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

Primary Purpose

Atopic Dermatitis

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Tralokinumab
Placebo
Sponsored by
LEO Pharma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atopic Dermatitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Leo Pharma Investigationel Site
  • Leo Pharma Investigationel Site
  • Leo Pharma Investigationel Site
  • Leo Pharma Investigationel Site
  • Leo Pharma Investigationel Site
  • Leo Pharma Investigationel Site
  • Leo Pharma Investigationel Site
  • Leo Pharma Investigationel Site
  • Leo Pharma Investigationel Site
  • Leo Pharma Investigationel Site
  • Leo Pharma Investigationel Site
  • Leo Pharma Investigationel Site
  • Leo Pharma Investigationel Site
  • Leo Pharma Investigationel Site
  • Leo Pharma Investigationel Site
  • Leo Pharma Investigationel Site
  • Leo Pharma Investigationel Site
  • Leo Pharma Investigationel Site
  • Leo Pharma Investigationel Site
  • Leo Pharma Investigationel Site
  • Leo Pharma Investigationel Site
  • Leo Pharma Investigationel Site
  • Leo Pharma Investigationel Site
  • Leo Pharma Investigationel Site
  • Leo Pharma Investigationel Site
  • Leo Pharma Investigationel Site
  • Leo Pharma Investigationel Site
  • Leo Pharma Investigationel Site
  • Leo Pharma Investigationel Site
  • Leo Pharma Investigationel Site
  • Leo Pharma Investigationel Site
  • Leo Pharma Investigationel Site
  • Leo Pharma Investigationel Site
  • Leo Pharma Investigationel Site
  • Leo Pharma Investigationel Site
  • Leo Pharma Investigationel Site
  • Leo Pharma Investigationel Site
  • Leo Pharma Investigationel Site
  • Leo Pharma Investigationel Site
  • Leo Pharma Investigationel Site
  • Leo Pharma Investigationel Site
  • Leo Pharma Investigationel Site
  • Leo Pharma Investigationel Site
  • Leo Pharma Investigationel Site
  • Leo Pharma Investigationel Site
  • Leo Pharma Investigationel Site
  • Leo Pharma Investigationel Site
  • Leo Pharma Investigationel Site
  • Leo Pharma Investigationel Site
  • Leo Pharma Investigationel Site
  • Leo Pharma Investigationel Site
  • Leo Pharma Investigationel Site
  • Leo Pharma Investigationel Site
  • Leo Pharma Investigationel Site
  • Leo Pharma Investigationel Site
  • Leo Pharma Investigationel Site
  • Leo Pharma Investigationel Site
  • Leo Pharma Investigationel Site
  • Leo Pharma Investigationel Site
  • Leo Pharma Investigationel Site
  • Leo Pharma Investigationel Site
  • Leo Pharma Investigationel Site
  • Leo Pharma Investigationel Site
  • Leo Pharma Investigationel Site
  • Leo Pharma Investigationel Site
  • Leo Pharma Investigationel Site
  • Leo Pharma Investigationel Site
  • Leo Pharma Investigationel Site
  • Leo Pharma Investigationel Site
  • Leo Pharma Investigationel Site
  • Leo Pharma Investigationel Site
  • Leo Pharma Investigationel Site
  • Leo Pharma Investigationel Site
  • Leo Pharma Investigationel Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Tralokinumab + TCS

Placebo + TCS

Arm Description

4 subcutaneous (SC) injections of tralokinumab 150 mg as a loading dose on Day 0, followed by 2 SC injections of tralokinumab 150 mg every 2 weeks (Q2W) regimen for 26 weeks. The last administration of the Investigational Medicinal Product (IMP) occurred at Week 24. From Day 0 to Week 24, a Topical corticosteroid (TCS) cream was dispensed to the participants at each IMP dosing visit (e.g., Q2W). Participants were instructed to treat active lesions as needed and to discontinue the TCS treatment when control was achieved.

4 subcutaneous (SC) injections of placebo as a loading dose on Day 0, followed by 2 SC injections of placebo every 2 weeks (Q2W) regimen for 26 weeks. The last administration of the Investigational Medicinal Product (IMP) occurred at Week 24. From Day 0 to Week 24, a Topical corticosteroid (TCS) cream was dispensed to the participants at each IMP dosing visit (e.g., Q2W). Participants were instructed to treat active lesions as needed and to discontinue the TCS treatment when control was achieved.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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'.
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.
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.
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).
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.
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'.
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.
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.
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).
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.
Number of Adverse Events From Week 0 to Week 40
All adverse events are presented below under Adverse Events

Full Information

First Posted
November 30, 2018
Last Updated
May 10, 2023
Sponsor
LEO Pharma
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1. Study Identification

Unique Protocol Identification Number
NCT03761537
Brief Title
Tralokinumab in Combination With Topical Corticosteroids in Subjects With Severe Atopic Dermatitis - ECZTRA 7
Acronym
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

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
December 13, 2018 (Actual)
Primary Completion Date
April 21, 2020 (Actual)
Study Completion Date
September 28, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
LEO Pharma

4. Oversight

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

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
277 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tralokinumab + TCS
Arm Type
Experimental
Arm Description
4 subcutaneous (SC) injections of tralokinumab 150 mg as a loading dose on Day 0, followed by 2 SC injections of tralokinumab 150 mg every 2 weeks (Q2W) regimen for 26 weeks. The last administration of the Investigational Medicinal Product (IMP) occurred at Week 24. From Day 0 to Week 24, a Topical corticosteroid (TCS) cream was dispensed to the participants at each IMP dosing visit (e.g., Q2W). Participants were instructed to treat active lesions as needed and to discontinue the TCS treatment when control was achieved.
Arm Title
Placebo + TCS
Arm Type
Placebo Comparator
Arm Description
4 subcutaneous (SC) injections of placebo as a loading dose on Day 0, followed by 2 SC injections of placebo every 2 weeks (Q2W) regimen for 26 weeks. The last administration of the Investigational Medicinal Product (IMP) occurred at Week 24. From Day 0 to Week 24, a Topical corticosteroid (TCS) cream was dispensed to the participants at each IMP dosing visit (e.g., Q2W). Participants were instructed to treat active lesions as needed and to discontinue the TCS treatment when control was achieved.
Intervention Type
Drug
Intervention Name(s)
Tralokinumab
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo contains the same excipients in the same concentration only lacking tralokinumab.
Primary Outcome Measure Information:
Title
At Least 75% Reduction in Eczema Area and Severity Index (EASI75) From Week 0 to Week 16
Description
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.
Time Frame
Week 0 to Week 16
Secondary Outcome Measure Information:
Title
Reduction of Worst Daily Pruritus Numeric Rating Scale (NRS) (Weekly Average) of at Least 4 From Week 0 to Week 16
Description
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'.
Time Frame
Week 0 to Week 16
Title
Change in Scoring Atopic Dermatitis (SCORAD) From Week 0 to Week 16
Description
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.
Time Frame
Week 0 to Week 16
Title
Change in Dermatology Life Quality Index (DLQI) Score From Week 0 to Week 16
Description
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.
Time Frame
Week 0 to Week 16
Title
Investigator's Global Assessment (IGA) Score of 0 (Clear) or 1 (Almost Clear) at Week 16
Description
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).
Time Frame
Week 16
Title
At Least 75% Reduction in Eczema Area and Severity Index (EASI75) From Week 0 to Week 26
Description
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.
Time Frame
Week 0 to Week 26
Title
Reduction of Worst Daily Pruritus Numeric Rating Scale (NRS) (Weekly Average) of at Least 4 From Week 0 to Week 26
Description
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'.
Time Frame
Week 0 to Week 26
Title
Change in Scoring Atopic Dermatitis (SCORAD) From Week 0 to Week 26
Description
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.
Time Frame
Week 0 to Week 26
Title
Change in Dermatology Life Quality Index (DLQI) Score From Week 0 to Week 26
Description
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.
Time Frame
Week 0 to Week 26
Title
Investigator's Global Assessment (IGA) Score of 0 (Clear) or 1 (Almost Clear) at Week 26
Description
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).
Time Frame
Week 26
Title
Frequency of Anti-drug Antibodies (ADA) From Week 0 to Week 40
Description
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.
Time Frame
Week 0 to Week 40
Title
Number of Adverse Events From Week 0 to Week 40
Description
All adverse events are presented below under Adverse Events
Time Frame
Week 0 to Week 40

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Expert
Organizational Affiliation
LEO Pharma
Official's Role
Study Director
Facility Information:
Facility Name
Leo Pharma Investigationel Site
City
Brussels
ZIP/Postal Code
1090
Country
Belgium
Facility Name
Leo Pharma Investigationel Site
City
Brussels
ZIP/Postal Code
1200
Country
Belgium
Facility Name
Leo Pharma Investigationel Site
City
Edegem
ZIP/Postal Code
2650
Country
Belgium
Facility Name
Leo Pharma Investigationel Site
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
Leo Pharma Investigationel Site
City
Gent
ZIP/Postal Code
B-9000
Country
Belgium
Facility Name
Leo Pharma Investigationel Site
City
Herstal
ZIP/Postal Code
B-4040
Country
Belgium
Facility Name
Leo Pharma Investigationel Site
City
Kortrijk
ZIP/Postal Code
8500
Country
Belgium
Facility Name
Leo Pharma Investigationel Site
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Leo Pharma Investigationel Site
City
Liège
ZIP/Postal Code
4000
Country
Belgium
Facility Name
Leo Pharma Investigationel Site
City
Loverval
ZIP/Postal Code
6280
Country
Belgium
Facility Name
Leo Pharma Investigationel Site
City
Maldegem
ZIP/Postal Code
9990
Country
Belgium
Facility Name
Leo Pharma Investigationel Site
City
Karlovy Vary
ZIP/Postal Code
36001
Country
Czechia
Facility Name
Leo Pharma Investigationel Site
City
Kutna Hora
ZIP/Postal Code
284 01
Country
Czechia
Facility Name
Leo Pharma Investigationel Site
City
Ostrava
ZIP/Postal Code
70852
Country
Czechia
Facility Name
Leo Pharma Investigationel Site
City
Pardubice
ZIP/Postal Code
53002
Country
Czechia
Facility Name
Leo Pharma Investigationel Site
City
Prague 5
ZIP/Postal Code
15006
Country
Czechia
Facility Name
Leo Pharma Investigationel Site
City
Prague 8
ZIP/Postal Code
180 81
Country
Czechia
Facility Name
Leo Pharma Investigationel Site
City
Prague
ZIP/Postal Code
11000
Country
Czechia
Facility Name
Leo Pharma Investigationel Site
City
Prague
ZIP/Postal Code
120 00
Country
Czechia
Facility Name
Leo Pharma Investigationel Site
City
Praha 3
ZIP/Postal Code
130 00
Country
Czechia
Facility Name
Leo Pharma Investigationel Site
City
Grenoble
ZIP/Postal Code
38000
Country
France
Facility Name
Leo Pharma Investigationel Site
City
Nice
ZIP/Postal Code
06202
Country
France
Facility Name
Leo Pharma Investigationel Site
City
Paris
ZIP/Postal Code
75010
Country
France
Facility Name
Leo Pharma Investigationel Site
City
Pierre-Bénite
ZIP/Postal Code
69495
Country
France
Facility Name
Leo Pharma Investigationel Site
City
Valence
ZIP/Postal Code
26000
Country
France
Facility Name
Leo Pharma Investigationel Site
City
Aachen
ZIP/Postal Code
52074
Country
Germany
Facility Name
Leo Pharma Investigationel Site
City
Augsburg
ZIP/Postal Code
86150
Country
Germany
Facility Name
Leo Pharma Investigationel Site
City
Bad Bentheim
ZIP/Postal Code
48455
Country
Germany
Facility Name
Leo Pharma Investigationel Site
City
Berlin
ZIP/Postal Code
10117,
Country
Germany
Facility Name
Leo Pharma Investigationel Site
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
Leo Pharma Investigationel Site
City
Dülmen
ZIP/Postal Code
48249
Country
Germany
Facility Name
Leo Pharma Investigationel Site
City
Frankfurt
ZIP/Postal Code
60590
Country
Germany
Facility Name
Leo Pharma Investigationel Site
City
Halle
ZIP/Postal Code
06097
Country
Germany
Facility Name
Leo Pharma Investigationel Site
City
Hanover
ZIP/Postal Code
30159
Country
Germany
Facility Name
Leo Pharma Investigationel Site
City
Jena
ZIP/Postal Code
07743
Country
Germany
Facility Name
Leo Pharma Investigationel Site
City
Kiel
ZIP/Postal Code
24105
Country
Germany
Facility Name
Leo Pharma Investigationel Site
City
Mainz
ZIP/Postal Code
55128
Country
Germany
Facility Name
Leo Pharma Investigationel Site
City
