NCT03562377 - Vaccine Responses in Tralokinumab-Treated Atopic Dermatitis - ECZTRA 5 (ECZema TRAlokinumab Trial No. 5) | Biotech Hunter

Enrollment

215

Participants

Timeline

Start Date

July 13, 2018

Primary Completion Date

September 17, 2019

Study Completion Date

November 22, 2019

Conditions

Atopic Dermatitis

Interventions

DRUG

Tralokinumab

Tralokinumab is a human recombinant monoclonal antibody of the IgG4 subclass that specifically binds to human IL-13 and blocks interaction with the IL-13 receptors. It is presented as a liquid formulation for subcutaneous administration.

DRUG

Placebo

Placebo contains the same excipients in the same concentration only lacking tralokinumab.

BIOLOGICAL

Tdap vaccine

Tetanus (lockjaw), diphtheria (infection of the nose and throat), and pertussis (whooping cough) vaccine. All subjects will receive 1 dose at Week 12.

BIOLOGICAL

Meningococcal vaccine

This vaccine is used to prevent meningococcal diseases (infection of the brain and spinal cord) and blood poisoning. All subjects will receive 1 dose at Week 12.

Trial Locations (51)

10021

Leo Pharma Investigational Site, New York

11201

LEO Pharma Investigational Site, Brooklyn

11375

Leo Pharma Investigational Site, Forest Hills

13045

Leo Pharma Investigational Site, Cortland

30328

LEO Pharma Investigational Site, Atlanta

33012

Leo Pharma Investigational Site, Hialeah

33122

Leo Pharma Investigational Site, Doral

33134

Leo Pharma Investigational Site, Coral Gables

37421

Leo Pharma Investigational Site, Chattanooga

43230

LEO Pharma Investigational Site, Gahanna

45219

Leo Pharma Investigational Site, Cincinnati

45231

LEO Pharma Investigational Site, Cincinnati

46617

Leo Pharma Investigational Site, South Bend

47150

Leo Pharma Investigational Site, New Albany

48034

LEO Pharma Investigational Site, Southfield

48103

Leo Pharma Investigational Site, Ann Arbor

59808

Leo Pharma Investigational Site, Missoula

72916

Leo Pharma Investigational Site, Fort Smith

75034

Leo Pharma Investigational Site, Frisco

75225

LEO Pharma Investigational Site, Dallas

78759

Leo Pharma Investigational Site, Austin

80045

LEO Pharma Investigational Site, Denver

80112

LEO Pharma Investigational Site, Centennial

80233

LEO Pharma Investigational Site, Thornton

90025

Leo Pharma Investigational Site, Los Angeles

90045

Leo Pharma Investigational Site, Los Angeles

90057

Leo Pharma Investigational Site, Los Angeles

90212

Leo Pharma Investigational Site, Beverly Hills

92123

LEO Pharma Investigational Site, San Diego

92660

Leo Pharma Investigational Site, Newport Beach

92708

Leo Pharma Investigational Site, Fountain Valley

93301

LEO Pharma Investigational Site, Bakersfield

97504

LEO Pharma Investigational Site, Medford

99202

Leo Pharma Investigational Site, Spokane

04401

LEO Pharma Investigational Site, Bangor

02115

Leo Pharma Investigational Site, Boston

02135

LEO Pharma Investigational Site, Brighton

08520

Leo Pharma Investigational Site, East Windsor

05403

Leo Pharma Investigational Site, South Burlington

T5K 1X3

LEO Pharma Investigational Site, Edmonton

T6G 1C3

LEO Pharma Investigational Site, Edmonton

V6H 4E1

LEO Pharma Investigational Site, Vancouver

A1A 4Y3

LEO Pharma Investigational Site, St. John's

L8S 1G5

LEO Pharma Investigational Site, Hamilton

N6H 5L5

LEO Pharma Investigational Site, London

L6J 7W5

LEO Pharma Investigational Site, Oakville

K9J 5K2

LEO Pharma Investigational Site, Peterborough

L4B 1A5

LEO Pharma Investigational Site, Richmond Hill

M4V 1R2

LEO Pharma Investigational Site, Toronto

N8X 2G1

LEO Pharma Investigational Site, Windsor

H4G 3E7

LEO Pharma Investigational Site, Verdun