Clinical trial NCT03761537: Tralokinumab in Combination With Topical Corticosteroids in Subjects With Severe Atopic Dermatitis - 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Atopic Dermatitis
Lead sponsor: LEO Pharma
Sponsor class: INDUSTRY
First posted: 2018-12-03
Enrollment: 277
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility 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

Primary outcomes:
measure: At Least 75% Reduction in Eczema Area and Severity Index (EASI75) From Week 0 to Week 16
timeFrame: Week 0 to Week 16
Secondary outcomes:
measure: Reduction of Worst Daily Pruritus Numeric Rating Scale (NRS) (Weekly Average) of at Least 4 From Week 0 to Week 16
timeFrame: Week 0 to Week 16
measure: Change in Scoring Atopic Dermatitis (SCORAD) From Week 0 to Week 16
timeFrame: Week 0 to Week 16
measure: Change in Dermatology Life Quality Index (DLQI) Score From Week 0 to Week 16
timeFrame: Week 0 to Week 16
measure: Investigator's Global Assessment (IGA) Score of 0 (Clear) or 1 (Almost Clear) at Week 16
timeFrame: Week 16
measure: At Least 75% Reduction in Eczema Area and Severity Index (EASI75) From Week 0 to Week 26
timeFrame: Week 0 to Week 26
measure: Reduction of Worst Daily Pruritus Numeric Rating Scale (NRS) (Weekly Average) of at Least 4 From Week 0 to Week 26
timeFrame: Week 0 to Week 26
measure: Change in Scoring Atopic Dermatitis (SCORAD) From Week 0 to Week 26
timeFrame: Week 0 to Week 26
measure: Change in Dermatology Life Quality Index (DLQI) Score From Week 0 to Week 26
timeFrame: Week 0 to Week 26
measure: Investigator's Global Assessment (IGA) Score of 0 (Clear) or 1 (Almost Clear) at Week 26
timeFrame: Week 26
measure: Frequency of Anti-drug Antibodies (ADA) From Week 0 to Week 40
timeFrame: Week 0 to Week 40
measure: Number of Adverse Events From Week 0 to Week 40
timeFrame: Week 0 to Week 40
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Leo Pharma Investigationel Site
city: Brussels
country: Belgium
facility: Leo Pharma Investigationel Site
city: Edegem
country: Belgium
facility: Leo Pharma Investigationel Site
city: Gent
country: Belgium
facility: Leo Pharma Investigationel Site
city: Gent
country: Belgium
facility: Leo Pharma Investigationel Site
city: Herstal
country: Belgium
facility: Leo Pharma Investigationel Site
city: Kortrijk
country: Belgium
facility: Leo Pharma Investigationel Site
city: Leuven
country: Belgium
facility: Leo Pharma Investigationel Site
city: Liège
country: Belgium
facility: Leo Pharma Investigationel Site
city: Loverval
country: Belgium
facility: Leo Pharma Investigationel Site
city: Maldegem
country: Belgium
facility: Leo Pharma Investigationel Site
city: Karlovy Vary
country: Czechia
facility: Leo Pharma Investigationel Site
city: Kutna Hora
country: Czechia
facility: Leo Pharma Investigationel Site
city: Ostrava
country: Czechia
facility: Leo Pharma Investigationel Site
city: Pardubice
country: Czechia
facility: Leo Pharma Investigationel Site
city: Prague 5
country: Czechia
facility: Leo Pharma Investigationel Site
city: Prague 8
country: Czechia
facility: Leo Pharma Investigationel Site
city: Prague
country: Czechia
facility: Leo Pharma Investigationel Site
city: Prague
country: Czechia
facility: Leo Pharma Investigationel Site
city: Praha 3
country: Czechia
facility: Leo Pharma Investigationel Site
city: Grenoble
country: France
facility: Leo Pharma Investigationel Site
city: Nice
country: France
facility: Leo Pharma Investigationel Site
city: Paris
country: France
facility: Leo Pharma Investigationel Site
city: Pierre-Bénite
country: France
facility: Leo Pharma Investigationel Site
city: Valence
country: France
facility: Leo Pharma Investigationel Site
city: Aachen
country: Germany
facility: Leo Pharma Investigationel Site
city: Augsburg
country: Germany
facility: Leo Pharma Investigationel Site
city: Bad Bentheim
country: Germany
facility: Leo Pharma Investigationel Site
city: Berlin
country: Germany
facility: Leo Pharma Investigationel Site
city: Dresden
country: Germany
facility: Leo Pharma Investigationel Site
city: Dülmen
country: Germany
facility: Leo Pharma Investigationel Site
city: Frankfurt
country: Germany
facility: Leo Pharma Investigationel Site
city: Halle
country: Germany
facility: Leo Pharma Investigationel Site
city: Hanover
country: Germany
facility: Leo Pharma Investigationel Site
city: Jena
country: Germany
facility: Leo Pharma Investigationel Site
city: Kiel
country: Germany
facility: Leo Pharma Investigationel Site
city: Mainz
country: Germany
facility: Leo Pharma Investigationel Site
city: München
country: Germany
facility: Leo Pharma Investigationel Site
city: Osnabrück
country: Germany
facility: Leo Pharma Investigationel Site
city: Selters
country: Germany
facility: Leo Pharma Investigationel Site
city: Białystok
country: Poland
facility: Leo Pharma Investigationel Site
city: Bochnia
country: Poland
facility: Leo Pharma Investigationel Site
city: Bydgoszcz
country: Poland
facility: Leo Pharma Investigationel Site
city: Gdańsk
country: Poland
facility: Leo Pharma Investigationel Site
city: Kraków
country: Poland
facility: Leo Pharma Investigationel Site
city: Kraków
country: Poland
facility: Leo Pharma Investigationel Site
city: Kraków
country: Poland
facility: Leo Pharma Investigationel Site
city: Lublin
country: Poland
facility: Leo Pharma Investigationel Site
city: Poznań
country: Poland
facility: Leo Pharma Investigationel Site
city: Rzeszów
country: Poland
facility: Leo Pharma Investigationel Site
city: Warszawa
country: Poland
facility: Leo Pharma Investigationel Site
city: Warszawa
country: Poland
facility: Leo Pharma Investigationel Site
city: Warszawa
country: Poland
facility: Leo Pharma Investigationel Site
city: Wrocław
country: Poland
facility: Leo Pharma Investigationel Site
city: Łódź
country: Poland
facility: Leo Pharma Investigationel Site
city: Łódź
country: Poland
facility: Leo Pharma Investigationel Site
city: Granada
country: Spain
facility: Leo Pharma Investigationel Site
state: Andalucía
city: Alicante
country: Spain
facility: Leo Pharma Investigationel Site
city: Barcelona
country: Spain
facility: Leo Pharma Investigationel Site
city: Barcelona
country: Spain
facility: Leo Pharma Investigationel Site
city: Barcelona
country: Spain
facility: Leo Pharma Investigationel Site
city: Bilbao
country: Spain
facility: Leo Pharma Investigationel Site
city: Córdoba
country: Spain
facility: Leo Pharma Investigationel Site
city: Madrid
country: Spain
facility: Leo Pharma Investigationel Site
city: Madrid
country: Spain
facility: Leo Pharma Investigationel Site
city: Madrid
country: Spain
facility: Leo Pharma Investigationel Site
city: Pamplona
country: Spain
facility: Leo Pharma Investigationel Site
city: Sevilla
country: Spain
facility: Leo Pharma Investigationel Site
city: Bradford
country: United Kingdom
facility: Leo Pharma Investigationel Site
city: Cottingham
country: United Kingdom
facility: Leo Pharma Investigationel Site
city: Kirkcaldy
country: United Kingdom
facility: Leo Pharma Investigationel Site
city: London
country: United Kingdom
facility: Leo Pharma Investigationel Site
city: Southampton
country: United Kingdom
facility: Leo Pharma Investigationel Site
city: Wakefield
country: United Kingdom
facility: Leo Pharma Investigationel Site
Study officials:
affiliation: LEO Pharma
name: Medical Expert
role: STUDY_DIRECTOR
References: