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Long-term Safety and Efficacy of Lebrikizumab in Adult and Adolescent Participant With Moderate-to-Severe Atopic Dermatitis (ADlong)

Primary Purpose

Atopic Dermatitis

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Lebrikizumab
Sponsored by
Almirall, S.A.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atopic Dermatitis focused on measuring Dermatitis

Eligibility Criteria

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

Inclusion Criteria: Participants who completed treatment with lebrikizumab in ADjoin and their last participant assessment visit (Week 100) in that study. For WOCBP: agree to remain abstinent (refrain from heterosexual intercourse) or use a highly effective contraceptive method during the treatment period and for at least 4 weeks after the last dose of lebrikizumab. NOTE: A WOCBP is defined as a postmenarcheal female, who has not reached a postmenopausal state (>=12 continuous months of amenorrhea with no identified cause other than menopause) and has not undergone surgical sterilization (removal of ovaries, fallopian tubes, and/or uterus). NOTE: The following are highly effective contraceptive methods: combined (estrogen and progestogen containing) hormonal contraception (oral, intravaginal, transdermal) associated with inhibition of ovulation, progestogen-only hormonal contraception (oral, injectable, implantable) associated with inhibition of ovulation, intrauterine device, intrauterine hormone-releasing system, bilateral tubal occlusion, bilateral tubal ligation, vasectomized partner, or sexual abstinence. In the context of this protocol, sexual abstinence is considered a highly effective method only if defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatments. The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the participant. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or post ovulation methods) and withdrawal are not acceptable methods of contraception. Ability to understand the purpose and risks of the trial, willingness and ability to comply with the protocol and provide written informed consent/assent in accordance with institutional and regulatory guidelines. Capable of giving signed informed consent/assent as described in which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. Exclusion Criteria: Participants who, having participated in ADjoin, had their last lebrikizumab dose administered in a window longer than 8 weeks prior to the Baseline Visit in the current study. Participants who, during their participation in the parent trial or ADjoin, developed an SAE or a severe AE that was deemed related to lebrikizumab, which in the opinion of the Investigator or of the medical monitor could indicate that continued treatment with lebrikizumab may present an unreasonable risk for the participant. Conditions in the parent study or ADjoin consistent with protocol-defined criteria for permanent study drug discontinuation, if deemed related to lebrikizumab or led to Investigator or Sponsor-initiated withdrawal of participant from the study (e.g., non-compliance, inability to complete study assessments, etc.). Treatment with a live (attenuated) vaccine from the time of last lebrikizumab dose in ADjoin prior to enrolment in the current study or planned during the study. Use of a prohibited medication from the time of last lebrikizumab dose in ADjoin prior to enrolment in the current study or planned during the study. Pregnant or breastfeeding women, and women planning to become pregnant or breastfeed during the study and for at least 4 weeks after the last dose of lebrikizumab. Severe concomitant illness(es) that in the Investigator's judgment would adversely affect the participant's participation in the study. Any other medical or psychological condition that in the opinion of the Investigator may suggest a new and/or insufficiently understood disease, may present an unreasonable risk to the study patient because of his/her participation in this clinical trial, may make participant's participation unreliable, or may interfere with study assessments. Any other conditions that, in the Investigator's opinion, might indicate the participant to be unsuitable for the trial. Participant who is an employee or relative of an employee at the research site or Almirall.

Sites / Locations

  • Investigator Site 7Recruiting
  • Investigator Site 8Recruiting
  • Investigator Site 9Recruiting
  • Investigator Site 10Recruiting
  • Investigator Site 11Recruiting
  • Investigator Site 12Recruiting
  • Investigator Site 1Recruiting
  • Investigator Site 2Recruiting
  • Investigator Site 3Recruiting
  • Investigator Site 4Recruiting
  • Investigator Site 5Recruiting
  • Investigator Site 6Recruiting
  • Investigator Site 23Recruiting
  • Investigator Site 24Recruiting
  • Investigator Site 25Recruiting
  • Investigator Site 26Recruiting
  • Investigator Site 27Recruiting
  • Investigator Site 28Recruiting
  • Investigator Site 29Recruiting
  • Investigator Site 30Recruiting
  • Investigator Site 31Recruiting
  • Investigator Site 13Recruiting
  • Investigator Site 14Recruiting
  • Investigator Site 15Recruiting
  • Investigator Site 16Recruiting
  • Investigator Site 17Recruiting
  • Investigator Site 18Recruiting
  • Investigator Site 19Recruiting
  • Investigator Site 20Recruiting
  • Investigator Site 21Recruiting
  • Investigator Site 22Recruiting
  • Investigator Site 32Recruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Lebrikizumab

