Back to resultsA Study of Lebrikizumab in Combination With Topical Corticosteroids in Participants Having Atopic Dermatitis (AD) That Are Not Adequately Controlled or Non-eligible for Cyclosporine
Primary Purpose
Dermatitis, Atopic, Eczema
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Lebrikizumab
Lebrikizumab-matching Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Dermatitis, Atopic focused on measuring Topical Corticosteroids, Cyclosporine
Eligibility Criteria
Inclusion Criteria:
- Adults and adolescents (aged greater than or equal to (>=) 12 to <18 years at the time of Informed Consent Form (ICF)/Informed Assent Form (IAF) and weighing >=40 kilograms).
- Chronic AD that has been present for >=1 year before the Screening visit.
- EASI score >=16 at the Baseline Visit.
- IGA score >=3 (moderate) (scale of 0 [clear] to 4 [severe]) at the Baseline visit.
- >=10% BSA of AD involvement at the Baseline visit.
- Inadequate response to existing topical medications
- Failure to cyclosporine or non-medically advisable to receive/continue receiving cyclosporine
- Signed ICF (and informed assent for adolescents as required)
Exclusion Criteria:
- Treatment with TCS within 1 week before the Baseline visit.
- Treatment with topical calcineurin inhibitors, phosphodiesterase-4 inhibitors such as crisaborole, or cannabinoids within 2 week before the Baseline visit.
- Treatment with interleukin 4 (IL-4) or interleukin 3 (IL-13) antagonists biological therapies before the Baseline visit. Exception: previous treatment with dupilumab will be allowed in a subset of patients
- Treatment with immunosuppressive/immunomodulating drugs, phototherapy and photochemotherapy within 4 weeks before the Baseline visit
- Uncontrolled chronic disease that might require bursts of oral corticosteroids
- Serious, opportunistic, chronic or recurring infections within 3 months of Screening or before randomization
- Current or chronic infection with hepatitis B virus, current infection with hepatitis C virus, known liver cirrhosis and/or chronic hepatitis of any etiology
- Known or suspected history of immunosuppression, history of HIV infection or positive HIV serology at Screening
- Any clinically significant laboratory test results obtained at the Screening visit
- Presence of skin comorbidities that may interfere with study assessments
- Have had an important side effect to TCS that would prevent further use.
Sites / Locations
- Alm Site 1
- Alm Site 2
- Alm Site 14
- Alm Site 17
- Alm Site 19
- Alm Site 20
- Alm Site 13
- Alm Site 16
- Alm Site 15
- Alm Site 18
- Alm Site 12
- Alm Site 28
- Alm Site 30
- Alm Site 24
- Alm Site 32
- Alm Site 31
- Alm Site 27
- Alm Site 26
- Alm Site 29
- Alm Site 25
- Alm Site 34
- Alm Site 33
- Alm Site 35
- Alm Site 45
- Alm Site 43
- Alm Site 38
- Alm Site 41
- Alm Site 46
- Alm Site 39
- Alm Site 48
- Alm Site 44
- Alm Site 36
- Alm Site 42
- Alm Site 47
- Alm Site 40
- Alm Site 37
- Alm Site 10
- Alm Site 3
- Alm Site 6
- Alm Site 8
- Alm Site 4
- Alm Site 5
- Alm Site 11
- Alm Site 7
- Alm Site 9
- Alm Site 23
- Alm Site 22
- Alm Site 21
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Lebrikizumab
Lebrikizumab-matching Placebo
Arm Description
Lebrikizumab administered subcutaneously (SC), 250 milligram (mg) dose once every two weeks (Q2W) in the induction period for 16 weeks. Participants achieving EASI75 at Week 16 will receive 1 injection each of 250 mg lebrikizumab and placebo at Week 16, no injections at Week 18 followed by 1 injection of lebrikizumab 250 mg once every four weeks (Q4W) after Week 20 up to Week 36. Participants not achieving EASI75 at Week 16 will receive 1 injection each of 250 mg lebrikizumab and placebo at Week 16 and 18, followed by 1 injection of lebrikizumab 250 mg Q2W after Week 20 up to Week 52.
Lebrikizumab-matching Placebo administered SC, 250 mg dose, Q2W in the induction period for 16 weeks. Participants will receive 2 injections each of 250 mg lebrikizumab-matching placebo at Week 16, no injections at Week 18 followed by 1 injection of lebrikizumab- matching placebo 250 mg Q4W after Week 20 up to Week 36.
Outcomes
Primary Outcome Measures
Percentage of Participants Achieving EASI 75 (>=75% Reduction From Baseline in EASI Score) at Week 16
The Eczema Area and Severity Index (EASI) is used to assess the severity and extent of AD; it is a composite index with scores ranging from 0 to 72, with higher values indicating more severe and or extensive disease.
Secondary Outcome Measures
Percentage of Participants With an Investigator Global Assessment (IGA) Score of 0 or 1 and 2-point Improvement at Week 16
The IGA is an instrument used to globally rate the severity of the participants's AD. It is based on a 5-point scale ranging from 0 (clear), 1 (almost clear), 2 (mild), 3 (moderate) and 4 (severe), and a score is selected using descriptors that best describe the overall appearance of the lesions at a given time point. The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting (minimal, palpable induration and significant induration).
Percentage of Participants With 4-point Improvement in Pruritus Numeric Rating Score (NRS)
The Pruritus NRS is an 11-point scale used by participants to rate their worst itch severity over the past 24 hours, with 0 indicating "No itch," and 10 indicating "Worst itch imaginable.
Percentage of Participants Achieving EASI90
The EASI is used to assess the severity and extent of AD; it is a composite index with scores ranging from 0 to 72, with higher values indicating more severe and or extensive disease. EASI 90 is defined as 90% reduction from baseline in the EASI score.
Percentage of Participants Achieving EASI 75, 90 and 50
The EASI is used to assess the severity and extent of AD; it is a composite index with scores ranging from 0 to 72, with higher values indicating more severe and or extensive disease. EASI 75 is defined as 75% reduction from baseline in the EASI score. EASI 90 is defined as 90% reduction from baseline in the EASI score. EASI 50 is defined as 50% reduction from baseline in the EASI score.
Change From Baseline in Body Surface Area (BSA)
The BSA assessment estimates the extent of disease or skin involvement with respect to AD and is expressed as a percentage of total body surface. BSA will be determined by the Investigator or designee using the participant palm = 1% BSA rule. The participant's palm is measured from the wrist to the proximal interphalangeal and thumb.
Change From Baseline in Scoring Atopic Dermatitis (SCORAD)
SCORAD is a validated clinical tool for assessing the extent and intensity of AD. There are 3 components: surface involvement, intensity part and subjective assessment. Surface involvement is assessed as proportion of involved surface area segment by segment by applying the rule of 9s and reported as the sum of all areas, with a score ranging from 0 to 100. Intensity part of the SCORAD consists of 6 items: erythema, oedema, oozing/crusting, excoriation, lichenification, and dryness. Each item is graded as follows: none (0), mild (1), moderate (2), or severe (3) (for a maximum of 18 total points). Subjective assessment of itch and of sleeplessness is recorded for each symptom using a visual analogue scale (VAS), where 0 is no itch (or sleeplessness) and 10 is the worst imaginable itch (or sleeplessness), for maximum possible score of 20. Formula is: A/5+7B/2+C, A: extent (0-100), B: intensity (0-18), C: subjective symptoms (0-20). The maximum score is 103 (higher values worse outcome).
Change From Baseline in Pruritus NRS
The Pruritus NRS is an 11-point scale used by participants to rate their worst itch severity over the past 24 hours, with 0 indicating "No itch," and 10 indicating "Worst itch imaginable."
Change From Baseline in the Sleep Loss Using PRO
Sleep loss will be assessed by all participants using a patient-related outcome (PRO) instrument. Participants (and if applicable, with help of parents/caregiver if required) will rate their sleep on a 5-point Likert scale (with scores ranging from 0 [not at all] to 4 [unable to sleep at all]). Assessments will be recorded by the participant using an electronic Diary.
Change from Baseline in Patient-Oriented Eczema Measure (POEM)
The POEM is a 7-item, validated questionnaire completed by the participant (and, if applicable, with help of parents/caregiver if required) to assess disease symptoms. Participants are asked to respond to questions on skin dryness, itching, flaking, cracking, sleep loss, bleeding, and weeping. All answers carry equal weight, with a total possible score ranging from 0 to 28 (answers scored as: No days = 0; 1-2 days = 1; 3-4 days = 2; 5-6 days = 3; every day = 4. A high score is indicative of a poor quality of life (QoL). POEM responses will be captured weekly using an electronic Diary.
Change From Baseline in Dermatology Life Quality Index (DLQI)/Children Dermatology Life Quality Index (CDLQI)
The DLQI is a 10-item validated questionnaire completed by the participant or caregiver used to assess the impact of skin disease on the participant's QoL during the previous week. The 10 questions cover the following topics: symptoms, embarrassment, shopping and home care, clothes, social and leisure, sport, work or study, close relationships, sex, and treatment. Each question is scored from 0 to 3 ("not at all," "a little," "a lot," and "very much"), giving a total score ranging from 0 to 30. A high score is indicative of a poor QoL. The CDLQI is validated from adolescents younger than age of 16 years, which is based on a set of 10 questions different from those of the DLQI. Each question is scored from 0 to 3, giving a possible total score range from 0 (meaning no impact of skin disease on quality of life) to 30 (meaning maximum impact on quality of life).
Percentage of Participants Achieving a 4-point Improvement in DLQI/CDLQI
The DLQI is a 10-item validated questionnaire completed by the participant or caregiver used to assess the impact of skin disease on the participant's QoL during the previous week. The 10 questions cover the following topics: symptoms, embarrassment, shopping and home care, clothes, social and leisure, sport, work or study, close relationships, sex, and treatment. Each question is scored from 0 to 3 ("not at all," "a little," "a lot," and "very much"), giving a total score ranging from 0 to 30. A high score is indicative of a poor QoL. The CDLQI is validated from adolescents younger than age of 16 years, which is based on a set of 10 questions different from those of the DLQI. Each question is scored from 0 to 3, giving a possible total score range from 0 (meaning no impact of skin disease on quality of life) to 30 (meaning maximum impact on quality of life).
Percentage of Participants with Topical Corticosteroids (TCS)-free Days
Proportion of participants TCS- free days will be reported
Time to TCS-free Use
Time to TCS- free Use (days) will be reported
Change from Baseline in Skin Pain NRS
The Skin Pain NRS is an 11-point scale completed by participants to rate their worst skin pain (example, discomfort or soreness) severity over the past 24 hours, with 0 indicating "No pain" and 10 indicating "Worst pain imaginable.
Percentage of Participants Achieving a 4- point Improvement in Skin Pain NRS
The Skin Pain NRS is an 11-point scale completed by participants to rate their worst skin pain (example, discomfort or soreness) severity over the past 24 hours, with O indicating "No pain" and 10 indicating "Worst pain imaginable.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05149313
Brief Title
A Study of Lebrikizumab in Combination With Topical Corticosteroids in Participants Having Atopic Dermatitis (AD) That Are Not Adequately Controlled or Non-eligible for Cyclosporine
Official Title
A Randomised, Double-Blind, Placebo-Controlled Phase 3 Clinical Trial to Assess the Efficacy and Safety of Lebrikizumab in Combination With Topical Corticosteroids in Adult and Adolescent Patients With Moderate-To-Severe Atopic Dermatitis That Are Not Adequately Controlled With Cyclosporine or For Whom Cyclosporine is Not Medically Advisable.
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
December 23, 2021 (Actual)
Primary Completion Date
December 28, 2022 (Actual)
Study Completion Date
December 28, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Almirall, S.A.
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.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The main purpose of this study is to evaluate the efficacy of lebrikizumab compared with placebo in participants not adequately controlled with cyclosporine or for whom cyclosporine is not medically advisable up to Week 16.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dermatitis, Atopic, Eczema
Keywords
Topical Corticosteroids, Cyclosporine
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
331 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lebrikizumab
Arm Type
Experimental
Arm Description
Lebrikizumab administered subcutaneously (SC), 250 milligram (mg) dose once every two weeks (Q2W) in the induction period for 16 weeks. Participants achieving EASI75 at Week 16 will receive 1 injection each of 250 mg lebrikizumab and placebo at Week 16, no injections at Week 18 followed by 1 injection of lebrikizumab 250 mg once every four weeks (Q4W) after Week 20 up to Week 36. Participants not achieving EASI75 at Week 16 will receive 1 injection each of 250 mg lebrikizumab and placebo at Week 16 and 18, followed by 1 injection of lebrikizumab 250 mg Q2W after Week 20 up to Week 52.
Arm Title
Lebrikizumab-matching Placebo
Arm Type
Placebo Comparator
Arm Description
Lebrikizumab-matching Placebo administered SC, 250 mg dose, Q2W in the induction period for 16 weeks. Participants will receive 2 injections each of 250 mg lebrikizumab-matching placebo at Week 16, no injections at Week 18 followed by 1 injection of lebrikizumab- matching placebo 250 mg Q4W after Week 20 up to Week 36.
Intervention Type
Biological
Intervention Name(s)
Lebrikizumab
Intervention Description
Lebrikizumab solution for injection administered subcutaneously.
Intervention Type
Drug
Intervention Name(s)
Lebrikizumab-matching Placebo
Intervention Description
Matching Placebo solution for injection administered subcutaneously.
Primary Outcome Measure Information:
Title
Percentage of Participants Achieving EASI 75 (>=75% Reduction From Baseline in EASI Score) at Week 16
Description
The Eczema Area and Severity Index (EASI) is used to assess the severity and extent of AD; it is a composite index with scores ranging from 0 to 72, with higher values indicating more severe and or extensive disease.
Time Frame
Baseline, Week 16
Secondary Outcome Measure Information:
Title
Percentage of Participants With an Investigator Global Assessment (IGA) Score of 0 or 1 and 2-point Improvement at Week 16
Description
The IGA is an instrument used to globally rate the severity of the participants's AD. It is based on a 5-point scale ranging from 0 (clear), 1 (almost clear), 2 (mild), 3 (moderate) and 4 (severe), and a score is selected using descriptors that best describe the overall appearance of the lesions at a given time point. The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting (minimal, palpable induration and significant induration).
Time Frame
Week 16
Title
Percentage of Participants With 4-point Improvement in Pruritus Numeric Rating Score (NRS)
Description
The Pruritus NRS is an 11-point scale used by participants to rate their worst itch severity over the past 24 hours, with 0 indicating "No itch," and 10 indicating "Worst itch imaginable.
Time Frame
Week 16
Title
Percentage of Participants Achieving EASI90
Description
The EASI is used to assess the severity and extent of AD; it is a composite index with scores ranging from 0 to 72, with higher values indicating more severe and or extensive disease. EASI 90 is defined as 90% reduction from baseline in the EASI score.
Time Frame
Week 16
Title
Percentage of Participants Achieving EASI 75, 90 and 50
Description
The EASI is used to assess the severity and extent of AD; it is a composite index with scores ranging from 0 to 72, with higher values indicating more severe and or extensive disease. EASI 75 is defined as 75% reduction from baseline in the EASI score. EASI 90 is defined as 90% reduction from baseline in the EASI score. EASI 50 is defined as 50% reduction from baseline in the EASI score.
Time Frame
Up to Week 16
Title
Change From Baseline in Body Surface Area (BSA)
Description
The BSA assessment estimates the extent of disease or skin involvement with respect to AD and is expressed as a percentage of total body surface. BSA will be determined by the Investigator or designee using the participant palm = 1% BSA rule. The participant's palm is measured from the wrist to the proximal interphalangeal and thumb.
Time Frame
Baseline up to Week 16
Title
Change From Baseline in Scoring Atopic Dermatitis (SCORAD)
Description
SCORAD is a validated clinical tool for assessing the extent and intensity of AD. There are 3 components: surface involvement, intensity part and subjective assessment. Surface involvement is assessed as proportion of involved surface area segment by segment by applying the rule of 9s and reported as the sum of all areas, with a score ranging from 0 to 100. Intensity part of the SCORAD consists of 6 items: erythema, oedema, oozing/crusting, excoriation, lichenification, and dryness. Each item is graded as follows: none (0), mild (1), moderate (2), or severe (3) (for a maximum of 18 total points). Subjective assessment of itch and of sleeplessness is recorded for each symptom using a visual analogue scale (VAS), where 0 is no itch (or sleeplessness) and 10 is the worst imaginable itch (or sleeplessness), for maximum possible score of 20. Formula is: A/5+7B/2+C, A: extent (0-100), B: intensity (0-18), C: subjective symptoms (0-20). The maximum score is 103 (higher values worse outcome).
Time Frame
Baseline up to Week 16
Title
Change From Baseline in Pruritus NRS
Description
The Pruritus NRS is an 11-point scale used by participants to rate their worst itch severity over the past 24 hours, with 0 indicating "No itch," and 10 indicating "Worst itch imaginable."
Time Frame
Baseline up to Week 16
Title
Change From Baseline in the Sleep Loss Using PRO
Description
Sleep loss will be assessed by all participants using a patient-related outcome (PRO) instrument. Participants (and if applicable, with help of parents/caregiver if required) will rate their sleep on a 5-point Likert scale (with scores ranging from 0 [not at all] to 4 [unable to sleep at all]). Assessments will be recorded by the participant using an electronic Diary.
Time Frame
Baseline up to Week 16
Title
Change from Baseline in Patient-Oriented Eczema Measure (POEM)
Description
The POEM is a 7-item, validated questionnaire completed by the participant (and, if applicable, with help of parents/caregiver if required) to assess disease symptoms. Participants are asked to respond to questions on skin dryness, itching, flaking, cracking, sleep loss, bleeding, and weeping. All answers carry equal weight, with a total possible score ranging from 0 to 28 (answers scored as: No days = 0; 1-2 days = 1; 3-4 days = 2; 5-6 days = 3; every day = 4. A high score is indicative of a poor quality of life (QoL). POEM responses will be captured weekly using an electronic Diary.
Time Frame
Baseline up to Week 16
Title
Change From Baseline in Dermatology Life Quality Index (DLQI)/Children Dermatology Life Quality Index (CDLQI)
Description
The DLQI is a 10-item validated questionnaire completed by the participant or caregiver used to assess the impact of skin disease on the participant's QoL during the previous week. The 10 questions cover the following topics: symptoms, embarrassment, shopping and home care, clothes, social and leisure, sport, work or study, close relationships, sex, and treatment. Each question is scored from 0 to 3 ("not at all," "a little," "a lot," and "very much"), giving a total score ranging from 0 to 30. A high score is indicative of a poor QoL. The CDLQI is validated from adolescents younger than age of 16 years, which is based on a set of 10 questions different from those of the DLQI. Each question is scored from 0 to 3, giving a possible total score range from 0 (meaning no impact of skin disease on quality of life) to 30 (meaning maximum impact on quality of life).
Time Frame
Up to Week 16
Title
Percentage of Participants Achieving a 4-point Improvement in DLQI/CDLQI
Description
The DLQI is a 10-item validated questionnaire completed by the participant or caregiver used to assess the impact of skin disease on the participant's QoL during the previous week. The 10 questions cover the following topics: symptoms, embarrassment, shopping and home care, clothes, social and leisure, sport, work or study, close relationships, sex, and treatment. Each question is scored from 0 to 3 ("not at all," "a little," "a lot," and "very much"), giving a total score ranging from 0 to 30. A high score is indicative of a poor QoL. The CDLQI is validated from adolescents younger than age of 16 years, which is based on a set of 10 questions different from those of the DLQI. Each question is scored from 0 to 3, giving a possible total score range from 0 (meaning no impact of skin disease on quality of life) to 30 (meaning maximum impact on quality of life).
Time Frame
Up to Week 16
Title
Percentage of Participants with Topical Corticosteroids (TCS)-free Days
Description
Proportion of participants TCS- free days will be reported
Time Frame
Baseline up to Week 16
Title
Time to TCS-free Use
Description
Time to TCS- free Use (days) will be reported
Time Frame
Up to Week 16
Title
Change from Baseline in Skin Pain NRS
Description
The Skin Pain NRS is an 11-point scale completed by participants to rate their worst skin pain (example, discomfort or soreness) severity over the past 24 hours, with 0 indicating "No pain" and 10 indicating "Worst pain imaginable.
Time Frame
Up to Week 16
Title
Percentage of Participants Achieving a 4- point Improvement in Skin Pain NRS
Description
The Skin Pain NRS is an 11-point scale completed by participants to rate their worst skin pain (example, discomfort or soreness) severity over the past 24 hours, with O indicating "No pain" and 10 indicating "Worst pain imaginable.
Time Frame
Week 16
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adults and adolescents (aged greater than or equal to (>=) 12 to <18 years at the time of Informed Consent Form (ICF)/Informed Assent Form (IAF) and weighing >=40 kilograms).
Chronic AD that has been present for >=1 year before the Screening visit.
EASI score >=16 at the Baseline Visit.
IGA score >=3 (moderate) (scale of 0 [clear] to 4 [severe]) at the Baseline visit.
>=10% BSA of AD involvement at the Baseline visit.
Inadequate response to existing topical medications
Failure to cyclosporine or non-medically advisable to receive/continue receiving cyclosporine
Signed ICF (and informed assent for adolescents as required)
Exclusion Criteria:
Treatment with TCS within 1 week before the Baseline visit.
Treatment with topical calcineurin inhibitors, phosphodiesterase-4 inhibitors such as crisaborole, or cannabinoids within 2 week before the Baseline visit.
Treatment with interleukin 4 (IL-4) or interleukin 3 (IL-13) antagonists biological therapies before the Baseline visit. Exception: previous treatment with dupilumab will be allowed in a subset of patients
Treatment with immunosuppressive/immunomodulating drugs, phototherapy and photochemotherapy within 4 weeks before the Baseline visit
Uncontrolled chronic disease that might require bursts of oral corticosteroids
Serious, opportunistic, chronic or recurring infections within 3 months of Screening or before randomization
Current or chronic infection with hepatitis B virus, current infection with hepatitis C virus, known liver cirrhosis and/or chronic hepatitis of any etiology
Known or suspected history of immunosuppression, history of HIV infection or positive HIV serology at Screening
Any clinically significant laboratory test results obtained at the Screening visit
Presence of skin comorbidities that may interfere with study assessments
Have had an important side effect to TCS that would prevent further use.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Study Director
Organizational Affiliation
Almirall, S.A.
Official's Role
Study Director
Facility Information:
Facility Name
Alm Site 1
City
Graz
Country
Austria
Facility Name
Alm Site 2
City
Gent
Country
Belgium
Facility Name
Alm Site 14
City
Bordeaux
Country
France
Facility Name
Alm Site 17
City
Le Mans
Country
France
Facility Name
Alm Site 19
City
Lille
Country
France
Facility Name
Alm Site 20
City
Lille
Country
France
Facility Name
Alm Site 13
City
Martigues
Country
France
Facility Name
Alm Site 16
City
Nantes
Country
France
Facility Name
Alm Site 15
City
Nice
Country
France
Facility Name
Alm Site 18
City
Pierre-Bénite
Country
France
Facility Name
Alm Site 12
City
Reims
Country
France
Facility Name
Alm Site 28
City
Bad Bentheim
Country
Germany
Facility Name
Alm Site 30
City
Berlin
Country
Germany
Facility Name
Alm Site 24
City
Blankenfelde
Country
Germany
Facility Name
Alm Site 32
City
Bonn
Country
Germany
Facility Name
Alm Site 31
City
Frankfurt
Country
Germany
Facility Name
Alm Site 27
City
Göttingen
Country
Germany
Facility Name
Alm Site 26
City
Hamburg
Country
Germany
Facility Name
Alm Site 29
City
Kiel
Country
Germany
Facility Name
Alm Site 25
City
Marburg
Country
Germany
Facility Name
Alm Site 34
City
Bergen Op Zoom
Country
Netherlands
Facility Name
Alm Site 33
City
Rotterdam
Country
Netherlands
Facility Name
Alm Site 35
City
Utrecht
Country
Netherlands
Facility Name
Alm Site 45
City
Białystok
Country
Poland
Facility Name
Alm Site 43
City
Chorzów
Country
Poland
Facility Name
Alm Site 38
City
Katowice
Country
Poland
Facility Name
Alm Site 41
City
Kraków
Country
Poland
Facility Name
Alm Site 46
City
Kraków
Country
Poland
Facility Name
Alm Site 39
City
Lublin
Country
Poland
Facility Name
Alm Site 48
City
Ostrowiec Świętokrzyski
Country
Poland
Facility Name
Alm Site 44
City
Rzeszów
Country
Poland
Facility Name
Alm Site 36
City
Szczecin
Country
Poland
Facility Name
Alm Site 42
City
Warsaw
Country
Poland
Facility Name
Alm Site 47
City
Warszawa
Country
Poland
Facility Name
Alm Site 40
City
Wrocław
Country
Poland
Facility Name
Alm Site 37
City
Łódź
Country
Poland
Facility Name
Alm Site 10
City
Alicante
Country
Spain
Facility Name
Alm Site 3
City
Badalona
Country
Spain
Facility Name
Alm Site 6
City
Barcelona
Country
Spain
Facility Name
Alm Site 8
City
Barcelona
Country
Spain
Facility Name
Alm Site 4
City
Bilbao
Country
Spain
Facility Name
Alm Site 5
City
Madrid
Country
Spain
Facility Name
Alm Site 11
City
Mieres
Country
Spain
Facility Name
Alm Site 7
City
Sevilla
Country
Spain
Facility Name
Alm Site 9
City
Zaragoza
Country
Spain
Facility Name
Alm Site 23
City
Poole
Country
United Kingdom
Facility Name
Alm Site 22
City
Salford
Country
United Kingdom
Facility Name
Alm Site 21
City
Southampton
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Study of Lebrikizumab in Combination With Topical Corticosteroids in Participants Having Atopic Dermatitis (AD) That Are Not Adequately Controlled or Non-eligible for Cyclosporine
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