Trial Outcomes & Findings for Safety Study of Tezepelumab (AMG 157) in Healthy Adults and Adults With Atopic Dermatitis (NCT NCT00757042)

Last Updated: 2022-09-21

Results Overview

Adverse events (AEs) include any untoward medical occurrence in a trial participant administered a study drug and does not necessarily have a causal relationship with this treatment. AEs include worsening of a pre-existing medical condition and laboratory value changes requiring therapy or adjustment in prior therapy. AEs were assessed for severity according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3, where Grade 1 = Mild AE, Grade 2 = Moderate AE, Grade 3 = severe AE, Grade 4 = life-threatening AE and Grade 5 = death due to AE. Relationship to study treatment was determined by the investigator. A serious adverse event (SAE) is defined as an AE that met 1 or more of below criteria: * was fatal; * was life threatening; * required in-patient hospitalization or prolongation of existing hospitalization; * resulted in persistent or significant disability/incapacity; * was a congenital anomaly/birth defect; * other significant medical hazard.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

78 participants

Primary outcome timeframe

For Part A Tezepelumab/Placebo 2.1 mg, 7 mg, 21 mg, 70 mg, and 210 mg SC: 85 days. For Part A Tezepelumab/Placebo 420 mg SC, 210 mg IV, and 700 mg IV and Part B: 113 days

Results posted on

2022-09-21

Participant Flow

This study was a single-ascending dose (SAD) study of tezepelumab in healthy adults (Part A; Cohorts 1-8) and adults with moderate to severe atopic dermatitis (AD) (Part B; Cohort 9). The study was conducted at seven centers in the United States, including one center that conducted the testing in all healthy adults and six centers that performed the study in AD participants. Dose escalation was based on blinded review of safety data up to day 15 from the previous cohort.

In Part A the first 2 participants enrolled in Cohort 1 were randomized in a 1:1 ratio and subsequent participants in this cohort were randomized in a 5:1 ratio to receive tezepelumab or placebo. For Cohorts 2 to 8 in Part A, participants were randomized in a 6:2 ratio to receive tezepelumab or placebo. In Part B, the first 2 participants were randomized in a 1:1 ratio, and subsequent participants in Cohort 9 were randomized in an 8:2 ratio to receive tezepelumab or placebo.

Participant milestones

Participant milestones
Measure	Part A: Tezepelumab 2.1 mg SC Healthy participants received a single dose of 2.1 mg tezepelumab administered subcutaneously (SC).	Part A: Tezepelumab 7 mg SC Healthy participants received a single dose of 7 mg tezepelumab administered subcutaneously.	Part A: Tezepelumab 21 mg SC Healthy participants received a single dose of 21 mg tezepelumab administered subcutaneously.	Part A: Tezepelumab 70 mg SC Healthy participants received a single dose of 70 mg tezepelumab administered subcutaneously.	Part A: Tezepelumab 210 mg SC Healthy participants received a single dose of 210 mg tezepelumab administered subcutaneously.	Part A: Tezepelumab 420 mg SC Healthy participants received a single dose of 420 mg tezepelumab administered subcutaneously.	Part A: Tezepelumab 210 mg IV Healthy participants received a single dose of 210 mg tezepelumab administered intravenously.	Part A: Tezepelumab 700 mg IV Healthy participants received a single dose of 700 mg tezepelumab administered intravenously.	Part A: Placebo Healthy participants received a single dose of placebo to tezepelumab administered subcutaneously or intravenously.	Part B: Tezepelumab 700 mg IV Participants with atopic dermatitis received a single dose of 700 mg tezepelumab administered intravenously.	Part B: Placebo IV Participants with atopic dermatitis received a single dose of placebo to tezepelumab administered intravenously.
Overall Study STARTED	6	6	6	6	6	6	6	6	16	10	4
Overall Study Received Study Drug	6	6	6	6	6	6	6	6	16	9	3
Overall Study COMPLETED	6	6	6	6	6	6	6	6	15	9	3
Overall Study NOT COMPLETED	0	0	0	0	0	0	0	0	1	1	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Part A: Placebo Healthy participants received a single dose of placebo to tezepelumab administered subcutaneously or intravenously.	Part B: Tezepelumab 700 mg IV Participants with atopic dermatitis received a single dose of 700 mg tezepelumab administered intravenously.	Part B: Placebo IV Participants with atopic dermatitis received a single dose of placebo to tezepelumab administered intravenously.
Overall Study Lost to Follow-up	1	0	0
Overall Study Ineligibility Determined	0	0	1
Overall Study Withdrawal by Subject	0	1	0

Baseline Characteristics

Safety Study of Tezepelumab (AMG 157) in Healthy Adults and Adults With Atopic Dermatitis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Part A: Tezepelumab 2.1 mg SC n=6 Participants Healthy participants received a single dose of 2.1 mg tezepelumab administered subcutaneously (SC).	Part A: Tezepelumab 7 mg SC n=6 Participants Healthy participants received a single dose of 7 mg tezepelumab administered subcutaneously.	Part A: Tezepelumab 21 mg SC n=6 Participants Healthy participants received a single dose of 21 mg tezepelumab administered subcutaneously.	Part A: Tezepelumab 70 mg SC n=6 Participants Healthy participants received a single dose of 70 mg tezepelumab administered subcutaneously.	Part A: Tezepelumab 210 mg SC n=6 Participants Healthy participants received a single dose of 210 mg tezepelumab administered subcutaneously.	Part A: Tezepelumab 420 mg SC n=6 Participants Healthy participants received a single dose of 420 mg tezepelumab administered subcutaneously.	Part A: Tezepelumab 210 mg IV n=6 Participants Healthy participants received a single dose of 210 mg tezepelumab administered intravenously.	Part A: Tezepelumab 700 mg IV n=6 Participants Healthy participants received a single dose of 700 mg tezepelumab administered intravenously.	Part A: Placebo n=16 Participants Healthy participants received a single dose of placebo to tezepelumab administered subcutaneously or intravenously.	Part B: Tezepelumab 700 mg IV n=9 Participants Participants with atopic dermatitis received a single dose of 700 mg tezepelumab administered intravenously.	Part B: Placebo IV n=3 Participants Participants with atopic dermatitis received a single dose of placebo to tezepelumab administered intravenously.	Total n=76 Participants Total of all reporting groups
Age, Continuous	28.2 years STANDARD_DEVIATION 4.9 • n=5 Participants	32.2 years STANDARD_DEVIATION 2.1 • n=7 Participants	36.8 years STANDARD_DEVIATION 2.6 • n=5 Participants	28.3 years STANDARD_DEVIATION 4.9 • n=4 Participants	33.7 years STANDARD_DEVIATION 4.1 • n=21 Participants	37.0 years STANDARD_DEVIATION 3.7 • n=10 Participants	33.0 years STANDARD_DEVIATION 7.5 • n=115 Participants	30.2 years STANDARD_DEVIATION 3.6 • n=24 Participants	32.3 years STANDARD_DEVIATION 7.6 • n=42 Participants	48.1 years STANDARD_DEVIATION 11.3 • n=42 Participants	45.3 years STANDARD_DEVIATION 5.5 • n=42 Participants	34.8 years STANDARD_DEVIATION 8.6 • n=42 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	1 Participants n=115 Participants	1 Participants n=24 Participants	3 Participants n=42 Participants	2 Participants n=42 Participants	0 Participants n=42 Participants	16 Participants n=42 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	4 Participants n=7 Participants	1 Participants n=5 Participants	5 Participants n=4 Participants	6 Participants n=21 Participants	6 Participants n=10 Participants	5 Participants n=115 Participants	5 Participants n=24 Participants	13 Participants n=42 Participants	7 Participants n=42 Participants	3 Participants n=42 Participants	60 Participants n=42 Participants
Race/Ethnicity, Customized White	1 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants	3 Participants n=21 Participants	2 Participants n=10 Participants	2 Participants n=115 Participants	2 Participants n=24 Participants	4 Participants n=42 Participants	8 Participants n=42 Participants	2 Participants n=42 Participants	27 Participants n=42 Participants
Race/Ethnicity, Customized Black or African American	2 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=10 Participants	0 Participants n=115 Participants	2 Participants n=24 Participants	1 Participants n=42 Participants	0 Participants n=42 Participants	1 Participants n=42 Participants	7 Participants n=42 Participants
Race/Ethnicity, Customized Hispanic or Latino	3 Participants n=5 Participants	5 Participants n=7 Participants	5 Participants n=5 Participants	4 Participants n=4 Participants	2 Participants n=21 Participants	2 Participants n=10 Participants	4 Participants n=115 Participants	1 Participants n=24 Participants	11 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	37 Participants n=42 Participants
Race/Ethnicity, Customized Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	1 Participants n=42 Participants	0 Participants n=42 Participants	3 Participants n=42 Participants
Race/Ethnicity, Customized Other	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	1 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	2 Participants n=42 Participants

PRIMARY outcome

Timeframe: For Part A Tezepelumab/Placebo 2.1 mg, 7 mg, 21 mg, 70 mg, and 210 mg SC: 85 days. For Part A Tezepelumab/Placebo 420 mg SC, 210 mg IV, and 700 mg IV and Part B: 113 days

Population: All participants who received at least 1 dose of study drug

Outcome measures

Outcome measures
Measure	Part B: Tezepelumab 700 mg IV n=6 Participants Participants with atopic dermatitis received a single dose of 700 mg tezepelumab administered intravenously.	Part B: Placebo n=6 Participants Participants with atopic dermatitis received a single dose of placebo to tezepelumab administered intravenously.	Part A: Tezepelumab 21 mg SC n=6 Participants Healthy participants received a single dose of 21 mg tezepelumab administered subcutaneously.	Part A: Tezepelumab 70 mg SC n=6 Participants Healthy participants received a single dose of 70 mg tezepelumab administered subcutaneously.	Part A: Tezepelumab 210 mg SC n=6 Participants Healthy participants received a single dose of 210 mg tezepelumab administered subcutaneously.	Part A: Tezepelumab 420 mg SC n=6 Participants Healthy participants received a single dose of 420 mg tezepelumab administered subcutaneously.	Part A: Tezepelumab 210 mg IV n=6 Participants Healthy participants received a single dose of 210 mg tezepelumab administered intravenously.	Part A: Tezepelumab 700 mg IV n=6 Participants Healthy participants received a single dose of 700 mg tezepelumab administered intravenously.	Part A: Placebo SC n=12 Participants Healthy participants received a single dose of placebo to tezepelumab administered subcutaneously.	Part A: Placebo IV n=4 Participants Healthy participants received a single dose of placebo to tezepelumab administered intravenously.	Part B: Tezepelumab 700 mg IV n=9 Participants Participants with atopic dermatitis received a single dose of 700 mg tezepelumab administered intravenously.	Part B: Placebo IV n=3 Participants Participants with atopic dermatitis received a single dose of placebo to tezepelumab administered intravenously.
Number of Participants With Adverse Events Any adverse event	3 Participants	5 Participants	1 Participants	6 Participants	2 Participants	3 Participants	4 Participants	5 Participants	8 Participants	3 Participants	7 Participants	3 Participants
Number of Participants With Adverse Events Serious adverse event	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Adverse Events AE leading to study drug discontinuation	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Adverse Events AE leading to discontinuation from study	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Adverse Events Fatal adverse event	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Adverse Events Treatment-related adverse event	1 Participants	0 Participants	0 Participants	0 Participants	2 Participants	1 Participants	2 Participants	0 Participants	4 Participants	1 Participants	3 Participants	3 Participants

PRIMARY outcome

Timeframe: Blood samples for the measurement of antibodies were collected on Days 29, 57, 85, and (for cohorts who received 420 mg Tezepelumab/placebo SC or any IV dose) 113.

Population: All participants who received at least 1 dose of study drug with a postbaseline result.

All study samples (tezepelumab and placebo) were tested using an electrochemiluminescence (ECL) based immunoassay to detect and confirm the presence of antibodies capable of binding to tezepelumab. Samples identified as positive in the immunoassay were tested in a receptor-binding ECL-based assay to detect neutralizing or inhibitory effects toward tezepelumab. The number of participants with positive anti-tezepelumab binding antibodies / neutralizing antibodies at any time post-baseline with a negative or no result at baseline is reported.

