Tralokinumab in Combination With Topical Corticosteroids for Moderate to Severe Atopic Dermatitis - ECZTRA 3
- Registration Number
- NCT03363854
- Lead Sponsor
- LEO Pharma
- Brief Summary
Primary objective:
To demonstrate that tralokinumab in combination with topical corticosteroids (TCS) is superior to placebo in combination with TCS in treating moderate-to-severe atopic dermatitis (AD).
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 with placebo in combination with TCS.
To assess the safety of tralokinumab in combination with TCS when used to treat moderate-to-severe AD for 32 weeks.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 380
- Age 18 and above.
- Diagnosis of AD as defined by the 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.
- 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.
- Subjects for whom TCS are medically inadvisable e.g., due to important side effects or safety risks in the opinion of the investigator.
- 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, topical calcineurin inhibitors (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 within 3 months or 5 half-lives, whichever is longer prior to randomisation.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Tralokinumab(initial)responders-> Tralokinumab(continuation A) Tralokinumab Week 0 to 16 (initial period): Tralokinumab loading SC injection on Day 0 followed by tralokinumab injection regimen A. Week 16 to 32 (continuation period): Tralokinumab continuation SC injection regimen A. Tralokinumab(initial)non-respon-> Tralokinumab(continuation A) Tralokinumab Week 0 to 16 (initial period): Tralokinumab loading SC injection on Day 0 followed by tralokinumab injection regimen A. Week 16 to 32 (continuation period): Tralokinumab continuation SC injection regimen A. Placebo (initial)non-respon-> Tralokinumab(continuation A) Placebo Week 0 to 16 (initial period): Placebo loading SC injection on Day 0 followed by placebo injection regimen A. Week 16 to 32 (continuation period): Tralokinumab continuation SC injection regimen A. Placebo(initial)responders-> Placebo(continuation A) Placebo Week 0 to 16 (initial period): Placebo loading SC injection on Day 0 followed by placebo injection regimen A. Week 16 to 32 (continuation period): Placebo continuation SC injection regimen A. Tralokinumab(initial)responders-> Tralokinumab(continuation B) Tralokinumab Week 0 to 16 (initial period): Tralokinumab loading SC injection on Day 0 followed by tralokinumab injection regimen A. Week 16 to 32 (continuation period): Tralokinumab continuation SC injection regimen B. Placebo (initial)non-respon-> Tralokinumab(continuation A) Tralokinumab Week 0 to 16 (initial period): Placebo loading SC injection on Day 0 followed by placebo injection regimen A. Week 16 to 32 (continuation period): Tralokinumab continuation SC injection regimen A.
- Primary Outcome Measures
Name Time Method Participants With Investigator's Global Assessment (IGA) Score of 0 (Clear) or 1 (Almost Clear) at Week 16 Week 16 IGA is used to evaluate the severity of atopic dermatitis. It is a 5-point score ranging from 0 (clear) to 4 (severe).
Participants Achieving at Least 75% Reduction in Eczema Area and Severity Index (EASI) at Week 16 Week 16 EASI is used to evaluate the extent and severity of atopic dermatitis. It is a composite score ranging from 0 to 72 with a higher score indicating a more extensive and/or severe condition.
- Secondary Outcome Measures
Name Time Method Change in Dermatology Life Quality Index (DLQI) Score From Baseline to Week 16 Week 0 to Week 16 DLQI is used by the participant to evaluate the impact of their condition on 10 different aspects of health-related quality of life (HRQoL) over the last week. Each item is scored on a 4-point Likert scale ranging from 0 (not at all/not relevant) to 3 (very much). The total score which is the sum of the 10 items ranges from 0 to 30, with a higher score indicating a poorer HRQoL.
Number of Atopic Dermatitis Flares Through Week 16 Week 0 to Week 16 Assessed as appearance of new flares since previous visit.
Participants Achieving at Least 75% Reduction in Scoring Atopic Dermatitis (SCORAD) at Week 16 Week 16 SCORAD is used to evaluate the extent and severity of atopic dermatitis as well as subjective symptoms. The score ranges from 0 to 103 with a higher score indicating a more extensive and/or severe condition.
Participants With Investigator's Global Assessment (IGA) Score of 0 (Clear) or 1 (Almost Clear) at Week 32 Among Participants With IGA Score of 0 or 1 at Week 16 After Initial Randomisation to Tralokinumab Week 32 IGA is used to evaluate the severity of atopic dermatitis. It is a 5-point score ranging from 0 (clear) to 4 (severe).
Reduction of Worst Daily Pruritus Numeric Rating Scale (NRS) (Weekly Average) of at Least 4 From Baseline to Week 16 Week 0 to Week 16 Worst Daily Pruritus NRS is used by the participant to evaluate their worst itch severity over the past 24 hours. The score ranges from 0 ('no itch') to 10 ('worst itch imaginable') on an 11-point scale.
Participants Achieving at Least 50% Reduction in Eczema Area and Severity Index (EASI) at Week 16 Week 16 EASI is used to evaluate the extent and severity of atopic dermatitis. It is a composite score ranging from 0 to 72 with a higher score indicating a more extensive and/or severe condition.
Change From Baseline to Week 16 in Worst Daily Pruritus Numeric Rating Scale (NRS) (Weekly Average) Week 0 to Week 16 Worst Daily Pruritus NRS is used by the participant to evaluate their worst itch severity over the past 24 hours. The score ranges from 0 ('no itch') to 10 ('worst itch imaginable') on an 11-point scale.
Change in Scoring Atopic Dermatitis (SCORAD) From Baseline to Week 16 Week 0 to Week 16 SCORAD is used to evaluate the extent and severity of atopic dermatitis as well as subjective symptoms. The score ranges from 0 to 103 with a higher score indicating a more extensive and/or severe condition.
Frequency of Anti-drug Antibodies (ADA) Week 0 to Week 16, Week 16 to Week 32 Presence of ADA from Week 0 to Week 32 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. Perishing ADAs were not assessed in the continuation treatment period.
Number of Days Without Topical Treatment Use From Baseline to Week 16 Week 1 to Week 16 Participants assessed their use of topical treatment over the past 24 hours using a response scale ('yes', 'no'). Measurements of number of days per week were used in the analysis.
Amount of Topical Corticosteroid (TCS) Used Through Week 16 Assuming no TCS Used From the Non-returned Tubes Week 1-2 to Week 15-16 Assessed as the amount of TCS weighed from previous visits, assuming no TCS was used from the non-returned tubes. Measurements were collected as TCS weight (g) between the visits.
Amount of Topical Corticosteroid (TCS) Used Through Week 16 Assuming All TCS Used From the Non-returned Tubes Week 1-2 to Week 15-16 Assessed as the amount of TCS weighed from previous visits, assuming all TCS was used from the non-returned tubes. Measurements were collected as TCS weight (g) between the visits.
Participants Achieving at Least 90% Reduction in Eczema Area and Severity Index (EASI) at Week 16 Week 16 EASI is used to evaluate the extent and severity of atopic dermatitis. It is a composite score ranging from 0 to 72 with a higher score indicating a more extensive and/or severe condition.
Change From Baseline to Week 16 in Eczema Area and Severity Index (EASI) Score Week 0 to Week 16 EASI is used to evaluate the extent and severity of atopic dermatitis. It is a composite score ranging from 0 to 72 with a higher score indicating a more extensive and/or severe condition.
Participants Achieving at Least 50% Reduction in Scoring Atopic Dermatitis (SCORAD) at Week 16 Week 16 SCORAD is used to evaluate the extent and severity of atopic dermatitis as well as subjective symptoms. The score ranges from 0 to 103 with a higher score indicating a more extensive and/or severe condition.
Reduction From Baseline to Week 16 of Dermatology Life Quality Index (DLQI) of at Least 4 Points Among Participants With Baseline DLQI ≥4 Week 0 to Week 16 DLQI is used by the participant to evaluate the impact of their condition on 10 different aspects of health-related quality of life (HRQoL) over the last week. Each item is scored on a 4-point Likert scale ranging from 0 (not at all/not relevant) to 3 (very much). The total score which is the sum of the 10 items ranges from 0 to 30, with a higher score indicating a poorer HRQoL.
Participants Achieving at Least 75% Reduction in Eczema Area and Severity Index (EASI) at Week 32 Among Participants Who Had Achieved at Least 75% Reduction in EASI at Week 16 After Initial Randomisation to Tralokinumab Week 32 EASI is used to evaluate the extent and severity of atopic dermatitis. It is a composite score ranging from 0 to 72 with a higher score indicating a more extensive and/or severe condition.
Trial Locations
- Locations (63)
Fundación Hospital Alcorcón
🇪🇸Madrid, Spain
Hospital General de Valencia
🇪🇸Valencia, Spain
St. Josef-Hospital, Ruhr-Universitet
🇩🇪Bochum, Germany
Klinikum der Johann Wolfgang Goethe-Universität Klinik
🇩🇪Frankfurt am Main, Germany
Universitätshautklinik Kiel
🇩🇪Kiel, Germany
University of Alabama-Birmingham
🇺🇸Birmingham, Alabama, United States
Clinical Science Institute
🇺🇸Santa Monica, California, United States
Center for Dermatology Clinical Research
🇺🇸Fremont, California, United States
Dermatology Research Associates
🇺🇸Los Angeles, California, United States
Danbury Clinical Research
🇺🇸Danbury, Connecticut, United States
International Dermatology Research
🇺🇸Miami, Florida, United States
L & C Professional Medical Research
🇺🇸Miami, Florida, United States
Lenus Research & Medical Group
🇺🇸Sweetwater, Florida, United States
Northwestern University
🇺🇸Chicago, Illinois, United States
Medical Dermatology Specialists
🇺🇸Atlanta, Georgia, United States
Indiana Clinical Trials Center
🇺🇸Plainfield, Indiana, United States
Study Center
🇺🇸Bangor, Maine, United States
Respiratory Medicine Research
🇺🇸Ypsilanti, Michigan, United States
Mount Sinai West Dermatoogy
🇺🇸New York, New York, United States
Wake Research
🇺🇸Raleigh, North Carolina, United States
Dermatologists of Greater Columbus
🇺🇸Bexley, Ohio, United States
Oregon Dermatology & Research
🇺🇸Portland, Oregon, United States
National Allergy and Asthma Research, LLC
🇺🇸North Charleston, South Carolina, United States
Universitair ziekenhuis Brussel
🇧🇪Brussels, Belgium
University Hospital Antwerp
🇧🇪Antwerp, Belgium
LEO Pharma Investigational Site
🇵🇱Rzeszów, Poland
Cliniques Universitaires St-Luc
🇧🇪Brussels, Belgium
Skin Care Centre
🇨🇦Vancouver, British Columbia, Canada
CCA Medical Research
🇨🇦Ajax, Ontario, Canada
Eastern Canada Cutaneous Research
🇨🇦Halifax, Nova Scotia, Canada
DermEdge Research
🇨🇦Mississauga, Ontario, Canada
York Dermatology Center
🇨🇦Richmond Hill, Ontario, Canada
Research Toronto
🇨🇦Toronto, Ontario, Canada
Interdisciplinary Study Association GmbH
🇩🇪Berlin, Germany
MensingDerma Research GmbH
🇩🇪Hamburg, Germany
Klinik und Poliklinik für Dermatologie und Allergologie
🇩🇪Bonn, Germany
Universitätsklinikum Jena
🇩🇪Jena, Germany
Radboud MC
🇳🇱Nijmegen, Netherlands
Amcademic Medical Center
🇳🇱Amsterdam, Netherlands
Erasmus MC, Rotterdam
🇳🇱Rotterdam, Netherlands
University Medical Centre Utrecht
🇳🇱Utrecht, Netherlands
Nzoz Med-Laser
🇵🇱Lublin, Poland
Derm Medica Sp.zo.o.
🇵🇱Wrocław, Poland
Hospital General de Alicante
🇪🇸Alicante, Spain
Wojskowy Instytut Medyczny
🇵🇱Warszawa, Poland
Wromedica s.c.
🇵🇱Wroclaw, Poland
Hospital Universitari de Bellvitge
🇪🇸Barcelona, Spain
Hospital de Pontevedra
🇪🇸Pontevedra, Spain
The Princess Alexandra Hospital
🇬🇧Harlow, Essex, United Kingdom
Addenbooke's Hospital
🇬🇧Cambridge, Cambridgeshire, United Kingdom
Russells Hall Hospital
🇬🇧Dudley, West Midlands, United Kingdom
Queen Elizabeth Hospital Birmingham
🇬🇧Birmingham, West Midlands, United Kingdom
California Dermatology & Clinical Research Institute
🇺🇸Encinitas, California, United States
Maritime Medical Research Centre
🇨🇦Bathurst, New Brunswick, Canada
Institute for Skin Advancement
🇨🇦Calgary, Alberta, Canada
Simcoderm Medical and Surgical Dermatology Centre
🇨🇦Barrie, Ontario, Canada
XLR8 Medical Research
🇨🇦Windsor, Ontario, Canada
Universitätsklinikum Tübingen
🇩🇪Tuebingen, Germany
The Royal Free Hospital
🇬🇧London, United Kingdom
First OC Dermatology
🇺🇸Fountain Valley, California, United States
East Surrey Hospital
🇬🇧Redhill, Surrey, United Kingdom
Olympian Clinical Research
🇺🇸Tampa, Florida, United States
Guy's and St Thomas' NHS Foundation Trust
🇬🇧London, United Kingdom