Arm Description

Adult and adolescent participants (12 to less than [<] 18 years and weighing greater than or equal to [>=] 40 kilogram [kg]) with moderate-to-severe AD will receive lebrikizumab 250 milligrams (mg) subcutaneous (SC) injection via pre-filled syringe (PFS) for every fourth week (Q4W) for up to Week 104. If participants response is below EASI50 at any visit, lebrikizumab dosing frequency may be increased to every two weeks (Q2W) at any time during the course of the study; thereafter, lebrikizumab Q4W dosing may be resumed at the Investigator's discretion. Lebrikizumab will be administered up to Week 106 for participants who continue Q2W dosing, and these participants will undergo a safety follow-up assessment at Week 110.

Outcomes

Primary Outcome Measures

Proportion of the Participants who will Discontinue from Study Treatment due to Treatment-emergent Adverse Events (TEAEs)

Secondary Outcome Measures

Percentage of Participants with Eczema Area and Severity Index (EASI) 50, EASI 75, and EASI 90 (>=50%, >=75%, and >=90%) Reduction in EASI Scores
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 50 is defined as 50% reduction from baseline in the EASI score. 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.
Percentage Change from Baseline of Parent study in EASI Score
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. Baseline (i.e., prior to first study drug administration) is defined for the parent studies, J2T-DM-KGAB (ADvocate-1), J2TDM-KGAC (ADvocate-2), J2T-DM-KGAD (ADhere), and J2T-DM-KGAE (ADore).
Percentage of Participants with EASI Score <=7
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. Baseline (i.e., prior to first study drug administration) is defined for the parent studies, J2T-DM-KGAB (ADvocate-1), J2TDM-KGAC (ADvocate-2), J2T-DM-KGAD (ADhere), and J2T-DM-KGAE (ADore).
Percentage of Participants Achieving Investigator Global Assessment (IGA) Score of 0 or 1
The IGA is an instrument used to globally rate the severity of the participants 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, and lichenification.
Percentage of Participants Achieving Pruritus Numeric Rating Score (NRS) <= 4
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 Change From Baseline of Parent Study in Body Surface Area (BSA) Involvement
BSA affected by AD will be assessed for 4 separate body regions: head and neck, trunk (including genital region), upper extremities, and lower extremities (including the buttocks). BSA was calculated using the participant's palm using the 1% rule, 1 palm was equivalent to 1% with estimates of the number of palms it takes to cover the affected AD area. Maximum number of palms were 10 palms for head and neck (10%), 20 palms for upper extremities (20%), 30 palms for trunk, including axilla and groin (30%), 40 palms for lower extremities, including buttocks (40%). %BSA for a body region was calculated as = total number of palms in a body region * % surface area equivalent to 1 palm. Overall percent BSA of all 4 body regions ranges from 0% to 100 % with higher values represent greater severity of AD. Baseline (i.e., prior to first study drug administration) is defined for the parent studies, J2T-DM-KGAB (ADvocate-1), J2TDM-KGAC (ADvocate-2), J2T-DM-KGAD (ADhere), and J2T-DM-KGAE (ADore).
Proportion of Participants with Topical Corticosteroids (TCS)-free Days
Proportion of participants TCS- free days will be reported.
Percentage of Participants with DLQI/CDLQI Score <=5
The DLQI is a 10-item validated questionnaire 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 at Least a 4-point Improvement from Baseline of Parent Study Dermatology Quality of Life Index/ Children's Dermatology Quality of Life Index (DLQI/CDLQI)
The DLQI is a 10-item validated questionnaire 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). Baseline (i.e., prior to first study drug administration) is defined for the parent studies, J2T-DM-KGAB (ADvocate-1), J2TDM-KGAC (ADvocate-2), J2T-DM-KGAD (ADhere), and J2T-DM-KGAE (ADore).

Full Information

First Posted
May 30, 2023
Last Updated
June 21, 2023
Sponsor
Almirall, S.A.
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1. Study Identification

Unique Protocol Identification Number
NCT05916365
Brief Title
Long-term Safety and Efficacy of Lebrikizumab in Adult and Adolescent Participant With Moderate-to-Severe Atopic Dermatitis
Acronym
ADlong
Official Title
A 2-year Open-label Extension Study to Assess the Long-term Safety and Efficacy of Lebrikizumab in Adult and Adolescent Patients With Moderate-to-Severe Atopic Dermatitis
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 23, 2023 (Actual)
Primary Completion Date
March 2026 (Anticipated)
Study Completion Date
April 2026 (Anticipated)

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
No
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 the study is to assess the long-term tolerability and effectiveness of lebrikizumab in adult and adolescent participants with moderate-to-severe atopic dermatitis (AD). Participants who complete the last assessment visit in ADjoin (Week 100) will be offered the opportunity to enroll in this extension study.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Lebrikizumab
Arm Type
Experimental
Arm Description
Adult and adolescent participants (12 to less than [<] 18 years and weighing greater than or equal to [>=] 40 kilogram [kg]) with moderate-to-severe AD will receive lebrikizumab 250 milligrams (mg) subcutaneous (SC) injection via pre-filled syringe (PFS) for every fourth week (Q4W) for up to Week 104. If participants response is below EASI50 at any visit, lebrikizumab dosing frequency may be increased to every two weeks (Q2W) at any time during the course of the study; thereafter, lebrikizumab Q4W dosing may be resumed at the Investigator's discretion. Lebrikizumab will be administered up to Week 106 for participants who continue Q2W dosing, and these participants will undergo a safety follow-up assessment at Week 110.
Intervention Type
Biological
Intervention Name(s)
Lebrikizumab
Intervention Description
Lebrikizumab solution for injection administered subcutaneously
Primary Outcome Measure Information:
Title
Proportion of the Participants who will Discontinue from Study Treatment due to Treatment-emergent Adverse Events (TEAEs)
Time Frame
Baseline up to Week 110
Secondary Outcome Measure Information:
Title
Percentage of Participants with Eczema Area and Severity Index (EASI) 50, EASI 75, and EASI 90 (>=50%, >=75%, and >=90%) Reduction in EASI Scores
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 50 is defined as 50% reduction from baseline in the EASI score. 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.
Time Frame
Baseline up to Week 108
Title
Percentage Change from Baseline of Parent study in EASI Score
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. Baseline (i.e., prior to first study drug administration) is defined for the parent studies, J2T-DM-KGAB (ADvocate-1), J2TDM-KGAC (ADvocate-2), J2T-DM-KGAD (ADhere), and J2T-DM-KGAE (ADore).
Time Frame
Baseline up to Week 108
Title
Percentage of Participants with EASI Score <=7
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. Baseline (i.e., prior to first study drug administration) is defined for the parent studies, J2T-DM-KGAB (ADvocate-1), J2TDM-KGAC (ADvocate-2), J2T-DM-KGAD (ADhere), and J2T-DM-KGAE (ADore).
Time Frame
Baseline up to Week 108
Title
Percentage of Participants Achieving Investigator Global Assessment (IGA) Score of 0 or 1
Description
The IGA is an instrument used to globally rate the severity of the participants 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, and lichenification.
Time Frame
Baseline up to Week 108
Title
Percentage of Participants Achieving Pruritus Numeric Rating Score (NRS) <= 4
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 108
Title
Percentage Change From Baseline of Parent Study in Body Surface Area (BSA) Involvement
Description
BSA affected by AD will be assessed for 4 separate body regions: head and neck, trunk (including genital region), upper extremities, and lower extremities (including the buttocks). BSA was calculated using the participant's palm using the 1% rule, 1 palm was equivalent to 1% with estimates of the number of palms it takes to cover the affected AD area. Maximum number of palms were 10 palms for head and neck (10%), 20 palms for upper extremities (20%), 30 palms for trunk, including axilla and groin (30%), 40 palms for lower extremities, including buttocks (40%). %BSA for a body region was calculated as = total number of palms in a body region * % surface area equivalent to 1 palm. Overall percent BSA of all 4 body regions ranges from 0% to 100 % with higher values represent greater severity of AD. Baseline (i.e., prior to first study drug administration) is defined for the parent studies, J2T-DM-KGAB (ADvocate-1), J2TDM-KGAC (ADvocate-2), J2T-DM-KGAD (ADhere), and J2T-DM-KGAE (ADore).
Time Frame
Baseline to Week 108
Title
Proportion of Participants with Topical Corticosteroids (TCS)-free Days
Description
Proportion of participants TCS- free days will be reported.
Time Frame
Baseline up to Week 108
Title
Percentage of Participants with DLQI/CDLQI Score <=5
Description
The DLQI is a 10-item validated questionnaire 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
Baseline up to Week 108
Title
Percentage of Participants Achieving at Least a 4-point Improvement from Baseline of Parent Study Dermatology Quality of Life Index/ Children's Dermatology Quality of Life Index (DLQI/CDLQI)
Description
The DLQI is a 10-item validated questionnaire 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). Baseline (i.e., prior to first study drug administration) is defined for the parent studies, J2T-DM-KGAB (ADvocate-1), J2TDM-KGAC (ADvocate-2), J2T-DM-KGAD (ADhere), and J2T-DM-KGAE (ADore).
Time Frame
Baseline to Week 108
Other Pre-specified Outcome Measures:
Title
Number of Participants with TEAEs, Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs)
Time Frame
Baseline up to Week 110

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Participants who completed treatment with lebrikizumab in ADjoin and their last participant assessment visit (Week 100) in that study. For WOCBP: agree to remain abstinent (refrain from heterosexual intercourse) or use a highly effective contraceptive method during the treatment period and for at least 4 weeks after the last dose of lebrikizumab. NOTE: A WOCBP is defined as a postmenarcheal female, who has not reached a postmenopausal state (>=12 continuous months of amenorrhea with no identified cause other than menopause) and has not undergone surgical sterilization (removal of ovaries, fallopian tubes, and/or uterus). NOTE: The following are highly effective contraceptive methods: combined (estrogen and progestogen containing) hormonal contraception (oral, intravaginal, transdermal) associated with inhibition of ovulation, progestogen-only hormonal contraception (oral, injectable, implantable) associated with inhibition of ovulation, intrauterine device, intrauterine hormone-releasing system, bilateral tubal occlusion, bilateral tubal ligation, vasectomized partner, or sexual abstinence. In the context of this protocol, sexual abstinence is considered a highly effective method only if defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatments. The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the participant. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or post ovulation methods) and withdrawal are not acceptable methods of contraception. Ability to understand the purpose and risks of the trial, willingness and ability to comply with the protocol and provide written informed consent/assent in accordance with institutional and regulatory guidelines. Capable of giving signed informed consent/assent as described in which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. Exclusion Criteria: Participants who, having participated in ADjoin, had their last lebrikizumab dose administered in a window longer than 8 weeks prior to the Baseline Visit in the current study. Participants who, during their participation in the parent trial or ADjoin, developed an SAE or a severe AE that was deemed related to lebrikizumab, which in the opinion of the Investigator or of the medical monitor could indicate that continued treatment with lebrikizumab may present an unreasonable risk for the participant. Conditions in the parent study or ADjoin consistent with protocol-defined criteria for permanent study drug discontinuation, if deemed related to lebrikizumab or led to Investigator or Sponsor-initiated withdrawal of participant from the study (e.g., non-compliance, inability to complete study assessments, etc.). Treatment with a live (attenuated) vaccine from the time of last lebrikizumab dose in ADjoin prior to enrolment in the current study or planned during the study. Use of a prohibited medication from the time of last lebrikizumab dose in ADjoin prior to enrolment in the current study or planned during the study. Pregnant or breastfeeding women, and women planning to become pregnant or breastfeed during the study and for at least 4 weeks after the last dose of lebrikizumab. Severe concomitant illness(es) that in the Investigator's judgment would adversely affect the participant's participation in the study. Any other medical or psychological condition that in the opinion of the Investigator may suggest a new and/or insufficiently understood disease, may present an unreasonable risk to the study patient because of his/her participation in this clinical trial, may make participant's participation unreliable, or may interfere with study assessments. Any other conditions that, in the Investigator's opinion, might indicate the participant to be unsuitable for the trial. Participant who is an employee or relative of an employee at the research site or Almirall.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Estrella Garcia
Phone
+34-620985953
Email
gco@almirall.com
First Name & Middle Initial & Last Name or Official Title & Degree
Andrea Pejenaute
Email
gco@almirall.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aleksandra Stjepanovic
Organizational Affiliation
Almirall, S.A.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Investigator Site 7
City
Darmstadt
State/Province
Hessen
ZIP/Postal Code
64283
Country
Germany
Individual Site Status
Recruiting
Facility Name
Investigator Site 8
City
Frankfurt
State/Province
Hessen
ZIP/Postal Code
60590
Country
Germany
Individual Site Status
Recruiting
Facility Name
Investigator Site 9
City
Osnabrück
State/Province
Lower Saxony
ZIP/Postal Code
49074
Country
Germany
Individual Site Status
Recruiting
Facility Name
Investigator Site 10
City
Bad Bentheim
State/Province
Niedersachsen
ZIP/Postal Code
48455
Country
Germany
Individual Site Status
Recruiting
Facility Name
Investigator Site 11
City
Münster
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
48149
Country
Germany
Individual Site Status
Recruiting
Facility Name
Investigator Site 12
City
Leipzig
State/Province
Saxony
ZIP/Postal Code
04103
Country
Germany
Individual Site Status
Recruiting
Facility Name
Investigator Site 1
City
Augsburg
ZIP/Postal Code
86150
Country
Germany
Individual Site Status
Recruiting
Facility Name
Investigator Site 2
City
Berlin
ZIP/Postal Code
10789
Country
Germany
Individual Site Status
Recruiting
Facility Name
Investigator Site 3
City
Berlin
ZIP/Postal Code
13055
Country
Germany
Individual Site Status
Recruiting
Facility Name
Investigator Site 4
City
Dresden
ZIP/Postal Code
D-01307
Country
Germany
Individual Site Status
Recruiting
Facility Name
Investigator Site 5
City
Hamburg
ZIP/Postal Code
20144
Country
Germany
Individual Site Status
Recruiting
Facility Name
Investigator Site 6
City
Hamburg
ZIP/Postal Code
20537
Country
Germany
Individual Site Status
Recruiting
Facility Name
Investigator Site 23
City
Wrocław
State/Province
Dolnośląskie
ZIP/Postal Code
51-503
Country
Poland
Individual Site Status
Recruiting
Facility Name
Investigator Site 24
City
Łódź
State/Province
Lodzkie
ZIP/Postal Code
90-436
Country
Poland
Individual Site Status
Recruiting
Facility Name
Investigator Site 25
City
Krakow
State/Province
Malopolskie
ZIP/Postal Code
31-559
Country
Poland
Individual Site Status
Recruiting
Facility Name
Investigator Site 26
City
Kraków
State/Province
Malopolskie
ZIP/Postal Code
30-033
Country
Poland
Individual Site Status
Recruiting
Facility Name
Investigator Site 27
City
Warsaw
State/Province
Mazowieckie
ZIP/Postal Code
02-625
Country
Poland
Individual Site Status
Recruiting
Facility Name
Investigator Site 28
City
Warszawa
State/Province
Mazowieckie
ZIP/Postal Code
02-507
Country
Poland
Individual Site Status
Recruiting
Facility Name
Investigator Site 29
City
Ossy
State/Province
Slaskie
ZIP/Postal Code
42-624
Country
Poland
Individual Site Status
Recruiting
Facility Name
Investigator Site 30
City
Gdańsk
State/Province
Woj. Pomorskie
ZIP/Postal Code
80-344
Country
Poland
Individual Site Status
Recruiting
Facility Name
Investigator Site 31
City
Iwonicz Zdroj
State/Province
Wojewodztwo Podkarpackie
ZIP/Postal Code
38-440
Country
Poland
Individual Site Status
Recruiting
Facility Name
Investigator Site 13
City
Gdansk
ZIP/Postal Code
80-462
Country
Poland
Individual Site Status
Recruiting
Facility Name
Investigator Site 14
City
Katowice
ZIP/Postal Code
40-600
Country
Poland
Individual Site Status
Recruiting
Facility Name
Investigator Site 15
City
Kielce
ZIP/Postal Code
25-155
Country
Poland
Individual Site Status
Recruiting
Facility Name
Investigator Site 16
City
Lublin
ZIP/Postal Code
20-081
Country
Poland
Individual Site Status
Recruiting
Facility Name
Investigator Site 17
City
Poznan
ZIP/Postal Code
60-214
Country
Poland
Individual Site Status
Recruiting
Facility Name
Investigator Site 18
City
Rzeszow
ZIP/Postal Code
35-055
Country
Poland
Individual Site Status
Recruiting
Facility Name
Investigator Site 19
City
Szczecin
ZIP/Postal Code
71-434
Country
Poland
Individual Site Status
Recruiting
Facility Name
Investigator Site 20
City
Tarnow
ZIP/Postal Code
33-100
Country
Poland
Individual Site Status
Recruiting
Facility Name
Investigator Site 21
City
Warszawa
ZIP/Postal Code
01-142
Country
Poland
Individual Site Status
Recruiting
Facility Name
Investigator Site 22
City
Wroclaw
ZIP/Postal Code
50-566
Country
Poland
Individual Site Status
Recruiting
Facility Name
Investigator Site 32
City
Katowice
State/Province
Śląskie
ZIP/Postal Code
40-611
Country
Poland
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Long-term Safety and Efficacy of Lebrikizumab in Adult and Adolescent Participant With Moderate-to-Severe Atopic Dermatitis

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