NCT02525094

Brief Summary

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

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
113

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Aug 2015

Shorter than P25 for phase_2

Geographic Reach
6 countries

29 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 29, 2015

Completed
17 days until next milestone

Study Start

First participant enrolled

August 15, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 17, 2015

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 9, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2016

Completed
1.6 years until next milestone

Results Posted

Study results publicly available

February 15, 2018

Completed
Last Updated

February 15, 2018

Status Verified

January 1, 2018

Enrollment Period

9 months

First QC Date

July 29, 2015

Results QC Date

October 13, 2017

Last Update Submit

January 19, 2018

Conditions

Atopic Dermatitis

Keywords

Eczema

Outcome Measures

Primary Outcomes (1)

  • 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

    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.

    Baseline (Day 1) and Week 12

Secondary Outcomes (11)

  • Percentage of Participants Achieving >= 75 % Reduction From Baseline in EASI75 at Week 12

    Baseline (Day 1) and Week 12

  • Mean Change From Baseline in EASI Total Score at Week 12

    Baseline (Day 1) and Week 12

  • 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

  • Mean Change From Baseline in the Scoring of Atopic Dermatitis (SCORAD) at Week 12

    Baseline (Day 1) and Week 12

  • Percentage of Participants Achieving >= 50% Reduction From Baseline in SCORAD 50

    Baseline (Day 1) and Week 12

  • +6 more secondary outcomes

Study Arms (2)

MEDI9929 280 mg

EXPERIMENTAL

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

Biological: MEDI9929

Placebo

PLACEBO COMPARATOR

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

Biological: Placebo

Interventions

MEDI9929BIOLOGICAL

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

MEDI9929 280 mg
PlaceboBIOLOGICAL

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

Placebo

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (29)

Research Site

North Miami Beach, Florida, 33162, United States

Location

Research Site

Tampa, Florida, 33624, United States

Location

Research Site

Arlington Hts, Illinois, 60005, United States

Location

Research Site

Carmel, Indiana, 46032, United States

Location

Research Site

Indianapolis, Indiana, 46256, United States

Location

Research Site

Berlin, New Jersey, 08009, United States

Location

Research Site

Charlotte, North Carolina, 28277, United States

Location

Research Site

Portland, Oregon, 97239, United States

Location

Research Site

ACT, 02606, Australia

Location

Research Site

Liverpool, 2170, Australia

Location

Research Site

Woolloongabba, 04102, Australia

Location

Research Site

Surrey, British Columbia, V3R 6A7, Canada

Location

Research Site

Barrie, Ontario, L4M 6L2, Canada

Location

Research Site

Québec, Quebec, G1V 4X7, Canada

Location

Research Site

Berlin, 10117, Germany

Location

Research Site

Frankfurt am Main, 60590, Germany

Location

Research Site

Gera, 07548, Germany

Location

Research Site

Hanover, 30625, Germany

Location

Research Site

Leipzig, 04103, Germany

Location

Research Site

München, 80337, Germany

Location

Research Site

Münster, 48149, Germany

Location

Research Site

Debrecen, 4032, Hungary

Location

Research Site

Kaposvár, 7400, Hungary

Location

Research Site

Miskolc, 3529, Hungary

Location

Research Site

Pécs, 7632, Hungary

Location

Research Site

Szeged, 6720, Hungary

Location

Research Site

Szombathely, 9700, Hungary

Location

Research Site

Tauranga, 3143, New Zealand

Location

Research Site

Wellington, 6021, New Zealand

Location

MeSH Terms

Conditions

Dermatitis, AtopicEczema

Interventions

tezepelumab

Condition Hierarchy (Ancestors)

Skin Diseases, GeneticGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDermatitisSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, EczematousHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Results Point of Contact

Title
Rene van der Merwe
Organization
MedImmune, LLC
information.center@astrazeneca.com
301-398-2532

Study Officials

  • Eric Simpson, MD

    Oregon Health and Science University

    PRINCIPAL INVESTIGATOR

  • Roderick Mcphee, MD

    MedImmune LLC

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 29, 2015

First Posted

August 17, 2015

Study Start

August 15, 2015

Primary Completion

May 9, 2016

Study Completion

July 15, 2016

Last Updated

February 15, 2018

Results First Posted

February 15, 2018

Record last verified: 2018-01

Locations

HU(6)CA(3)US(8)NZ(2)DE(7)AU(3)