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Evaluation of the Efficacy and Safety of Lebrikizumab (LY3650150) in Moderate to Severe Atopic Dermatitis (ADvocate1)

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

Johnson Dermatology
Wallace Medical Group, Inc.
California Dermatology & Clinical Research Institute
Belle Aimee Skincare Clinic
Dermatology Research Associates
ACRC Studies
Central Connecticut Dermatology
St. Francis Medical Institute
Community Research Foundation Inc
ForCare Clinical Research
IACT Health - VHC
The Indiana Clinical Trials Center
Skin Sciences, PLLC
Beacon Clinical Research, LLC
Henry Ford Hospital
St Joseph Dermatology and Vein Clinic
MediSearch Clinical Trials
JDR Dermatology Research
ALLCUTIS Research
Icahn Sch of Med at Mt. Sinai
Sadick Research Group
Wake Research Associates
Lynn Health Science Institute
Vital Prospects Clinical Research Institute, P.C.
Clinical Research Institute
Oregon Medical Research Center
Clinical Partners, LLC
Bellaire Dermatology
Progressive Clinical Research
Premier Clinical Research
The St. George Hospital
Holdsworth House Medical Practice
Skin & Cancer Foundation Australia
The Skin Centre
Veracity Clinical Research Pty Ltd
Eastern Clinical Research Unit
Emeritus Research
Skin Health Institute Inc.
Sinclair Dermatology
Fremantle Dermatology
Burswood Dermatology
CARe Clinic
CCA Medical Research
Skin Health
Dermatology and Dermatologic Surgery
The Centre for Dermatology
Kliiniliste uuringute Keskus OU
Hopital Saint-Louis
CHU de Bordeaux Hopital Saint Andre
CHU DIJON - Hopital le Bocage
Cabinet Médical
Hopital Larrey
Korea University Ansan Hospital
Pusan National University Hospital
Hanyang University Medical Center
Ulsan University Hospital
Ajou University Hospital
Soon Chun Hyang University Seoul Hospital
Incheon St. Mary's Hospital
Severance Hospital
Konkuk University Medical Center
Chungang University Hospital
Hallym University Kangnam Sacred Heart Hospital
Clinic of Dermatology and STD
Health Center 4, Affiliate Diagnostic Center
Health and Aesthetics LTD
Latvian Dermatology Institute
Smite Aija - Practice in Dermatology Venereology
JSC "CD8 Alergology Clinic"
Hospital of Lithuanian University of Health Sciences Kauno klinikos
Jsc Renmeda
JSC "Center for Diagnosis and Treatment of Allergic Diseases"
Children's Hospital, Affiliate of Vilnius University Hospital Santaros klinikos
Inlita (Santaros CTC)
Vilnius University Hospital Santaros klinikos
Alergo-Med Specjalistyczna Przychodnia Lekarska Sp Z O.O.
Diamond Clinic
Centralny Szpital Kliniczny MSWiA
Centrum Medyczne Angelius Provita
Twoja Przychodnia - Szczecinskie Centrum Medyczne
Zespol Naukowo - Leczniczy "Iwolang" Sp. z o.o.
GynCentrum Sp z o.o.
Specjalistyczny Osrodek Alergologiczno-Internistyczny ALL-ME
Samodzielny Publiczny Szpital Kliniczny nr 1
Centrum Alergologii Teresa Hofman
Clinical Research Group Sp. z o.o.
CityClinic Przychodnia Lekarsko-Psychologiczna
Sant Joan de Deu Serveis En Salut Mental
Hospital De Basurto
Hospital General Universitario Alicante
Hospital Germans Trias i Pujol
Hospital de la Santa Creu i Sant Pau
Hospital Infanta Leonor
Hospital Universitario Virgen Macarena

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Lebrikizumab 250 Q2W

Lebrikizumab 250 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 Q2W until Week 50. For participants who received placebo in the Induction Period, the maintenance loading dose is: Two 250 mg Lebrikizumab SC injections on Week 16. Two 250 mg Lebrikizumab SC injections on Week 18. To maintain the blind, for participants who received Lebrikizumab in the Induction Period, the maintenance loading dose is: One 250 mg Lebrikizumab SC injection and one placebo SC injection on Week 16. One 250 mg Lebrikizumab SC injection and one placebo SC injection on Week 18.

Maintenance Period (Week 16-Week 52): 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. For participants who received placebo in the Induction Period, the maintenance loading dose is: Two 250 mg Lebrikizumab SC injections on Week 16. Two placebo injections on Week 18. To maintain the blind, for participants who received Lebrikizumab in the Induction Period, the maintenance loading dose is: One 250 mg Lebrikizumab SC injection and one placebo SC injection on Week 16. Two placebo injections on Week 18

Maintenance Period (Week 16-Week 52): Blinded loading doses based on prior treatment assignment will be administered, followed by one 250 mg Lebrikizumab SC injection Q2W until Week 50 in an open-label fashion. For participants who received placebo in the Induction Period, the loading dose is: Two 250 mg Lebrikizumab SC injections on Week 16. Two 250 mg Lebrikizumab SC injections on Week 18. To maintain the loading dose blind, for participants who received Lebrikizumab in the Induction Period, the loading dose is: One 250 mg Lebrikizumab SC injection and one placebo SC injection on Week 16. One 250 mg Lebrikizumab SC injection and one placebo SC injection on Week 18. For participants who do not maintain an acceptable response during the Maintenance Period and entered the Escape Arm, the loading doses will be administrated at entry and 2 weeks after entry based on the treatment assignment prior to entering 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 atopic dermatitis - 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% improvement 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 in Adults

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 atopic dermatitis - 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 score was obtained by weight-averaging these 4 scores and will range from 0 (none) to 72 (severe). The EASI-90 responder is defined as a participant who achieves a ≥ 90% improvement from baseline in the EASI score.

Percent 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."

Percent Change in EASI Score From Baseline to Week 16

The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease, 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 score was obtained by weight-averaging these 4 scores and will range from 0 (none) 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 atopic dermatitis - 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 score was obtained by weight-averaging these 4 scores and will range from 0 (none) to 72 (severe). The EASI-90 responder is defined as a participant who achieves a ≥ 90% improvement 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

Percent 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 at 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."

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

The SCORAD index uses the rule of nines to assess disease extent and evaluates 6 clinical characteristics to determine disease severity: (1) erythema, (2) edema/papulation, (3) oozing/crusts, (4) excoriation, (5) lichenification, and (6) dryness on a scale of 0 to 3 (0=absence, 1=mild, 2=moderate, 3=severe). The SCORAD index also assesses subjective symptoms of pruritus and sleep loss with VAS where 0 is no itching or no trouble sleeping and 10 is unbearable itching or a lot of trouble sleeping. These 3 aspects: extent of disease (A: 0-1-2), disease severity (B: 0-18), & subjective symptoms (C: 0-20) combine using A/5 + 7*B/2+ C to give a maximum possible score of 103, where 0 = no disease and 103 = severe disease. LS Mean was calculated using the 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): Average Serum Concentration of Lebrikizumab at Week 52

PK: Average serum concentration of lebrikizumab at the Week 52 trough timepoint. Serum concentration is a combined measure obtained from Baseline, Week 4, Week 16, Week 32, Week 52 and average measure was reported at week 52.

Percentage of Participants From Those Re-randomized Having Achieved EASI-75 at Week 16 Who Continued to Exhibit EASI-75 at Week 52 (EASI-75 Calculated Relative to Baseline 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 and 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."

Percent Change in SCORAD (Having Achieved EASI-75 at Week 16) From Baseline at Week 52

The SCORAD index uses the rule of nines to assess disease extent and evaluates 6 clinical characteristics to determine disease severity: (1) erythema, (2) edema/papulation, (3) oozing/crusts, (4) excoriation, (5) lichenification, and (6) dryness on a scale of 0 to 3 (0=absence, 1=mild, 2=moderate, 3=severe). The SCORAD index also assesses subjective symptoms of pruritus and sleep loss with VAS where 0 is no itching or no trouble sleeping and 10 is unbearable itching or a lot of trouble sleeping. These 3 aspects: extent of disease (A: 0-1-2), disease severity (B: 0-18), & subjective symptoms (C: 0-20) combine using A/5 + 7*B/2+ C to give a maximum possible score of 103, where 0 = no disease and 103 = severe disease. LS mean was calculated using ANCOVA model with treatment group, baseline value, and stratification factors 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 EQ-5D-5L is a 2-part measurement. The first part is 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, with higher score indicating 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 Depression 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 depression has 8 questions on Emotion Distress-Depression (or Pediatric Depressive 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 depression. 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

PROMIS is a set of person-centered measures that evaluates and monitors physical, mental, and social health in adults and children. The PROMIS measures will be completed by the participant in the study clinic. 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 Depression at Week 16 - Adults

PROMIS is a set of person-centered measures that evaluates and monitors physical, mental, and social health in adults and children. The PROMIS measures will be completed by the participant in the study clinic. PROMIS depression has 8 questions on Emotion Distress-Depression (or Pediatric Depressive 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 depression. 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 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 - Adolescents

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

NCT04146363

First Posted

October 29, 2019

Last Updated

November 2, 2022

Sponsor

Eli Lilly and Company

Collaborators

Dermira, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT04146363

Brief Title

Evaluation of the Efficacy and Safety of Lebrikizumab (LY3650150) in Moderate to Severe Atopic Dermatitis (ADvocate1)

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

November 2022

Overall Recruitment Status

Completed

Study Start Date

September 24, 2019 (Actual)

Primary Completion Date

June 21, 2021 (Actual)

Study Completion Date

May 3, 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

424 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Arm Title

Lebrikizumab 250 Q2W

Arm Type

Experimental

Arm Description

Arm Title

Lebrikizumab 250 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 in Adults

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 atopic dermatitis - 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 score was obtained by weight-averaging these 4 scores and will range from 0 (none) to 72 (severe). The EASI-90 responder is defined as a participant who achieves a ≥ 90% improvement from baseline in the EASI score.

Time Frame

Baseline to Week 16

Title

Percent 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

Percent Change in EASI Score From Baseline to Week 16

Description

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 atopic dermatitis - 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 score was obtained by weight-averaging these 4 scores and will range from 0 (none) to 72 (severe). The EASI-90 responder is defined as a participant who achieves a ≥ 90% improvement 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

Percent 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 at 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

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

Description

Time Frame

Baseline, Week 16

Title

Pharmacokinetics (PK): Average Serum Concentration of Lebrikizumab at Week 52

Description

Time Frame

Predose: Baseline, Week 4, Week 16, Week 32, Week 52

Title

Percentage of Participants From Those Re-randomized Having Achieved EASI-75 at Week 16 Who Continued 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

Percent Change in SCORAD (Having Achieved EASI-75 at Week 16) From Baseline at Week 52

Description

The SCORAD index uses the rule of nines to assess disease extent and evaluates 6 clinical characteristics to determine disease severity: (1) erythema, (2) edema/papulation, (3) oozing/crusts, (4) excoriation, (5) lichenification, and (6) dryness on a scale of 0 to 3 (0=absence, 1=mild, 2=moderate, 3=severe). The SCORAD index also assesses subjective symptoms of pruritus and sleep loss with VAS where 0 is no itching or no trouble sleeping and 10 is unbearable itching or a lot of trouble sleeping. These 3 aspects: extent of disease (A: 0-1-2), disease severity (B: 0-18), & subjective symptoms (C: 0-20) combine using A/5 + 7*B/2+ C to give a maximum possible score of 103, where 0 = no disease and 103 = severe disease. LS mean was calculated using ANCOVA model with treatment group, baseline value, and stratification factors geographic region, age group, baseline IGA (3 versus 4) score as fixed factors and baseline value as covariate.

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 Depression at Week 16 - Adolescents

Description

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 depression has 8 questions on Emotion Distress-Depression (or Pediatric Depressive 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 depression. 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.

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 - Adults

Description

PROMIS is a set of person-centered measures that evaluates and monitors physical, mental, and social health in adults and children. The PROMIS measures will be completed by the participant in the study clinic. PROMIS depression has 8 questions on Emotion Distress-Depression (or Pediatric Depressive 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 depression. 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.

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 - Adolescents

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

Johnson Dermatology

City

Fort Smith

State/Province

Arkansas

ZIP/Postal Code

72916

Country

United States

Facility Name

Wallace Medical Group, Inc.

City

Beverly Hills

State/Province

California

ZIP/Postal Code

90211

Country

United States

Facility Name

California Dermatology & Clinical Research Institute

City

Encinitas

State/Province

California

ZIP/Postal Code

92024

Country

United States

Facility Name

Belle Aimee Skincare Clinic

City

Fountain Valley

State/Province

California

ZIP/Postal Code

92708

Country

United States

Facility Name

Dermatology Research Associates

City

Los Angeles

State/Province

California

ZIP/Postal Code

90045

Country

United States

Facility Name

ACRC Studies

City

San Diego

State/Province

California

ZIP/Postal Code

92119

Country

United States

Facility Name

Central Connecticut Dermatology

City

Cromwell

State/Province

Connecticut

ZIP/Postal Code

06416

Country

United States

Facility Name

St. Francis Medical Institute

City

Clearwater

State/Province

Florida

ZIP/Postal Code

33765

Country

United States

Facility Name

Community Research Foundation Inc

City

Miami

State/Province

Florida

ZIP/Postal Code

33145

Country

United States

Facility Name

ForCare Clinical Research

City

Tampa

State/Province

Florida

ZIP/Postal Code

33613-1244

Country

United States

Facility Name

IACT Health - VHC

City

Columbus

State/Province

Georgia

ZIP/Postal Code

31903

Country

United States

Facility Name

The Indiana Clinical Trials Center

City

Plainfield

State/Province

Indiana

ZIP/Postal Code

46168

Country

United States

Facility Name

Skin Sciences, PLLC

City

Louisville

State/Province

Kentucky

ZIP/Postal Code

40217

Country

United States

Facility Name

Beacon Clinical Research, LLC

City

Quincy

State/Province

Massachusetts

ZIP/Postal Code

02169

Country

United States

Facility Name

Henry Ford Hospital

City

Detroit

State/Province

Michigan

ZIP/Postal Code

48202

Country

United States

Facility Name

St Joseph Dermatology and Vein Clinic

City

Saint Joseph

State/Province

Michigan

ZIP/Postal Code

49085

Country

United States

Facility Name

MediSearch Clinical Trials

City

Saint Joseph

State/Province

Missouri

ZIP/Postal Code

64506

Country

United States

Facility Name

JDR Dermatology Research

City

Las Vegas

State/Province

Nevada

ZIP/Postal Code

89148

Country

United States

Facility Name

ALLCUTIS Research

City

Portsmouth

State/Province

New Hampshire

ZIP/Postal Code

03801

Country

United States

Facility Name

Icahn Sch of Med at Mt. Sinai

City

New York

State/Province

New York

ZIP/Postal Code

10029

Country

United States

Facility Name

Sadick Research Group

City

New York

State/Province

New York

ZIP/Postal Code

10075

Country

United States

Facility Name

Wake Research Associates

City

Raleigh

State/Province

North Carolina

ZIP/Postal Code

27612

Country

United States

Facility Name

Lynn Health Science Institute

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73112

Country

United States

Facility Name

Vital Prospects Clinical Research Institute, P.C.

City

Tulsa

State/Province

Oklahoma

ZIP/Postal Code

74136

Country

United States

Facility Name

Clinical Research Institute

City

Medford

State/Province

Oregon

ZIP/Postal Code

97504

Country

United States

Facility Name

Oregon Medical Research Center

City

Portland

State/Province

Oregon

ZIP/Postal Code

97223

Country

United States

Facility Name

Clinical Partners, LLC

City

Johnston

State/Province

Rhode Island

ZIP/Postal Code

02919

Country

United States

Facility Name

Bellaire Dermatology

City

Bellaire

State/Province

Texas

ZIP/Postal Code

77401

Country

United States

Facility Name

Progressive Clinical Research

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78213

Country

United States

Facility Name

Premier Clinical Research

City

Spokane

State/Province

Washington

ZIP/Postal Code

99202

Country

United States

Facility Name

The St. George Hospital

City

Kogarah

State/Province

New South Wales

ZIP/Postal Code

2217

Country

Australia

Facility Name

Holdsworth House Medical Practice

City

Sydney

State/Province

New South Wales

ZIP/Postal Code

2010

Country

Australia

Facility Name

Skin & Cancer Foundation Australia

City

Westmead

State/Province

New South Wales

ZIP/Postal Code

2145

Country

Australia

Facility Name

The Skin Centre

City

Benowa

State/Province

Queensland

ZIP/Postal Code

4217

Country

Australia

Facility Name

Veracity Clinical Research Pty Ltd

City

Woolloongabba

State/Province

Queensland

ZIP/Postal Code

4102

Country

Australia

Facility Name

Eastern Clinical Research Unit

City

Box Hill

State/Province

Victoria

ZIP/Postal Code

3128

Country

Australia

Facility Name

Emeritus Research

City

Camberwell

State/Province

Victoria

ZIP/Postal Code

3124

Country

Australia

Facility Name

Skin Health Institute Inc.

City

Carlton

State/Province

Victoria

ZIP/Postal Code

3053

Country

Australia

Facility Name

Sinclair Dermatology

City

East Melbourne

State/Province

Victoria

ZIP/Postal Code

3002

Country

Australia

Facility Name

Fremantle Dermatology

City

Fremantle

State/Province

Western Australia

ZIP/Postal Code

6160

Country

Australia

Facility Name

Burswood Dermatology

City

Victoria Park

State/Province

Western Australia

ZIP/Postal Code

06100

Country

Australia

Facility Name

CARe Clinic

City

Red Deer

State/Province

Alberta

ZIP/Postal Code

T4P1K4

Country

Canada

Facility Name

CCA Medical Research

City

Ajax

State/Province

Ontario

ZIP/Postal Code

L1S7K8

Country

Canada

Facility Name

Skin Health

City

Cobourg

State/Province

Ontario

ZIP/Postal Code

K9A 0Z4

Country

Canada

Facility Name

Dermatology and Dermatologic Surgery

City

Ottawa

State/Province

Ontario

ZIP/Postal Code

K2G6E2

Country

Canada

Facility Name

The Centre for Dermatology

City

Richmond Hill

State/Province

Ontario

ZIP/Postal Code

L4B 1A5

Country

Canada

Facility Name

Kliiniliste uuringute Keskus OU

City

Tartu

ZIP/Postal Code

50160

Country

Estonia

Facility Name

Hopital Saint-Louis

City

Paris

State/Province

Cedex 10

ZIP/Postal Code

75475

Country

France

Facility Name

CHU de Bordeaux Hopital Saint Andre

City

Bordeaux Cedex

ZIP/Postal Code

33075

Country

France

Facility Name

CHU DIJON - Hopital le Bocage

City

Dijon Cedex

ZIP/Postal Code

21079

Country

France

Facility Name

Cabinet Médical

City

Martigues

ZIP/Postal Code

13500

Country

France

Facility Name

Hopital Larrey

City

Toulouse cedex 9

ZIP/Postal Code

31059

Country

France

Facility Name

Korea University Ansan Hospital

City

Ansan-si

State/Province

Gyeonggi-do

ZIP/Postal Code

15355

Country

Korea, Republic of

Facility Name

Pusan National University Hospital

City

Pusan

State/Province

Korea

ZIP/Postal Code

49241

Country

Korea, Republic of

Facility Name

Hanyang University Medical Center

City

Seoul

State/Province

Korea

ZIP/Postal Code

04763

Country

Korea, Republic of

Facility Name

Ulsan University Hospital

City

Ulsan

State/Province

Korea

ZIP/Postal Code

44033

Country

Korea, Republic of

Facility Name

Ajou University Hospital

City

Suwon-si

State/Province

Kyung Gi-Do, Korea

ZIP/Postal Code

16499

Country

Korea, Republic of

Facility Name

Soon Chun Hyang University Seoul Hospital

City

Seoul

State/Province

Yongsan-gu

ZIP/Postal Code

04401

Country

Korea, Republic of

Facility Name

Incheon St. Mary's Hospital

City

Incheon

ZIP/Postal Code

21431

Country

Korea, Republic of

Facility Name

Severance Hospital

City

Seoul

ZIP/Postal Code

03722

Country

Korea, Republic of

Facility Name

Konkuk University Medical Center

City

Seoul

ZIP/Postal Code

05030

Country

Korea, Republic of

Facility Name

Chungang University Hospital

City

Seoul

ZIP/Postal Code

06973

Country

Korea, Republic of

Facility Name

Hallym University Kangnam Sacred Heart Hospital

City

Seoul

ZIP/Postal Code

07441

Country

Korea, Republic of

Facility Name

Clinic of Dermatology and STD

City

Riga

ZIP/Postal Code

LV-1001

Country

Latvia

Facility Name

Health Center 4, Affiliate Diagnostic Center

City

Riga

ZIP/Postal Code

LV-1003

Country

Latvia

Facility Name

Health and Aesthetics LTD

City

Riga

ZIP/Postal Code

LV-1009

Country

Latvia

Facility Name

Latvian Dermatology Institute

City

Riga

ZIP/Postal Code

LV-1011

Country

Latvia

Facility Name

Smite Aija - Practice in Dermatology Venereology

City

Talsi

ZIP/Postal Code

LV-3201

Country

Latvia

Facility Name

JSC "CD8 Alergology Clinic"

City

Kaunas

ZIP/Postal Code

LT-44192

Country

Lithuania

Facility Name

Hospital of Lithuanian University of Health Sciences Kauno klinikos

City

Kaunas

ZIP/Postal Code

LT-50161

Country

Lithuania

Facility Name

Jsc Renmeda

City

Vilnius

ZIP/Postal Code

LT-07195

Country

Lithuania

Facility Name

JSC "Center for Diagnosis and Treatment of Allergic Diseases"

City

Vilnius

ZIP/Postal Code

LT-08109

Country

Lithuania

Facility Name

Children's Hospital, Affiliate of Vilnius University Hospital Santaros klinikos

City

Vilnius

ZIP/Postal Code

LT-08406

Country

Lithuania

Facility Name

Inlita (Santaros CTC)

City

Vilnius

ZIP/Postal Code

LT-08406

Country

Lithuania

Facility Name

Vilnius University Hospital Santaros klinikos

City

Vilnius

ZIP/Postal Code

LT-08441

Country

Lithuania

Facility Name

Alergo-Med Specjalistyczna Przychodnia Lekarska Sp Z O.O.

City

Tarnow

State/Province

Malopolska

ZIP/Postal Code

33100

Country

Poland

Facility Name

Diamond Clinic

City

Krakow

State/Province

Malopolskie

ZIP/Postal Code

31-559

Country

Poland

Facility Name

Centralny Szpital Kliniczny MSWiA

City

Warszawa

State/Province

Mazowieckie

ZIP/Postal Code

02-507

Country

Poland

Facility Name

Centrum Medyczne Angelius Provita

City

Katowice

State/Province

Slaskie

ZIP/Postal Code

40-611

Country

Poland

Facility Name

Twoja Przychodnia - Szczecinskie Centrum Medyczne

City

Szczecin

State/Province

West Pomeranian

ZIP/Postal Code

71-434

Country

Poland

Facility Name

Zespol Naukowo - Leczniczy "Iwolang" Sp. z o.o.

City

Iwonicz Zdroj

State/Province

Wojewodztwo Podkarpackie

ZIP/Postal Code

38-440

Country

Poland

Facility Name

GynCentrum Sp z o.o.

City

Katowice

ZIP/Postal Code

40-851

Country

Poland

Facility Name

Specjalistyczny Osrodek Alergologiczno-Internistyczny ALL-ME

City

Krakow

ZIP/Postal Code

31-023

Country

Poland

Facility Name

Samodzielny Publiczny Szpital Kliniczny nr 1

City

Lublin

ZIP/Postal Code

20-081

Country

Poland

Facility Name

Centrum Alergologii Teresa Hofman

City

Poznan

ZIP/Postal Code

60-214

Country

Poland

Facility Name

Clinical Research Group Sp. z o.o.

City

Warszawa

ZIP/Postal Code

01-142

Country

Poland

Facility Name

CityClinic Przychodnia Lekarsko-Psychologiczna

City

Wroclaw

ZIP/Postal Code

50-566

Country

Poland

Facility Name

Sant Joan de Deu Serveis En Salut Mental

City

SANT BOI DE Llobrega

State/Province

Barcelona

ZIP/Postal Code

08830

Country

Spain

Facility Name

Hospital De Basurto

City

Bilbao

State/Province

Vizcaya

ZIP/Postal Code

48013

Country

Spain

Facility Name

Hospital General Universitario Alicante

City

Alicante

ZIP/Postal Code

03010

Country

Spain

Facility Name

Hospital Germans Trias i Pujol

City

Badalona

ZIP/Postal Code

08916

Country

Spain

Facility Name

Hospital de la Santa Creu i Sant Pau

City

Barcelona

ZIP/Postal Code

08041

Country

Spain

Facility Name

Hospital Infanta Leonor

City

Madrid

ZIP/Postal Code

28031

Country

Spain

Facility Name

Hospital Universitario Virgen Macarena

City

Sevilla

ZIP/Postal Code

41009

Country

Spain

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/6duv4kD1B48RPwp63igF1U

Description

Evaluation of the Efficacy and Safety of Lebrikizumab (LY3650150) in Moderate to Severe Atopic Dermatitis (ADvocate1)

Learn more about this trial

Evaluation of the Efficacy and Safety of Lebrikizumab (LY3650150) in Moderate to Severe Atopic Dermatitis (ADvocate1)

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