations Troponin I Increased	0.00% 0/60 • From first dose to Week 24 Safety Analysis Set	1.6% 1/61 • Number of events 1 • From first dose to Week 24 Safety Analysis Set	0.00% 0/59 • From first dose to Week 24 Safety Analysis Set	0.00% 0/60 • From first dose to Week 24 Safety Analysis Set	0.00% 0/60 • From first dose to Week 24 Safety Analysis Set
Infections and infestations Cellulitis	0.00% 0/60 • From first dose to Week 24 Safety Analysis Set	1.6% 1/61 • Number of events 1 • From first dose to Week 24 Safety Analysis Set	0.00% 0/59 • From first dose to Week 24 Safety Analysis Set	0.00% 0/60 • From first dose to Week 24 Safety Analysis Set	0.00% 0/60 • From first dose to Week 24 Safety Analysis Set
Skin and subcutaneous tissue disorders Dermatitis Atopic	0.00% 0/60 • From first dose to Week 24 Safety Analysis Set	0.00% 0/61 • From first dose to Week 24 Safety Analysis Set	3.4% 2/59 • Number of events 2 • From first dose to Week 24 Safety Analysis Set	1.7% 1/60 • Number of events 1 • From first dose to Week 24 Safety Analysis Set	5.0% 3/60 • Number of events 3 • From first dose to Week 24 Safety Analysis Set
Musculoskeletal and connective tissue disorders Joint Instability	0.00% 0/60 • From first dose to Week 24 Safety Analysis Set	0.00% 0/61 • From first dose to Week 24 Safety Analysis Set	1.7% 1/59 • Number of events 1 • From first dose to Week 24 Safety Analysis Set	0.00% 0/60 • From first dose to Week 24 Safety Analysis Set	0.00% 0/60 • From first dose to Week 24 Safety Analysis Set
Skin and subcutaneous tissue disorders Dermatitis Exfoliative Generalized	0.00% 0/60 • From first dose to Week 24 Safety Analysis Set	0.00% 0/61 • From first dose to Week 24 Safety Analysis Set	0.00% 0/59 • From first dose to Week 24 Safety Analysis Set	1.7% 1/60 • Number of events 1 • From first dose to Week 24 Safety Analysis Set	0.00% 0/60 • From first dose to Week 24 Safety Analysis Set
Infections and infestations Eczema Herpeticum	0.00% 0/60 • From first dose to Week 24 Safety Analysis Set	0.00% 0/61 • From first dose to Week 24 Safety Analysis Set	0.00% 0/59 • From first dose to Week 24 Safety Analysis Set	1.7% 1/60 • Number of events 1 • From first dose to Week 24 Safety Analysis Set	0.00% 0/60 • From first dose to Week 24 Safety Analysis Set

