Clinical trial NCT04212169: Efficacy and Safety of MEDI3506 in Adult Subjects With Atopic Dermatitis
Official title: A Phase 2 Randomized, Double-blinded, Placebo-controlled Study to Evaluate the Efficacy and Safety of MEDI3506 in Adult Subjects With Moderate-to-severe Atopic Dermatitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Atopic Dermatitis
Keywords: MEDI3506
Safety
Efficacy
Atopic Dermatitis
Eczema
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2019-12-26
Enrollment: 148
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomised to receive MEDI3506 dose 1, MEDI3506 Dose 2 or MEDI3506 dose 3 or placebo.
Primary purpose: TREATMENT

Brief summary: This is a research study to determine the efficacy and safety of investigational drug MEDI3506 for the treatment of adult subjects with Atopic Dermatitis.

Detailed description: This is a research study to determine the efficacy and safety of investigational drug MEDI3506 for the treatment of adult subjects with Atopic Dermatitis.

Each participant will be assigned randomly to a treatment arm, which could be different strengths of the active treatment or a placebo which does not contain active treatment. Both Participants and investigators will be masked to the treatment assignment.

Approximately 152 participants will take part in this study. There is a 4 weeks screening period to determine eligibility. After eligibility is confirmed, participants will receive investigational drug or placebo during the 16 weeks treatment period. This is then followed by an 8-week follow-up period.

Eligibility criteria: Inclusion Criteria:

* Age 18 to 65 years inclusive at the time of consent.
* Body mass index between 19.0 and 40.0 kg/m2 inclusive.
* Documented history of chronic AD, for at least 1 year prior to screening Visit 1.
* Meets at minimum 1 of the criteria, as follows:

  * History of inadequate response to topical medications for AD
  * Subject intolerance to treatment with topical medications for AD, or
  * Topical medications are otherwise medically inadvisable
* AD that affects ≥ 10% of the body surface area (BSA).
* An EASI score of ≥ 12 at Visit 1 and ≥ 16 at Visit 3 (Day 1).
* An IGA score of ≥ 3.

Exclusion Criteria:

* Any active medical or psychiatric condition, or other reason, that would interfere with evaluation of the investigational product or interpretation of subject safety or study results.
* Any other clinically relevant abnormal findings from physical examination (including vital signs and electrocardiogram \[ECG\]) or from safety laboratory analysis.
* Active dermatologic conditions that might confound the diagnosis of AD or would interfere with the assessment of the skin.
* Known active allergic or irritant contact dermatitis.

Primary outcomes:
measure: Percent Change From Baseline to Week 16 in EASI Score
timeFrame: Week 16
Secondary outcomes:
measure: Percentage of Subjects Achieving a 90% Reduction From Baseline in EASI Score at Week 16
timeFrame: Week 16
measure: Percentage of Subjects Achieving a 75% Reduction From Baseline in EASI Score at Week 16
timeFrame: Week 16
measure: Percentage of Subjects Achieving a 50% Reduction From Baseline in EASI Score at Week 16
timeFrame: Week 16
measure: Percentage of Subjects Achieving an IGA of 0 (Clear) or 1 (Almost Clear) With at Least a 2 Grade Reduction From Baseline Score at Week 16
timeFrame: Week 16
measure: Percentage of Subjects Achieving a Reduction of ≥ 3 From Baseline to Week 16 in Weekly Mean of Daily Peak Pruritus NRS
timeFrame: Week 16
measure: Change From Baseline to Week 16 in Weekly Mean of Daily Peak Pruritus NRS
timeFrame: Week 16
measure: Change From Baseline to Week 16 in Weekly Mean of Daily Peak Skin Pain NRS
timeFrame: Week 16
measure: SCORAD: Percent Change From Baseline to Week 16
timeFrame: Week 16
measure: Change From Baseline to Week 16 in Percentage Body Surface Area (BSA) Affected by AD
timeFrame: Week 16
measure: Change From Baseline to Week 16 in DLQI
timeFrame: Week 16
measure: Patient Description of Atopic Dermatitis or Eczema From Patient Global Impression of Severity at Week 16
timeFrame: Week 16
measure: Change From Baseline to Week 16 in POEM
timeFrame: Week 16
measure: Change From Baseline to Week 16 in 5-D Itch
timeFrame: Week 16
measure: Occurrence of Adverse Events
timeFrame: up to 24 weeks
measure: Oral or Tympanic Temperature Taken During Vital Signs Assessment
timeFrame: Baseline, week 16 and week 24
measure: Systolic Blood Pressure Taken During Vital Signs Assessment
timeFrame: Baseline, week 16 and week 24
measure: Heart Rate Taken During Vital Signs Assessment
timeFrame: Baseline, week 16 and week 24
measure: Respiratory Rate Collected During Vital Signs Assessment
timeFrame: Baseline, week 16 and week 24
measure: Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Haematology
timeFrame: up to 24 weeks
measure: Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Serum Chemistry
timeFrame: up to 24 weeks
measure: Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Urinalysis
timeFrame: up to 24 weeks
measure: Heart Rate (Beats/Min) Recorded on ECGs
timeFrame: Baseline, week 16 and week 24
measure: QT (Miliseconds) Recorded on ECGs
timeFrame: Baseline, week 16 and week 24
measure: Number of Participants With Investigator's Overall ECGs Evaluations, e.g. Normal/Abnormal and Their Clinical Significance
timeFrame: Week 16 and week 24
measure: Left Ventricular Ejection Fraction Measured by Echocardiogram
timeFrame: Baseline and week 16
measure: Serum MEDI3506 Concentration Profiles
timeFrame: Week 16 and week 24
measure: Occurence of Anti-drug Antibody During the Treatment and Follow-up Periods
timeFrame: up to 24 weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Research Site
state: Alabama
city: Santa Monica
country: United States
facility: Research Site
state: California
city: Jacksonville
country: United States
facility: Research Site
state: Florida
city: Miami
country: United States
facility: Research Site
state: Florida
city: Orlando
country: United States
facility: Research Site
state: Florida
city: Baton Rouge
country: United States
facility: Research Site
state: Louisiana
city: Charlotte
country: United States
facility: Research Site
state: North Carolina
city: Tulsa
country: United States
facility: Research Site
state: Oklahoma
city: Providence
country: United States
facility: Research Site
state: Rhode Island
city: Spartanburg
country: United States
facility: Research Site
state: South Carolina
city: Memphis
country: United States
facility: Research Site
state: Tennessee
city: San Antonio
country: United States
facility: Research Site
state: Texas
city: San Antonio
country: United States
facility: Research Site
state: Texas
city: Box Hill
country: Australia
facility: Research Site
city: Carlton
country: Australia
facility: Research Site
city: East Melbourne
country: Australia
facility: Research Site
city: Fremantle
country: Australia
facility: Research Site
city: Berlin
country: Germany
facility: Research Site
city: Dresden
country: Germany
facility: Research Site
city: Hamburg
country: Germany
facility: Research Site
city: Mahlow
country: Germany
facility: Research Site
city: Bialystok
country: Poland
facility: Research Site
city: Kielce
country: Poland
facility: Research Site
city: Poznan
country: Poland
facility: Research Site
city: Skierniewice
country: Poland
facility: Research Site
city: Wroclaw
country: Poland
facility: Research Site
city: Łódź
country: Poland
facility: Research Site
city: Alcobendas
country: Spain
facility: Research Site
city: Leganés
country: Spain
facility: Research Site
city: Sevilla
country: Spain
facility: Research Site
city: Corby
country: United Kingdom
facility: Research Site
city: High Wycombe
country: United Kingdom
facility: Research Site
city: Kenilworth
country: United Kingdom
facility: Research Site
city: Northwood
country: United Kingdom
facility: Research Site
city: Romford
country: United Kingdom
facility: Research Site
city: Shipley
country: United Kingdom
facility: Research Site
city: Sidcup
country: United Kingdom
facility: Research Site
city: Wokingham
country: United Kingdom
facility: Research Site
Study officials:
References: