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Evaluation of the Efficacy and Safety of Lebrikizumab (LY3650150) in Moderate to Severe Atopic Dermatitis (ADvocate2)

Primary Purpose

Atopic Dermatitis

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Lebrikizumab

Placebo

About this trial

This is an interventional treatment trial for Atopic Dermatitis focused on measuring Eczema, Dermatitis, Dermatitis, Atopic, Skin Diseases

Eligibility Criteria

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

Inclusion Criteria:

Male or female adults and adolescents (≥12 years and ≥40 kg)
Chronic atopic dermatitis (according to American Academy of Dermatology Consensus Criteria) that has been present for ≥1 year before the screening visit
Eczema Area and Severity Index (EASI) score ≥16 at the baseline visit
Investigator Global Assessment (IGA) score ≥3 (scale of 0 to 4) at the baseline visit
≥10% body surface area (BSA) of atopic dermatitis involvement at the baseline visit
History of inadequate response to treatment with topical medications; or determination that topical treatments are otherwise medically inadvisable

Exclusion Criteria:

Prior treatment with dupilumab or tralokinumab
Treatment with topical corticosteroids, calcineurin inhibitors or phosphodiesterase-4 inhibitors such as crisaborole within 1 week prior to the baseline visit
Treatment with any of the following agents within 4 weeks prior to the baseline visit:
- Immunosuppressive/immunomodulating drugs (e.g., systemic corticosteroids, cyclosporine, mycophenolate-mofetil, IFN-γ, Janus kinase inhibitors, azathioprine, methotrexate, etc.)
- Phototherapy and photochemotherapy (PUVA) for AD
Treatment with the following prior to the baseline visit:
- An investigational drug within 8 weeks or within 5 half-lives (if known) of baseline, whichever is longer
- Cell-depleting biologics, including to rituximab, within 6 months of baseline
- Other biologics within 5 half-lives (if known) or 16 weeks of baseline, whichever is longer
Treatment with a live (attenuated) vaccine within 12 weeks of the baseline visit or planned during the study
Uncontrolled chronic disease that might require bursts of oral corticosteroids, e.g., co-morbid severe uncontrolled asthma
Evidence of active acute or chronic hepatitis
History of human immunodeficiency virus (HIV) infection or positive HIV serology
History of malignancy, including mycosis fungoides, within 5 years before the screening visit, except completely treated in situ carcinoma of the cervix, completely treated and resolved non-metastatic squamous or basal cell carcinoma of the skin
Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed during the study

Sites / Locations

Investigate MD
Northwest Arkansas Clinical Trials Center
Bakersfield Dermatology and Skin Cancer Medical Group
Center For Dermatology Clinical Research, Inc.
Woodward Centre
Dermatology Research Associates
LA Universal Research Center, INC
University Clinical Trials, Inc.
San Luis Dermatology & Laser Clinic
Clinical Physiology Associates, Clinical Study Center
Direct Helpers Medical Center
The Community Research of South Florida
Solutions Through Advanced Research, Inc.
Georgia Pollens Clinical Research Centers, Inc
Marietta Dermatology Clinical Research
Advanced Medical Research
Arlington Dermatology
NorthShore University HealthSystem
Kansas City Dermatology, PA
Meridian Clinical Research
ActivMed Practices and Research
Tufts Medical Center
Great Lakes Research Group, Inc.
Clarkston Skin Research
Associated Skin Care Specialists
Central Dermatology PC
Forest Hills Dermatology Group
OnSite Clinical Solutions
Wilmington Dermatology Center
Dermatology and Skin Surgery Center
DermDOX
Peak Research LLC
Dermatology & Laser Center of Charleston
Palmetto Clinical Trial Services
Arlington Research Center, Inc
Innovate Research, LLC
Austin Institute for Clinical Research
University of Utah MidValley Dematology
Virginia Clinical Research, Inc.
Dermatology Associates
DCC Sveti Georgi
Diagnostic and Consultation Center 14
Alexandrovska University Hospital
Euro Derma clinic
Military Medical Academy
Medical centre Alitera-Med EOOD
Dr. Chih-ho Hong Medical Inc.
Simcoderm Medical & Surgical Dermatology Centre
Lynderm Research Inc.
North York Research Inc.
Ottawa Allergy Research Corp
K. Papp Clinical Research
Derma-Study-Center Friedrichshafen GmbH
Studienzentrum Dr.Beate Schwarz
Hautarztpraxis am Löwenmarkt
licca Fachklinik
Rosenpark Research Geschäftsbereich der Rosenparkklinik GmbH
Klinikum der Johann Wolfgang Goethe-Universität Frankfurt
Elbe Klinikum Buxtehude
Klinische Forschung Osnabrück
Fachklinik Bad Bentheim
Hautzentrum im Jahrhunderthaus
Universitätsklinikum Münster
Universität Leipzig - Universitätsklinikum
SIBAmed Studienzentrum GmbH & Co. KG
Universitätsklinikum Schleswig-Holstein
Praxis Dr. Michael Dietlen
Charité Universitätsmedizin Berlin Campus Buch
ISA GmbH
Praxis für Ganzheitliche Dermatologie im Ärztehaus
Universitätsklinikum Hamburg
TFS Trial Form Support GmbH
Clinica De Enfermedades Cronicas y Procedimientos Especiales
Derma Norte del Bajío, S.C.
National University Hospital
Singapore General Hospital
Kk Women'S and Childrens Hospital
National Skin Centre NSC
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung Medical University Chung-Ho Institutional Review B
Taipei Medical University- Shuang Ho Hospital
China Medical University Hospital
Chung Shan Medical University Hospital
National Taiwan University Hospital
Chang Gung Memorial Hospital - Linkou
Municipal Healthcare Institution Kharkiv City Dermatoverenologic Dispensary N2
Rivne Regional Dermatology and Venereology Dispensary
Treatment-diagnostic center PE "Asclepius"
Community Institution Zaporizhzhya Regional Dermatovenereology Clinical Hospital of Zaporizhzhya Regional Council

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Lebrikizumab Q2W

Lebrikizumab Q4W

Escape Arm (Lebrikizumab Q2W)

Arm Description

Induction Period (Baseline-Week 16): Two subcutaneous (SC) injections of Placebo as a loading dose at Baseline and Week 2 followed by a single injection every 2 weeks (Q2W) from Week 4 until Week 14. Maintenance Period (Week 16-Week 52): Two placebo SC injections as loading dose on Week 16 and Week 18. One placebo SC injection Q2W until Week 50.

Induction Period (Baseline-Week 16): 500 milligram (mg) Lebrikizumab (2 x 250 mg) SC injections as a loading dose at Baseline and Week 2 visits followed by a single 250 mg Lebrikizumab injection Q2W from Week 4 until Week 14. Maintenance Period (Week 16-Week 52): One 250 mg Lebrikizumab SC injection and one placebo SC injection as maintenance loading dose on Week 16 and Week 18. One 250 mg Lebrikizumab SC injection Q2W until Week 50.

Maintenance Period (Week 16-Week 52): One 250 mg Lebrikizumab SC injection and one placebo SC injection as maintenance loading dose on Week 16 and two placebo SC injections on Week 18. One 250 mg Lebrikizumab SC injection Every 4 weeks (Q4W) on Weeks 20, 24, 28, 32, 36, 40, 44, and 48. One placebo SC injection Q4W on Weeks 22, 26, 30, 34, 38, 42, 46, and 50.

Maintenance Period (Week 16-Week 52): Participants who require topical or systemic rescue treatment for atopic dermatitis during the Induction Period, or are non-responders at Week 16, will be eligible for treatment in an Escape Arm where participants will receive open-label lebrikizumab Q2W from Week 16 through Week 52. In addition, participants who do not maintain an acceptable response during the Maintenance Period (have an EASI score <50% of baseline), will be eligible for the Escape Arm.

Outcomes

Primary Outcome Measures

Percentage of Participants With an Investigator Global Assessment (IGA) Score of 0 or 1 and a Reduction ≥2 Points From Baseline to Week 16

The IGA measures the investigator's global assessment of the participant's overall severity of their atopic dermatitis (AD), based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification.

Percentage of Participants Achieving Eczema Area And Severity Index (EASI-75) (≥75% Reduction in EASI Score) From Baseline to Week 16

The EASI assesses objective physician estimates of 2 dimensions of AD - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 to 72 (severe). The EASI-75 responder is defined as a participant who achieves a ≥ 75% reduction from baseline in the EASI score.

Secondary Outcome Measures

Percentage of Participants With an IGA Score of 0 or 1 and a Reduction ≥2 Points From Baseline to Week 2

The IGA measures the investigator's global assessment of the participant's overall severity of their AD, based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification.

Percentage of Participants With an IGA Score of 0 or 1 and a Reduction ≥2 Points From Baseline to Week 4

Percentage of Participants With an IGA Score of 0 or 1 and a Reduction ≥2 Points From Baseline to Week 16

Percentage of Participants Achieving EASI-90 (≥90% Reduction in EASI Score) From Baseline to Week 16

The EASI assesses objective physician estimates of 2 dimensions of AD - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 to 72 (severe). The EASI-90 responder is defined as a participant who achieves a ≥ 90% reduction from baseline in the EASI score.

Percentage Change in Pruritus Numerical Rating Scale (NRS) Score From Baseline to Week 16

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." Least Squares (LS) Mean was calculated using analysis of covariance (ANCOVA) model with treatment and randomization strata (region, disease severity, age) as fixed factors and baseline value as covariate.

Percentage of Participants With a Pruritus NRS Score of ≥4-points at Baseline Who Achieve a ≥4-point Reduction in Pruritus NRS Score From Baseline to Week 16

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 With a Pruritus NRS Score of ≥5-points at Baseline Who Achieve a ≥4-point Reduction in Pruritus NRS Score From Baseline to Week 16

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 in EASI Score From Baseline to Week 16

The EASI assesses objective physician estimates of 2 dimensions of AD - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 to 72 (severe). LS Mean was calculated using ANCOVA model with treatment, stratification factors of geographic region, age group, baseline IGA score (IGA 3 versus 4) as fixed factors baseline value as covariate.

Change From Baseline in Percent Body Surface Area (BSA) at Week 16

The 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). Each body region will be assessed for disease extent ranging from 0% to 100% involvement. 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%). Percent of 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 representing greater severity of AD.

Percentage of Participants Achieving EASI-90 From Baseline to Week 4

The EASI assesses objective physician estimates of 2 dimensions of AD - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 to 72 (severe). The EASI-90 responder is defined as a participant who achieves a ≥ 90% reduction from baseline in the EASI score.

Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 16

The DLQI is a 10-item, validated questionnaire used to assess the impact of skin disease on the quality of life of an affected person. 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, over the previous week. Response categories include "Not at all," "A little," "A lot," and "Very much," with corresponding scores of 0, 1, 2, and 3 respectively. Questions 3-10 also have an additional response category of "Not relevant" which is scored as "0". Questions are scored from 0 to 3, giving a possible total score range from 0 (no impact of skin disease on quality of life) to 30 (maximum impact on quality of life). A high score is indicative of a poor quality of life. LS Mean was calculated using the ANCOVA model with treatment, baseline value, and stratification factors of geographic region, age group, baseline IGA (3 versus 4) score as fixed factors.

Percentage of Participants Achieving ≥4-point Improvement in DLQI From Baseline to Week 16

Percentage of Participants With a DLQI Total Score of ≥4-point at Baseline Achieving ≥4-point Improvement in DLQI From Baseline to Week 16

Percentage Change in Sleep-loss Score From Baseline to Week 16

Sleep Loss due to interference of itch will be assessed by the participant. Participants rate their interference of itch on sleep based on a 5-point Likert scale [0 (not at all) to 4 (unable to sleep at all)]. Higher scores indicated a greater impact and worse outcome. Assessments will be recorded daily by the participant using an electronic diary. LS Mean was calculated using ANCOVA model with treatment, baseline value, and stratification factors of geographic region, age group, baseline IGA (3 versus 4) score as fixed factors.

Change From Baseline in Sleep-loss Score at Week 16

Percentage of Participants With a Sleep-loss Score ≥2 Points at Baseline Who Achieve a ≥2 Points Reduction From Baseline to Week 16

Percentage of Participants With a Pruritus NRS Score of ≥4 Points at Baseline Who Achieve a ≥4-point Reduction From Baseline to Week 1

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 With a Pruritus NRS Score of ≥4 Points at Baseline Who Achieve a ≥4-point Reduction From Baseline to Week 2

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 With a Pruritus NRS Score of ≥4 Points at Baseline Who Achieve a ≥4-point Reduction From Baseline to Week 4

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 With a Pruritus NRS Score of ≥5 Points at Baseline Who Achieve a ≥4-point Reduction From Baseline to Week 1

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 With a Pruritus NRS Score of ≥5 Points at Baseline Who Achieve a ≥4-point Reduction From Baseline to Week 2

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 With a Pruritus NRS Score of ≥5 Points at Baseline Who Achieve a ≥4-point Reduction From Baseline to Week 4

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 in SCORing Atopic Dermatitis (SCORAD) From Baseline to Week 16

SCORAD is validated tool for assessing the extent and intensity of AD, it consists of 3 components: A=extent of AD as a percentage of each defined body area and reported as sum of all areas, with maximum score of 100%. B=severity of 6 specific symptoms of AD (redness, swelling, oozing/crusting, excoriation, skin thickening/lichenification, dryness) assessed using following scale: none=0, mild=1, moderate=2, or severe=3 for maximum of 18 total points. C=subjective assessment of itch and sleeplessness recorded by participant on visual analog scale (VAS), where 0=no itch/no sleeplessness and 10=worst imaginable itch/sleeplessness with maximum score of 20. SCORAD total score is calculated: A/5+7*B/2+ C to give total score range of 0 to 103, where 0=no disease to 103=severe disease. LS Mean was calculated using ANCOVA model with treatment group and stratification factors of geographic region, age group, baseline IGA (3 versus 4) score as fixed factors and baseline value as covariate.

Pharmacokinetics (PK): Trough Serum Concentrations of Lebrikizumab in Maintenance Period (C-trough)

C-trough was the concentration of study drug in the blood immediately before the next dose was administered. Trough serum concentration of Lebrikizumab was assessed at predose week 52.

Percentage of Participants From Those Re-randomized Having Achieved EASI-75 at Week 16 Who Continue to Exhibit EASI-75 at Week 52 (EASI-75 Calculated Relative to Baseline EASI Score)

The EASI assesses objective physician estimates of 2 dimensions of AD - disease extent, i.e., percentage of skin affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI-75 score was obtained by weight-averaging these 4 scores and will range from 0 (none) to 72 (severe). The EASI-75 responder is defined as a participant who achieves a ≥ 75% reduction from baseline in the EASI score.

Percentage of Participants From Those Re-randomized Having Achieved IGA 0 or 1 and a ≥2-point Improvement From Baseline at Week 16 Who Continue to Exhibit an IGA 0 or 1 and a ≥2-point Improvement From Baseline at Week 52

Percentage of Participants From Those With a Pruritus NRS of ≥4-points at Baseline Re-randomized Having Achieved ≥4-point Reduction From Baseline at Week 16 Who Continue to Exhibit ≥4-point Reduction From Baseline at Week 52

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 From Those With a Pruritus NRS of ≥5-points at Baseline Re-randomized Having Achieved ≥4-point Reduction From Baseline at Week 16 Who Continue to Exhibit ≥4-point Reduction From Baseline at Week 52

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 in SCORAD (From Those Re-randomized Having Achieved EASI-75 at Week 16) From Baseline at Week 52

SCORAD is a validated tool for assessing the extent and intensity of AD, it consists of 3 components: A=extent of AD as a percentage of each defined body area and reported as sum of all areas, with maximum score of 100%. B=severity of 6 specific symptoms of AD (redness, swelling, oozing/crusting, excoriation, skin thickening/lichenification, dryness) assessed using following scale: none=0, mild=1, moderate=2, or severe=3 for maximum of 18 total points. C=subjective assessment of itch and sleeplessness recorded by participant on VAS, where 0=no itch/no sleeplessness and 10=worst imaginable itch/sleeplessness with maximum score of 20. SCORAD total score is calculated: A/5+7*B/2+ C to give total score range of 0 to 103, where 0=no disease to 103=severe disease. LS Mean was calculated using ANCOVA model with treatment group and stratification factors of geographic region, age group, baseline IGA (3 versus 4) score as fixed factors and baseline value as covariate.

Change From Baseline in European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) at Week 16 - Health State Index

The European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) is a is a 2-part questionnaire which measure health status of the participant. The first component (Health state) is a descriptive system of the respondent's health comprised of the following 5 participant-reported dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The responses are used to derive the health state index scores using the United Kingdom (UK) algorithm, with scores ranging from -0.594 to 1, and the United States (US) algorithm, with scores ranging from -0.109 to 1. A higher score indicates better health state. LS Mean was calculated using the ANCOVA model with treatment and stratification factors of geographic region, age group, baseline IGA (3 versus 4) score as fixed factors and baseline value as covariate.

Change From Baseline in EQ-5D-5L at Week 16 - Visual Analog Scale (VAS)

The EQ-5D-5L is a 2-part measurement. The second part is assessed using a VAS that ranged from 0 to 100 millimeter (mm), where 0 is the worst health you can imagine and 100 is the best health you can imagine. LS Mean was calculated using the ANCOVA model with treatment and stratification factors of geographic region, age group, baseline IGA (3 versus 4) score as fixed factors and baseline value as covariate.

Change From Baseline in Patient Oriented Eczema Measure (POEM) at Week 16

POEM is a 7-item, validated, questionnaire used by the participant to assess disease symptoms over the last week. The participant is asked to respond to 7 questions on skin dryness, itching, flaking, cracking, sleep loss, bleeding and weeping. All 7 answers carry equal weight with a total possible score from 0 to 28 (answers scored as: No days=0; 1-2 days = 1; 3-4 days = 2; 5-6 days = 3; everyday = 4). A high score is indicative of a poor quality of life. POEM responses will be captured using an electronic diary and transferred into the clinical database. LS Mean was calculated using MMRM model using treatment, baseline value, visit, the interaction of the baseline value-by-visit, the interaction of treatment by-visit as covariates, geographic region, age group, baseline IGA (3 versus 4) score as fixed.

Change From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety at Week 16-Adolescents

PROMIS® is a set of person-centered measures that evaluates and monitors physical, mental, and social health in adults and children. Participants ≤17 years will complete pediatric versions for the duration of the study. PROMIS anxiety has 8 questions on Emotion Distress-Anxiety (or Pediatric Anxiety Symptom). Each question has 5 response options with values from 1 to 5. Total raw scores were converted to T-Scores (mean = 50 and a standard deviation = 10) with higher scores representing greater anxiety. LS Mean was calculated using the ANCOVA model with treatment and stratification factors of geographic region, age group, baseline IGA (3 versus 4) score as fixed factors and baseline value as covariate.

Change From Baseline in PROMIS Anxiety at Week 16 - Adults

Change From Baseline in PROMIS Depression at Week 16- Adolescents

Change From Baseline in PROMIS Depression at Week 16- Adults

Change From Baseline in Asthma Control Questionnaire (ACQ-5) Score at Week 16 in Participants Who Have Self-reported Comorbid Asthma

The ACQ-5 is a five-item, self-completed questionnaire, which is used as a measure of asthma control of a participant. The five questions (concerning nocturnal awakening, waking in the morning, activity limitation, shortness of breath and wheeze) enquire about the frequency and/or severity of symptoms over the previous week. The response options for all these questions range from zero (no impairment/limitation) to six (total impairment/ limitation) scale. The ACQ-5 score is the average of the individual item scores and ranges from 0 (totally controlled) to 6 (severely uncontrolled). Higher scores indicate lower asthma control. LS Mean was calculated using ANCOVA with treatment, geographic region, age group, baseline IGA (3 versus 4) score as fixed factors and baseline value as covariate.

Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) at Week 16

The CDLQI questionnaire is designed for use in children (4 to 16 years of age). It consists of 10 items that are grouped into 6 domains: symptoms & feelings, leisure, school or holidays, personal relationships, sleep, & treatment. The scoring of each question is: Very much =3; Quite a lot = 2; Only a little = 1; Not at all = 0. CDLQI total score is calculated by summing all 10 items responses, and has a range of 0 to 30 (higher scores are indicative of greater impairment). LS Mean was calculated using MMRM model which includes treatment, baseline value, visit, the interaction of the baseline value-by-visit as covariates, the interaction of treatment by-visit, geographic region, age group, and baseline IGA (3 versus 4) score as fixed factors.

Full Information

NCT ID

NCT04178967

First Posted

November 25, 2019

Last Updated

April 24, 2023

Sponsor

Eli Lilly and Company

Collaborators

Dermira, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT04178967

Brief Title

Evaluation of the Efficacy and Safety of Lebrikizumab (LY3650150) in Moderate to Severe Atopic Dermatitis

Acronym

ADvocate2

Official Title

A Randomized, Double-blind, Placebo Controlled Trial to Evaluate the Efficacy and Safety of Lebrikizumab in Patients With Moderate to Severe Atopic Dermatitis.

Study Type

Interventional

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Completed

Study Start Date

October 29, 2019 (Actual)

Primary Completion Date

July 12, 2021 (Actual)

Study Completion Date

April 28, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Eli Lilly and Company

Collaborators

Dermira, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This is a randomized, double-blind, placebo-controlled, parallel-group study which is 52 weeks in duration. The study is designed to confirm the safety and efficacy of lebrikizumab as monotherapy for treatment of moderate-to-severe atopic dermatitis utilizing a 16-week induction treatment period and a 36-week long-term maintenance treatment period.

