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

Atopic Dermatitis Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02347176
• Other study ID #: D2213C00001
• Status: Completed
• Phase: Phase 2
• Start date: January 23, 2015
• Est. completion date: February 5, 2016

Study information

• Verified date: April 2018
• Source: MedImmune LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 204
• Est. completion date: February 5, 2016
• Est. primary completion date: November 27, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Other:
• Placebo
Subcutaneous injection with placebo

Biological:
• Tralokinumab Dose 1
Subcutaneous injection with tralokinumab
• Tralokinumab Dose 2
Subcutaneous injection with tralokinumab
• Tralokinumab Dose 3
Subcutaneous injection with tralokinumab

Locations

Country	Name	City	State
Australia	Research Site	East Melbourne
Australia	Research Site	Kogarah
Australia	Research Site	Liverpool
Australia	Research Site	Sydney
Australia	Research Site	Woolloongabba
Canada	Research Site	Courtice	Ontario
Canada	Research Site	Markham	Ontario
Canada	Research Site	Peterborough	Ontario
Canada	Research Site	Surrey	British Columbia
Canada	Research Site	Waterloo	Ontario
Canada	Research Site	Windsor	Ontario
Germany	Research Site	Berlin
Germany	Research Site	Bochum
Germany	Research Site	Dresden
Germany	Research Site	Dülmen
Germany	Research Site	Frankfurt/Main
Germany	Research Site	Hannover
Germany	Research Site	Munchen
Germany	Research Site	Münster
Germany	Research Site	Stuttgart-Weilimdorf
Germany	Research Site	Wuppertal
Japan	Research Site	Nakano-ku
Japan	Research Site	Shibuya-ku
Japan	Research Site	Shinjuku-ku
Japan	Research Site	Shinjuku-ku
Japan	Research Site	Shinjuku-ku
Japan	Research Site	Yokohama-shi
Poland	Research Site	Katowice
Poland	Research Site	Lódz
Poland	Research Site	Szczecin
Poland	Research Site	Warszawa
Poland	Research Site	Wroclaw
Poland	Research Site	Wroclaw
United States	Research Site	Berlin	New Jersey
United States	Research Site	Charleston	South Carolina
United States	Research Site	Clearwater	Florida
United States	Research Site	Fremont	California
United States	Research Site	Fullerton	California
United States	Research Site	Houston	Texas
United States	Research Site	Houston	Texas
United States	Research Site	Los Angeles	California
United States	Research Site	Miami	Florida
United States	Research Site	New York	New York
United States	Research Site	Norfolk	Virginia
United States	Research Site	Oceanside	California
United States	Research Site	Pflugerville	Texas
United States	Research Site	Phoenix	Arizona
United States	Research Site	Portland	Oregon
United States	Research Site	Rancho Santa Margarita	California
United States	Research Site	Rochester	New York
United States	Research Site	Rogers	Arkansas
United States	Research Site	San Antonio	Texas
United States	Research Site	San Antonio	Texas
United States	Research Site	Santa Monica	California
United States	Research Site	Verona	New Jersey
United States	Research Site	Warren	Michigan
United States	Research Site	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
MedImmune LLC

Countries where clinical trial is conducted

United States,  Australia,  Canada,  Germany,  Japan,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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