Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    LP0162-1334
Previous Study | Return to List | Next Study

Tralokinumab Monotherapy for Adolescent Subjects With Moderate to Severe Atopic Dermatitis - ECZTRA 6 (ECZema TRAlokinumab Trial no. 6).

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03526861
Recruitment Status : Active, not recruiting
First Posted : May 16, 2018
Last Update Posted : November 5, 2019
Sponsor:
Information provided by (Responsible Party):
LEO Pharma

Brief Summary:

Primary objective:

To evaluate the efficacy of subcutaneous (SC) administration of tralokinumab compared with placebo in treating adolescent subjects (age 12 to <18 years) with moderate-to-severe AD.

Secondary objectives:

To evaluate the efficacy of tralokinumab on severity and extent of AD, itch, and health-related quality of life compared with placebo.

To investigate the safety, immunogenicity, and tolerability of SC administration of tralokinumab compared with placebo when used to treat adolescent subjects (age 12 to <18 years) with moderate-to-severe AD.


Condition or disease Intervention/treatment Phase
Atopic Dermatitis Drug: Tralokinumab Drug: Placebos Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 294 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking Description: 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 the investigational medicinal products (IMPs) will contain no evidence of their identity. Since tralokinumab and placebo are visually distinct and not matched for viscosity, IMP will be handled and administered by a qualified, unblinded healthcare professional at the site who will not be involved in the management of trial subjects and who will not perform any of the assessments.
Primary Purpose: Treatment
Official Title: A Randomised, Double-blind, Placebo-controlled, Parallel-group, Multi-centre Trial to Evaluate the Efficacy, Safety, and Tolerability of Tralokinumab Monotherapy in Adolescent Subjects With Moderate-to-severe Atopic Dermatitis (AD) Who Are Candidates for Systemic Therapy
Actual Study Start Date : June 19, 2018
Estimated Primary Completion Date : April 20, 2020
Estimated Study Completion Date : February 20, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

Arm Intervention/treatment
Experimental: Tralokinumab(Dose1) initial-> Tralokinumab(Dose1) maintenanceA

Week 0 to 16 (initial period):

Tralokinumab (Dose 1) loading SC injection on Day 0 followed by tralokinumab (Dose 1) injection regimen A.

Week 16 to 52 (maintenance period):

Tralokinumab (Dose 1) maintenance SC injection regimen A.

Drug: Tralokinumab
Tralokinumab is a human recombinant monoclonal antibody of the immunoglobulin G4 (IgG4) subclass that specifically binds to human interleukin (IL) 13 and blocks interaction with the IL-13 receptors.

Experimental: Tralokinumab(Dose1) initial-> Tralokinumab(Dose1) maintenanceB

Week 0 to 16 (initial period):

Tralokinumab (Dose 1) loading SC injection on Day 0 followed by tralokinumab (Dose 1) injection regimen A.

Week 16 to 52 (maintenance period):

Tralokinumab (Dose 1) maintenance SC injection regimen B.

Drug: Tralokinumab
Tralokinumab is a human recombinant monoclonal antibody of the immunoglobulin G4 (IgG4) subclass that specifically binds to human interleukin (IL) 13 and blocks interaction with the IL-13 receptors.

Experimental: Tralokinumab(Dose2) initial-> Tralokinumab(Dose2) maintenanceA

Week 0 to 16 (initial period):

Tralokinumab (Dose 2) loading SC injection on Day 0 followed by tralokinumab (Dose 2) injection regimen A.

Week 16 to 52 (maintenance period):

Tralokinumab (Dose 2) maintenance SC injection regimen A.

Drug: Tralokinumab
Tralokinumab is a human recombinant monoclonal antibody of the immunoglobulin G4 (IgG4) subclass that specifically binds to human interleukin (IL) 13 and blocks interaction with the IL-13 receptors.

Experimental: Tralokinumab(Dose2) initial-> Tralokinumab(Dose2) maintenanceB

Week 0 to 16 (initial period):

Tralokinumab (Dose 2) loading SC injection on Day 0 followed by tralokinumab (Dose 2) injection regimen A.

Week 16 to 52 (maintenance period):

Tralokinumab (Dose 2) maintenance SC injection regimen B.

Drug: Tralokinumab
Tralokinumab is a human recombinant monoclonal antibody of the immunoglobulin G4 (IgG4) subclass that specifically binds to human interleukin (IL) 13 and blocks interaction with the IL-13 receptors.

Experimental: Placebo initial-> Placebo maintenance

Week 0 to 16 (initial period):

Placebo loading SC injection on Day 0 followed by placebo injection regimen A.

Week 16 to 52 (maintenance period):

Placebo continuation SC injection regimen A.

Drug: Placebos
Placebo contains the same excipients in the same concentration only lacking tralokinumab.
Other Name: Placebo

Experimental: Tralokinumab (Dose1) initial-> Open-label tralokinumab

Week 0 to 16 (initial period):

Tralokinumab (Dose 1) loading SC injection on Day 0 followed by tralokinumab (Dose 1) injection regimen A.

Week 16 to 52:

Tralokinumab (Dose 1) maintenance SC regimen A - open-label with allowed use of topical corticosteroids

Drug: Tralokinumab
Tralokinumab is a human recombinant monoclonal antibody of the immunoglobulin G4 (IgG4) subclass that specifically binds to human interleukin (IL) 13 and blocks interaction with the IL-13 receptors.

Experimental: Tralokinumab (Dose2) initial-> Open-label tralokinumab

Week 0 to 16 (initial period):

Tralokinumab (Dose 2) loading SC injection on Day 0 followed by tralokinumab (Dose 2) injection regimen A.

Week 16 to 52:

Tralokinumab (Dose 1) maintenance SC regimen A - open-label with allowed use of topical corticosteroids

Drug: Tralokinumab
Tralokinumab is a human recombinant monoclonal antibody of the immunoglobulin G4 (IgG4) subclass that specifically binds to human interleukin (IL) 13 and blocks interaction with the IL-13 receptors.

Experimental: Placebo initial-> Open-label tralokinumab

Week 0 to 16 (initial period):

Placebo loading SC injection on Day 0 followed by placebo injection regimen A.

Week 16 to 52:

Tralokinumab (Dose 1) maintenance SC regimen A - open-label with allowed use of topical corticosteroids

Drug: Tralokinumab
Tralokinumab is a human recombinant monoclonal antibody of the immunoglobulin G4 (IgG4) subclass that specifically binds to human interleukin (IL) 13 and blocks interaction with the IL-13 receptors.

Drug: Placebos
Placebo contains the same excipients in the same concentration only lacking tralokinumab.
Other Name: Placebo




Primary Outcome Measures :
  1. Investigator's Global Assessment (IGA) score of 0 (clear) or 1 (almost clear) at Week 16. [ Time Frame: 16 weeks ]
    The IGA is an instrument used in clinical trials to rate the severity of the subject's global AD and is based on a 5-point scale ranging from 0 (clear) to 4 (severe).

  2. At least 75% reduction in Eczema Area and Severity Index (EASI75) at Week 16. [ Time Frame: 16 weeks ]
    The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of AD. The EASI is a composite index with scores ranging from 0 to 72, with higher values indicating more severe and/or more extensive condition.


Secondary Outcome Measures :
  1. Change in Scoring Atopic Dermatitis (SCORAD) from baseline to Week 16. [ Time Frame: 16 weeks ]
    The SCORAD is a validated tool to evaluate the extent and severity of AD lesions, along with subjective symptoms. The maximum total score is 103, with higher values indicating more severe disease.

  2. Reduction of Adolescent Pruritus numeric rating scale (NRS) (weekly average) of at least 4 from baseline to Week 16. [ Time Frame: 16 weeks ]
    The Adolescent Pruritus NRS is used by subjects to assess their worst itch over the past 24 hours using an 11-point NRS with 0 indicating 'no itch' and 10 indicating 'worst itch possible'.

  3. Change in Children's Dermatology Life Quality Index (CDLQI) score from baseline to Week 16. [ Time Frame: 16 weeks ]
    The CDLQI is a validated questionnaire with content specific to those with dermatology conditions. It consists of 10 items addressing the subject's perception of the impact of their skin disease on various aspects of their quality of life over the last week such as dermatology-related symptoms and feelings, leisure, school or holidays, personal relationships, sleep, and the treatment. Each item is scored on a 4-point Likert scale (0 = 'not at all'; 1 = 'only a little'; 2 = 'quite a lot'; 3 = 'very much'). Item 7 (on school time) has one additional response category 'prevented school', which is also scored '3'. The total score of the CDLQI is the sum of the 10 items (0 to 30); a high score is indicative of a poor quality of life.

  4. Number of adverse events. [ Time Frame: 66 weeks ]
  5. Occurrence of anti-drug antibodies (yes/no). [ Time Frame: 66 weeks ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   12 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 12 to 17.
  • Diagnosis of AD as defined by the Hanifin and Rajka (1980) criteria for AD.
  • History of AD for ≥1 year.
  • History of topical corticosteroid (TCS; Europe: Class 3 or higher; US: Class 4 or lower) and/or topical calcineurin inhibitor (TCI) treatment failure or subjects for whom these topical AD treatments are medically inadvisable.
  • AD involvement of ≥10% body surface area at screening and baseline.
  • Stable dose of emollient twice daily (or more, as needed) for at least 14 days before randomisation.

Exclusion Criteria:

  • Active dermatologic conditions that may confound the diagnosis of AD.
  • Use of tanning beds or phototherapy within 6 weeks prior to randomisation.
  • Treatment with systemic immunosuppressive/immunomodulating drugs and/or systemic corticosteroid within 4 weeks prior to randomisation.
  • Treatment with TCS, TCI, or topical phosphodiesterase 4 (PDE-4) inhibitor within 2 weeks prior to randomisation.
  • Receipt of any marketed biological therapy (i.e. immunoglobulin, anti immunoglobulin E) including dupilumab or investigational biologic agents.
  • Active skin infection within 1 week prior to randomisation.
  • Clinically significant infection within 4 weeks prior to randomisation.
  • A helminth parasitic infection within 6 months prior to the date informed consent is obtained.
  • Tuberculosis requiring treatment within the 12 months prior to screening.
  • Known primary immunodeficiency disorder.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03526861


  Show 87 Study Locations
Sponsors and Collaborators
LEO Pharma
Investigators
Layout table for investigator information
Study Director: Medical expert LEO Pharma

Layout table for additonal information
Responsible Party: LEO Pharma
ClinicalTrials.gov Identifier: NCT03526861     History of Changes
Other Study ID Numbers: LP0162-1334
2017-005143-33 ( EudraCT Number )
First Posted: May 16, 2018    Key Record Dates
Last Update Posted: November 5, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Dermatitis, Atopic
Dermatitis
Eczema
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs