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

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ClinicalTrials.gov Identifier: NCT02347176
Recruitment Status : Completed
First Posted : January 27, 2015
Results First Posted : June 7, 2017
Last Update Posted : May 23, 2018
Sponsor:
Information provided by (Responsible Party):
MedImmune LLC

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

Condition or disease Intervention/treatment Phase
Atopic Dermatitis Other: Placebo Biological: Tralokinumab Dose 1 Biological: Tralokinumab Dose 2 Biological: Tralokinumab Dose 3 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 204 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : January 23, 2015
Actual Primary Completion Date : November 27, 2015
Actual Study Completion Date : February 5, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02347176


Locations
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Sponsors and Collaborators
MedImmune LLC
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: MedImmune LLC
ClinicalTrials.gov Identifier: NCT02347176    
Other Study ID Numbers: D2213C00001
First Posted: January 27, 2015    Key Record Dates
Results First Posted: June 7, 2017
Last Update Posted: May 23, 2018
Last Verified: April 2018
Additional relevant MeSH terms:
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Dermatitis, Atopic
Dermatitis
Eczema
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
 Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs