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

Phase 2

Completed

Conditions: Atopic Dermatitis

Interventions: Biological: Placebo
Biological: MEDI9929

Registration Number: NCT02525094

Lead Sponsor: MedImmune LLC

Brief Summary: To assess the efficacy and safety of MEDI9929 in adult subjects with Atopic Dermatitis

Detailed Description: This is a Phase 2a, randomized, double-blinded, placebo-controlled study to evaluate the efficacy and safety of MEDI9929 administered subcutaneously to adult subjects with moderate to severe Atopic Dermatitis. Subjects will be randomized in a 1:1 fashion and will be stratified at screening. Approximately 100 subjects are planned to be randomized at approximately 35 sites in 6 countries

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 113

Inclusion Criteria

AD meeting Hanifin and Rajka criteria
Age 18-75 years inclusive at screening
Atopic dermatitis that affects greater than/equal to 10% body surface area
Moderate to severe AD
Effective birth control in line with protocol details

Exclusion Criteria

Active dermatologic conditions which may confuse the diagnosis of Atopic Dermatitis
Hepatitis B, C or HIV
Pregnant or breastfeeding
History of anaphylaxis following any biologic therapy
History of clinically significant infections within 4 weeks prior to Visit 3
Diagnosis of helminth parasitic infection within 6 months to screening
History of Cancer except basal cell
Receipt of any marketed or investigational biologic agent within 4 months to visit 3
Any clinically relevant abnormal finding
Major surgery within 8 weeks prior to Visit 1

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Participants will receive 6 subcutaneous doses of placebo every 2 weeks for 12 weeks, with the last dose at Week 10.
MEDI9929 280 mg	MEDI9929	Participants will receive 6 subcutaneous doses of MEDI9929 280 mg every 2 weeks for 12 weeks, with the last dose at Week 10.

Primary Outcome Measures

Name	Time	Method
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	Baseline (Day 1) and Week 12	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.

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants Achieving >= 75 % Reduction From Baseline in EASI75 at Week 12	Baseline (Day 1) and Week 12	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.
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	Baseline (Day 1) and Week 12	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.
Mean Change From Baseline in Average Pruritus Numeric Rating Scale (NRS) at Week 12	Baseline (Day 1) and Week 12	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.
Mean Change From Baseline in EASI Total Score at Week 12	Baseline (Day 1) and Week 12	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.
Mean Trough Serum Concentration of MEDI9929	Week 0 (Pre dose), Weeks 4, 8, and 12 (post dose)	The mean serum concentrations of MEDI9929 was observed at specified timepoints.
Number of Participants Who Developed Detectable MEDI9929 Anti-drug Antibodies	Baseline (Day 1) to Week 22	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.
Percentage of Participants Achieving >= 75% Reduction From Baseline in SCORAD 75	Baseline (Day 1) and Week 12	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.
Mean Change From Baseline in the Scoring of Atopic Dermatitis (SCORAD) at Week 12	Baseline (Day 1) and Week 12	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.
Percentage of Participants Achieving >= 50% Reduction From Baseline in SCORAD 50	Baseline (Day 1) and Week 12	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.
Mean Change From Baseline in 5-D Pruritus Score at Week 12	Baseline (Day 1) and Week 12	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.
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)	From treatment administration (Day1) to 22 weeks	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.