6. Conditions and Keywords

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

Atopic Dermatitis

Keywords

Eczema, Dermatitis, Dermatitis, Atopic, Skin Diseases

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Model Description

Randomized, double-blind, parallel group, placebo controlled

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Masking Description

Double-blind

Allocation

Randomized

Enrollment

445 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Arm Title

Lebrikizumab Q2W

Arm Type

Experimental

Arm Description

Arm Title

Lebrikizumab Q4W

Arm Type

Experimental

Arm Description

Arm Title

Escape Arm (Lebrikizumab Q2W)

Arm Type

Experimental

Arm Description

Intervention Type

Biological

Intervention Name(s)

Lebrikizumab

Other Intervention Name(s)

LY3650150, DRM06

Intervention Description

Subcutaneous injection

Intervention Type

Other

Intervention Name(s)

Placebo

Intervention Description

Subcutaneous Injection

Primary Outcome Measure Information:

Title

Percentage of Participants With an Investigator Global Assessment (IGA) Score of 0 or 1 and a Reduction ≥2 Points From Baseline to Week 16

Description

Time Frame

Baseline to Week 16

Title

Percentage of Participants Achieving Eczema Area And Severity Index (EASI-75) (≥75% Reduction in EASI Score) From Baseline to Week 16

Description

Time Frame

Baseline to Week 16

Secondary Outcome Measure Information:

Title

Percentage of Participants With an IGA Score of 0 or 1 and a Reduction ≥2 Points From Baseline to Week 2

Description

Time Frame

Baseline to Week 2

Title

Percentage of Participants With an IGA Score of 0 or 1 and a Reduction ≥2 Points From Baseline to Week 4

Description

Time Frame

Baseline to Week 4

Title

Percentage of Participants With an IGA Score of 0 or 1 and a Reduction ≥2 Points From Baseline to Week 16

Description

Time Frame

Baseline to Week 16

Title

Percentage of Participants Achieving EASI-90 (≥90% Reduction in EASI Score) From Baseline to Week 16

Description

The EASI assesses objective physician estimates of 2 dimensions of AD - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 to 72 (severe). The EASI-90 responder is defined as a participant who achieves a ≥ 90% reduction from baseline in the EASI score.

Time Frame

Baseline to Week 16

Title

Percentage Change in Pruritus Numerical Rating Scale (NRS) Score From Baseline to Week 16

Description

Time Frame

Baseline, Week 16

Title

Percentage of Participants With a Pruritus NRS Score of ≥4-points at Baseline Who Achieve a ≥4-point Reduction in Pruritus NRS Score From Baseline to Week 16

Description

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 to Week 16

Title

Percentage of Participants With a Pruritus NRS Score of ≥5-points at Baseline Who Achieve a ≥4-point Reduction in Pruritus NRS Score From Baseline to Week 16

Description

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 to Week 16

Title

Percentage Change in EASI Score From Baseline to Week 16

Description

The EASI assesses objective physician estimates of 2 dimensions of AD - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 to 72 (severe). LS Mean was calculated using ANCOVA model with treatment, stratification factors of geographic region, age group, baseline IGA score (IGA 3 versus 4) as fixed factors baseline value as covariate.

Time Frame

Baseline, Week 16

Title

Change From Baseline in Percent Body Surface Area (BSA) at Week 16

Description

Time Frame

Baseline, Week 16

Title

Percentage of Participants Achieving EASI-90 From Baseline to Week 4

Description

The EASI assesses objective physician estimates of 2 dimensions of AD - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 to 72 (severe). The EASI-90 responder is defined as a participant who achieves a ≥ 90% reduction from baseline in the EASI score.

Time Frame

Baseline to Week 4

Title

Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 16

Description

Time Frame

Baseline, Week 16

Title

Percentage of Participants Achieving ≥4-point Improvement in DLQI From Baseline to Week 16

Description

Time Frame

Baseline to Week 16

Title

Percentage of Participants With a DLQI Total Score of ≥4-point at Baseline Achieving ≥4-point Improvement in DLQI From Baseline to Week 16

Description

Time Frame

Baseline to Week 16

Title

Percentage Change in Sleep-loss Score From Baseline to Week 16

Description

Time Frame

Baseline, Week 16

Title

Change From Baseline in Sleep-loss Score at Week 16

Description

Time Frame

Baseline, Week 16

Title

Percentage of Participants With a Sleep-loss Score ≥2 Points at Baseline Who Achieve a ≥2 Points Reduction From Baseline to Week 16

Description

Time Frame

Baseline to Week 16

Title

Percentage of Participants With a Pruritus NRS Score of ≥4 Points at Baseline Who Achieve a ≥4-point Reduction From Baseline to Week 1

Description

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 to Week 1

Title

Percentage of Participants With a Pruritus NRS Score of ≥4 Points at Baseline Who Achieve a ≥4-point Reduction From Baseline to Week 2

Description

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 to Week 2

Title

Percentage of Participants With a Pruritus NRS Score of ≥4 Points at Baseline Who Achieve a ≥4-point Reduction From Baseline to Week 4

Description

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 to Week 4

Title

Percentage of Participants With a Pruritus NRS Score of ≥5 Points at Baseline Who Achieve a ≥4-point Reduction From Baseline to Week 1

Description

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 to Week 1

Title

Percentage of Participants With a Pruritus NRS Score of ≥5 Points at Baseline Who Achieve a ≥4-point Reduction From Baseline to Week 2

Description

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 to Week 2

Title

Percentage of Participants With a Pruritus NRS Score of ≥5 Points at Baseline Who Achieve a ≥4-point Reduction From Baseline to Week 4

Description

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 to Week 4

Title

Percentage Change in SCORing Atopic Dermatitis (SCORAD) From Baseline to Week 16

Description

Time Frame

Baseline, Week 16

Title

Pharmacokinetics (PK): Trough Serum Concentrations of Lebrikizumab in Maintenance Period (C-trough)

Description

C-trough was the concentration of study drug in the blood immediately before the next dose was administered. Trough serum concentration of Lebrikizumab was assessed at predose week 52.

Time Frame

Predose at Week 52

Title

Percentage of Participants From Those Re-randomized Having Achieved EASI-75 at Week 16 Who Continue to Exhibit EASI-75 at Week 52 (EASI-75 Calculated Relative to Baseline EASI Score)

Description

Time Frame

Baseline to Week 52

Title

Description

Time Frame

Baseline to Week 52

Title

Description

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 to Week 52

Title

Description

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 to Week 52

Title

Percentage Change in SCORAD (From Those Re-randomized Having Achieved EASI-75 at Week 16) From Baseline at Week 52

Description

Time Frame

Baseline, Week 52

Title

Change From Baseline in European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) at Week 16 - Health State Index

Description

Time Frame

Baseline, Week 16

Title

Change From Baseline in EQ-5D-5L at Week 16 - Visual Analog Scale (VAS)

Description

Time Frame

Baseline, Week 16

Title

Change From Baseline in Patient Oriented Eczema Measure (POEM) at Week 16

Description

Time Frame

Baseline, Week 16

Title

Change From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety at Week 16-Adolescents

Description

Time Frame

Baseline, Week 16

Title

Change From Baseline in PROMIS Anxiety at Week 16 - Adults

Description

Time Frame

Baseline, Week 16

Title

Change From Baseline in PROMIS Depression at Week 16- Adolescents

Description

Time Frame

Baseline, Week 16

Title

Change From Baseline in PROMIS Depression at Week 16- Adults

Description

Time Frame

Baseline, Week 16

Title

Change From Baseline in Asthma Control Questionnaire (ACQ-5) Score at Week 16 in Participants Who Have Self-reported Comorbid Asthma

Description

Time Frame

Baseline, Week 16

Title

Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) at Week 16

Description

Time Frame

Baseline, Week 16

10. Eligibility

Sex

All

Minimum Age & Unit of Time

12 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male or female adults and adolescents (≥12 years and ≥40 kg) Chronic atopic dermatitis (according to American Academy of Dermatology Consensus Criteria) that has been present for ≥1 year before the screening visit Eczema Area and Severity Index (EASI) score ≥16 at the baseline visit Investigator Global Assessment (IGA) score ≥3 (scale of 0 to 4) at the baseline visit ≥10% body surface area (BSA) of atopic dermatitis involvement at the baseline visit History of inadequate response to treatment with topical medications; or determination that topical treatments are otherwise medically inadvisable Exclusion Criteria: Prior treatment with dupilumab or tralokinumab Treatment with topical corticosteroids, calcineurin inhibitors or phosphodiesterase-4 inhibitors such as crisaborole within 1 week prior to the baseline visit Treatment with any of the following agents within 4 weeks prior to the baseline visit: Immunosuppressive/immunomodulating drugs (e.g., systemic corticosteroids, cyclosporine, mycophenolate-mofetil, IFN-γ, Janus kinase inhibitors, azathioprine, methotrexate, etc.) Phototherapy and photochemotherapy (PUVA) for AD Treatment with the following prior to the baseline visit: An investigational drug within 8 weeks or within 5 half-lives (if known) of baseline, whichever is longer Cell-depleting biologics, including to rituximab, within 6 months of baseline Other biologics within 5 half-lives (if known) or 16 weeks of baseline, whichever is longer Treatment with a live (attenuated) vaccine within 12 weeks of the baseline visit or planned during the study Uncontrolled chronic disease that might require bursts of oral corticosteroids, e.g., co-morbid severe uncontrolled asthma Evidence of active acute or chronic hepatitis History of human immunodeficiency virus (HIV) infection or positive HIV serology History of malignancy, including mycosis fungoides, within 5 years before the screening visit, except completely treated in situ carcinoma of the cervix, completely treated and resolved non-metastatic squamous or basal cell carcinoma of the skin Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed during the study

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Organizational Affiliation

Eli Lilly and Company

Official's Role

Study Director

Facility Information:

Facility Name

Investigate MD

City

Scottsdale

State/Province

Arizona

ZIP/Postal Code

85255

Country

United States

Facility Name

Northwest Arkansas Clinical Trials Center

City

Rogers

State/Province

Arkansas

ZIP/Postal Code

72758

Country

United States

Facility Name

Bakersfield Dermatology and Skin Cancer Medical Group

City

Bakersfield

State/Province

California

ZIP/Postal Code

93309

Country

United States

Facility Name

Center For Dermatology Clinical Research, Inc.

City

Fremont

State/Province

California

ZIP/Postal Code

94538

Country

United States

Facility Name

Woodward Centre

City

Fresno

State/Province

California

ZIP/Postal Code

93720

Country

United States

Facility Name

Dermatology Research Associates

City

Los Angeles

State/Province

California

ZIP/Postal Code

90045

Country

United States

Facility Name

LA Universal Research Center, INC

City

Los Angeles

State/Province

California

ZIP/Postal Code

90057

Country

United States

Facility Name

University Clinical Trials, Inc.

City

San Diego

State/Province

California

ZIP/Postal Code

92123

Country

United States

Facility Name

San Luis Dermatology & Laser Clinic

City

San Luis Obispo

State/Province

California

ZIP/Postal Code

93405

Country

United States

Facility Name

Clinical Physiology Associates, Clinical Study Center

City

Fort Myers

State/Province

Florida

ZIP/Postal Code

33916-9452

Country

United States

Facility Name

Direct Helpers Medical Center

City

Hialeah

State/Province

Florida

ZIP/Postal Code

33012

Country

United States

Facility Name

The Community Research of South Florida

City

Hialeah

State/Province

Florida

ZIP/Postal Code

33016

Country

United States

Facility Name

Solutions Through Advanced Research, Inc.

City

Jacksonville

State/Province

Florida

ZIP/Postal Code

32256

Country

United States

Facility Name

Georgia Pollens Clinical Research Centers, Inc

City

Albany

State/Province

Georgia

ZIP/Postal Code

31707

Country

United States

Facility Name

Marietta Dermatology Clinical Research

City

Marietta

State/Province

Georgia

ZIP/Postal Code

30060

Country

United States

Facility Name

Advanced Medical Research

City

Sandy Springs

State/Province

Georgia

ZIP/Postal Code

30328

Country

United States

Facility Name

Arlington Dermatology

City

Rolling Meadows

State/Province

Illinois

ZIP/Postal Code

60008

Country

United States

Facility Name

NorthShore University HealthSystem

City

Skokie

State/Province

Illinois

ZIP/Postal Code

60077

Country

United States

Facility Name

Kansas City Dermatology, PA

City

Overland Park

State/Province

Kansas

ZIP/Postal Code

66215

Country

United States

Facility Name

Meridian Clinical Research

City

Baton Rouge

State/Province

Louisiana

ZIP/Postal Code

70808

Country

United States

Facility Name

ActivMed Practices and Research

City

Beverly

State/Province

Massachusetts

ZIP/Postal Code

01915

Country

United States

Facility Name

Tufts Medical Center

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02111

Country

United States

Facility Name

Great Lakes Research Group, Inc.

City

Bay City

State/Province

Michigan

ZIP/Postal Code

48706

Country

United States

Facility Name

Clarkston Skin Research

City

Clarkston

State/Province

Michigan

ZIP/Postal Code

48346

Country

United States

Facility Name

Associated Skin Care Specialists

City

Fridley

State/Province

Minnesota

ZIP/Postal Code

55432

Country

United States

Facility Name

Central Dermatology PC

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63117

Country

United States

Facility Name

Forest Hills Dermatology Group

City

Kew Gardens

State/Province

New York

ZIP/Postal Code

11415

Country

United States

Facility Name

OnSite Clinical Solutions

City

Charlotte

State/Province

North Carolina

ZIP/Postal Code

28277

Country

United States

Facility Name

Wilmington Dermatology Center

City

Wilmington

State/Province

North Carolina

ZIP/Postal Code

28405

Country

United States

Facility Name

Dermatology and Skin Surgery Center

City

Exton

State/Province

Pennsylvania

ZIP/Postal Code

19341

Country

United States

Facility Name

DermDOX

City

Hazleton

State/Province

Pennsylvania

ZIP/Postal Code

18201

Country

United States

Facility Name

Peak Research LLC

City

Upper Saint Clair

State/Province

Pennsylvania

ZIP/Postal Code

15241

Country

United States

Facility Name

Dermatology & Laser Center of Charleston

City

Charleston

State/Province

South Carolina

ZIP/Postal Code

29407

Country

United States

Facility Name

Palmetto Clinical Trial Services

City

Greenville

State/Province

South Carolina

ZIP/Postal Code

29601

Country

United States

Facility Name

Arlington Research Center, Inc

City

Arlington

State/Province

Texas

ZIP/Postal Code

76011

Country

United States

Facility Name

Innovate Research, LLC

City

Fort Worth

State/Province

Texas

ZIP/Postal Code

76244

Country

United States

Facility Name

Austin Institute for Clinical Research

City

Pflugerville

State/Province

Texas

ZIP/Postal Code

78660

Country

United States

Facility Name

University of Utah MidValley Dematology

City

Murray

State/Province

Utah

ZIP/Postal Code

84107

Country

United States

Facility Name

Virginia Clinical Research, Inc.

City

Norfolk

State/Province

Virginia

ZIP/Postal Code

23502

Country

United States

Facility Name

Dermatology Associates

City

Seattle

State/Province

Washington

ZIP/Postal Code

98101

Country

United States

Facility Name

DCC Sveti Georgi

City

Plovdiv

ZIP/Postal Code

4000

Country

Bulgaria

Facility Name

Diagnostic and Consultation Center 14

City

Sofia

ZIP/Postal Code

1408

Country

Bulgaria

Facility Name

Alexandrovska University Hospital

City

Sofia

ZIP/Postal Code

1432

Country

Bulgaria

Facility Name

Euro Derma clinic

City

Sofia

ZIP/Postal Code

1606

Country

Bulgaria

Facility Name

Military Medical Academy

City

Sofia

ZIP/Postal Code

1606

Country

Bulgaria

Facility Name

Medical centre Alitera-Med EOOD

City

Sofia

ZIP/Postal Code

1618

Country

Bulgaria

Facility Name

Dr. Chih-ho Hong Medical Inc.

City

Surrey

State/Province

British Columbia

ZIP/Postal Code

V3R 6A7

Country

Canada

Facility Name

Simcoderm Medical & Surgical Dermatology Centre

City

Barrie

State/Province

Ontario

ZIP/Postal Code

L4M 7G1

Country

Canada

Facility Name

Lynderm Research Inc.

City

Markham

State/Province

Ontario

ZIP/Postal Code

L3P1X2

Country

Canada

Facility Name

North York Research Inc.

City

North York

State/Province

Ontario

ZIP/Postal Code

M2M4J5

Country

Canada

Facility Name

Ottawa Allergy Research Corp

City

Ottawa

State/Province

Ontario

ZIP/Postal Code

K1G 6C6

Country

Canada

Facility Name

K. Papp Clinical Research

City

Waterloo

State/Province

Ontario

ZIP/Postal Code

N2J 1C4

Country

Canada

Facility Name

Derma-Study-Center Friedrichshafen GmbH

City

Friedrichshafen

State/Province

Baden-Württemberg

ZIP/Postal Code

88045

Country

Germany

Facility Name

Studienzentrum Dr.Beate Schwarz

City

Langenau

State/Province

Baden-Württemberg

ZIP/Postal Code

89129

Country

Germany

Facility Name

Hautarztpraxis am Löwenmarkt

City

Stuttgart

State/Province

Baden-Württemberg

ZIP/Postal Code

70499

Country

Germany

Facility Name

licca Fachklinik

City

Augsburg

State/Province

Bayern

ZIP/Postal Code

86179

Country

Germany

Facility Name

Rosenpark Research Geschäftsbereich der Rosenparkklinik GmbH

City

Darmstadt

State/Province

Hessen

ZIP/Postal Code

64283

Country

Germany

Facility Name

Klinikum der Johann Wolfgang Goethe-Universität Frankfurt

City

Frankfurt am Main

State/Province

Hessen

ZIP/Postal Code

60590

Country

Germany

Facility Name

Elbe Klinikum Buxtehude

City

Buxtehude

State/Province

Niedersachsen

ZIP/Postal Code

21614

Country

Germany

Facility Name

Klinische Forschung Osnabrück

City

Osnabrück

State/Province

Niedersachsen

ZIP/Postal Code

49074

Country

Germany

Facility Name

Fachklinik Bad Bentheim

City

Bad Bentheim

State/Province

Nordrhein-Westfalen

ZIP/Postal Code

48455

Country

Germany

Facility Name

Hautzentrum im Jahrhunderthaus

City

Bochum

State/Province

Nordrhein-Westfalen

ZIP/Postal Code

44793

Country

Germany

Facility Name

Universitätsklinikum Münster

City

Münster

State/Province

Nordrhein-Westfalen

ZIP/Postal Code

48149

Country

Germany

Facility Name

Universität Leipzig - Universitätsklinikum

City

Leipzig

State/Province

Sachsen

ZIP/Postal Code

04103

Country

Germany

Facility Name

SIBAmed Studienzentrum GmbH & Co. KG

City

Leipzig

State/Province

Saxony

ZIP/Postal Code

04103

Country

Germany

Facility Name

Universitätsklinikum Schleswig-Holstein

City

Lübeck

State/Province

Schleswig-Holstein

ZIP/Postal Code

23538

Country

Germany

Facility Name

Praxis Dr. Michael Dietlen

City

Augsburg

ZIP/Postal Code

86150

Country

Germany

Facility Name

Charité Universitätsmedizin Berlin Campus Buch

City

Berlin

ZIP/Postal Code

10117

Country

Germany

Facility Name

ISA GmbH

City

Berlin

ZIP/Postal Code

10789

Country

Germany

Facility Name

Praxis für Ganzheitliche Dermatologie im Ärztehaus

City

Berlin

ZIP/Postal Code

13055

Country

Germany

Facility Name

Universitätsklinikum Hamburg

City

Hamburg

ZIP/Postal Code

20246

Country

Germany

Facility Name

TFS Trial Form Support GmbH

City

Hamburg

ZIP/Postal Code

20537

Country

Germany

Facility Name

Clinica De Enfermedades Cronicas y Procedimientos Especiales

City

Morelia

State/Province

Michoacan Morelia

ZIP/Postal Code

CP 58249

Country

Mexico

Facility Name

Derma Norte del Bajío, S.C.

City

Aguascalientes

ZIP/Postal Code

20130

Country

Mexico

Facility Name

National University Hospital

City

Singapore

ZIP/Postal Code

119074

Country

Singapore

Facility Name

Singapore General Hospital

City

Singapore

ZIP/Postal Code

169078

Country

Singapore

Facility Name

Kk Women'S and Childrens Hospital

City

Singapore

ZIP/Postal Code

229899

Country

Singapore

Facility Name

National Skin Centre NSC

City

Singapore

ZIP/Postal Code

308205

Country

Singapore

Facility Name

Kaohsiung Chang Gung Memorial Hospital

City

Niaosong Dist

State/Province

Kaohsiung City

ZIP/Postal Code

833

Country

Taiwan

Facility Name

Kaohsiung Medical University Chung-Ho Institutional Review B

City

Kaohsiung

ZIP/Postal Code

807

Country

Taiwan

Facility Name

Taipei Medical University- Shuang Ho Hospital

City

New Taipei City

ZIP/Postal Code

235

Country

Taiwan

Facility Name

China Medical University Hospital

City

Taichung City

ZIP/Postal Code

40447

Country

Taiwan

Facility Name

Chung Shan Medical University Hospital

City

Taichung

ZIP/Postal Code

402

Country

Taiwan

Facility Name

National Taiwan University Hospital

City

Taipei

ZIP/Postal Code

10002

Country

Taiwan

Facility Name

Chang Gung Memorial Hospital - Linkou

City

Taoyuan City

ZIP/Postal Code

33305

Country

Taiwan

Facility Name

Municipal Healthcare Institution Kharkiv City Dermatoverenologic Dispensary N2

City

Kharkiv

ZIP/Postal Code

61038

Country

Ukraine

Facility Name

Rivne Regional Dermatology and Venereology Dispensary

City

Rivne

ZIP/Postal Code

39028

Country

Ukraine

Facility Name

Treatment-diagnostic center PE "Asclepius"

City

Uzhhorod

ZIP/Postal Code

88002

Country

Ukraine

Facility Name

Community Institution Zaporizhzhya Regional Dermatovenereology Clinical Hospital of Zaporizhzhya Regional Council

City

Zaporizhzhya

ZIP/Postal Code

69000

Country

Ukraine

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

IPD Sharing Time Frame

Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.

IPD Sharing Access Criteria

A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

IPD Sharing URL

https://vivli.org/

Links:

URL

https://trials.lillytrialguide.com/en-US/trial/AmPN68cQaViDZ8pT3j6hD

Description

Evaluation of the Efficacy and Safety of Lebrikizumab (LY3650150) in Moderate to Severe Atopic Dermatitis (ADvocate2)

Learn more about this trial

Evaluation of the Efficacy and Safety of Lebrikizumab (LY3650150) in Moderate to Severe Atopic Dermatitis

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