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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

Tracking Information
First Submitted Date  ICMJE January 5, 2015
First Posted Date  ICMJE January 27, 2015
Results First Submitted Date  ICMJE May 11, 2017
Results First Posted Date  ICMJE June 7, 2017
Last Update Posted Date May 23, 2018
Actual Study Start Date  ICMJE January 23, 2015
Actual Primary Completion Date November 27, 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 24, 2018)
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: January 26, 2015)
Change from baseline in Eczema Area and Severity Index (EASI) [ Time Frame: 12 Weeks ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 24, 2018)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: January 26, 2015)
  • Percentage of subjects achieving Investigator's Global Assessment (IGA) of 0 (clear) or 1 (almost clear) [ Time Frame: 12 weeks ]
  • Change from baseline in Scoring of Atopic Dermatitis (SCORAD) [ Time Frame: 12 weeks ]
  • Percentage of subjects achieving EASI50 [ Time Frame: 12 weeks ]
  • Percentage of subjects achieving SCORAD50 [ Time Frame: 12 weeks ]
  • Change from baseline in pruritus, assessed using a numeric rating scale (NRS) [ Time Frame: 12 weeks ]
  • Safety and Tolerability of Tralokinumab (e.g., vital signs, ECG results, haematology, chemistry and adverse events) [ Time Frame: 22 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Phase 2 Study to Evaluate the Efficacy and Safety of Tralokinumab in Adults With Atopic Dermatitis
Official Title  ICMJE 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
Brief Summary The aim of the study is to evaluate the efficacy and safety of tralokinumab in adults with atopic dermatitis
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Atopic Dermatitis
Intervention  ICMJE
  • Other: Placebo
    Subcutaneous injection with placebo
  • Biological: Tralokinumab Dose 1
    Subcutaneous injection with tralokinumab
  • Biological: Tralokinumab Dose 2
    Subcutaneous injection with tralokinumab
  • Biological: Tralokinumab Dose 3
    Subcutaneous injection with tralokinumab
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Placebo matched to Tralokinumab will be administered subcutaneously to participants once every 2 Weeks (Q2W) for 12 weeks.
    Intervention: Other: Placebo
  • Experimental: Tralokinumab Dose 1
    Tralokinumab Dose 1 will be administered subcutaneously once every 2 Weeks (Q2W) for 12 weeks.
    Intervention: Biological: Tralokinumab Dose 1
  • Experimental: Tralokinumab Dose 2
    Tralokinumab Dose 2 will be administered subcutaneously once every 2 Weeks (Q2W) for 12 weeks.
    Intervention: Biological: Tralokinumab Dose 2
  • Experimental: Tralokinumab Dose 3
    Tralokinumab Dose 3 will be administered subcutaneously once every 2 Weeks (Q2W) for 12 weeks.
    Intervention: Biological: Tralokinumab Dose 3
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 24, 2018)
204
Original Estimated Enrollment  ICMJE
 (submitted: January 26, 2015)
184
Actual Study Completion Date  ICMJE February 5, 2016
Actual Primary Completion Date November 27, 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Canada,   Germany,   Japan,   Poland,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02347176
Other Study ID Numbers  ICMJE D2213C00001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party MedImmune LLC
Study Sponsor  ICMJE MedImmune LLC
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account MedImmune LLC
Verification Date April 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP