Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.

Tralokinumab in Combination With Topical Corticosteroids in Subjects With Severe Atopic Dermatitis Who Are Not Adequately Controlled With or Have Contraindications to Oral Cyclosporine A (ECZTRA 7)

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: NCT03761537
Recruitment Status : Active, not recruiting
First Posted : December 3, 2018
Last Update Posted : December 23, 2019
Sponsor:
Information provided by (Responsible Party):
LEO Pharma

Brief Summary:

Primary objective:

To demonstrate that tralokinumab in combination with TCS is superior to placebo in combination with topical corticosteroids (TCS) in treating severe AD in subjects who are not adequately controlled with or have contraindications to oral cyclosporine A (CSA).

Secondary objectives:

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

To evaluate the safety of tralokinumab in combination with TCS when treating severe AD in subjects who are not adequately controlled with or have contraindications to oral CSA compared to placebo in combination with TCS.


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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 333 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomised, Double-blind, Placebo-controlled, Parallel-group, Multi-centre, Phase 3 Trial Investigating the Efficacy, Safety, and Tolerability of Tralokinumab Administered in Combination With Topical Corticosteroids to Adult Subjects With Severe Atopic Dermatitis Who Are Not Adequately Controlled With or Have Contraindications to Oral Cyclosporine A
Actual Study Start Date : December 28, 2018
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : May 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

Arm Intervention/treatment
Experimental: Tralokinumab
Tralokinumab loading SC injection on Day 0 followed by multiple tralokinumab injections
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 (SC) administration.

Placebo Comparator: Placebo
Placebo loading SC injection on Day 0 followed by multiple placebo injections
Other: Placebo
Placebo contains the same excipients in the same concentration only lacking tralokinumab.




Primary Outcome Measures :
  1. At least 75 reduction in EASI score (EASI75) [ Time Frame: Week 16 ]
    EASI (Eczema Area and Severity Index) 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. IGA score of 0 (clear) or 1 (almost clear) [ Time Frame: Week 0 to Week 16 ]
    IGA (Investigator's Global Assessment) 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. IGA score of 0 (clear) or 1 (almost clear) [ Time Frame: Week 0 to Week 26 ]
    IGA (Investigator's Global Assessment) 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)

  3. Change in SCORAD [ Time Frame: Week 0 to Week 16 ]
    SCORAD (Scoring Atopic Dermatitis) 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

  4. Change in SCORAD [ Time Frame: Week 0 to Week 26 ]
    SCORAD (Scoring Atopic Dermatitis) 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

  5. EASI75 response [ Time Frame: Week 26 ]
    EASI (Eczema Area and Severity Index) 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

  6. Reduction of Worst Daily Pruritus NRS (weekly average) of at least 4 [ Time Frame: Week 16 ]
    NRS (Numeric Summary Score). Subjects will assess their worst itch severity over the past 24 hours using an 11-point numeric rating scale ('Worst Daily Pruritus NRS') with 0 indicating 'no itch' and 10 indicating 'worst itch imaginable'

  7. Reduction of Worst Daily Pruritus NRS (weekly average) of at least 4 [ Time Frame: Week 26 ]
    NRS (Numeric Summary Score). Subjects will assess their worst itch severity over the past 24 hours using an 11-point numeric rating scale ('Worst Daily Pruritus NRS') with 0 indicating 'no itch' and 10 indicating 'worst itch imaginable'

  8. Change in DLQI score [ Time Frame: Week 0 to Week 16 ]
    DLQI (Dermatology Life Quality Index) 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 different aspects of their health-related quality of life (HRQoL) over the last week such as dermatology-related symptoms and feelings, daily activities, leisure, work or school, personal relationships, and the treatment. Each item is scored on a 4-point Likert scale (0 = not at all ∕not relevant; 1 = a little; 2 = a lot; 3 = very much). The total score is the sum of the 10 items (0 to 30); a high score is indicative of a poor HRQoL

  9. Change in DLQI score [ Time Frame: Week 0 to Week 26 ]
    DLQI (Dermatology Life Quality Index) 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 different aspects of their health-related quality of life (HRQoL) over the last week such as dermatology-related symptoms and feelings, daily activities, leisure, work or school, personal relationships, and the treatment. Each item is scored on a 4-point Likert scale (0 = not at all ∕not relevant; 1 = a little; 2 = a lot; 3 = very much). The total score is the sum of the 10 items (0 to 30); a high score is indicative of a poor HRQoL

  10. Adverse events [ Time Frame: Week 0 to Week 40 ]
    Number of adverse events

  11. Presence of anti-drug antibodies [ Time Frame: Week 0 to Week 40 ]
    yes/no



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:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • Age 18 and above
  • Diagnosis of AD as defined by the Hanifin and Rajka (1980) criteria for AD
  • History of AD for 1 year or more
  • Subjects with a history within 1 year prior to screening of inadequate response to treatment with topical medications or subjects for whom topical treatments are otherwise medically inadvisable
  • AD involvement of 10% (or more) body surface area at screening and baseline (visit 3) according to component A of SCORAD
  • Documented history of either no previous CSA exposure and not currently a candidate for CSA treatment OR previous exposure to CSA in which case CSA treatment should not be continued or restarted
  • Subjects must have applied a stable dose of emollient twice daily (or more, as needed) for at least 14 days before randomisation

Key Exclusion Criteria:

  • Subjects for whom TCSs are medically inadvisable in the opinion of the investigator
  • Use of tanning beds or phototherapy (NBUVB, UVB, UVA1, PUVA), within 6 weeks prior to randomisation
  • Treatment with immunomodulatory medications or bleach baths within 4 weeks prior to randomisation
  • Treatment with topical phosphodiesterase-4 (PDE-4) inhibitor within 2 weeks prior to randomisation
  • Receipt of any marketed or investigational biologic agent (e.g. cell-depleting agents or dupilumab) within 6 months prior to randomisation or until cell counts return to normal, whichever is longer
  • History of any active skin infection within 1 week prior to randomisation
  • History of a clinically significant infection (systemic infection or serious skin infection requiring parenteral treatment) within 4 weeks prior to randomisation
  • A helminth parasitic infection within 6 months prior to the date informed consent is obtained that has not been treated with, or has failed to respond to, standard of care therapy
  • Tuberculosis requiring treatment within the 12 months prior to screening. Evaluation will be according to local guidelines as per local standard of care
  • History of any known primary immunodeficiency disorder including a positive HIV test at screening, or the subject taking antiretroviral medications

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): NCT03761537


Locations
Show Show 72 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: NCT03761537    
Other Study ID Numbers: LP0162-1346
First Posted: December 3, 2018    Key Record Dates
Last Update Posted: December 23, 2019
Last Verified: December 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
Product Manufactured in and Exported from the U.S.: Yes
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
Cyclosporine
Cyclosporins
Antibodies, Monoclonal
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antifungal Agents
Anti-Infective Agents
Dermatologic Agents
Antirheumatic Agents
Calcineurin Inhibitors