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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02525094




Registration number
NCT02525094
Ethics application status
Date submitted
29/07/2015
Date registered
17/08/2015
Date last updated
15/02/2018

Titles & IDs
Public title
Phase 2a Study to Evaluate the Efficacy and Safety of MEDI9929 in Adults With Atopic Dermatitis
Scientific 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
Secondary ID [1] 0 0
D5240C00001
Universal Trial Number (UTN)
Trial acronym
ALLEVIAD
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Atopic Dermatitis 0 0
Condition category
Condition code
Skin 0 0 0 0
Dermatological conditions
Skin 0 0 0 0
Other skin conditions
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - MEDI9929
Treatment: Other - Placebo

Experimental: MEDI9929 280 mg - Participants will receive 6 subcutaneous doses of MEDI9929 280 mg every 2 weeks for 12 weeks, with the last dose at Week 10.

Placebo comparator: Placebo - Participants will receive 6 subcutaneous doses of placebo every 2 weeks for 12 weeks, with the last dose at Week 10.


Treatment: Other: MEDI9929
Participants will receive 6 subcutaneous doses of MEDI9929 280 mg every 2 weeks for 12 weeks, with the last dose at Week 10.

Treatment: Other: Placebo
Participants will receive 6 subcutaneous doses of placebo every 2 weeks for 12 weeks, with the last dose at Week 10.
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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
Timepoint [1] 0 0
Baseline (Day 1) and Week 12
Secondary outcome [1] 0 0
Percentage of Participants Achieving >= 75 % Reduction From Baseline in EASI75 at Week 12
Timepoint [1] 0 0
Baseline (Day 1) and Week 12
Secondary outcome [2] 0 0
Mean Change From Baseline in EASI Total Score at Week 12
Timepoint [2] 0 0
Baseline (Day 1) and Week 12
Secondary outcome [3] 0 0
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
Timepoint [3] 0 0
Baseline (Day 1) and Week 12
Secondary outcome [4] 0 0
Mean Change From Baseline in the Scoring of Atopic Dermatitis (SCORAD) at Week 12
Timepoint [4] 0 0
Baseline (Day 1) and Week 12
Secondary outcome [5] 0 0
Percentage of Participants Achieving >= 50% Reduction From Baseline in SCORAD 50
Timepoint [5] 0 0
Baseline (Day 1) and Week 12
Secondary outcome [6] 0 0
Percentage of Participants Achieving >= 75% Reduction From Baseline in SCORAD 75
Timepoint [6] 0 0
Baseline (Day 1) and Week 12
Secondary outcome [7] 0 0
Mean Change From Baseline in Average Pruritus Numeric Rating Scale (NRS) at Week 12
Timepoint [7] 0 0
Baseline (Day 1) and Week 12
Secondary outcome [8] 0 0
Mean Change From Baseline in 5-D Pruritus Score at Week 12
Timepoint [8] 0 0
Baseline (Day 1) and Week 12
Secondary outcome [9] 0 0
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
Timepoint [9] 0 0
From treatment administration (Day1) to 22 weeks
Secondary outcome [10] 0 0
Mean Trough Serum Concentration of MEDI9929
Timepoint [10] 0 0
Week 0 (Pre dose), Weeks 4, 8, and 12 (post dose)
Secondary outcome [11] 0 0
Number of Participants Who Developed Detectable MEDI9929 Anti-drug Antibodies
Timepoint [11] 0 0
Baseline (Day 1) to Week 22

Eligibility
Key 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
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
15/08/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
15/07/2016
Sample size
Target
Accrual to date
Final
113
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Research Site - ACT
Recruitment hospital [2] 0 0
Research Site - Liverpool
Recruitment hospital [3] 0 0
Research Site - Woolloongabba
Recruitment postcode(s) [1] 0 0
02606 - ACT
Recruitment postcode(s) [2] 0 0
2170 - Liverpool
Recruitment postcode(s) [3] 0 0
04102 - Woolloongabba
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Florida
Country [2] 0 0
United States of America
State/province [2] 0 0
Illinois
Country [3] 0 0
United States of America
State/province [3] 0 0
Indiana
Country [4] 0 0
United States of America
State/province [4] 0 0
New Jersey
Country [5] 0 0
United States of America
State/province [5] 0 0
North Carolina
Country [6] 0 0
United States of America
State/province [6] 0 0
Oregon
Country [7] 0 0
Canada
State/province [7] 0 0
British Columbia
Country [8] 0 0
Canada
State/province [8] 0 0
Ontario
Country [9] 0 0
Canada
State/province [9] 0 0
Quebec
Country [10] 0 0
Germany
State/province [10] 0 0
Berlin
Country [11] 0 0
Germany
State/province [11] 0 0
Frankfurt/Main
Country [12] 0 0
Germany
State/province [12] 0 0
Gera
Country [13] 0 0
Germany
State/province [13] 0 0
Hannover
Country [14] 0 0
Germany
State/province [14] 0 0
Leipzig
Country [15] 0 0
Germany
State/province [15] 0 0
München
Country [16] 0 0
Germany
State/province [16] 0 0
Münster
Country [17] 0 0
Hungary
State/province [17] 0 0
Debrecen
Country [18] 0 0
Hungary
State/province [18] 0 0
Kaposvár
Country [19] 0 0
Hungary
State/province [19] 0 0
Miskolc
Country [20] 0 0
Hungary
State/province [20] 0 0
Pécs
Country [21] 0 0
Hungary
State/province [21] 0 0
Szeged
Country [22] 0 0
Hungary
State/province [22] 0 0
Szombathely
Country [23] 0 0
New Zealand
State/province [23] 0 0
Tauranga
Country [24] 0 0
New Zealand
State/province [24] 0 0
Wellington

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
MedImmune LLC
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Amgen
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
To assess the efficacy and safety of MEDI9929 in adult subjects with Atopic Dermatitis
Trial website
https://clinicaltrials.gov/study/NCT02525094
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Eric Simpson, MD
Address 0 0
Oregon Health and Science University
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT02525094