Clinical trial NCT02525094: Phase 2a Study to Evaluate the Efficacy and Safety of MEDI9929 in Adults With Atopic Dermatitis
Official title: A Phase 2a, Randomized, Double-blinded, Placebo-controlled Study to Evaluate the Efficacy and Safety of MEDI9929 in Adult Subjects With Moderate-to-Severe Atopic Dermatitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Atopic Dermatitis
Keywords: Eczema
Lead sponsor: MedImmune LLC
Sponsor class: INDUSTRY
Collaborators: name: Amgen
First posted: 2015-08-17
Enrollment: 113
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: Baseline (Day 1) and Week 12
Secondary outcomes:
measure: Percentage of Participants Achieving >= 75 % Reduction From Baseline in EASI75 at Week 12
timeFrame: Baseline (Day 1) and Week 12
measure: Mean Change From Baseline in EASI Total Score at Week 12
timeFrame: Baseline (Day 1) and Week 12
measure: 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
timeFrame: Baseline (Day 1) and Week 12
measure: Mean Change From Baseline in the Scoring of Atopic Dermatitis (SCORAD) at Week 12
timeFrame: Baseline (Day 1) and Week 12
measure: Percentage of Participants Achieving >= 50% Reduction From Baseline in SCORAD 50
timeFrame: Baseline (Day 1) and Week 12
measure: Percentage of Participants Achieving >= 75% Reduction From Baseline in SCORAD 75
timeFrame: Baseline (Day 1) and Week 12
measure: Mean Change From Baseline in Average Pruritus Numeric Rating Scale (NRS) at Week 12
timeFrame: Baseline (Day 1) and Week 12
measure: Mean Change From Baseline in 5-D Pruritus Score at Week 12
timeFrame: Baseline (Day 1) and Week 12
measure: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
timeFrame: From treatment administration (Day1) to 22 weeks
measure: Mean Trough Serum Concentration of MEDI9929
timeFrame: Week 0 (Pre dose), Weeks 4, 8, and 12 (post dose)
measure: Number of Participants Who Developed Detectable MEDI9929 Anti-drug Antibodies
timeFrame: Baseline (Day 1) to Week 22
Other outcomes:
Locations:
city: North Miami Beach
country: United States
facility: Research Site
state: Florida
city: Tampa
country: United States
facility: Research Site
state: Florida
city: Arlington Hts
country: United States
facility: Research Site
state: Illinois
city: Carmel
country: United States
facility: Research Site
state: Indiana
city: Indianapolis
country: United States
facility: Research Site
state: Indiana
city: Berlin
country: United States
facility: Research Site
state: New Jersey
city: Charlotte
country: United States
facility: Research Site
state: North Carolina
city: Portland
country: United States
facility: Research Site
state: Oregon
city: ACT
country: Australia
facility: Research Site
city: Liverpool
country: Australia
facility: Research Site
city: Woolloongabba
country: Australia
facility: Research Site
city: Surrey
country: Canada
facility: Research Site
state: British Columbia
city: Barrie
country: Canada
facility: Research Site
state: Ontario
city: Quebec
country: Canada
facility: Research Site
city: Berlin
country: Germany
facility: Research Site
city: Frankfurt/Main
country: Germany
facility: Research Site
city: Gera
country: Germany
facility: Research Site
city: Hannover
country: Germany
facility: Research Site
city: Leipzig
country: Germany
facility: Research Site
city: München
country: Germany
facility: Research Site
city: Münster
country: Germany
facility: Research Site
city: Debrecen
country: Hungary
facility: Research Site
city: Kaposvár
country: Hungary
facility: Research Site
city: Miskolc
country: Hungary
facility: Research Site
city: Pécs
country: Hungary
facility: Research Site
city: Szeged
country: Hungary
facility: Research Site
city: Szombathely
country: Hungary
facility: Research Site
city: Tauranga
country: New Zealand
facility: Research Site
city: Wellington
country: New Zealand
facility: Research Site
Study officials:
affiliation: Oregon Health and Science University
name: Eric Simpson, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: MedImmune LLC
name: Roderick Mcphee, MD
role: STUDY_DIRECTOR
References: