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

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: Completed
• Conditions: Atopic Dermatitis
• Intervention / Treatment: Other: Placebo; Biological: Tralokinumab Dose 1; Biological: Tralokinumab Dose 2; Biological: Tralokinumab Dose 3

• Study Type: Interventional
• Enrollment (Actual): 204
• Phase: Phase 2

Contacts and Locations

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

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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	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

Outcome Measure	Measure Description	Time Frame
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.	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	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	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	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	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	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	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	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

• Sponsor: MedImmune LLC

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 23, 2015
• Primary Completion (Actual): November 27, 2015
• Study Completion (Actual): February 5, 2016

Study Registration Dates

• First Submitted: January 5, 2015
• First Submitted That Met QC Criteria: January 26, 2015
• First Posted (Estimate): January 27, 2015

Study Record Updates

• Last Update Posted (Actual): May 23, 2018
• Last Update Submitted That Met QC Criteria: April 24, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Hypersensitivity, Immediate; Genetic Diseases, Inborn; Skin Diseases, Genetic; Hypersensitivity; Skin Diseases, Eczematous; Dermatitis; Eczema; Dermatitis, Atopic; Physiological Effects of Drugs; Immunologic Factors; Antibodies, Monoclonal
• Other Study ID Numbers: D2213C00001