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

NCT03562377 | Completed Phase 2 Results FDA Drug

• 1 other identifier: LP0162-1341
• Study Type: interventional
• Target: 215
• Locations: 2 countries
• Sites: 51

Brief Summary

The purpose of this trial is to test if treatment with the trial drug, tralokinumab, can affect the body's immune response to vaccines. The trial will also evaluate the efficacy of tralokinumab when it is given concomitantly with vaccines. The trial includes a screening period of 2 to 6 weeks, a treatment period of 16 weeks (Weeks 0 to 16), and a 14-week off-treatment follow-up period for the assessment of safety (Weeks 16 to 30). Eligible subjects may transfer to an open-label, long-term trial at Week 16 or later.

Conditions

Atopic Dermatitis

Outcome Measures

Primary Outcomes (2)

• Positive Anti-tetanus Response at Week 16

  The antibody response to Tdap vaccine will be assessed by measuring serum anti-tetanus IgG by an immunoassay. A positive response is defined as a 3-fold IgG increase compared to Week 12 if IgG ≤1.0 IU/mL at Week 12; or IgG ≥2.5 IU/mL if IgG \>1.0 IU/mL at Week 12.

  Week 12 to Week 16

• Positive Anti-meningococcal Response at Week 16

  The antibody response to meningococcal vaccine will be assessed by measuring serum anti-meningococcal IgG by an immunoassay. A positive response is defined as at least a 3-fold increase compared to Week 12.

  Week 12 to Week 16

Secondary Outcomes (4)

• Participants With Investigator's Global Assessment (IGA) Score of 0 (Clear) or 1 (Almost Clear) at Week 16

  Week 0 to Week 16

• Participants Achieving at Least 75% Reduction in Eczema Area and Severity Index (EASI) at Week 16.

  Week 0 to Week 16

• Number of AEs.

  Week 0 to Week 16

• Presence of Anti-drug Antibodies (ADA).

  Week 0 to Week 16

Study Arms (2)

Tralokinumab

EXPERIMENTAL

Week 0 to 16: Tralokinumab will be given as subcutaneous injections. Subjects will receive a tralokinumab loading dose at Day 0 followed by tralokinumab injection regimen A. The last administration will occur at Week 14.

Drug: Tralokinumab; Biological: Tdap vaccine; Biological: Meningococcal vaccine

Placebo

PLACEBO COMPARATOR

Placebo (dummy treatment) will be given as subcutaneous injections. Subjects will receive a placebo loading dose at Day 0 followed by placebo injection regimen A. The last administration will occur at Week 14.

Drug: Placebo; Biological: Tdap vaccine; Biological: Meningococcal vaccine

Interventions

Tralokinumab DRUG

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.

Tralokinumab

Placebo DRUG

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

Placebo

Tdap vaccine BIOLOGICAL

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

Placebo; Tralokinumab

Meningococcal vaccine BIOLOGICAL

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.

Placebo; Tralokinumab

Eligibility Criteria

• Age: 18 Years - 54 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age 18 to 54 years
• Diagnosis of AD as defined by Hanifin and Rajka (1980) criteria for AD
• History of AD for ≥1 year
• Subjects who have a recent history of inadequate response to treatment with topical medications or for whom topical treatments are otherwise medically inadvisable
• AD involvement of ≥10% body surface area at screening and baseline
• An EASI score of ≥12 at screening and 16 at baseline
• An IGA score of ≥3 at screening and at baseline
• Subjects must have applied a stable dose of emollient twice daily (or more, as needed) for at least 14 days before randomisation

You may not qualify if:

• Subjects for whom administration of the meningococcal vaccine provided in this trial is contraindicated or medically inadvisable, according to local label of the vaccine
• Subjects for whom administration of the tetanus, diphtheria, and pertussis vaccine provided in this trial is contraindicated or medically inadvisable, according to local label of the vaccine
• Active dermatologic conditions that may confound the diagnosis of AD or would interfere with assessment of treatment
• Use of tanning beds or phototherapy within 6 weeks prior to randomization
• Treatment with systemic immunosuppressive/immunomodulating medications and/or systemic corticosteroids within 4 weeks prior to randomization
• Treatment with the topical medications topical corticosteroids (TCS), topical calcineurin inhibitor (TCI) or phosphodiesterase 4 (PDE-4) inhibitor within 2 weeks prior to randomization
• Receipt of any vaccine (except influenza virus vaccines) within 3 months prior to screening, any meningococcal vaccine within 1 year prior to screening, or any tetanus-, diphtheria-, or pertussis-containing vaccine within 5 years prior to screening
• Receipt of any marketed (i.e. immunoglobulin, anti-IgE) or investigational biologic agent, including dupilumab
• History of any active skin infection within 1 week prior to randomization
• History of a clinically significant infection (systemic infection or serious skin infection requiring parenteral treatment) within 4 weeks prior to randomization

Sponsors & Collaborators

• LEO Pharma: lead

Study Sites (51)

Leo Pharma Investigational Site

Fort Smith, Arkansas, 72916, United States

Location

LEO Pharma Investigational Site

Bakersfield, California, 93301, United States

Location

Leo Pharma Investigational Site

Beverly Hills, California, 90212, United States

Location

Leo Pharma Investigational Site

Fountain Valley, California, 92708, United States

Location

Leo Pharma Investigational Site

Los Angeles, California, 90025, United States

Location

Leo Pharma Investigational Site

Los Angeles, California, 90045, United States

Location

Leo Pharma Investigational Site

Los Angeles, California, 90057, United States

Location

Leo Pharma Investigational Site

Newport Beach, California, 92660, United States

Location

LEO Pharma Investigational Site

San Diego, California, 92123, United States

Location

LEO Pharma Investigational Site

Centennial, Colorado, 80112, United States

Location

LEO Pharma Investigational Site

Denver, Colorado, 80045, United States

Location

LEO Pharma Investigational Site

Thornton, Colorado, 80233, United States

Location

Leo Pharma Investigational Site

Coral Gables, Florida, 33134, United States

Location

Leo Pharma Investigational Site

Doral, Florida, 33122, United States

Location

Leo Pharma Investigational Site

Hialeah, Florida, 33012, United States

Location

LEO Pharma Investigational Site

Atlanta, Georgia, 30328, United States

Location

Leo Pharma Investigational Site

New Albany, Indiana, 47150, United States

Location

Leo Pharma Investigational Site

South Bend, Indiana, 46617, United States

Location

LEO Pharma Investigational Site

Bangor, Maine, 04401, United States

Location

Leo Pharma Investigational Site

Boston, Massachusetts, 02115, United States

Location

LEO Pharma Investigational Site

Brighton, Massachusetts, 02135, United States

Location

Leo Pharma Investigational Site

Ann Arbor, Michigan, 48103, United States

Location

LEO Pharma Investigational Site

Southfield, Michigan, 48034, United States

Location

Leo Pharma Investigational Site

Missoula, Montana, 59808, United States

Location

Leo Pharma Investigational Site

East Windsor, New Jersey, 08520, United States

Location

LEO Pharma Investigational Site

Brooklyn, New York, 11201, United States

Location

Leo Pharma Investigational Site

Cortland, New York, 13045, United States

Location

Leo Pharma Investigational Site

Forest Hills, New York, 11375, United States

Location

Leo Pharma Investigational Site

New York, New York, 10021, United States

Location

Leo Pharma Investigational Site

Cincinnati, Ohio, 45219, United States

Location

LEO Pharma Investigational Site

Cincinnati, Ohio, 45231, United States

Location

LEO Pharma Investigational Site

Gahanna, Ohio, 43230, United States

Location

LEO Pharma Investigational Site

Medford, Oregon, 97504, United States

Location

Leo Pharma Investigational Site

Chattanooga, Tennessee, 37421, United States

Location

Leo Pharma Investigational Site

Austin, Texas, 78759, United States

Location

LEO Pharma Investigational Site

Dallas, Texas, 75225, United States

Location

Leo Pharma Investigational Site

Frisco, Texas, 75034, United States

Location

Leo Pharma Investigational Site

South Burlington, Vermont, 05403, United States

Location

Leo Pharma Investigational Site

Spokane, Washington, 99202, United States

Location

LEO Pharma Investigational Site

Edmonton, Alberta, T5K 1X3, Canada

Location

LEO Pharma Investigational Site

Edmonton, Alberta, T6G 1C3, Canada

Location

LEO Pharma Investigational Site

Vancouver, British Colombia, V6H 4E1, Canada

Location

LEO Pharma Investigational Site

St. John's, Newfoundland and Labrador, A1A 4Y3, Canada

Location

LEO Pharma Investigational Site

Hamilton, Ontario, L8S 1G5, Canada

Location

LEO Pharma Investigational Site

London, Ontario, N6H 5L5, Canada

Location

LEO Pharma Investigational Site

Oakville, Ontario, L6J 7W5, Canada

Location

LEO Pharma Investigational Site

Peterborough, Ontario, K9J 5K2, Canada

Location

LEO Pharma Investigational Site

Richmond Hill, Ontario, L4B 1A5, Canada

Location

LEO Pharma Investigational Site

Toronto, Ontario, M4V 1R2, Canada

Location

LEO Pharma Investigational Site

Windsor, Ontario, N8X 2G1, Canada

Location

LEO Pharma Investigational Site

Verdun, Quebec, H4G 3E7, Canada

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

tralokinumab; Meningococcal Vaccines

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Bacterial Vaccines; Vaccines; Biological Products; Complex Mixtures

Results Point of Contact

• Title: Disclosure
• Organization: LEO Pharma A/S

disclosure@leo-pharma.com

+45

Study Officials

• Medical Expert

  LEO Pharma

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Neither the subject nor any of the investigator or LEO staff who are involved in the treatment or clinical evaluation and monitoring of the subjects will be aware of the treatment received. The packaging and labelling of tralokinumab/placebo will contain no evidence of their identity. Since tralokinumab and placebo are visually distinct and not matched for viscosity, they will be handled and administered by a qualified, unblinded healthcare professional at the trial site who will not be involved in the management of trial subjects.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2018
• First Posted: June 19, 2018
• Study Start: July 13, 2018
• Primary Completion: September 17, 2019
• Study Completion: November 22, 2019
• Last Updated: March 11, 2025
• Results First Posted: March 5, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (39); CA (12)