Back to resultsStudy to Assess the Safety and Efficacy of Lebrikizumab (LY3650150) in Adolescent Participants With Moderate-to-Severe Atopic Dermatitis (ADore)
Primary Purpose
Atopic Dermatitis
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Lebrikizumab
Sponsored by
About this trial
This is an interventional treatment trial for Atopic Dermatitis focused on measuring Eczema, Dermatitis, Dermatitis, Atopic, Skin Diseases
Eligibility Criteria
Inclusion Criteria:
- Male or female adolescent (≥12 years to <18 years, and weighing ≥40 kg).
- Chronic AD (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 AD 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:
- Participation in a prior lebrikizumab clinical study.
Treatment with the following prior to the baseline visit:
- An investigational drug within 8 weeks or within 5 half-lives (if known), whichever is longer.
- Dupilumab within 8 weeks.
- B-cell-depleting biologics, including to rituximab, within 6 months.
- Other biologics within 5 half-lives (if known) or 16 weeks, 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.
- Evidence of active acute or chronic hepatitis
- History of human immunodeficiency virus (HIV) infection or positive HIV serology at screening.
- 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
- Pinnacle Research Group
- Arkansas Research Trials, LLC
- Hope Clinical Research
- First OC Dermatology
- MD Studies
- Integrative Skin Science and Research
- University of California, San Diego/Rady Children's Hospital, San Diego - Pediatric & Adolescent Dermatology
- Southern California Dermatology, Inc.
- IMMUNOe International Research Centers
- C&R Research Services USA
- Florida Academic Centers Research and Education, LLC
- Pediatric Skin Research, LLC
- Encore Medical Research
- Solutions Through Advanced Research, Inc.
- Well Pharma Medical Research Corp.
- Sanchez Clinical Research Inc
- Miami Dermatology and Laser Research
- Park Avenue Dermatology
- ForCare Clinical Research
- Georgia Pollens Clinical Research Centers, Inc
- Advanced Medical Research
- Georgia Skin & Cancer Clinic
- Northwestern University
- Sneeze, Wheeze, & Itch Associates LLC
- Dawes Fretzin Clinical Research Group, LLC
- Kansas Medical Clinic
- Skin Sciences, PLLC
- Tulane Univ School of Med
- Dermatology and Skin Cancer Specialists
- Great Lakes Research Group, Inc.
- St Joseph Dermatology and Vein Clinic
- Central Dermatology PC
- ALLCUTIS Research
- Forest Hills Dermatology Group
- Advanced Asthma and Allergy
- Ohio Pediatric Research Association
- Central States Research
- Vital Prospects Clinical Research Institute, P.C.
- Paddington Testing Company Inc
- Arlington Research Center, Inc
- Encore Imaging & Medical Research
- Cutis Wellness Dermatology
- Progressive Clinical Research
- Texas Dermatology and Laser Specialists
- Acclaim Dermatology, PLLC
- Center for Clinical Studies
- PI-Coor Clinical Research, LLC
- Virginia Clinical Research, Inc.
- Woden Dermatology
- The Skin Hospital
- The Skin Centre
- Veracity Clinical Research Pty Ltd
- Sinclair Dermatology
- Royal Childrens Hospital Melbourne
- Burswood Dermatology
- Captain Stirling Medical Centre
- Institute for Skin Advancement
- CARe Clinic
- Lynderm Research Inc.
- The Centre for Clinical Trials, Inc
- AvantDerm
- Dermoklinika Centrum Medyczne s.c. M. Kierstan J. Narbutt A. Lesiak
- Grazyna Pulka Specjalistyczny Osrodek "ALL-MED"
- Diamond Clinic
- Centrum Medyczne Evimed
- Gabinet Dermatlogiczny. Beata Krecisz
- Zespol Naukowo - Leczniczy "Iwolang" Sp. z o.o.
- Provita Sp. z o.o
- Samodzielny Publiczny Szpital Kliniczny Nr 1 w Lublinie
- CityClinic Przychodnia Lekarsko-Psychologiczna
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Lebrikizumab 250 mg
Arm Description
Participants received two subcutaneous (SC) injections of 250 milligram(mg) Lebrikizumab at Baseline and Week 2 followed by a single injection every 2 weeks (Q2W) from Week 4 up to (but not including) Week 52.
Outcomes
Primary Outcome Measures
Percentage of Participants Discontinued From Study Treatment Due to Adverse Events (AEs)
The percentage of participants who discontinued from study treatment due to 1 or more AEs assessed is summarized cumulatively. A summary of all SAE's, regardless of causality, is located in the Reported Adverse Events section.
Secondary Outcome Measures
Percentage of Participants With an Investigator Global Assessment (IGA) Score of 0 or 1 and a Reduction ≥2-points From Baseline
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 Achieving ≥75% Reduction From Baseline in Eczema Area and Severity Instrument (EASI) Score (EASI-75)
The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - 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 responder is defined as a participant who achieves a ≥ 75% improvement from baseline in the EASI score.
Percentage Change From Baseline in EASI Score
The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - 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).
Percentage of Participants Achieving EASI-50 (≥50 Reduction From Baseline in EASI Score)
The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - 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 responder is defined as a participant who achieves a ≥ 50% improvement from baseline in the EASI score.
Percentage of Participants Achieving EASI-90 (≥90% Reduction From Baseline in EASI Score)
The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - 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 responder is defined as a participant who achieves a ≥ 90% improvement from baseline in the EASI score.
Change From Baseline in Body Surface Area (BSA)
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.
Change From Baseline in Patient-Reported Outcomes Information System (PROMIS) Anxiety
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.
Change From Baseline in Patient-Reported Outcomes Information System (PROMIS) Depression
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. Questions are measured on a 5-point scale with 1 being "Never" and 5 being "Always". Responses for each section will be summed and converted to T-Scores using the Assessment Center PROMIS Scoring Service, which rescales the raw score to a standardized T-Score with a population mean of 50 and a standard deviation of 10. Total raw scores were converted to T-scores with higher scores indicating greater severity of symptoms.
Change From Baseline in Dermatology Life Quality Index (DLQI)
The DLQI questionnaire designed for participants aged 17 years or more 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.
Change From Baseline in Children's Dermatology Life Quality Index (CDLQI)
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).
Pharmacokinetics (PK): Average Serum Concentration of Lebrikizumab
Pharmacokinetics (PK): Average Serum Concentration of Lebrikizumab was evaluated at Week 52.
Full Information
NCT ID
NCT04250350
First Posted
January 30, 2020
Last Updated
January 30, 2023
Sponsor
Eli Lilly and Company
Collaborators
Dermira, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT04250350
Brief Title
Study to Assess the Safety and Efficacy of Lebrikizumab (LY3650150) in Adolescent Participants With Moderate-to-Severe Atopic Dermatitis
Acronym
ADore
Official Title
An Open-Label, Single-Arm Study to Assess the Safety and Efficacy of Lebrikizumab in Adolescent Patients With Moderate-to-Severe Atopic Dermatitis
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
February 11, 2020 (Actual)
Primary Completion Date
April 20, 2022 (Actual)
Study Completion Date
June 22, 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
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This is an open-label, single arm study of 52 weeks duration. The study will assess the safety and efficacy of lebrikizumab in adolescent participants (≥12 to <18 years weighing ≥40 kilograms) with moderate-to-severe atopic dermatitis (AD) who are candidates for systemic therapy.
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
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
206 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lebrikizumab 250 mg
Arm Type
Experimental
Arm Description
Participants received two subcutaneous (SC) injections of 250 milligram(mg) Lebrikizumab at Baseline and Week 2 followed by a single injection every 2 weeks (Q2W) from Week 4 up to (but not including) Week 52.
Intervention Type
Biological
Intervention Name(s)
Lebrikizumab
Other Intervention Name(s)
LY3650150, DRM06
Intervention Description
Subcutaneous injection
Primary Outcome Measure Information:
Title
Percentage of Participants Discontinued From Study Treatment Due to Adverse Events (AEs)
Description
The percentage of participants who discontinued from study treatment due to 1 or more AEs assessed is summarized cumulatively. A summary of all SAE's, regardless of causality, is located in the Reported Adverse Events section.
Time Frame
Week 52
Secondary 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
Description
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.
Time Frame
Week 52
Title
Percentage of Participants Achieving ≥75% Reduction From Baseline in Eczema Area and Severity Instrument (EASI) Score (EASI-75)
Description
The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - 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 responder is defined as a participant who achieves a ≥ 75% improvement from baseline in the EASI score.
Time Frame
Week 52
Title
Percentage Change From Baseline in EASI Score
Description
The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - 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).
Time Frame
Baseline, Week 52
Title
Percentage of Participants Achieving EASI-50 (≥50 Reduction From Baseline in EASI Score)
Description
The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - 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 responder is defined as a participant who achieves a ≥ 50% improvement from baseline in the EASI score.
Time Frame
Week 52
Title
Percentage of Participants Achieving EASI-90 (≥90% Reduction From Baseline in EASI Score)
Description
The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - 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 responder is defined as a participant who achieves a ≥ 90% improvement from baseline in the EASI score.
Time Frame
Week 52
Title
Change From Baseline in Body Surface Area (BSA)
Description
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.
Time Frame
Baseline, Week 52
Title
Change From Baseline in Patient-Reported Outcomes Information System (PROMIS) Anxiety
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 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.
Time Frame
Baseline, Week 52
Title
Change From Baseline in Patient-Reported Outcomes Information System (PROMIS) Depression
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. Questions are measured on a 5-point scale with 1 being "Never" and 5 being "Always". Responses for each section will be summed and converted to T-Scores using the Assessment Center PROMIS Scoring Service, which rescales the raw score to a standardized T-Score with a population mean of 50 and a standard deviation of 10. Total raw scores were converted to T-scores with higher scores indicating greater severity of symptoms.
Time Frame
Baseline, Week 52
Title
Change From Baseline in Dermatology Life Quality Index (DLQI)
Description
The DLQI questionnaire designed for participants aged 17 years or more 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.
Time Frame
Baseline, Week 52
Title
Change From Baseline in Children's Dermatology Life Quality Index (CDLQI)
Description
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).
Time Frame
Baseline, Week 52
Title
Pharmacokinetics (PK): Average Serum Concentration of Lebrikizumab
Description
Pharmacokinetics (PK): Average Serum Concentration of Lebrikizumab was evaluated at Week 52.
Time Frame
Predose: Week 52
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male or female adolescent (≥12 years to <18 years, and weighing ≥40 kg).
Chronic AD (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 AD 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:
Participation in a prior lebrikizumab clinical study.
Treatment with the following prior to the baseline visit:
An investigational drug within 8 weeks or within 5 half-lives (if known), whichever is longer.
Dupilumab within 8 weeks.
B-cell-depleting biologics, including to rituximab, within 6 months.
Other biologics within 5 half-lives (if known) or 16 weeks, 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.
Evidence of active acute or chronic hepatitis
History of human immunodeficiency virus (HIV) infection or positive HIV serology at screening.
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
Pinnacle Research Group
City
Anniston
State/Province
Alabama
ZIP/Postal Code
36207
Country
United States
Facility Name
Arkansas Research Trials, LLC
City
North Little Rock
State/Province
Arkansas
ZIP/Postal Code
72117
Country
United States
Facility Name
Hope Clinical Research
City
Canoga Park
State/Province
California
ZIP/Postal Code
91303
Country
United States
Facility Name
First OC Dermatology
City
Fountain Valley
State/Province
California
ZIP/Postal Code
92708
Country
United States
Facility Name
MD Studies
City
Fountain Valley
State/Province
California
ZIP/Postal Code
92708
Country
United States
Facility Name
Integrative Skin Science and Research
City
Sacramento
State/Province
California
ZIP/Postal Code
95825
Country
United States
Facility Name
University of California, San Diego/Rady Children's Hospital, San Diego - Pediatric & Adolescent Dermatology
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Southern California Dermatology, Inc.
City
Santa Ana
State/Province
California
ZIP/Postal Code
92701
Country
United States
Facility Name
IMMUNOe International Research Centers
City
Centennial
State/Province
Colorado
ZIP/Postal Code
80112
Country
United States
Facility Name
C&R Research Services USA
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33134
Country
United States
Facility Name
Florida Academic Centers Research and Education, LLC
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33134
Country
United States
Facility Name
Pediatric Skin Research, LLC
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33146
Country
United States
Facility Name
Encore Medical Research
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
Facility Name
Solutions Through Advanced Research, Inc.
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Facility Name
Well Pharma Medical Research Corp.
City
Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
Facility Name
Sanchez Clinical Research Inc
City
Miami
State/Province
Florida
ZIP/Postal Code
33157
Country
United States
Facility Name
Miami Dermatology and Laser Research
City
Miami
State/Province
Florida
ZIP/Postal Code
33173
Country
United States
Facility Name
Park Avenue Dermatology
City
Orange Park
State/Province
Florida
ZIP/Postal Code
32073
Country
United States
Facility Name
ForCare Clinical Research
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613-1244
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
Advanced Medical Research
City
Sandy Springs
State/Province
Georgia
ZIP/Postal Code
30328
Country
United States
Facility Name
Georgia Skin & Cancer Clinic
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31419
Country
United States
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Sneeze, Wheeze, & Itch Associates LLC
City
Normal
State/Province
Illinois
ZIP/Postal Code
61761
Country
United States
Facility Name
Dawes Fretzin Clinical Research Group, LLC
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46250
Country
United States
Facility Name
Kansas Medical Clinic
City
Topeka
State/Province
Kansas
ZIP/Postal Code
66614
Country
United States
Facility Name
Skin Sciences, PLLC
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40217
Country
United States
Facility Name
Tulane Univ School of Med
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Dermatology and Skin Cancer Specialists
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20850
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
St Joseph Dermatology and Vein Clinic
City
Saint Joseph
State/Province
Michigan
ZIP/Postal Code
49085
Country
United States
Facility Name
Central Dermatology PC
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63117
Country
United States
Facility Name
ALLCUTIS Research
City
Portsmouth
State/Province
New Hampshire
ZIP/Postal Code
03801
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
Advanced Asthma and Allergy
City
Watertown
State/Province
New York
ZIP/Postal Code
13601
Country
United States
Facility Name
Ohio Pediatric Research Association
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45414
Country
United States
Facility Name
Central States Research
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74136
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
Paddington Testing Company Inc
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19103
Country
United States
Facility Name
Arlington Research Center, Inc
City
Arlington
State/Province
Texas
ZIP/Postal Code
76011
Country
United States
Facility Name
Encore Imaging & Medical Research
City
Houston
State/Province
Texas
ZIP/Postal Code
77065
Country
United States
Facility Name
Cutis Wellness Dermatology
City
Laredo
State/Province
Texas
ZIP/Postal Code
78041
Country
United States
Facility Name
Progressive Clinical Research
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78213
Country
United States
Facility Name
Texas Dermatology and Laser Specialists
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78218
Country
United States
Facility Name
Acclaim Dermatology, PLLC
City
Sugar Land
State/Province
Texas
ZIP/Postal Code
77497
Country
United States
Facility Name
Center for Clinical Studies
City
Webster
State/Province
Texas
ZIP/Postal Code
77598
Country
United States
Facility Name
PI-Coor Clinical Research, LLC
City
Burke
State/Province
Virginia
ZIP/Postal Code
22015
Country
United States
Facility Name
Virginia Clinical Research, Inc.
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Facility Name
Woden Dermatology
City
Phillip
State/Province
Australian Capital Territory
ZIP/Postal Code
2606
Country
Australia
Facility Name
The Skin Hospital
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
02010
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
Sinclair Dermatology
City
East Melbourne
State/Province
Victoria
ZIP/Postal Code
3002
Country
Australia
Facility Name
Royal Childrens Hospital Melbourne
City
Parkville
State/Province
Victoria
ZIP/Postal Code
3052
Country
Australia
Facility Name
Burswood Dermatology
City
Victoria Park
State/Province
Western Australia
ZIP/Postal Code
06100
Country
Australia
Facility Name
Captain Stirling Medical Centre
City
Nedlands
ZIP/Postal Code
6009
Country
Australia
Facility Name
Institute for Skin Advancement
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T3A 2N1
Country
Canada
Facility Name
CARe Clinic
City
Red Deer
State/Province
Alberta
ZIP/Postal Code
T4N 6V7
Country
Canada
Facility Name
Lynderm Research Inc.
City
Markham
State/Province
Ontario
ZIP/Postal Code
L3P 1X3
Country
Canada
Facility Name
The Centre for Clinical Trials, Inc
City
Oakville
State/Province
Ontario
ZIP/Postal Code
L6J7W5
Country
Canada
Facility Name
AvantDerm
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5A3R6
Country
Canada
Facility Name
Dermoklinika Centrum Medyczne s.c. M. Kierstan J. Narbutt A. Lesiak
City
Lodz
State/Province
Lodzkie
ZIP/Postal Code
90-436
Country
Poland
Facility Name
Grazyna Pulka Specjalistyczny Osrodek "ALL-MED"
City
Krakow
State/Province
Malopolskie
ZIP/Postal Code
30-033
Country
Poland
Facility Name
Diamond Clinic
City
Krakow
State/Province
Malopolskie
ZIP/Postal Code
31-559
Country
Poland
Facility Name
Centrum Medyczne Evimed
City
Warszawa
State/Province
Mazowieckie
ZIP/Postal Code
02-625
Country
Poland
Facility Name
Gabinet Dermatlogiczny. Beata Krecisz
City
Kielce
State/Province
Swietokrzyskie
ZIP/Postal Code
25-155
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
Provita Sp. z o.o
City
Katowice
ZIP/Postal Code
40-611
Country
Poland
Facility Name
Samodzielny Publiczny Szpital Kliniczny Nr 1 w Lublinie
City
Lublin
ZIP/Postal Code
20-081
Country
Poland
Facility Name
CityClinic Przychodnia Lekarsko-Psychologiczna
City
Wroclaw
ZIP/Postal Code
50-566
Country
Poland
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 European Union (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/3TxlZTL9UMFNAZAnnCFnbk
Description
Study to Assess the Safety and Efficacy of Lebrikizumab (LY3650150) in Adolescent Participants With Moderate-to-Severe Atopic Dermatitis (ADore)
Learn more about this trial
Study to Assess the Safety and Efficacy of Lebrikizumab (LY3650150) in Adolescent Participants With Moderate-to-Severe Atopic Dermatitis
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