München
ZIP/Postal Code
80337
Country
Germany
Facility Name
Leo Pharma Investigationel Site
City
Osnabrück
ZIP/Postal Code
49074
Country
Germany
Facility Name
Leo Pharma Investigationel Site
City
Selters
ZIP/Postal Code
56242
Country
Germany
Facility Name
Leo Pharma Investigationel Site
City
Białystok
ZIP/Postal Code
15-375
Country
Poland
Facility Name
Leo Pharma Investigationel Site
City
Bochnia
ZIP/Postal Code
32-700
Country
Poland
Facility Name
Leo Pharma Investigationel Site
City
Bydgoszcz
ZIP/Postal Code
85-094
Country
Poland
Facility Name
Leo Pharma Investigationel Site
City
Gdańsk
ZIP/Postal Code
80-546
Country
Poland
Facility Name
Leo Pharma Investigationel Site
City
Kraków
ZIP/Postal Code
30-149
Country
Poland
Facility Name
Leo Pharma Investigationel Site
City
Kraków
ZIP/Postal Code
31-530
Country
Poland
Facility Name
Leo Pharma Investigationel Site
City
Kraków
ZIP/Postal Code
31-559
Country
Poland
Facility Name
Leo Pharma Investigationel Site
City
Lublin
ZIP/Postal Code
20-081
Country
Poland
Facility Name
Leo Pharma Investigationel Site
City
Poznań
ZIP/Postal Code
60-369
Country
Poland
Facility Name
Leo Pharma Investigationel Site
City
Rzeszów
ZIP/Postal Code
35-312
Country
Poland
Facility Name
Leo Pharma Investigationel Site
City
Warszawa
ZIP/Postal Code
01-817
Country
Poland
Facility Name
Leo Pharma Investigationel Site
City
Warszawa
ZIP/Postal Code
02-625
Country
Poland
Facility Name
Leo Pharma Investigationel Site
City
Warszawa
ZIP/Postal Code
02-953
Country
Poland
Facility Name
Leo Pharma Investigationel Site
City
Wrocław
ZIP/Postal Code
51-685
Country
Poland
Facility Name
Leo Pharma Investigationel Site
City
Łódź
ZIP/Postal Code
90-242
Country
Poland
Facility Name
Leo Pharma Investigationel Site
City
Łódź
ZIP/Postal Code
90-752
Country
Poland
Facility Name
Leo Pharma Investigationel Site
City
Granada
State/Province
Andalucía
ZIP/Postal Code
18014
Country
Spain
Facility Name
Leo Pharma Investigationel Site
City
Alicante
ZIP/Postal Code
03010
Country
Spain
Facility Name
Leo Pharma Investigationel Site
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Leo Pharma Investigationel Site
City
Barcelona
ZIP/Postal Code
08041
Country
Spain
Facility Name
Leo Pharma Investigationel Site
City
Barcelona
ZIP/Postal Code
08907
Country
Spain
Facility Name
Leo Pharma Investigationel Site
City
Bilbao
ZIP/Postal Code
48013
Country
Spain
Facility Name
Leo Pharma Investigationel Site
City
Córdoba
ZIP/Postal Code
14004
Country
Spain
Facility Name
Leo Pharma Investigationel Site
City
Madrid
ZIP/Postal Code
28006
Country
Spain
Facility Name
Leo Pharma Investigationel Site
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Leo Pharma Investigationel Site
City
Madrid
ZIP/Postal Code
28942
Country
Spain
Facility Name
Leo Pharma Investigationel Site
City
Pamplona
ZIP/Postal Code
31008
Country
Spain
Facility Name
Leo Pharma Investigationel Site
City
Sevilla
ZIP/Postal Code
41007
Country
Spain
Facility Name
Leo Pharma Investigationel Site
City
Bradford
ZIP/Postal Code
BD5 0NA
Country
United Kingdom
Facility Name
Leo Pharma Investigationel Site
City
Cottingham
ZIP/Postal Code
HU16 5JQ
Country
United Kingdom
Facility Name
Leo Pharma Investigationel Site
City
Kirkcaldy
ZIP/Postal Code
KY2 5AH
Country
United Kingdom
Facility Name
Leo Pharma Investigationel Site
City
London
ZIP/Postal Code
E11 1NR
Country
United Kingdom
Facility Name
Leo Pharma Investigationel Site
City
Southampton
ZIP/Postal Code
SO16 6YD
Country
United Kingdom
Facility Name
Leo Pharma Investigationel Site
City
Wakefield
ZIP/Postal Code
WF1 4DG
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes

Learn more about this trial

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

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