Trial Outcomes & Findings for Phase 2a Study to Evaluate the Efficacy and Safety of MEDI9929 in Adults With Atopic Dermatitis (NCT NCT02525094)

Last Updated: 2018-02-15

Results Overview

The eczema area and severity index (EASI) evaluates 4 natural anatomical regions for severity (0 \[none\] to 3 \[severe\]) and extent of key disease signs and focuses on the key acute and chronic signs of inflammation (erythema, induration/papulation, excoriation, and lichenification). The total score is the sum of the four body-region scores, maximum=72, minimum=0. The higher values indicating more severe disease. The EASI50 responder defined as a participant who achieved at least 50% reduction in EASI score from baseline.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

113 participants

Primary outcome timeframe

Baseline (Day 1) and Week 12

Results posted on

2018-02-15

Participant Flow

The study was conducted from 15Aug2015 to 15Jul2016.

A total of 155 participants were screened, of which 113 were randomized into the study.

Participant milestones

Participant milestones
Measure	Placebo Participants received 6 subcutaneous doses of placebo every 2 weeks for 12 weeks (with the last dose at Week 10) and were followed up till Week 22. Additionally, the participants received maintenance therapy of Class 3 topical corticosteroids (TCS) cream or ointment for lesional skin from the start of the run-in period (Visit 2, Week -2) to Week 22.	MEDI9929 280 mg Participants received 6 subcutaneous doses of MEDI9929 280 mg every 2 weeks for 12 weeks (with the last dose at Week 10) and were followed up till Week 22. Additionally, the participants received maintenance therapy of Class 3 topical corticosteroids (TCS) cream or ointment for lesional skin from the start of the run-in period (Visit 2, Week -2) to Week 22.
Overall Study STARTED	57	56
Overall Study Treated	56	55
Overall Study COMPLETED	49	48
Overall Study NOT COMPLETED	8	8

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Participants received 6 subcutaneous doses of placebo every 2 weeks for 12 weeks (with the last dose at Week 10) and were followed up till Week 22. Additionally, the participants received maintenance therapy of Class 3 topical corticosteroids (TCS) cream or ointment for lesional skin from the start of the run-in period (Visit 2, Week -2) to Week 22.	MEDI9929 280 mg Participants received 6 subcutaneous doses of MEDI9929 280 mg every 2 weeks for 12 weeks (with the last dose at Week 10) and were followed up till Week 22. Additionally, the participants received maintenance therapy of Class 3 topical corticosteroids (TCS) cream or ointment for lesional skin from the start of the run-in period (Visit 2, Week -2) to Week 22.
Overall Study Lost to Follow-up	2	1
Overall Study Withdrawal by Subject	5	6
Overall Study Not Treated	1	1

Baseline Characteristics

Phase 2a Study to Evaluate the Efficacy and Safety of MEDI9929 in Adults With Atopic Dermatitis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=56 Participants Participants received 6 subcutaneous doses of placebo every 2 weeks for 12 weeks (with the last dose at Week 10) and were followed up till Week 22. Additionally, the participants received maintenance therapy of Class 3 topical corticosteroids (TCS) cream or ointment for lesional skin from the start of the run-in period (Visit 2, Week -2) to Week 22.	MEDI9929 280 mg n=55 Participants Participants received 6 subcutaneous doses of MEDI9929 280 mg every 2 weeks for 12 weeks (with the last dose at Week 10) and were followed up till Week 22. Additionally, the participants received maintenance therapy of Class 3 topical corticosteroids (TCS) cream or ointment for lesional skin from the start of the run-in period (Visit 2, Week -2) to Week 22.	Total n=111 Participants Total of all reporting groups
Age, Continuous	38.8 Years STANDARD_DEVIATION 15.3 • n=5 Participants	38.5 Years STANDARD_DEVIATION 14.9 • n=7 Participants	38.7 Years STANDARD_DEVIATION 15.0 • n=5 Participants
Age, Customized 18-35 years	28 Participants n=5 Participants	27 Participants n=7 Participants	55 Participants n=5 Participants
Age, Customized 36-75 years	28 Participants n=5 Participants	28 Participants n=7 Participants	56 Participants n=5 Participants
Sex: Female, Male Female	26 Participants n=5 Participants	23 Participants n=7 Participants	49 Participants n=5 Participants
Sex: Female, Male Male	30 Participants n=5 Participants	32 Participants n=7 Participants	62 Participants n=5 Participants
Eczema Area and Severity Index Score <= 25 points	36 Participants n=5 Participants	33 Participants n=7 Participants	69 Participants n=5 Participants
Eczema Area and Severity Index Score > 25 points	20 Participants n=5 Participants	22 Participants n=7 Participants	42 Participants n=5 Participants
Investigator's Global Assessment Category 2	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Investigator's Global Assessment Category 3	46 Participants n=5 Participants	44 Participants n=7 Participants	90 Participants n=5 Participants
Investigator's Global Assessment Category 4	10 Participants n=5 Participants	10 Participants n=7 Participants	20 Participants n=5 Participants
Atopic Dermatitis Status IgE >= 150 kU/L and Positive Serum Specific IgEa	50 Participants n=5 Participants	47 Participants n=7 Participants	97 Participants n=5 Participants
Atopic Dermatitis Status IgE >= 150 kU/L and Negative Serum Specific IgE	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Atopic Dermatitis Status IgE < 150 kU/L and Positive Serum Specific IgE	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Atopic Dermatitis Status IgE < 150 kU/L and Negative Serum Specific IgEb	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
Atopic Dermatitis Status Missing	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline (Day 1) and Week 12

Population: Intent-To-Treat (ITT) population included all participants who were randomized and received any study investigational product.

Outcome measures

Outcome measures
Measure	Placebo n=56 Participants Participants received 6 subcutaneous doses of placebo every 2 weeks for 12 weeks (with the last dose at Week 10) and were followed up till Week 22. Additionally, the participants received maintenance therapy of Class 3 topical corticosteroids (TCS) cream or ointment for lesional skin from the start of the run-in period (Visit 2, Week -2) to Week 22.	MEDI9929 280 mg n=55 Participants Participants received 6 subcutaneous doses of MEDI9929 280 mg every 2 weeks for 12 weeks (with the last dose at Week 10) and were followed up till Week 22. Additionally, the participants received maintenance therapy of Class 3 topical corticosteroids (TCS) cream or ointment for lesional skin from the start of the run-in period (Visit 2, Week -2) to Week 22.
Percentage of Participants Achieving Greater Than or Equal to (>=) 50 Percent (%) Reduction From Baseline in Eczema Area and Severity Index (EASI 50) at Week 12	48.2 Percentage of participants	64.7 Percentage of participants

SECONDARY outcome

Timeframe: Baseline (Day 1) and Week 12

Population: ITT population included all participants who were randomized and received any study investigational product.

The EASI evaluates 4 natural anatomical regions for severity (0 \[none\] to 3 \[severe\]) and extent of key disease signs and focuses on the key acute and chronic signs of inflammation (erythema, induration/papulation, excoriation, and lichenification). The total score is the sum of the four body-region scores, maximum=72, minimum=0. The higher values indicating more severe disease. The EASI75 responder defined as a participant who achieves at least a 75% reduction in EASI score from baseline.

Outcome measures

Outcome measures
Measure	Placebo n=56 Participants Participants received 6 subcutaneous doses of placebo every 2 weeks for 12 weeks (with the last dose at Week 10) and were followed up till Week 22. Additionally, the participants received maintenance therapy of Class 3 topical corticosteroids (TCS) cream or ointment for lesional skin from the start of the run-in period (Visit 2, Week -2) to Week 22.	MEDI9929 280 mg n=55 Participants Participants received 6 subcutaneous doses of MEDI9929 280 mg every 2 weeks for 12 weeks (with the last dose at Week 10) and were followed up till Week 22. Additionally, the participants received maintenance therapy of Class 3 topical corticosteroids (TCS) cream or ointment for lesional skin from the start of the run-in period (Visit 2, Week -2) to Week 22.
Percentage of Participants Achieving >= 75 % Reduction From Baseline in EASI75 at Week 12	19.8 Percentage of participants	24.4 Percentage of participants

SECONDARY outcome

Timeframe: Baseline (Day 1) and Week 12

Population: ITT population included all participants who were randomized and received any study investigational product.

Outcome measures

Outcome measures
Measure	Placebo n=56 Participants Participants received 6 subcutaneous doses of placebo every 2 weeks for 12 weeks (with the last dose at Week 10) and were followed up till Week 22. Additionally, the participants received maintenance therapy of Class 3 topical corticosteroids (TCS) cream or ointment for lesional skin from the start of the run-in period (Visit 2, Week -2) to Week 22.	MEDI9929 280 mg n=55 Participants Participants received 6 subcutaneous doses of MEDI9929 280 mg every 2 weeks for 12 weeks (with the last dose at Week 10) and were followed up till Week 22. Additionally, the participants received maintenance therapy of Class 3 topical corticosteroids (TCS) cream or ointment for lesional skin from the start of the run-in period (Visit 2, Week -2) to Week 22.
Mean Change From Baseline in EASI Total Score at Week 12 Baseline	24.48 units on a scale Standard Deviation 11.21	24.05 units on a scale Standard Deviation 12.38
Mean Change From Baseline in EASI Total Score at Week 12 Week 12	-11.23 units on a scale Standard Deviation 8.73	-12.16 units on a scale Standard Deviation 9.96

SECONDARY outcome

Timeframe: Baseline (Day 1) and Week 12

Population: ITT population included all participants who were randomized and received any study investigational product.

The investigator's global assessment (IGA) allows investigators to assess overall disease severity at one given time point and consists of a 5-point severity scale from clear to severe disease (0 = clear, 1 = almost clear, 2 = mild disease, 3 = moderate disease, and 4 = severe disease). A participant has IGA response if they achieve a score of 0 (clear) or 1 (almost clear) and at least a 2-grade reduction from baseline.

Outcome measures

Outcome measures
Measure	Placebo n=56 Participants Participants received 6 subcutaneous doses of placebo every 2 weeks for 12 weeks (with the last dose at Week 10) and were followed up till Week 22. Additionally, the participants received maintenance therapy of Class 3 topical corticosteroids (TCS) cream or ointment for lesional skin from the start of the run-in period (Visit 2, Week -2) to Week 22.	MEDI9929 280 mg n=55 Participants Participants received 6 subcutaneous doses of MEDI9929 280 mg every 2 weeks for 12 weeks (with the last dose at Week 10) and were followed up till Week 22. Additionally, the participants received maintenance therapy of Class 3 topical corticosteroids (TCS) cream or ointment for lesional skin from the start of the run-in period (Visit 2, Week -2) to Week 22.
Percentage of Participants Achieving Investigator's Global Assessment (IGA) Response of 0 (Clear) or 1 (Almost Clear) and at Least a 2-Grade Reduction From Baseline	12.8 Percentage of participants	19.3 Percentage of participants

SECONDARY outcome

Timeframe: Baseline (Day 1) and Week 12

Population: ITT population included all participants who were randomized and received any study investigational product.

The scoring of atopic dermatitis (SCORAD) is a clinical tool for assessing the severity (that is, extent, intensity) of atopic dermatitis (AD). The tool evaluates the extent and intensity of the AD lesions, along with participant symptoms. The range of the SCORAD is 0-103, where 0 indicates no eczema. The higher values indicating more severe disease.

Outcome measures

Outcome measures
Measure	Placebo n=56 Participants Participants received 6 subcutaneous doses of placebo every 2 weeks for 12 weeks (with the last dose at Week 10) and were followed up till Week 22. Additionally, the participants received maintenance therapy of Class 3 topical corticosteroids (TCS) cream or ointment for lesional skin from the start of the run-in period (Visit 2, Week -2) to Week 22.	MEDI9929 280 mg n=55 Participants Participants received 6 subcutaneous doses of MEDI9929 280 mg every 2 weeks for 12 weeks (with the last dose at Week 10) and were followed up till Week 22. Additionally, the participants received maintenance therapy of Class 3 topical corticosteroids (TCS) cream or ointment for lesional skin from the start of the run-in period (Visit 2, Week -2) to Week 22.
Mean Change From Baseline in the Scoring of Atopic Dermatitis (SCORAD) at Week 12 Baseline	58.66 units on a scale Standard Deviation 13.32	57.68 units on a scale Standard Deviation 14.80
Mean Change From Baseline in the Scoring of Atopic Dermatitis (SCORAD) at Week 12 Week 12	-19.35 units on a scale Standard Deviation 17.49	-24.24 units on a scale Standard Deviation 16.94

SECONDARY outcome

Timeframe: Baseline (Day 1) and Week 12

Population: ITT population included all participants who were randomized and received any study investigational product.

The SCORAD is a clinical tool for assessing the severity (that is, extent, intensity) of atopic dermatitis (AD). The tool evaluates the extent and intensity of the AD lesions, along with participant symptoms. The range of the SCORAD is 0-103, where 0 indicates no eczema. The higher values indicating more severe disease. The SCORAD 50 responder defined as a participant who achieves at least a 50% reduction in SCORAD score from baseline.

Outcome measures

Outcome measures
Measure	Placebo n=56 Participants Participants received 6 subcutaneous doses of placebo every 2 weeks for 12 weeks (with the last dose at Week 10) and were followed up till Week 22. Additionally, the participants received maintenance therapy of Class 3 topical corticosteroids (TCS) cream or ointment for lesional skin from the start of the run-in period (Visit 2, Week -2) to Week 22.	MEDI9929 280 mg n=55 Participants Participants received 6 subcutaneous doses of MEDI9929 280 mg every 2 weeks for 12 weeks (with the last dose at Week 10) and were followed up till Week 22. Additionally, the participants received maintenance therapy of Class 3 topical corticosteroids (TCS) cream or ointment for lesional skin from the start of the run-in period (Visit 2, Week -2) to Week 22.
Percentage of Participants Achieving >= 50% Reduction From Baseline in SCORAD 50	29.4 Percentage of participants	41.0 Percentage of participants

SECONDARY outcome

Timeframe: Baseline (Day 1) and Week 12

Population: ITT population included all participants who were randomized and received any study investigational product.

The SCORAD is a clinical tool for assessing the severity (that is, extent, intensity) of atopic dermatitis (AD). The tool evaluates the extent and intensity of the AD lesions, along with participant symptoms. The range of the SCORAD is 0-103, where 0 indicates no eczema. The higher values indicating more severe disease. The SCORAD 75 responder is defined as a participant who achieves at least a 75% reduction in SCORAD score from baseline.

Outcome measures

Outcome measures
Measure	Placebo n=56 Participants Participants received 6 subcutaneous doses of placebo every 2 weeks for 12 weeks (with the last dose at Week 10) and were followed up till Week 22. Additionally, the participants received maintenance therapy of Class 3 topical corticosteroids (TCS) cream or ointment for lesional skin from the start of the run-in period (Visit 2, Week -2) to Week 22.	MEDI9929 280 mg n=55 Participants Participants received 6 subcutaneous doses of MEDI9929 280 mg every 2 weeks for 12 weeks (with the last dose at Week 10) and were followed up till Week 22. Additionally, the participants received maintenance therapy of Class 3 topical corticosteroids (TCS) cream or ointment for lesional skin from the start of the run-in period (Visit 2, Week -2) to Week 22.
Percentage of Participants Achieving >= 75% Reduction From Baseline in SCORAD 75	7.4 Percentage of participants	9.8 Percentage of participants

SECONDARY outcome

Timeframe: Baseline (Day 1) and Week 12

Population: ITT population included all participants who were randomized and received any study investigational product.

Pruritus is assessed using an Numeric Rating Scale (NRS) (0 - 10) with 0= no itch and 10= worst imaginable itch. Daily pruritus assessments were summarized as weekly peak score and a change from baseline in weekly peak score was calculated.

Outcome measures

Outcome measures
Measure	Placebo n=56 Participants Participants received 6 subcutaneous doses of placebo every 2 weeks for 12 weeks (with the last dose at Week 10) and were followed up till Week 22. Additionally, the participants received maintenance therapy of Class 3 topical corticosteroids (TCS) cream or ointment for lesional skin from the start of the run-in period (Visit 2, Week -2) to Week 22.	MEDI9929 280 mg n=55 Participants Participants received 6 subcutaneous doses of MEDI9929 280 mg every 2 weeks for 12 weeks (with the last dose at Week 10) and were followed up till Week 22. Additionally, the participants received maintenance therapy of Class 3 topical corticosteroids (TCS) cream or ointment for lesional skin from the start of the run-in period (Visit 2, Week -2) to Week 22.
Mean Change From Baseline in Average Pruritus Numeric Rating Scale (NRS) at Week 12 Baseline	5.15 units on a scale Standard Deviation 2.10	5.26 units on a scale Standard Deviation 2.02
Mean Change From Baseline in Average Pruritus Numeric Rating Scale (NRS) at Week 12 Week 12	-1.39 units on a scale Standard Deviation 1.93	-1.90 units on a scale Standard Deviation 1.99

SECONDARY outcome

Timeframe: Baseline (Day 1) and Week 12

Population: ITT population included all participants who were randomized and received any study investigational product.

The 5-D pruritus scale is a brief questionnaire designed to assess itch. This scale takes into account the multidimensional nature of pruritus, its impact on quality of life, and is capable of detecting change over time. The 5-D pruritus scale included 5 domains (duration, degree, direction, disability, and distribution of pruritus). The total 5-D score was obtained by scoring each of the domains separately and then summing them together. 5-D total scores ranged between 5 (no pruritus) and 25 (most severe pruritus). The higher values indicating more severe pruritus.

Outcome measures

Outcome measures
Measure	Placebo n=56 Participants Participants received 6 subcutaneous doses of placebo every 2 weeks for 12 weeks (with the last dose at Week 10) and were followed up till Week 22. Additionally, the participants received maintenance therapy of Class 3 topical corticosteroids (TCS) cream or ointment for lesional skin from the start of the run-in period (Visit 2, Week -2) to Week 22.	MEDI9929 280 mg n=55 Participants Participants received 6 subcutaneous doses of MEDI9929 280 mg every 2 weeks for 12 weeks (with the last dose at Week 10) and were followed up till Week 22. Additionally, the participants received maintenance therapy of Class 3 topical corticosteroids (TCS) cream or ointment for lesional skin from the start of the run-in period (Visit 2, Week -2) to Week 22.
Mean Change From Baseline in 5-D Pruritus Score at Week 12 Baseline	16.7 units on a scale Standard Deviation 3.7	16.0 units on a scale Standard Deviation 3.7
Mean Change From Baseline in 5-D Pruritus Score at Week 12 Week 12	-3.9 units on a scale Standard Deviation 4.5	-3.6 units on a scale Standard Deviation 4.4

SECONDARY outcome

Timeframe: From treatment administration (Day1) to 22 weeks

Population: As-treated population included all participants who received any study drug. Participants who received at least one dose of MEDI9929 during study, regardless of randomized treatment assignment, were analyzed under MEDI9929. One participant who randomized to placebo but received an incorrect first dose of MEDI9929 was included in "MEDI9929" group.

An Adverse event is any unfavourable and unintended signs (including abnormal laboratory findings), symptoms, or diseases temporally associated with use of investigational product, whether or not considered related to investigational product. Serious adverse event is any AE that resulted in:death;inpatient hospitalization or prolongation of existing hospitalization;persistent or significant disability or incapacity;is life-threatening;is a congenital anomaly/birth defect in offspring of a study participant;or was an important medical event that may not have resulted in death, threatened life,or required hospitalization and that, based on appropriate medical judgment, may have jeopardized participant and may have required medical or surgical intervention to prevent one of outcomes above. TEAEs are defined as AEs present at baseline that worsened in intensity after administration of study drug, or events absent at baseline that emerged after administration of study drug until Week 22.

Outcome measures

Outcome measures
Measure	Placebo n=55 Participants Participants received 6 subcutaneous doses of placebo every 2 weeks for 12 weeks (with the last dose at Week 10) and were followed up till Week 22. Additionally, the participants received maintenance therapy of Class 3 topical corticosteroids (TCS) cream or ointment for lesional skin from the start of the run-in period (Visit 2, Week -2) to Week 22.	MEDI9929 280 mg n=56 Participants Participants received 6 subcutaneous doses of MEDI9929 280 mg every 2 weeks for 12 weeks (with the last dose at Week 10) and were followed up till Week 22. Additionally, the participants received maintenance therapy of Class 3 topical corticosteroids (TCS) cream or ointment for lesional skin from the start of the run-in period (Visit 2, Week -2) to Week 22.
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) TEAEs	40 Participants	38 Participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) TESAEs	3 Participants	2 Participants

SECONDARY outcome

Timeframe: Week 0 (Pre dose), Weeks 4, 8, and 12 (post dose)

Population: PK population included all participants who received MEDI9929 and had a sufficient number of serum concentration measurements for computing PK parameters.

The mean serum concentrations of MEDI9929 was observed at specified timepoints.

Outcome measures

Outcome measures
Measure	Placebo n=55 Participants Participants received 6 subcutaneous doses of placebo every 2 weeks for 12 weeks (with the last dose at Week 10) and were followed up till Week 22. Additionally, the participants received maintenance therapy of Class 3 topical corticosteroids (TCS) cream or ointment for lesional skin from the start of the run-in period (Visit 2, Week -2) to Week 22.	MEDI9929 280 mg Participants received 6 subcutaneous doses of MEDI9929 280 mg every 2 weeks for 12 weeks (with the last dose at Week 10) and were followed up till Week 22. Additionally, the participants received maintenance therapy of Class 3 topical corticosteroids (TCS) cream or ointment for lesional skin from the start of the run-in period (Visit 2, Week -2) to Week 22.
Mean Trough Serum Concentration of MEDI9929 Week 0	NA mcg/mL Standard Deviation NA All pre-first-dose values were below the limit of quantification and not calculated.	—
Mean Trough Serum Concentration of MEDI9929 Week 4	34.7 mcg/mL Standard Deviation 10.9	—
Mean Trough Serum Concentration of MEDI9929 Week 8	50.5 mcg/mL Standard Deviation 17.5	—
Mean Trough Serum Concentration of MEDI9929 Week 12	54.9 mcg/mL Standard Deviation 21.5	—

SECONDARY outcome

Timeframe: Baseline (Day 1) to Week 22

Population: ITT population included all participants who were randomized and received any study investigational product.

A participant was considered ADA-positive across the study if they had a positive reading (titer of 50 or higher) at any time point during the study period.

Outcome measures

Outcome measures
Measure	Placebo n=56 Participants Participants received 6 subcutaneous doses of placebo every 2 weeks for 12 weeks (with the last dose at Week 10) and were followed up till Week 22. Additionally, the participants received maintenance therapy of Class 3 topical corticosteroids (TCS) cream or ointment for lesional skin from the start of the run-in period (Visit 2, Week -2) to Week 22.	MEDI9929 280 mg n=55 Participants Participants received 6 subcutaneous doses of MEDI9929 280 mg every 2 weeks for 12 weeks (with the last dose at Week 10) and were followed up till Week 22. Additionally, the participants received maintenance therapy of Class 3 topical corticosteroids (TCS) cream or ointment for lesional skin from the start of the run-in period (Visit 2, Week -2) to Week 22.
Number of Participants Who Developed Detectable MEDI9929 Anti-drug Antibodies Baseline	2 Participants	1 Participants
Number of Participants Who Developed Detectable MEDI9929 Anti-drug Antibodies Week 22	2 Participants	0 Participants

Adverse Events

Placebo

Serious events: 3 serious events

Other events: 33 other events

Deaths: 0 deaths

MEDI9929 280 mg

Serious events: 2 serious events

Other events: 29 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Placebo n=55 participants at risk Participants received 6 subcutaneous doses of placebo every 2 weeks for 12 weeks (with the last dose at Week 10) and were followed up till Week 22. Additionally, the participants received maintenance therapy of Class 3 topical corticosteroids (TCS) cream or ointment for lesional skin from the start of the run-in period (Visit 2, Week -2) to Week 22.	MEDI9929 280 mg n=56 participants at risk Participants received 6 subcutaneous doses of MEDI9929 280 mg every 2 weeks for 12 weeks (with the last dose at Week 10) and were followed up till Week 22. Additionally, the participants received maintenance therapy of Class 3 topical corticosteroids (TCS) cream or ointment for lesional skin from the start of the run-in period (Visit 2, Week -2) to Week 22.
General disorders Chest pain	1.8% 1/55 • Number of events 1 • From treatment administration (Day1) to 22 weeks AEs were reported for As-treated population, which included all participants who received any study drug. Participants who received at least one dose of MEDI9929, regardless of randomized treatment, were analyzed under MEDI9929. One participant who randomized to placebo but received an incorrect first dose of MEDI9929 was included in MEDI9929 group	0.00% 0/56 • From treatment administration (Day1) to 22 weeks AEs were reported for As-treated population, which included all participants who received any study drug. Participants who received at least one dose of MEDI9929, regardless of randomized treatment, were analyzed under MEDI9929. One participant who randomized to placebo but received an incorrect first dose of MEDI9929 was included in MEDI9929 group
Infections and infestations Cellulitis	1.8% 1/55 • Number of events 1 • From treatment administration (Day1) to 22 weeks AEs were reported for As-treated population, which included all participants who received any study drug. Participants who received at least one dose of MEDI9929, regardless of randomized treatment, were analyzed under MEDI9929. One participant who randomized to placebo but received an incorrect first dose of MEDI9929 was included in MEDI9929 group	0.00% 0/56 • From treatment administration (Day1) to 22 weeks AEs were reported for As-treated population, which included all participants who received any study drug. Participants who received at least one dose of MEDI9929, regardless of randomized treatment, were analyzed under MEDI9929. One participant who randomized to placebo but received an incorrect first dose of MEDI9929 was included in MEDI9929 group
Infections and infestations Infected dermal cyst	0.00% 0/55 • From treatment administration (Day1) to 22 weeks AEs were reported for As-treated population, which included all participants who received any study drug. Participants who received at least one dose of MEDI9929, regardless of randomized treatment, were analyzed under MEDI9929. One participant who randomized to placebo but received an incorrect first dose of MEDI9929 was included in MEDI9929 group	1.8% 1/56 • Number of events 1 • From treatment administration (Day1) to 22 weeks AEs were reported for As-treated population, which included all participants who received any study drug. Participants who received at least one dose of MEDI9929, regardless of randomized treatment, were analyzed under MEDI9929. One participant who randomized to placebo but received an incorrect first dose of MEDI9929 was included in MEDI9929 group
Nervous system disorders Syncope	1.8% 1/55 • Number of events 1 • From treatment administration (Day1) to 22 weeks AEs were reported for As-treated population, which included all participants who received any study drug. Participants who received at least one dose of MEDI9929, regardless of randomized treatment, were analyzed under MEDI9929. One participant who randomized to placebo but received an incorrect first dose of MEDI9929 was included in MEDI9929 group	0.00% 0/56 • From treatment administration (Day1) to 22 weeks AEs were reported for As-treated population, which included all participants who received any study drug. Participants who received at least one dose of MEDI9929, regardless of randomized treatment, were analyzed under MEDI9929. One participant who randomized to placebo but received an incorrect first dose of MEDI9929 was included in MEDI9929 group
Skin and subcutaneous tissue disorders Dermatitis atopic	1.8% 1/55 • Number of events 1 • From treatment administration (Day1) to 22 weeks AEs were reported for As-treated population, which included all participants who received any study drug. Participants who received at least one dose of MEDI9929, regardless of randomized treatment, were analyzed under MEDI9929. One participant who randomized to placebo but received an incorrect first dose of MEDI9929 was included in MEDI9929 group	1.8% 1/56 • Number of events 1 • From treatment administration (Day1) to 22 weeks AEs were reported for As-treated population, which included all participants who received any study drug. Participants who received at least one dose of MEDI9929, regardless of randomized treatment, were analyzed under MEDI9929. One participant who randomized to placebo but received an incorrect first dose of MEDI9929 was included in MEDI9929 group

Other adverse events

Additional Information

Rene van der Merwe

MedImmune, LLC

Phone: 301-398-2532

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee MedImmune has 60 days to review results communications prior to public release and may delete information that compromises on-going studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it being understood that results shall be published regardless of outcome.
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