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Phase 2 Study to Evaluate the Efficacy and Safety of Tralokinumab in Adults With Atopic Dermatitis (D2213C00001)

Primary Purpose

Atopic Dermatitis

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Placebo
Tralokinumab Dose 1
Tralokinumab Dose 2
Tralokinumab Dose 3
Sponsored by
MedImmune LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atopic Dermatitis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Physician diagnosis of atopic dermatitis for greater than (>) 1 year
  • Atopic dermatitis involvement of greater than or equal to (>=) 10 percent (%) body surface area
  • EASI score of >= 12
  • SCORAD of >= 25
  • IGA score of >= 3
  • Effective birth control in line with protocol details

Exclusion Criteria:

  • History of anaphylaxis following any biologic therapy
  • Hepatitis B, C or human immunodeficiency virus
  • Pregnant or breastfeeding
  • History of cancer
  • Previous receipt of tralokinumab

Sites / Locations

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Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Experimental

Experimental

Experimental

Arm Label

Placebo

Tralokinumab Dose 1

Tralokinumab Dose 2

Tralokinumab Dose 3

Arm Description

Placebo matched to Tralokinumab will be administered subcutaneously to participants once every 2 Weeks (Q2W) for 12 weeks.

Tralokinumab Dose 1 will be administered subcutaneously once every 2 Weeks (Q2W) for 12 weeks.

Tralokinumab Dose 2 will be administered subcutaneously once every 2 Weeks (Q2W) for 12 weeks.

Tralokinumab Dose 3 will be administered subcutaneously once every 2 Weeks (Q2W) for 12 weeks.

Outcomes

Primary Outcome Measures

Absolute Change From Baseline in Eczema Area and Severity Index (EASI) Total Score at Week 12
EASI evaluates 4 natural anatomical regions for severity and extent of key disease signs and focuses on the key acute and chronic signs of inflammation (erythema, induration/papulation, excoriation, and lichenification). The maximum total score is 72, with higher values indicating more severe disease. The data presented here is Adjusted mean change after excluding the data from participants who took prohibited medications.
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 at Week 12
The IGA allows investigators to assess overall disease severity at one given time point and consists of a 6-point severity scale from clear to very severe disease (0 = clear, 1 = almost clear, 2 = mild disease, 3 = moderate disease, 4 = severe disease, and 5 = very 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.

Secondary Outcome Measures

Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)
An adverse event (AE) present at baseline that worsened in intensity after administration of investigational product or events absent at baseline that emerged after administration of study drug until Week 22. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening situation (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect in the offspring of a participant who received Tralokinumab. Treatment-emergent adverse events between administration of investigational product and Week 22 that were absent before treatment or that worsened relative to pre-treatment state.
Number of Participants With Vital Signs and Physical Examination Abnormalities Reported as Treatment Emergent Adverse Events
Vital sign parameters included blood pressure, temperature, pulse rate, and respiratory rate. TEAEs were 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.
Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment Emergent Adverse Events
An abnormal laboratory finding which required an action or intervention by the investigator, or a finding judged by the investigator to represent a change beyond the range of normal physiologic fluctuation were reported as an adverse event. Treatment-emergent adverse events between administration of investigational product and Week 22 that were absent before treatment or that worsened relative to pre-treatment state. Laboratory evaluations (haematology, serum chemistry and urinalysis) of blood and urine samples were performed.
Number of Participants With Electrocardiogram (ECG) Abnormalities Reported as Treatment Emergent Adverse Events
AEs observed in participants with clinically significant ECG abnormalities were assessed. ECG parameters included heart rate, RR, PR, QRS and QT intervals. Treatment-emergent adverse events between administration of investigational product and Week 22 that were absent before treatment or that worsened relative to pre-treatment state.
Adjusted Percentage of Participants Achieving 50 Percent (%) Reduction From Baseline in Eczema Area and Severity Index (EASI) at Week 12
EASI50 responder is defined as a participant who achieves at least a 50% reduction in EASI score from baseline. Data from participants who took prohibited medications were excluded from this analysis and a last observation carried forward (LOCF) analysis was used.
Absolute Change From Baseline in Scoring of Atopic Dermatitis (SCORAD) at 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 maximum total score is 103, with higher values indicating more severe disease. The data presented here is Adjusted mean change after excluding the data from participants who took prohibited medications.
Adjusted Percentage of Participants Achieving 50 Percent (%) Reduction From Baseline in SCORAD at Week 12
SCORAD 50 responder is defined as a participant who achieves at least a 50% reduction in SCORAD score from baseline. Data from participants who took prohibited medications were excluded from this analysis and a LOCF analysis was used.
Change From Baseline in Pruritus Numeric Rating Scale (NRS) (7-day Mean Score) at Week 12
Pruritus assessed using an 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. The data presented here is Adjusted mean change after excluding the data from participants who took prohibited medications.

Full Information

First Posted
January 5, 2015
Last Updated
April 24, 2018
Sponsor
MedImmune LLC
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1. Study Identification

Unique Protocol Identification Number
NCT02347176
Brief Title
Phase 2 Study to Evaluate the Efficacy and Safety of Tralokinumab in Adults With Atopic Dermatitis
Acronym
D2213C00001
Official Title
A Phase 2b, Randomized, Double-blinded, Placebo-controlled, Dose-ranging Study to Evaluate the Efficacy and Safety of Tralokinumab in Adult Subjects With Moderate-to-Severe Atopic Dermatitis
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
January 23, 2015 (Actual)
Primary Completion Date
November 27, 2015 (Actual)
Study Completion Date
February 5, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
MedImmune LLC

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The aim of the study is to evaluate the efficacy and safety of tralokinumab in adults with atopic dermatitis

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
204 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo matched to Tralokinumab will be administered subcutaneously to participants once every 2 Weeks (Q2W) for 12 weeks.
Arm Title
Tralokinumab Dose 1
Arm Type
Experimental
Arm Description
Tralokinumab Dose 1 will be administered subcutaneously once every 2 Weeks (Q2W) for 12 weeks.
Arm Title
Tralokinumab Dose 2
Arm Type
Experimental
Arm Description
Tralokinumab Dose 2 will be administered subcutaneously once every 2 Weeks (Q2W) for 12 weeks.
Arm Title
Tralokinumab Dose 3
Arm Type
Experimental
Arm Description
Tralokinumab Dose 3 will be administered subcutaneously once every 2 Weeks (Q2W) for 12 weeks.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Subcutaneous injection with placebo
Intervention Type
Biological
Intervention Name(s)
Tralokinumab Dose 1
Intervention Description
Subcutaneous injection with tralokinumab
Intervention Type
Biological
Intervention Name(s)
Tralokinumab Dose 2
Intervention Description
Subcutaneous injection with tralokinumab
Intervention Type
Biological
Intervention Name(s)
Tralokinumab Dose 3
Intervention Description
Subcutaneous injection with tralokinumab
Primary Outcome Measure Information:
Title
Absolute Change From Baseline in Eczema Area and Severity Index (EASI) Total Score at Week 12
Description
EASI evaluates 4 natural anatomical regions for severity and extent of key disease signs and focuses on the key acute and chronic signs of inflammation (erythema, induration/papulation, excoriation, and lichenification). The maximum total score is 72, with higher values indicating more severe disease. The data presented here is Adjusted mean change after excluding the data from participants who took prohibited medications.
Time Frame
Baseline (Day 1) and Week 12
Title
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 at Week 12
Description
The IGA allows investigators to assess overall disease severity at one given time point and consists of a 6-point severity scale from clear to very severe disease (0 = clear, 1 = almost clear, 2 = mild disease, 3 = moderate disease, 4 = severe disease, and 5 = very 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.
Time Frame
Week 12
Secondary Outcome Measure Information:
Title
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)
Description
An adverse event (AE) present at baseline that worsened in intensity after administration of investigational product or events absent at baseline that emerged after administration of study drug until Week 22. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening situation (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect in the offspring of a participant who received Tralokinumab. Treatment-emergent adverse events between administration of investigational product and Week 22 that were absent before treatment or that worsened relative to pre-treatment state.
Time Frame
From Study Drug Administration (Day 1) to Week 22
Title
Number of Participants With Vital Signs and Physical Examination Abnormalities Reported as Treatment Emergent Adverse Events
Description
Vital sign parameters included blood pressure, temperature, pulse rate, and respiratory rate. TEAEs were 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.
Time Frame
From Study Drug Administration (Day 1) to Week 22
Title
Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment Emergent Adverse Events
Description
An abnormal laboratory finding which required an action or intervention by the investigator, or a finding judged by the investigator to represent a change beyond the range of normal physiologic fluctuation were reported as an adverse event. Treatment-emergent adverse events between administration of investigational product and Week 22 that were absent before treatment or that worsened relative to pre-treatment state. Laboratory evaluations (haematology, serum chemistry and urinalysis) of blood and urine samples were performed.
Time Frame
From Study Drug Administration (Day 1) to Week 22
Title
Number of Participants With Electrocardiogram (ECG) Abnormalities Reported as Treatment Emergent Adverse Events
Description
AEs observed in participants with clinically significant ECG abnormalities were assessed. ECG parameters included heart rate, RR, PR, QRS and QT intervals. Treatment-emergent adverse events between administration of investigational product and Week 22 that were absent before treatment or that worsened relative to pre-treatment state.
Time Frame
From Study Drug Administration (Day 1) to Week 22
Title
Adjusted Percentage of Participants Achieving 50 Percent (%) Reduction From Baseline in Eczema Area and Severity Index (EASI) at Week 12
Description
EASI50 responder is defined as a participant who achieves at least a 50% reduction in EASI score from baseline. Data from participants who took prohibited medications were excluded from this analysis and a last observation carried forward (LOCF) analysis was used.
Time Frame
Week 12
Title
Absolute Change From Baseline in Scoring of Atopic Dermatitis (SCORAD) at Week 12
Description
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 maximum total score is 103, with higher values indicating more severe disease. The data presented here is Adjusted mean change after excluding the data from participants who took prohibited medications.
Time Frame
Baseline (Day 1) and Week 12
Title
Adjusted Percentage of Participants Achieving 50 Percent (%) Reduction From Baseline in SCORAD at Week 12
Description
SCORAD 50 responder is defined as a participant who achieves at least a 50% reduction in SCORAD score from baseline. Data from participants who took prohibited medications were excluded from this analysis and a LOCF analysis was used.
Time Frame
Week 12
Title
Change From Baseline in Pruritus Numeric Rating Scale (NRS) (7-day Mean Score) at Week 12
Description
Pruritus assessed using an 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. The data presented here is Adjusted mean change after excluding the data from participants who took prohibited medications.
Time Frame
Baseline (Day 1) and Week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Physician diagnosis of atopic dermatitis for greater than (>) 1 year Atopic dermatitis involvement of greater than or equal to (>=) 10 percent (%) body surface area EASI score of >= 12 SCORAD of >= 25 IGA score of >= 3 Effective birth control in line with protocol details Exclusion Criteria: History of anaphylaxis following any biologic therapy Hepatitis B, C or human immunodeficiency virus Pregnant or breastfeeding History of cancer Previous receipt of tralokinumab
Facility Information:
Facility Name
Research Site
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85018
Country
United States
Facility Name
Research Site
City
Rogers
State/Province
Arkansas
ZIP/Postal Code
72758
Country
United States
Facility Name
Research Site
City
Fremont
State/Province
California
ZIP/Postal Code
94538
Country
United States
Facility Name
Research Site
City
Fullerton
State/Province
California
ZIP/Postal Code
92835
Country
United States
Facility Name
Research Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90045
Country
United States
Facility Name
Research Site
City
Oceanside
State/Province
California
ZIP/Postal Code
92056
Country
United States
Facility Name
Research Site
City
Rancho Santa Margarita
State/Province
California
ZIP/Postal Code
92688
Country
United States
Facility Name
Research Site
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
Research Site
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33759
Country
United States
Facility Name
Research Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33144
Country
United States
Facility Name
Research Site
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01605
Country
United States
Facility Name
Research Site
City
Warren
State/Province
Michigan
ZIP/Postal Code
48088
Country
United States
Facility Name
Research Site
City
Berlin
State/Province
New Jersey
ZIP/Postal Code
08009
Country
United States
Facility Name
Research Site
City
Verona
State/Province
New Jersey
ZIP/Postal Code
07044
Country
United States
Facility Name
Research Site
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Research Site
City
Rochester
State/Province
New York
ZIP/Postal Code
14625
Country
United States
Facility Name
Research Site
City
Portland
State/Province
Oregon
ZIP/Postal Code
97241
Country
United States
Facility Name
Research Site
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29414
Country
United States
Facility Name
Research Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77004
Country
United States
Facility Name
Research Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77056
Country
United States
Facility Name
Research Site
City
Pflugerville
State/Province
Texas
ZIP/Postal Code
78660
Country
United States
Facility Name
Research Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78218
Country
United States
Facility Name
Research Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Research Site
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Facility Name
Research Site
City
East Melbourne
ZIP/Postal Code
3002
Country
Australia
Facility Name
Research Site
City
Kogarah
ZIP/Postal Code
02217
Country
Australia
Facility Name
Research Site
City
Liverpool
ZIP/Postal Code
2170
Country
Australia
Facility Name
Research Site
City
Sydney
ZIP/Postal Code
02010
Country
Australia
Facility Name
Research Site
City
Woolloongabba
ZIP/Postal Code
04102
Country
Australia
Facility Name
Research Site
City
Surrey
State/Province
British Columbia
ZIP/Postal Code
V3V 0C6
Country
Canada
Facility Name
Research Site
City
Courtice
State/Province
Ontario
ZIP/Postal Code
L1E 3C3
Country
Canada
Facility Name
Research Site
City
Markham
State/Province
Ontario
ZIP/Postal Code
L3P1X2
Country
Canada
Facility Name
Research Site
City
Peterborough
State/Province
Ontario
ZIP/Postal Code
K9J 5K2
Country
Canada
Facility Name
Research Site
City
Waterloo
State/Province
Ontario
ZIP/Postal Code
N2J 1C4
Country
Canada
Facility Name
Research Site
City
Windsor
State/Province
Ontario
ZIP/Postal Code
N8W 5L7
Country
Canada
Facility Name
Research Site
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Research Site
City
Bochum
ZIP/Postal Code
44803
Country
Germany
Facility Name
Research Site
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
Research Site
City
Dülmen
ZIP/Postal Code
48249
Country
Germany
Facility Name
Research Site
City
Frankfurt/Main
ZIP/Postal Code
60590
Country
Germany
Facility Name
Research Site
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Facility Name
Research Site
City
Munchen
ZIP/Postal Code
80337
Country
Germany
Facility Name
Research Site
City
Münster
ZIP/Postal Code
48149
Country
Germany
Facility Name
Research Site
City
Stuttgart-Weilimdorf
ZIP/Postal Code
70499
Country
Germany
Facility Name
Research Site
City
Wuppertal
ZIP/Postal Code
42287
Country
Germany
Facility Name
Research Site
City
Nakano-ku
ZIP/Postal Code
164-0001
Country
Japan
Facility Name
Research Site
City
Shibuya-ku
ZIP/Postal Code
150-0034
Country
Japan
Facility Name
Research Site
City
Shinjuku-ku
ZIP/Postal Code
160-0004
Country
Japan
Facility Name
Research Site
City
Shinjuku-ku
ZIP/Postal Code
160-0023
Country
Japan
Facility Name
Research Site
City
Shinjuku-ku
ZIP/Postal Code
169-0075
Country
Japan
Facility Name
Research Site
City
Yokohama-shi
ZIP/Postal Code
220-0073
Country
Japan
Facility Name
Research Site
City
Katowice
ZIP/Postal Code
40-611
Country
Poland
Facility Name
Research Site
City
Szczecin
ZIP/Postal Code
70-332
Country
Poland
Facility Name
Research Site
City
Warszawa
ZIP/Postal Code
04-141
Country
Poland
Facility Name
Research Site
City
Wrocław
ZIP/Postal Code
50-368
Country
Poland
Facility Name
Research Site
City
Wrocław
ZIP/Postal Code
51-318
Country
Poland
Facility Name
Research Site
City
Łódź
ZIP/Postal Code
90-436
Country
Poland

12. IPD Sharing Statement

Citations:
PubMed Identifier
33333295
Citation
Silverberg JI, Guttman-Yassky E, Gooderham M, Worm M, Rippon S, O'Quinn S, van der Merwe R, Kragh N, Kurbasic A, Wollenberg A. Health-related quality of life with tralokinumab in moderate-to-severe atopic dermatitis: A phase 2b randomized study. Ann Allergy Asthma Immunol. 2021 May;126(5):576-583.e4. doi: 10.1016/j.anai.2020.12.004. Epub 2020 Dec 15.
Results Reference
derived
PubMed Identifier
29906525
Citation
Wollenberg A, Howell MD, Guttman-Yassky E, Silverberg JI, Kell C, Ranade K, Moate R, van der Merwe R. Treatment of atopic dermatitis with tralokinumab, an anti-IL-13 mAb. J Allergy Clin Immunol. 2019 Jan;143(1):135-141. doi: 10.1016/j.jaci.2018.05.029. Epub 2018 Jun 12.
Results Reference
derived

Learn more about this trial

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

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