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

April 24, 2018 updated by: MedImmune LLC

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

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
204

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • East Melbourne, Australia, 3002
        • Research Site
      • Kogarah, Australia, 02217
        • Research Site
      • Liverpool, Australia, 2170
        • Research Site
      • Sydney, Australia, 02010
        • Research Site
      • Woolloongabba, Australia, 04102
        • Research Site
  • Canada
    • British Columbia
      • Surrey, British Columbia, Canada, V3V 0C6
        • Research Site
    • Ontario
      • Courtice, Ontario, Canada, L1E 3C3
        • Research Site
      • Markham, Ontario, Canada, L3P1X2
        • Research Site
      • Peterborough, Ontario, Canada, K9J 5K2
        • Research Site
      • Waterloo, Ontario, Canada, N2J 1C4
        • Research Site
      • Windsor, Ontario, Canada, N8W 5L7
        • Research Site
  • Germany
      • Berlin, Germany, 10117
        • Research Site
      • Bochum, Germany, 44803
        • Research Site
      • Dresden, Germany, 01307
        • Research Site
      • Dülmen, Germany, 48249
        • Research Site
      • Frankfurt/Main, Germany, 60590
        • Research Site
      • Hannover, Germany, 30625
        • Research Site
      • Munchen, Germany, 80337
        • Research Site
      • Münster, Germany, 48149
        • Research Site
      • Stuttgart-Weilimdorf, Germany, 70499
        • Research Site
      • Wuppertal, Germany, 42287
        • Research Site
  • Japan
      • Nakano-ku, Japan, 164-0001
        • Research Site
      • Shibuya-ku, Japan, 150-0034
        • Research Site
      • Shinjuku-ku, Japan, 160-0023
        • Research Site
      • Shinjuku-ku, Japan, 169-0075
        • Research Site
      • Shinjuku-ku, Japan, 160-0004
        • Research Site
      • Yokohama-shi, Japan, 220-0073
        • Research Site
  • Poland
      • Katowice, Poland, 40-611
        • Research Site
      • Szczecin, Poland, 70-332
        • Research Site
      • Warszawa, Poland, 04-141
        • Research Site
      • Wrocław, Poland, 50-368
        • Research Site
      • Wrocław, Poland, 51-318
        • Research Site
      • Łódź, Poland, 90-436
        • Research Site
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85018
        • Research Site
    • Arkansas
      • Rogers, Arkansas, United States, 72758
        • Research Site
    • California
      • Fremont, California, United States, 94538
        • Research Site
      • Fullerton, California, United States, 92835
        • Research Site
      • Los Angeles, California, United States, 90045
        • Research Site
      • Oceanside, California, United States, 92056
        • Research Site
      • Rancho Santa Margarita, California, United States, 92688
        • Research Site
      • Santa Monica, California, United States, 90404
        • Research Site
    • Florida
      • Clearwater, Florida, United States, 33759
        • Research Site
      • Miami, Florida, United States, 33144
        • Research Site
    • Massachusetts
      • Worcester, Massachusetts, United States, 01605
        • Research Site
    • Michigan
      • Warren, Michigan, United States, 48088
        • Research Site
    • New Jersey
      • Berlin, New Jersey, United States, 08009
        • Research Site
      • Verona, New Jersey, United States, 07044
        • Research Site
    • New York
      • New York, New York, United States, 10029
        • Research Site
      • Rochester, New York, United States, 14625
        • Research Site
    • Oregon
      • Portland, Oregon, United States, 97241
        • Research Site
    • South Carolina
      • Charleston, South Carolina, United States, 29414
        • Research Site
    • Texas
      • Houston, Texas, United States, 77004
        • Research Site
      • Houston, Texas, United States, 77056
        • Research Site
      • Pflugerville, Texas, United States, 78660
        • Research Site
      • San Antonio, Texas, United States, 78229
        • Research Site
      • San Antonio, Texas, United States, 78218
        • Research Site
    • Virginia
      • Norfolk, Virginia, United States, 23507
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo
Placebo matched to Tralokinumab will be administered subcutaneously to participants once every 2 Weeks (Q2W) for 12 weeks.
Other: Placebo
Subcutaneous injection with placebo
Experimental: Tralokinumab Dose 1
Tralokinumab Dose 1 will be administered subcutaneously once every 2 Weeks (Q2W) for 12 weeks.
Biological: Tralokinumab Dose 1
Subcutaneous injection with tralokinumab
Experimental: Tralokinumab Dose 2
Tralokinumab Dose 2 will be administered subcutaneously once every 2 Weeks (Q2W) for 12 weeks.
Biological: Tralokinumab Dose 2
Subcutaneous injection with tralokinumab
Experimental: Tralokinumab Dose 3
Tralokinumab Dose 3 will be administered subcutaneously once every 2 Weeks (Q2W) for 12 weeks.
Biological: Tralokinumab Dose 3
Subcutaneous injection with tralokinumab

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Absolute Change From Baseline in Eczema Area and Severity Index (EASI) Total Score at Week 12
Time Frame: Baseline (Day 1) and 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.
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 at Week 12
Time Frame: 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.
Week 12

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)
Time Frame: From Study Drug Administration (Day 1) to Week 22
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.
From Study Drug Administration (Day 1) to Week 22
Number of Participants With Vital Signs and Physical Examination Abnormalities Reported as Treatment Emergent Adverse Events
Time Frame: From Study Drug Administration (Day 1) to Week 22
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.
From Study Drug Administration (Day 1) to Week 22
Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment Emergent Adverse Events
Time Frame: From Study Drug Administration (Day 1) to Week 22
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.
From Study Drug Administration (Day 1) to Week 22
Number of Participants With Electrocardiogram (ECG) Abnormalities Reported as Treatment Emergent Adverse Events
Time Frame: From Study Drug Administration (Day 1) to Week 22
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.
From Study Drug Administration (Day 1) to Week 22
Adjusted Percentage of Participants Achieving 50 Percent (%) Reduction From Baseline in Eczema Area and Severity Index (EASI) at Week 12
Time Frame: 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.
Week 12
Absolute Change From Baseline in Scoring of Atopic Dermatitis (SCORAD) at Week 12
Time Frame: Baseline (Day 1) and 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.
Baseline (Day 1) and Week 12
Adjusted Percentage of Participants Achieving 50 Percent (%) Reduction From Baseline in SCORAD at Week 12
Time Frame: 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.
Week 12
Change From Baseline in Pruritus Numeric Rating Scale (NRS) (7-day Mean Score) at Week 12
Time Frame: Baseline (Day 1) and 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.
Baseline (Day 1) and Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
MedImmune LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 23, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 27, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 5, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 5, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 26, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 27, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 23, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 24, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • D2213C00001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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