Outcome measures

Outcome measures
Measure	Part B: Tezepelumab 700 mg IV n=6 Participants Participants with atopic dermatitis received a single dose of 700 mg tezepelumab administered intravenously.	Part B: Placebo n=6 Participants Participants with atopic dermatitis received a single dose of placebo to tezepelumab administered intravenously.	Part A: Tezepelumab 21 mg SC n=6 Participants Healthy participants received a single dose of 21 mg tezepelumab administered subcutaneously.	Part A: Tezepelumab 70 mg SC n=6 Participants Healthy participants received a single dose of 70 mg tezepelumab administered subcutaneously.	Part A: Tezepelumab 210 mg SC n=6 Participants Healthy participants received a single dose of 210 mg tezepelumab administered subcutaneously.	Part A: Tezepelumab 420 mg SC n=6 Participants Healthy participants received a single dose of 420 mg tezepelumab administered subcutaneously.	Part A: Tezepelumab 210 mg IV n=6 Participants Healthy participants received a single dose of 210 mg tezepelumab administered intravenously.	Part A: Tezepelumab 700 mg IV n=6 Participants Healthy participants received a single dose of 700 mg tezepelumab administered intravenously.	Part A: Placebo SC n=15 Participants Healthy participants received a single dose of placebo to tezepelumab administered subcutaneously.	Part A: Placebo IV n=9 Participants Healthy participants received a single dose of placebo to tezepelumab administered intravenously.	Part B: Tezepelumab 700 mg IV n=3 Participants Participants with atopic dermatitis received a single dose of 700 mg tezepelumab administered intravenously.	Part B: Placebo IV Participants with atopic dermatitis received a single dose of placebo to tezepelumab administered intravenously.
Number of Participants Who Developed Anti-tezepelumab Antibodies Anti-tezepelumab binding antibodies	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	—
Number of Participants Who Developed Anti-tezepelumab Antibodies Anti-tezepelumab neutralizing antibodies	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—

SECONDARY outcome

Timeframe: Day 1 predose, 0.25, 0.5, and 1 hour after start of infusion (for IV cohorts only), 4, 8, 24, 48, 72 hours postdose and days 5, 6, 7, 11, 15, 22, 29, 43, 57, 71, 85, and (for cohorts who received 420 mg tezepelumab SC or any IV dose) 113.

Population: Participants in Part A who received tezepelumab and had a sufficient number of serum concentration measurements for computing the pharmacokinetic (PK) parameter.

The time at which the maximum concentration of tezepelumab was observed was estimated based on the serum concentrations of tezepelumab using noncompartmental methods. The concentration of tezepelumab in human serum was measured using a validated enzyme-linked immunosorbent assay (ELISA). The lower limit of quantification of the assay was 10 ng/mL.

Outcome measures

Outcome measures
Measure	Part B: Tezepelumab 700 mg IV n=6 Participants Participants with atopic dermatitis received a single dose of 700 mg tezepelumab administered intravenously.	Part B: Placebo n=6 Participants Participants with atopic dermatitis received a single dose of placebo to tezepelumab administered intravenously.	Part A: Tezepelumab 21 mg SC n=6 Participants Healthy participants received a single dose of 21 mg tezepelumab administered subcutaneously.	Part A: Tezepelumab 70 mg SC n=6 Participants Healthy participants received a single dose of 70 mg tezepelumab administered subcutaneously.	Part A: Tezepelumab 210 mg SC n=6 Participants Healthy participants received a single dose of 210 mg tezepelumab administered subcutaneously.	Part A: Tezepelumab 420 mg SC n=6 Participants Healthy participants received a single dose of 420 mg tezepelumab administered subcutaneously.	Part A: Tezepelumab 210 mg IV n=6 Participants Healthy participants received a single dose of 210 mg tezepelumab administered intravenously.	Part A: Tezepelumab 700 mg IV n=6 Participants Healthy participants received a single dose of 700 mg tezepelumab administered intravenously.	Part A: Placebo SC Healthy participants received a single dose of placebo to tezepelumab administered subcutaneously.	Part A: Placebo IV Healthy participants received a single dose of placebo to tezepelumab administered intravenously.	Part B: Tezepelumab 700 mg IV Participants with atopic dermatitis received a single dose of 700 mg tezepelumab administered intravenously.	Part B: Placebo IV Participants with atopic dermatitis received a single dose of placebo to tezepelumab administered intravenously.
Part A: Time of Maximum Observed Concentration (Tmax) of Tezepelumab	190.94 hours Interval 117.87 to 332.15	237.09 hours Interval 140.5 to 335.07	142.10 hours Interval 117.43 to 336.1	130.87 hours Interval 69.27 to 237.9	93.65 hours Interval 70.22 to 359.17	80.89 hours Interval 68.27 to 116.58	1.13 hours Interval 1.08 to 8.0	1.04 hours Interval 1.02 to 1.17	—	—	—	—

SECONDARY outcome

Population: Participants in Part A who received tezepelumab and had a sufficient number of serum concentration measurements for computing the PK parameter.

The maximum observed serum concentration of tezepelumab was estimated based on the serum concentrations of tezepelumab using noncompartmental methods. The concentration of tezepelumab in human serum was measured using a validated enzyme-linked immunosorbent assay (ELISA). The lower limit of quantification of the assay was 10 ng/mL.

Outcome measures

Outcome measures
Measure	Part B: Tezepelumab 700 mg IV n=6 Participants Participants with atopic dermatitis received a single dose of 700 mg tezepelumab administered intravenously.	Part B: Placebo n=6 Participants Participants with atopic dermatitis received a single dose of placebo to tezepelumab administered intravenously.	Part A: Tezepelumab 21 mg SC n=6 Participants Healthy participants received a single dose of 21 mg tezepelumab administered subcutaneously.	Part A: Tezepelumab 70 mg SC n=6 Participants Healthy participants received a single dose of 70 mg tezepelumab administered subcutaneously.	Part A: Tezepelumab 210 mg SC n=6 Participants Healthy participants received a single dose of 210 mg tezepelumab administered subcutaneously.	Part A: Tezepelumab 420 mg SC n=6 Participants Healthy participants received a single dose of 420 mg tezepelumab administered subcutaneously.	Part A: Tezepelumab 210 mg IV n=6 Participants Healthy participants received a single dose of 210 mg tezepelumab administered intravenously.	Part A: Tezepelumab 700 mg IV n=6 Participants Healthy participants received a single dose of 700 mg tezepelumab administered intravenously.	Part A: Placebo SC Healthy participants received a single dose of placebo to tezepelumab administered subcutaneously.	Part A: Placebo IV Healthy participants received a single dose of placebo to tezepelumab administered intravenously.	Part B: Tezepelumab 700 mg IV Participants with atopic dermatitis received a single dose of 700 mg tezepelumab administered intravenously.	Part B: Placebo IV Participants with atopic dermatitis received a single dose of placebo to tezepelumab administered intravenously.
Part A: Maximum Observed Concentration (Cmax) of Tezepelumab	0.257 μg/mL Standard Deviation 0.0824	0.792 μg/mL Standard Deviation 0.0593	2.01 μg/mL Standard Deviation 0.620	7.82 μg/mL Standard Deviation 2.25	23.6 μg/mL Standard Deviation 10.3	58.0 μg/mL Standard Deviation 19.3	64.4 μg/mL Standard Deviation 10.2	219 μg/mL Standard Deviation 38.3	—	—	—	—

SECONDARY outcome

Population: Participants in Part A who received tezepelumab and had a sufficient number of serum concentration measurements for computing the PK parameter.

The PK parameter AUC0-t was estimated based on the serum concentrations of tezepelumab using noncompartmental methods and the linear/log trapezoidal method. The concentration of tezepelumab in human serum was measured using a validated ELISA. The lower limit of quantification of the assay was 10 ng/mL.

Outcome measures

Outcome measures
Measure	Part B: Tezepelumab 700 mg IV n=6 Participants Participants with atopic dermatitis received a single dose of 700 mg tezepelumab administered intravenously.	Part B: Placebo n=6 Participants Participants with atopic dermatitis received a single dose of placebo to tezepelumab administered intravenously.	Part A: Tezepelumab 21 mg SC n=6 Participants Healthy participants received a single dose of 21 mg tezepelumab administered subcutaneously.	Part A: Tezepelumab 70 mg SC n=6 Participants Healthy participants received a single dose of 70 mg tezepelumab administered subcutaneously.	Part A: Tezepelumab 210 mg SC n=6 Participants Healthy participants received a single dose of 210 mg tezepelumab administered subcutaneously.	Part A: Tezepelumab 420 mg SC n=6 Participants Healthy participants received a single dose of 420 mg tezepelumab administered subcutaneously.	Part A: Tezepelumab 210 mg IV n=6 Participants Healthy participants received a single dose of 210 mg tezepelumab administered intravenously.	Part A: Tezepelumab 700 mg IV n=6 Participants Healthy participants received a single dose of 700 mg tezepelumab administered intravenously.	Part A: Placebo SC Healthy participants received a single dose of placebo to tezepelumab administered subcutaneously.	Part A: Placebo IV Healthy participants received a single dose of placebo to tezepelumab administered intravenously.	Part B: Tezepelumab 700 mg IV Participants with atopic dermatitis received a single dose of 700 mg tezepelumab administered intravenously.	Part B: Placebo IV Participants with atopic dermatitis received a single dose of placebo to tezepelumab administered intravenously.
Part A: Area Under the Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-t) of Tezepelumab	8.12 day*μg/mL Standard Deviation 1.96	32.9 day*μg/mL Standard Deviation 2.75	76.7 day*μg/mL Standard Deviation 31.6	278 day*μg/mL Standard Deviation 64.3	867 day*μg/mL Standard Deviation 349	2050 day*μg/mL Standard Deviation 627	1150 day*μg/mL Standard Deviation 176	3440 day*μg/mL Standard Deviation 253	—	—	—	—

SECONDARY outcome

Population: Participants in Part A who received tezepelumab and had a sufficient number of serum concentration measurements for computing the PK parameter.

The PK parameter AUCinf was estimated based on the serum concentrations of tezepelumab using noncompartmental methods and the linear/log trapezoidal method. The concentration of tezepelumab in human serum was measured using a validated ELISA. The lower limit of quantification of the assay was 10 ng/mL.

Outcome measures

Outcome measures
Measure	Part B: Tezepelumab 700 mg IV n=6 Participants Participants with atopic dermatitis received a single dose of 700 mg tezepelumab administered intravenously.	Part B: Placebo n=6 Participants Participants with atopic dermatitis received a single dose of placebo to tezepelumab administered intravenously.	Part A: Tezepelumab 21 mg SC n=6 Participants Healthy participants received a single dose of 21 mg tezepelumab administered subcutaneously.	Part A: Tezepelumab 70 mg SC n=6 Participants Healthy participants received a single dose of 70 mg tezepelumab administered subcutaneously.	Part A: Tezepelumab 210 mg SC n=6 Participants Healthy participants received a single dose of 210 mg tezepelumab administered subcutaneously.	Part A: Tezepelumab 420 mg SC n=6 Participants Healthy participants received a single dose of 420 mg tezepelumab administered subcutaneously.	Part A: Tezepelumab 210 mg IV n=6 Participants Healthy participants received a single dose of 210 mg tezepelumab administered intravenously.	Part A: Tezepelumab 700 mg IV n=6 Participants Healthy participants received a single dose of 700 mg tezepelumab administered intravenously.	Part A: Placebo SC Healthy participants received a single dose of placebo to tezepelumab administered subcutaneously.	Part A: Placebo IV Healthy participants received a single dose of placebo to tezepelumab administered intravenously.	Part B: Tezepelumab 700 mg IV Participants with atopic dermatitis received a single dose of 700 mg tezepelumab administered intravenously.	Part B: Placebo IV Participants with atopic dermatitis received a single dose of placebo to tezepelumab administered intravenously.
Part A: Area Under the Concentration-Time Curve From Time Zero Extrapolated to Infinity (AUCinf) of Tezepelumab	8.69 day*μg/mL Standard Deviation 1.97	36.6 day*μg/mL Standard Deviation 4.60	84.6 day*μg/mL Standard Deviation 37.9	303 day*μg/mL Standard Deviation 70.3	976 day*μg/mL Standard Deviation 409	2140 day*μg/mL Standard Deviation 677	1200 day*μg/mL Standard Deviation 208	3530 day*μg/mL Standard Deviation 322	—	—	—	—

SECONDARY outcome

Population: Participants in Part A who received tezepelumab and had a sufficient number of serum concentration measurements for computing the PK parameter.

Elimination half-life was estimated based on the serum concentrations of tezepelumab using noncompartmental methods based on the terminal phase of the concentration-time profile. The concentration of tezepelumab in human serum was measured using a validated ELISA. The lower limit of quantification of the assay was 10 ng/mL.

Outcome measures

Outcome measures
Measure	Part B: Tezepelumab 700 mg IV n=6 Participants Participants with atopic dermatitis received a single dose of 700 mg tezepelumab administered intravenously.	Part B: Placebo n=6 Participants Participants with atopic dermatitis received a single dose of placebo to tezepelumab administered intravenously.	Part A: Tezepelumab 21 mg SC n=6 Participants Healthy participants received a single dose of 21 mg tezepelumab administered subcutaneously.	Part A: Tezepelumab 70 mg SC n=6 Participants Healthy participants received a single dose of 70 mg tezepelumab administered subcutaneously.	Part A: Tezepelumab 210 mg SC n=6 Participants Healthy participants received a single dose of 210 mg tezepelumab administered subcutaneously.	Part A: Tezepelumab 420 mg SC n=6 Participants Healthy participants received a single dose of 420 mg tezepelumab administered subcutaneously.	Part A: Tezepelumab 210 mg IV n=6 Participants Healthy participants received a single dose of 210 mg tezepelumab administered intravenously.	Part A: Tezepelumab 700 mg IV n=6 Participants Healthy participants received a single dose of 700 mg tezepelumab administered intravenously.	Part A: Placebo SC Healthy participants received a single dose of placebo to tezepelumab administered subcutaneously.	Part A: Placebo IV Healthy participants received a single dose of placebo to tezepelumab administered intravenously.	Part B: Tezepelumab 700 mg IV Participants with atopic dermatitis received a single dose of 700 mg tezepelumab administered intravenously.	Part B: Placebo IV Participants with atopic dermatitis received a single dose of placebo to tezepelumab administered intravenously.
Part A: Elimination Half-life (t1/2) of Tezepelumab	19.9 days Standard Deviation 4.81	23.4 days Standard Deviation 4.30	22.7 days Standard Deviation 4.81	22.5 days Standard Deviation 1.35	25.7 days Standard Deviation 5.52	23.3 days Standard Deviation 2.89	24.5 days Standard Deviation 6.28	20.7 days Standard Deviation 6.44	—	—	—	—

SECONDARY outcome

Timeframe: Day 1 predose, 0.25, 0.5, 1, 4, 8, 72 hours postdose and days, 7, 15, 22, 29, 43, 57, 71, 85, and 113.

Population: Participants in Part B who received tezepelumab and had a sufficient number of serum concentration measurements for computing the PK parameter.

Tmax was estimated based on the serum concentrations of tezepelumab using noncompartmental methods. The concentration of tezepelumab in human serum was measured using a validated ELISA. The lower limit of quantification of the assay was 10 ng/mL.

Outcome measures

Outcome measures
Measure	Part B: Tezepelumab 700 mg IV n=9 Participants Participants with atopic dermatitis received a single dose of 700 mg tezepelumab administered intravenously.	Part B: Placebo Participants with atopic dermatitis received a single dose of placebo to tezepelumab administered intravenously.	Part A: Tezepelumab 21 mg SC Healthy participants received a single dose of 21 mg tezepelumab administered subcutaneously.	Part A: Tezepelumab 70 mg SC Healthy participants received a single dose of 70 mg tezepelumab administered subcutaneously.	Part A: Tezepelumab 210 mg SC Healthy participants received a single dose of 210 mg tezepelumab administered subcutaneously.	Part A: Tezepelumab 420 mg SC Healthy participants received a single dose of 420 mg tezepelumab administered subcutaneously.	Part A: Tezepelumab 210 mg IV Healthy participants received a single dose of 210 mg tezepelumab administered intravenously.	Part A: Tezepelumab 700 mg IV Healthy participants received a single dose of 700 mg tezepelumab administered intravenously.	Part A: Placebo SC Healthy participants received a single dose of placebo to tezepelumab administered subcutaneously.	Part A: Placebo IV Healthy participants received a single dose of placebo to tezepelumab administered intravenously.	Part B: Tezepelumab 700 mg IV Participants with atopic dermatitis received a single dose of 700 mg tezepelumab administered intravenously.	Part B: Placebo IV Participants with atopic dermatitis received a single dose of placebo to tezepelumab administered intravenously.
Part B: Time of Maximum Observed Concentration (Tmax) of Tezepelumab	4.08 hours Interval 1.0 to 8.12	—	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Day 1 predose, 0.25, 0.5, 1, 4, 8, 72 hours postdose and days, 7, 15, 22, 29, 43, 57, 71, 85, and 113.

Population: Participants in Part B who received tezepelumab and had a sufficient number of serum concentration measurements for computing the PK parameter.

Cmax was estimated based on the serum concentrations of tezepelumab using noncompartmental methods. The concentration of tezepelumab in human serum was measured using a validated ELISA. The lower limit of quantification of the assay was 10 ng/mL.

Outcome measures

Outcome measures
Measure	Part B: Tezepelumab 700 mg IV n=9 Participants Participants with atopic dermatitis received a single dose of 700 mg tezepelumab administered intravenously.	Part B: Placebo Participants with atopic dermatitis received a single dose of placebo to tezepelumab administered intravenously.	Part A: Tezepelumab 21 mg SC Healthy participants received a single dose of 21 mg tezepelumab administered subcutaneously.	Part A: Tezepelumab 70 mg SC Healthy participants received a single dose of 70 mg tezepelumab administered subcutaneously.	Part A: Tezepelumab 210 mg SC Healthy participants received a single dose of 210 mg tezepelumab administered subcutaneously.	Part A: Tezepelumab 420 mg SC Healthy participants received a single dose of 420 mg tezepelumab administered subcutaneously.	Part A: Tezepelumab 210 mg IV Healthy participants received a single dose of 210 mg tezepelumab administered intravenously.	Part A: Tezepelumab 700 mg IV Healthy participants received a single dose of 700 mg tezepelumab administered intravenously.	Part A: Placebo SC Healthy participants received a single dose of placebo to tezepelumab administered subcutaneously.	Part A: Placebo IV Healthy participants received a single dose of placebo to tezepelumab administered intravenously.	Part B: Tezepelumab 700 mg IV Participants with atopic dermatitis received a single dose of 700 mg tezepelumab administered intravenously.	Part B: Placebo IV Participants with atopic dermatitis received a single dose of placebo to tezepelumab administered intravenously.
Part B: Maximum Observed Concentration (Cmax) of Tezepelumab	253 μg/mL Standard Deviation 57.2	—	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Day 1 predose, 0.25, 0.5, 1, 4, 8, 72 hours postdose and days, 7, 15, 22, 29, 43, 57, 71, 85, and 113.

Population: Participants in Part B who received tezepelumab and had a sufficient number of serum concentration measurements for computing the PK parameter.

Outcome measures

Outcome measures
Measure	Part B: Tezepelumab 700 mg IV n=9 Participants Participants with atopic dermatitis received a single dose of 700 mg tezepelumab administered intravenously.	Part B: Placebo Participants with atopic dermatitis received a single dose of placebo to tezepelumab administered intravenously.	Part A: Tezepelumab 21 mg SC Healthy participants received a single dose of 21 mg tezepelumab administered subcutaneously.	Part A: Tezepelumab 70 mg SC Healthy participants received a single dose of 70 mg tezepelumab administered subcutaneously.	Part A: Tezepelumab 210 mg SC Healthy participants received a single dose of 210 mg tezepelumab administered subcutaneously.	Part A: Tezepelumab 420 mg SC Healthy participants received a single dose of 420 mg tezepelumab administered subcutaneously.	Part A: Tezepelumab 210 mg IV Healthy participants received a single dose of 210 mg tezepelumab administered intravenously.	Part A: Tezepelumab 700 mg IV Healthy participants received a single dose of 700 mg tezepelumab administered intravenously.	Part A: Placebo SC Healthy participants received a single dose of placebo to tezepelumab administered subcutaneously.	Part A: Placebo IV Healthy participants received a single dose of placebo to tezepelumab administered intravenously.	Part B: Tezepelumab 700 mg IV Participants with atopic dermatitis received a single dose of 700 mg tezepelumab administered intravenously.	Part B: Placebo IV Participants with atopic dermatitis received a single dose of placebo to tezepelumab administered intravenously.
Part B: Area Under the Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-t) of Tezepelumab	3660 day*μg/mL Standard Deviation 990	—	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Day 1 predose, 0.25, 0.5, 1, 4, 8, 72 hours postdose and days, 7, 15, 22, 29, 43, 57, 71, 85, and 113.

Population: Participants in Part B who received tezepelumab and had a sufficient number of serum concentration measurements for computing the PK parameter.

Outcome measures

Outcome measures
Measure	Part B: Tezepelumab 700 mg IV n=9 Participants Participants with atopic dermatitis received a single dose of 700 mg tezepelumab administered intravenously.	Part B: Placebo Participants with atopic dermatitis received a single dose of placebo to tezepelumab administered intravenously.	Part A: Tezepelumab 21 mg SC Healthy participants received a single dose of 21 mg tezepelumab administered subcutaneously.	Part A: Tezepelumab 70 mg SC Healthy participants received a single dose of 70 mg tezepelumab administered subcutaneously.	Part A: Tezepelumab 210 mg SC Healthy participants received a single dose of 210 mg tezepelumab administered subcutaneously.	Part A: Tezepelumab 420 mg SC Healthy participants received a single dose of 420 mg tezepelumab administered subcutaneously.	Part A: Tezepelumab 210 mg IV Healthy participants received a single dose of 210 mg tezepelumab administered intravenously.	Part A: Tezepelumab 700 mg IV Healthy participants received a single dose of 700 mg tezepelumab administered intravenously.	Part A: Placebo SC Healthy participants received a single dose of placebo to tezepelumab administered subcutaneously.	Part A: Placebo IV Healthy participants received a single dose of placebo to tezepelumab administered intravenously.	Part B: Tezepelumab 700 mg IV Participants with atopic dermatitis received a single dose of 700 mg tezepelumab administered intravenously.	Part B: Placebo IV Participants with atopic dermatitis received a single dose of placebo to tezepelumab administered intravenously.
Part B: Area Under the Concentration-Time Curve From Time Zero Extrapolated to Infinity (AUCinf) of Tezepelumab	3830 day*μg/mL Standard Deviation 1230	—	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Day 1 predose, 0.25, 0.5, 1, 4, 8, 72 hours postdose and days, 7, 15, 22, 29, 43, 57, 71, 85, and 113.

Population: Participants in Part B who received tezepelumab and had a sufficient number of serum concentration measurements for computing the PK parameter.

Outcome measures

Outcome measures
Measure	Part B: Tezepelumab 700 mg IV n=9 Participants Participants with atopic dermatitis received a single dose of 700 mg tezepelumab administered intravenously.	Part B: Placebo Participants with atopic dermatitis received a single dose of placebo to tezepelumab administered intravenously.	Part A: Tezepelumab 21 mg SC Healthy participants received a single dose of 21 mg tezepelumab administered subcutaneously.	Part A: Tezepelumab 70 mg SC Healthy participants received a single dose of 70 mg tezepelumab administered subcutaneously.	Part A: Tezepelumab 210 mg SC Healthy participants received a single dose of 210 mg tezepelumab administered subcutaneously.	Part A: Tezepelumab 420 mg SC Healthy participants received a single dose of 420 mg tezepelumab administered subcutaneously.	Part A: Tezepelumab 210 mg IV Healthy participants received a single dose of 210 mg tezepelumab administered intravenously.	Part A: Tezepelumab 700 mg IV Healthy participants received a single dose of 700 mg tezepelumab administered intravenously.	Part A: Placebo SC Healthy participants received a single dose of placebo to tezepelumab administered subcutaneously.	Part A: Placebo IV Healthy participants received a single dose of placebo to tezepelumab administered intravenously.	Part B: Tezepelumab 700 mg IV Participants with atopic dermatitis received a single dose of 700 mg tezepelumab administered intravenously.	Part B: Placebo IV Participants with atopic dermatitis received a single dose of placebo to tezepelumab administered intravenously.
Part B: Elimination Half-life (t1/2) of Tezepelumab	22.2 days Standard Deviation 4.72	—	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline and days 15, 29, 43, 57, 85, and 113

Population: All participants in Part B who received at least 1 dose of study drug and with available data at each time point.

EASI is a tool used to measure the severity of AD. The index involves an assessment of the average intensity of 4 clinical signs (erythema, infiltration/papulation, excoriations, and lichenification) at 4 body areas (head/neck, upper extremities, trunk, lower extremities) assessed on a scale: 0 = none, 1 = mild, 2 = moderate, 3 = severe. The percent of affected area for each of the 4 body areas is also assessed using the following 6-point scale: 0 = 0%, 1 = \< 10%, 2 =10% to 29%, 3 = 30% to 49%, 4 = 50% to 69%, 5 = 70% to 89%, 6 = 90% to 100%. The total score for each body region is obtained by multiplying the sum of the severity scores of the 4 clinical signs by the area score, with adjustment for the proportion of the body region to the whole body. The sum of the scores for each body region gives the total EASI score, which ranges from 0 to 72, with higher scores indicating greater disease severity.

Outcome measures

Outcome measures
Measure	Part B: Tezepelumab 700 mg IV n=9 Participants Participants with atopic dermatitis received a single dose of 700 mg tezepelumab administered intravenously.	Part B: Placebo n=3 Participants Participants with atopic dermatitis received a single dose of placebo to tezepelumab administered intravenously.	Part A: Tezepelumab 21 mg SC Healthy participants received a single dose of 21 mg tezepelumab administered subcutaneously.	Part A: Tezepelumab 70 mg SC Healthy participants received a single dose of 70 mg tezepelumab administered subcutaneously.	Part A: Tezepelumab 210 mg SC Healthy participants received a single dose of 210 mg tezepelumab administered subcutaneously.	Part A: Tezepelumab 420 mg SC Healthy participants received a single dose of 420 mg tezepelumab administered subcutaneously.	Part A: Tezepelumab 210 mg IV Healthy participants received a single dose of 210 mg tezepelumab administered intravenously.	Part A: Tezepelumab 700 mg IV Healthy participants received a single dose of 700 mg tezepelumab administered intravenously.	Part A: Placebo SC Healthy participants received a single dose of placebo to tezepelumab administered subcutaneously.	Part A: Placebo IV Healthy participants received a single dose of placebo to tezepelumab administered intravenously.	Part B: Tezepelumab 700 mg IV Participants with atopic dermatitis received a single dose of 700 mg tezepelumab administered intravenously.	Part B: Placebo IV Participants with atopic dermatitis received a single dose of placebo to tezepelumab administered intravenously.
Part B: Percentage of Participants Achieving at Least a 50% Reduction From Baseline in Eczema Area and Severity Index (EASI 50) Score Day 15	22 percentage of participants	0 percentage of participants	—	—	—	—	—	—	—	—	—	—
Part B: Percentage of Participants Achieving at Least a 50% Reduction From Baseline in Eczema Area and Severity Index (EASI 50) Score Day 29	22 percentage of participants	0 percentage of participants	—	—	—	—	—	—	—	—	—	—
Part B: Percentage of Participants Achieving at Least a 50% Reduction From Baseline in Eczema Area and Severity Index (EASI 50) Score Day 43	22 percentage of participants	33 percentage of participants	—	—	—	—	—	—	—	—	—	—
Part B: Percentage of Participants Achieving at Least a 50% Reduction From Baseline in Eczema Area and Severity Index (EASI 50) Score Day 57	22 percentage of participants	0 percentage of participants	—	—	—	—	—	—	—	—	—	—
Part B: Percentage of Participants Achieving at Least a 50% Reduction From Baseline in Eczema Area and Severity Index (EASI 50) Score Day 85	50 percentage of participants	0 percentage of participants	—	—	—	—	—	—	—	—	—	—
Part B: Percentage of Participants Achieving at Least a 50% Reduction From Baseline in Eczema Area and Severity Index (EASI 50) Score Day 113	33 percentage of participants	33 percentage of participants	—	—	—	—	—	—	—	—	—	—
Part B: Percentage of Participants Achieving at Least a 50% Reduction From Baseline in Eczema Area and Severity Index (EASI 50) Score At any postdose time point	56 percentage of participants	33 percentage of participants	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline and days 15, 29, 43, 57, 85, and 113

Population: All participants in Part B who received at least 1 dose of study drug and with available data at each time point.

Outcome measures

Outcome measures
Measure	Part B: Tezepelumab 700 mg IV n=9 Participants Participants with atopic dermatitis received a single dose of 700 mg tezepelumab administered intravenously.	Part B: Placebo n=3 Participants Participants with atopic dermatitis received a single dose of placebo to tezepelumab administered intravenously.	Part A: Tezepelumab 21 mg SC Healthy participants received a single dose of 21 mg tezepelumab administered subcutaneously.	Part A: Tezepelumab 70 mg SC Healthy participants received a single dose of 70 mg tezepelumab administered subcutaneously.	Part A: Tezepelumab 210 mg SC Healthy participants received a single dose of 210 mg tezepelumab administered subcutaneously.	Part A: Tezepelumab 420 mg SC Healthy participants received a single dose of 420 mg tezepelumab administered subcutaneously.	Part A: Tezepelumab 210 mg IV Healthy participants received a single dose of 210 mg tezepelumab administered intravenously.	Part A: Tezepelumab 700 mg IV Healthy participants received a single dose of 700 mg tezepelumab administered intravenously.	Part A: Placebo SC Healthy participants received a single dose of placebo to tezepelumab administered subcutaneously.	Part A: Placebo IV Healthy participants received a single dose of placebo to tezepelumab administered intravenously.	Part B: Tezepelumab 700 mg IV Participants with atopic dermatitis received a single dose of 700 mg tezepelumab administered intravenously.	Part B: Placebo IV Participants with atopic dermatitis received a single dose of placebo to tezepelumab administered intravenously.
Part B: Percentage of Participants Achieving at Least a 75% Reduction From Baseline in Eczema Area and Severity Index (EASI 75) Score Day 15	0 percentage of participants	0 percentage of participants	—	—	—	—	—	—	—	—	—	—
Part B: Percentage of Participants Achieving at Least a 75% Reduction From Baseline in Eczema Area and Severity Index (EASI 75) Score Day 29	0 percentage of participants	0 percentage of participants	—	—	—	—	—	—	—	—	—	—
Part B: Percentage of Participants Achieving at Least a 75% Reduction From Baseline in Eczema Area and Severity Index (EASI 75) Score Day 43	0 percentage of participants	0 percentage of participants	—	—	—	—	—	—	—	—	—	—
Part B: Percentage of Participants Achieving at Least a 75% Reduction From Baseline in Eczema Area and Severity Index (EASI 75) Score Day 57	11 percentage of participants	0 percentage of participants	—	—	—	—	—	—	—	—	—	—
Part B: Percentage of Participants Achieving at Least a 75% Reduction From Baseline in Eczema Area and Severity Index (EASI 75) Score Day 85	13 percentage of participants	0 percentage of participants	—	—	—	—	—	—	—	—	—	—
Part B: Percentage of Participants Achieving at Least a 75% Reduction From Baseline in Eczema Area and Severity Index (EASI 75) Score Day 113	22 percentage of participants	0 percentage of participants	—	—	—	—	—	—	—	—	—	—
Part B: Percentage of Participants Achieving at Least a 75% Reduction From Baseline in Eczema Area and Severity Index (EASI 75) Score At any postdose time point	22 percentage of participants	0 percentage of participants	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline and days 15, 29, 43, 57, 85, and 113

Population: All participants in Part B who received at least 1 dose of study drug and with available data at each time point.

EASI is a tool used to measure the severity of AD. The index involves an assessment of the intensity of 4 clinical signs (erythema, infiltration/papulation, excoriations, and lichenification) at 4 body areas (head/neck, upper extremities, trunk, lower extremities) assessed on a scale from 0 (none) to 3 (severe). The percent affected area for each of the 4 body areas is assessed on a 6-point scale from 0 (0%) to 6 (90% to 100%). The total score for each body region is obtained by multiplying the sum of the severity scores of the 4 clinical signs by the area score, with adjustment for the proportion of the body region to the whole body. The total EASI score is the sum of the scores for each body region, and ranges from 0 to 72, with higher scores indicating greater disease severity. Percent change from baseline = \[(Post-baseline Value - Baseline Value) / Baseline Value\] x 100. A negative change from baseline indicates improvement.

Outcome measures

Outcome measures
Measure	Part B: Tezepelumab 700 mg IV n=9 Participants Participants with atopic dermatitis received a single dose of 700 mg tezepelumab administered intravenously.	Part B: Placebo n=3 Participants Participants with atopic dermatitis received a single dose of placebo to tezepelumab administered intravenously.	Part A: Tezepelumab 21 mg SC Healthy participants received a single dose of 21 mg tezepelumab administered subcutaneously.	Part A: Tezepelumab 70 mg SC Healthy participants received a single dose of 70 mg tezepelumab administered subcutaneously.	Part A: Tezepelumab 210 mg SC Healthy participants received a single dose of 210 mg tezepelumab administered subcutaneously.	Part A: Tezepelumab 420 mg SC Healthy participants received a single dose of 420 mg tezepelumab administered subcutaneously.	Part A: Tezepelumab 210 mg IV Healthy participants received a single dose of 210 mg tezepelumab administered intravenously.	Part A: Tezepelumab 700 mg IV Healthy participants received a single dose of 700 mg tezepelumab administered intravenously.	Part A: Placebo SC Healthy participants received a single dose of placebo to tezepelumab administered subcutaneously.	Part A: Placebo IV Healthy participants received a single dose of placebo to tezepelumab administered intravenously.	Part B: Tezepelumab 700 mg IV Participants with atopic dermatitis received a single dose of 700 mg tezepelumab administered intravenously.	Part B: Placebo IV Participants with atopic dermatitis received a single dose of placebo to tezepelumab administered intravenously.
Part B: Percent Change From Baseline in Eczema Area and Severity Index (EASI) Score Day 15	-12.47 percent change Standard Deviation 43.32	15.10 percent change Standard Deviation 55.84	—	—	—	—	—	—	—	—	—	—
Part B: Percent Change From Baseline in Eczema Area and Severity Index (EASI) Score Day 29	-23.61 percent change Standard Deviation 32.82	-25.03 percent change Standard Deviation 20.38	—	—	—	—	—	—	—	—	—	—
Part B: Percent Change From Baseline in Eczema Area and Severity Index (EASI) Score Day 43	-17.04 percent change Standard Deviation 44.28	-32.41 percent change Standard Deviation 31.81	—	—	—	—	—	—	—	—	—	—
Part B: Percent Change From Baseline in Eczema Area and Severity Index (EASI) Score Day 57	-22.83 percent change Standard Deviation 41.23	-1.89 percent change Standard Deviation 37.24	—	—	—	—	—	—	—	—	—	—
Part B: Percent Change From Baseline in Eczema Area and Severity Index (EASI) Score Day 85	-31.70 percent change Standard Deviation 42.14	-23.01 percent change Standard Deviation 21.16	—	—	—	—	—	—	—	—	—	—
Part B: Percent Change From Baseline in Eczema Area and Severity Index (EASI) Score Day 113	-25.25 percent change Standard Deviation 49.40	-11.28 percent change Standard Deviation 54.63	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline and days 15, 29, 43, 57, 85, and 113

Population: All participants in Part B who received at least 1 dose of study drug and with available data at each time point.

IGA score is a static 6-point measure of disease activity based on an overall assessment of skin lesions. The IGA was scored on a scale of 0 to 5, where 0 (clear) = no inflammatory signs of AD; 1. (almost clear) = just perceptible erythema and just perceptible papulation/infiltration; 2. (mild) = mild erythema and mild papulation and infiltration; 3. (moderate) = moderate erythema and moderate papulation and infiltration; 4. (severe) = severe disease with severe erythema and severe papulation and infiltration; 5. (very severe) = severe disease with severe erythema and severe papulation and infiltration with oozing/crusting. A negative change from baseline indicates improvement.