Other adverse events

Other adverse events
Measure	Placebo n=60 participants at risk Participants received matching placebo to etokimab, administered SC Q4W for up to 16 weeks.	Etokimab 20 mg SC Q4W n=61 participants at risk Participants received etokimab 20 mg administered SC Q4W for up to 16 weeks.	Etokimab 300 mg / 150 mg SC Q8W n=59 participants at risk Participants received a 300 mg loading dose of etokimab on Day 1 then 150 mg etokimab administered SC every 8 weeks (Q8W) for up to 16 weeks. At Weeks 4 and 12 participants received placebo.	Etokimab 300 mg / 150 mg SC Q4W n=60 participants at risk Participants received a 300 mg loading dose of etokimab on Day 1 then 150 mg etokimab administered SC Q4W for up to 16 weeks.	Etokimab 600 mg / 300 mg SC Q4W n=60 participants at risk Participants received a 600 mg loading dose of etokimab on Day 1 then 300 mg etokimab administered SC Q4W for up to 16 weeks.
Skin and subcutaneous tissue disorders Eczema	0.00% 0/60 • From first dose to Week 24 Safety Analysis Set	1.6% 1/61 • From first dose to Week 24 Safety Analysis Set	3.4% 2/59 • From first dose to Week 24 Safety Analysis Set	5.0% 3/60 • From first dose to Week 24 Safety Analysis Set	8.3% 5/60 • From first dose to Week 24 Safety Analysis Set
Infections and infestations Oral Herpes	0.00% 0/60 • From first dose to Week 24 Safety Analysis Set	0.00% 0/61 • From first dose to Week 24 Safety Analysis Set	5.1% 3/59 • From first dose to Week 24 Safety Analysis Set	3.3% 2/60 • From first dose to Week 24 Safety Analysis Set	1.7% 1/60 • From first dose to Week 24 Safety Analysis Set
Infections and infestations Impetigo	1.7% 1/60 • From first dose to Week 24 Safety Analysis Set	0.00% 0/61 • From first dose to Week 24 Safety Analysis Set	5.1% 3/59 • From first dose to Week 24 Safety Analysis Set	0.00% 0/60 • From first dose to Week 24 Safety Analysis Set	0.00% 0/60 • From first dose to Week 24 Safety Analysis Set
Infections and infestations Nasopharyngitis	6.7% 4/60 • From first dose to Week 24 Safety Analysis Set	6.6% 4/61 • From first dose to Week 24 Safety Analysis Set	8.5% 5/59 • From first dose to Week 24 Safety Analysis Set	8.3% 5/60 • From first dose to Week 24 Safety Analysis Set	10.0% 6/60 • From first dose to Week 24 Safety Analysis Set
Infections and infestations Upper respiratory tract infection	5.0% 3/60 • From first dose to Week 24 Safety Analysis Set	4.9% 3/61 • From first dose to Week 24 Safety Analysis Set	1.7% 1/59 • From first dose to Week 24 Safety Analysis Set	3.3% 2/60 • From first dose to Week 24 Safety Analysis Set	5.0% 3/60 • From first dose to Week 24 Safety Analysis Set
Skin and subcutaneous tissue disorders Dermatitis atopic	18.3% 11/60 • From first dose to Week 24 Safety Analysis Set	19.7% 12/61 • From first dose to Week 24 Safety Analysis Set	10.2% 6/59 • From first dose to Week 24 Safety Analysis Set	13.3% 8/60 • From first dose to Week 24 Safety Analysis Set	15.0% 9/60 • From first dose to Week 24 Safety Analysis Set
Infections and infestations Conjunctivitis	5.0% 3/60 • From first dose to Week 24 Safety Analysis Set	1.6% 1/61 • From first dose to Week 24 Safety Analysis Set	1.7% 1/59 • From first dose to Week 24 Safety Analysis Set	0.00% 0/60 • From first dose to Week 24 Safety Analysis Set	0.00% 0/60 • From first dose to Week 24 Safety Analysis Set
Nervous system disorders Headache	5.0% 3/60 • From first dose to Week 24 Safety Analysis Set	8.2% 5/61 • From first dose to Week 24 Safety Analysis Set	5.1% 3/59 • From first dose to Week 24 Safety Analysis Set	5.0% 3/60 • From first dose to Week 24 Safety Analysis Set	1.7% 1/60 • From first dose to Week 24 Safety Analysis Set
Nervous system disorders Dizziness	0.00% 0/60 • From first dose to Week 24 Safety Analysis Set	0.00% 0/61 • From first dose to Week 24 Safety Analysis Set	1.7% 1/59 • From first dose to Week 24 Safety Analysis Set	0.00% 0/60 • From first dose to Week 24 Safety Analysis Set	5.0% 3/60 • From first dose to Week 24 Safety Analysis Set
Musculoskeletal and connective tissue disorders Arthralgia	5.0% 3/60 • From first dose to Week 24 Safety Analysis Set	0.00% 0/61 • From first dose to Week 24 Safety Analysis Set	1.7% 1/59 • From first dose to Week 24 Safety Analysis Set	3.3% 2/60 • From first dose to Week 24 Safety Analysis Set	1.7% 1/60 • From first dose to Week 24 Safety Analysis Set
Investigations Blood creatine phosphokinase increased	5.0% 3/60 • From first dose to Week 24 Safety Analysis Set	1.6% 1/61 • From first dose to Week 24 Safety Analysis Set	0.00% 0/59 • From first dose to Week 24 Safety Analysis Set	1.7% 1/60 • From first dose to Week 24 Safety Analysis Set	1.7% 1/60 • From first dose to Week 24 Safety Analysis Set

Additional Information

Clinical Project Leader

AnaptysBio, Inc.

Phone: 858-362-6295

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place