Tralokinumab in Combination With Topical Corticosteroids in Subjects With Severe Atopic Dermatitis - ECZTRA 7

Atopic Dermatitis Clinical Trial

— ECZTRA 7  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03761537
• Other study ID #: LP0162-1346
• Status: Completed
• Phase: Phase 3
• Start date: December 13, 2018
• Est. completion date: September 28, 2020

Study information

• Verified date: May 2023
• Source: LEO Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Primary objective:

To demonstrate that tralokinumab in combination with topical corticosteroids (TCS) is superior to placebo in combination with 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 277
• Est. completion date: September 28, 2020
• Est. primary completion date: April 21, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

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.

Other:
• Placebo
Placebo contains the same excipients in the same concentration only lacking tralokinumab.

Locations

Country	Name	City	State
Belgium	Leo Pharma Investigationel Site	Brussels
Belgium	Leo Pharma Investigationel Site	Brussels
Belgium	Leo Pharma Investigationel Site	Edegem
Belgium	Leo Pharma Investigationel Site	Gent
Belgium	Leo Pharma Investigationel Site	Gent
Belgium	Leo Pharma Investigationel Site	Herstal
Belgium	Leo Pharma Investigationel Site	Kortrijk
Belgium	Leo Pharma Investigationel Site	Leuven
Belgium	Leo Pharma Investigationel Site	Liège
Belgium	Leo Pharma Investigationel Site	Loverval
Belgium	Leo Pharma Investigationel Site	Maldegem
Czechia	Leo Pharma Investigationel Site	Karlovy Vary
Czechia	Leo Pharma Investigationel Site	Kutna Hora
Czechia	Leo Pharma Investigationel Site	Ostrava
Czechia	Leo Pharma Investigationel Site	Pardubice
Czechia	Leo Pharma Investigationel Site	Prague
Czechia	Leo Pharma Investigationel Site	Prague
Czechia	Leo Pharma Investigationel Site	Prague 5
Czechia	Leo Pharma Investigationel Site	Prague 8
Czechia	Leo Pharma Investigationel Site	Praha 3
France	Leo Pharma Investigationel Site	Grenoble
France	Leo Pharma Investigationel Site	Nice
France	Leo Pharma Investigationel Site	Paris
France	Leo Pharma Investigationel Site	Pierre-Bénite
France	Leo Pharma Investigationel Site	Valence
Germany	Leo Pharma Investigationel Site	Aachen
Germany	Leo Pharma Investigationel Site	Augsburg
Germany	Leo Pharma Investigationel Site	Bad Bentheim
Germany	Leo Pharma Investigationel Site	Berlin
Germany	Leo Pharma Investigationel Site	Dresden
Germany	Leo Pharma Investigationel Site	Dülmen
Germany	Leo Pharma Investigationel Site	Frankfurt
Germany	Leo Pharma Investigationel Site	Halle
Germany	Leo Pharma Investigationel Site	Hanover
Germany	Leo Pharma Investigationel Site	Jena
Germany	Leo Pharma Investigationel Site	Kiel
Germany	Leo Pharma Investigationel Site	Mainz
Germany	Leo Pharma Investigationel Site	München
Germany	Leo Pharma Investigationel Site	Osnabrück
Germany	Leo Pharma Investigationel Site	Selters
Poland	Leo Pharma Investigationel Site	Bialystok
Poland	Leo Pharma Investigationel Site	Bochnia
Poland	Leo Pharma Investigationel Site	Bydgoszcz
Poland	Leo Pharma Investigationel Site	Gdansk
Poland	Leo Pharma Investigationel Site	Kraków
Poland	Leo Pharma Investigationel Site	Kraków
Poland	Leo Pharma Investigationel Site	Kraków
Poland	Leo Pharma Investigationel Site	Lódz
Poland	Leo Pharma Investigationel Site	Lódz
Poland	Leo Pharma Investigationel Site	Lublin
Poland	Leo Pharma Investigationel Site	Poznan
Poland	Leo Pharma Investigationel Site	Rzeszów
Poland	Leo Pharma Investigationel Site	Warszawa
Poland	Leo Pharma Investigationel Site	Warszawa
Poland	Leo Pharma Investigationel Site	Warszawa
Poland	Leo Pharma Investigationel Site	Wroclaw
Spain	Leo Pharma Investigationel Site	Alicante
Spain	Leo Pharma Investigationel Site	Barcelona
Spain	Leo Pharma Investigationel Site	Barcelona
Spain	Leo Pharma Investigationel Site	Barcelona
Spain	Leo Pharma Investigationel Site	Bilbao
Spain	Leo Pharma Investigationel Site	Córdoba
Spain	Leo Pharma Investigationel Site	Granada	Andalucía
Spain	Leo Pharma Investigationel Site	Madrid
Spain	Leo Pharma Investigationel Site	Madrid
Spain	Leo Pharma Investigationel Site	Madrid
Spain	Leo Pharma Investigationel Site	Pamplona
Spain	Leo Pharma Investigationel Site	Sevilla
United Kingdom	Leo Pharma Investigationel Site	Bradford
United Kingdom	Leo Pharma Investigationel Site	Cottingham
United Kingdom	Leo Pharma Investigationel Site	Kirkcaldy
United Kingdom	Leo Pharma Investigationel Site	London
United Kingdom	Leo Pharma Investigationel Site	Southampton
United Kingdom	Leo Pharma Investigationel Site	Wakefield

Sponsors (1)

Lead Sponsor	Collaborator
LEO Pharma

Countries where clinical trial is conducted

Belgium,  Czechia,  France,  Germany,  Poland,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	At Least 75% Reduction in Eczema Area and Severity Index (EASI75) From Week 0 to 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.	Week 0 to Week 16
Secondary	Reduction of Worst Daily Pruritus Numeric Rating Scale (NRS) (Weekly Average) of at Least 4 From Week 0 to Week 16	Subjects will assess their worst itch severity over the past 24 hours using an 11-point NRS ('Worst Daily Pruritus NRS') with 0 indicating 'no itch' and 10 indicating 'worst itch imaginable'.	Week 0 to Week 16
Secondary	Change in Scoring Atopic Dermatitis (SCORAD) From Week 0 to Week 16	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.	Week 0 to Week 16
Secondary	Change in Dermatology Life Quality Index (DLQI) Score From Week 0 to Week 16	DLQI 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.	Week 0 to Week 16
Secondary	Investigator's Global Assessment (IGA) Score of 0 (Clear) or 1 (Almost Clear) at Week 16	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).	Week 16
Secondary	At Least 75% Reduction in Eczema Area and Severity Index (EASI75) From Week 0 to 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.	Week 0 to Week 26
Secondary	Reduction of Worst Daily Pruritus Numeric Rating Scale (NRS) (Weekly Average) of at Least 4 From Week 0 to Week 26	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'.	Week 0 to Week 26
Secondary	Change in Scoring Atopic Dermatitis (SCORAD) From Week 0 to Week 26	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.	Week 0 to Week 26
Secondary	Change in Dermatology Life Quality Index (DLQI) Score From Week 0 to Week 26	DLQI 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.	Week 0 to Week 26
Secondary	Investigator's Global Assessment (IGA) Score of 0 (Clear) or 1 (Almost Clear) at Week 26	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).	Week 26
Secondary	Frequency of Anti-drug Antibodies (ADA) From Week 0 to Week 40	Presence of ADA from Week 0 to Week 40 was measured. Data were reported in the following categories: positive (presence of ADA at baseline and/or presence of ADA at at least 1 post-baseline assessment), perishing (presence of ADA at baseline and absence of ADA at all post-baseline assessments), negative (absence of ADA at all assessments), no post-baseline ADA assessment.	Week 0 to Week 40
Secondary	Number of Adverse Events From Week 0 to Week 40	All adverse events are presented below under Adverse Events	Week 0 to Week 40