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A Study of Lebrikizumab (LY3650150) in Participants With Moderate-to-Severe Atopic Dermatitis

Primary Purpose

Atopic Dermatitis

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Lebrikizumab

Placebo

About this trial

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

Eligibility Criteria

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

Inclusion Criteria:

Male or female, 18 years or older.
Chronic AD as defined by Hanifin and Rajka (1980) that has been present for ≥1 year before the screening visit .
Eczema Area and Severity Index (EASI) score ≥16 at the screening and the baseline visit.
Investigator Global Assessment (IGA) score ≥3 (scale of 0 to 4) at the screening and the baseline visit.
≥10% body surface area (BSA) of AD involvement at the screening and the baseline visit.

Exclusion Criteria:

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 topical corticosteroids (TCS) or topical calcineurin inhibitors (TCI) within 1 week prior to the baseline visit.
Treatment with:
An investigational drug within 8 weeks or within 5 half-lives (if known), whichever is longer, prior to the baseline visit.
Dupilumab within 3 months prior to baseline visit.
Cell-depleting biologics, including rituximab, within 6 months prior to the baseline visit.
Other biologics within 5 half-lives (if known) or 16 weeks prior to baseline visit (whichever is longer).
Use of prescription moisturizers within 7 days of the baseline visit.

Sites / Locations

Clear Dermatology & Aesthetics Center
Dermatology Trial Associates
Northwest Arkansas Clinical Trials Center
Center for Dermatology Clinical Research, Inc.
University of Southern California
Dermatology Research Associates
Stanford Medicine Outpatient Center-Medical Dermatology Clinic
Center for Dermatology and Laser Surgery
UCSD Dermatology
TCR Medical Corporation
Clinical Science Institute
George Washington Medical Faculty Associates
Total Vein and Skin
Florida Academic Centers Research and Education, LLC
Olympian Clinical Research
Tory Sullivan, MD PA
International Clinical Research - US, LLC
Integrated Clinical Research, LLC
Marietta Dermatology Clinical Research, Inc.
Advanced Medical Research, PC
Dundee Dermatology
Dawes Fretzin Clinical Research Group, LLC
The Indiana Clinical Trials Center
Kansas City Dermatology, PA
Skin Sciences, PLLC
Meridian Clinical Research, LLC
Dermatology and Skin Cancer Specialists, LLC
ActivMed Practices & Research, Inc.
Tufts Medical Center
Somerset Skin Centre
JDR Dermatology Research
ActivMed Practices & Research, Inc.
Academic Dermatology Associates
Schweiger Dermatology, PLLC
Icahn School of Medicine
Sadick Research Group, LLC.
DermResearchCenter of New York, Inc.
Piedmont Plastic Surgery and Dermatology
Wake Research Associates, LLC
Wilmington Dermatology Center
University Hospitals Cleveland Medical Center
Lynn Health Science Institute
Oregon Medical Research Center
Clinical Partners, LLC
Clinical Research Center of the Carolinas
Rivergate Dermatology Clinical Research Center
International Clinical Research - Tennessee LLC
Tennessee Clinical Research Center
Arlington Research Center, Inc.
Westlake Dermatology Clinical Research Center
Bellaire Dermatology Associates
Menter Dermatology Research
The University of Texas Health
Progressive Clinical Research, PA
Center for Clinical Studies, LTD. LLP
Virginia Clinical Research, Inc.
Dermatology Associates of Seattle
Premier Clinical Research

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Arm Label

125 milligrams (mg) Lebrikizumab - Every 4 Weeks (Q4W)

250 mg Lebrikizumab - Q4W

250 mg Lebrikizumab - Every 2 Weeks (Q2W)

Group 4 - Placebo

Arm Description

125 mg Lebrikizumab administered subcutaneously (SC) once Q4W. Baseline: Loading dose 250 mg Lebrikizumab SC (two injections SC 1-milliliter (mL) of 125 mg/mL Lebrikizumab and 1-mL placebo). Week 2: Four 1-mL SC injections placebo. Weeks 4, 8, 12: 125 mg SC Lebrikizumab and 1-mL SC placebo. Weeks 6, 10, 14: Two 1-mL SC placebo.

250 mg Lebrikizumab administered SC once Q4W. Baseline: Loading dose of 500 mg (four 1-mL SC injections of 125 mg/mL Lebrikizumab). Week 2: Four 1-mL SC injections of placebo. Weeks 4, 8, 12: 250 mg (two 1-mL injections of 125 mg/mL Lebrikizumab). Weeks 6, 10, 14: Two 1-mL injections of placebo.

250 mg Lebrikizumab administered SC once Q2W. Baseline and Week 2: Loading dose of 500 mg (four 1-mL SC injections of 125 mg/mL Lebrikizumab). Week 4, 6, 8, 10, 12, 14: 250 mg (two 1-mL SC injections of 125 mg/mL Lebrikizumab).

Placebo administered SC once Q2W. Baseline and Week 2: Four 1-mL SC injections of placebo. Week 4, 6, 8, 10, 12, 14: Two 1-mL SC injections of placebo.

Outcomes

Primary Outcome Measures

Percent Change From Baseline in Eczema Area and Severity Index (EASI)

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). Least Square (LS) Means were calculated using analysis of covariance (ANCOVA) with the factor of treatment and the baseline EASI as covariate. Note: Missing values were imputed using Markov Chain Monte Carlo (MCMC) multiple imputation.

Secondary Outcome Measures

Percentage of Participants With a 75% Improvement From Baseline in EASI (EASI75) at Week 16

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 of Participants With an Investigator Global Assessment (IGA) Score of 0 (Clear) or 1 (Almost Clear) and a Reduction ≥2 Points From Baseline to Week 16 (5-point Scale)

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 EASI <7 at Week 16

Percentage of Participants Achieving EASI50 at Week 16

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 EASI90 at Week 16

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

Percent Change From Baseline in the Sleep Loss Scale Score

The Sleep Loss Scale is used by the participants to report the impact of itching on their sleep every night. Participants responded to the question to what extent did your itching interfere with your sleep last night. The scale ranged from 0 to 4, with 0 (not at all) to 4 (unable to sleep at all). Higher scores indicated a greater impact and worse outcome. Assessments were recorded daily by the participant using an electronic diary. Least Squares (LS) Means were calculated using ANCOVA with the factor of treatment and the baseline sleep-loss scale as covariates.

Percent Change From Baseline in Pruritus Numeric Rating Score (NRS)

The Pruritus NRS is an 11-point scale used by participants to assess their worst itch severity over the past 24 hours, with 0 indicating no itch and 10 indicating worst itch imaginable. Pruritus assessments were recorded daily by the participant using an electronic diary. LS Means were calculated using ANCOVA with the factor of treatments and the baseline pruritus NRS as covariates.

Percentage of Participants With Pruritus NRS Change of ≥3 at Week 16

The Pruritus NRS is an 11-point scale used by participants to assess their worst itch severity over the past 24 hours, with 0 indicating no itch and 10 indicating worst itch imaginable. Assessments were recorded daily by the participant using an electronic diary. The percentage of participants who are dichotomized to success (pruritus NRS greater than or equal to 3-point improvement) at Week 16 will be analyzed using a Cochran-Mantel-Haenszel (CMH) test.

Percentage of Participants With Pruritus NRS Change of ≥4 From Baseline to Week 16

The Pruritus NRS is an 11-point scale used by participants to assess their worst itch severity over the past 24 hours, with 0 indicating no itch and 10 indicating worst itch imaginable. Assessments were recorded daily by the participant using an electronic diary. The percentage of participants who are dichotomized to success (pruritus NRS greater than or equal to 4-point improvement) at Week 16 will be analyzed using a Cochran-Mantel-Haenszel (CMH) test.

Change From Baseline in Body Surface Area (BSA) Involved With Atopic Dermatitis (AD)

The body surface area (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 Atopic Dermatitis Impact Questionnaire (ADIQ) Score

The ADIQ is a 17-item questionnaire used to assess the participant's AD-specific health-related quality of life. Each item is rated on a 5-point scale from 0 to 4, with higher numbers indicating greater burden. The questionnaire assesses AD's impact on emotions, energy, activities of daily living, and social activities. The ADIQ has a recall specification of 7 days. Assessments were recorded by the participant using an electronic diary and transferred to the clinical database.The ADIQ score is calculated by summing the score of each of the 14 questions resulting in a maximum of 56 and a minimum of 0, with higher scores indicating greater burden.

Full Information

NCT ID

NCT03443024

First Posted

February 16, 2018

Last Updated

April 9, 2021

Sponsor

Eli Lilly and Company

Collaborators

Dermira, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT03443024

Brief Title

A Study of Lebrikizumab (LY3650150) in Participants With Moderate-to-Severe Atopic Dermatitis

Official Title

A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging 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

July 2020

Overall Recruitment Status

Completed

Study Start Date

January 30, 2018 (Actual)

Primary Completion Date

February 7, 2019 (Actual)

Study Completion Date

May 23, 2019 (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

5. Study Description

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of lebrikizumab compared with placebo in participants with moderate-to-severe atopic dermatitis.

6. Conditions and Keywords

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

Atopic Dermatitis

Keywords

Eczema

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

280 (Actual)

8. Arms, Groups, and Interventions

Arm Title

125 milligrams (mg) Lebrikizumab - Every 4 Weeks (Q4W)

Arm Type

Experimental

Arm Description

Arm Title

250 mg Lebrikizumab - Q4W

Arm Type

Experimental

Arm Description

Arm Title

250 mg Lebrikizumab - Every 2 Weeks (Q2W)

Arm Type

Experimental

Arm Description

Arm Title

Group 4 - Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo administered SC once Q2W. Baseline and Week 2: Four 1-mL SC injections of placebo. Week 4, 6, 8, 10, 12, 14: Two 1-mL SC injections of placebo.

Intervention Type

Biological

Intervention Name(s)

Lebrikizumab

Other Intervention Name(s)

LY3650150, DRM06

Intervention Description

Sterile liquid solution administered subcutaneously.

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Solution administered subcutaneously.

Primary Outcome Measure Information:

Title

Percent Change From Baseline in Eczema Area and Severity Index (EASI)

Description

Time Frame

Baseline, Week 16

Secondary Outcome Measure Information:

Title

Percentage of Participants With a 75% Improvement From Baseline in EASI (EASI75) at Week 16

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 16

Title

Percentage of Participants With an Investigator Global Assessment (IGA) Score of 0 (Clear) or 1 (Almost Clear) and a Reduction ≥2 Points From Baseline to Week 16 (5-point Scale)

Description

Time Frame

Week 16

Title

Percentage of Participants With EASI <7 at Week 16

Description

Time Frame

Week 16

Title

Percentage of Participants Achieving EASI50 at Week 16

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 16

Title

Percentage of Participants Achieving EASI90 at Week 16

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 16

Title

Percent Change From Baseline in the Sleep Loss Scale Score

Description

Time Frame

Baseline, Week 16

Title

Percent Change From Baseline in Pruritus Numeric Rating Score (NRS)

Description

Time Frame

Baseline, Week 16

Title

Percentage of Participants With Pruritus NRS Change of ≥3 at Week 16

Description

The Pruritus NRS is an 11-point scale used by participants to assess their worst itch severity over the past 24 hours, with 0 indicating no itch and 10 indicating worst itch imaginable. Assessments were recorded daily by the participant using an electronic diary. The percentage of participants who are dichotomized to success (pruritus NRS greater than or equal to 3-point improvement) at Week 16 will be analyzed using a Cochran-Mantel-Haenszel (CMH) test.

Time Frame

Week 16

Title

Percentage of Participants With Pruritus NRS Change of ≥4 From Baseline to Week 16

Description

The Pruritus NRS is an 11-point scale used by participants to assess their worst itch severity over the past 24 hours, with 0 indicating no itch and 10 indicating worst itch imaginable. Assessments were recorded daily by the participant using an electronic diary. The percentage of participants who are dichotomized to success (pruritus NRS greater than or equal to 4-point improvement) at Week 16 will be analyzed using a Cochran-Mantel-Haenszel (CMH) test.

Time Frame

Week 16

Title

Change From Baseline in Body Surface Area (BSA) Involved With Atopic Dermatitis (AD)

Description

Time Frame

Baseline, Week 16

Title

Change From Baseline in Atopic Dermatitis Impact Questionnaire (ADIQ) Score

Description

Time Frame

Baseline, Week 16

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male or female, 18 years or older. Chronic AD as defined by Hanifin and Rajka (1980) that has been present for ≥1 year before the screening visit . Eczema Area and Severity Index (EASI) score ≥16 at the screening and the baseline visit. Investigator Global Assessment (IGA) score ≥3 (scale of 0 to 4) at the screening and the baseline visit. ≥10% body surface area (BSA) of AD involvement at the screening and the baseline visit. Exclusion Criteria: 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 topical corticosteroids (TCS) or topical calcineurin inhibitors (TCI) within 1 week prior to the baseline visit. Treatment with: An investigational drug within 8 weeks or within 5 half-lives (if known), whichever is longer, prior to the baseline visit. Dupilumab within 3 months prior to baseline visit. Cell-depleting biologics, including rituximab, within 6 months prior to the baseline visit. Other biologics within 5 half-lives (if known) or 16 weeks prior to baseline visit (whichever is longer). Use of prescription moisturizers within 7 days of the baseline visit.

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

Clear Dermatology & Aesthetics Center

City

Scottsdale

State/Province

Arizona

ZIP/Postal Code

85255

Country

United States

Facility Name

Dermatology Trial Associates

City

Bryant

State/Province

Arkansas

ZIP/Postal Code

72022

Country

United States

Facility Name

Northwest Arkansas Clinical Trials Center

City

Rogers

State/Province

Arkansas

ZIP/Postal Code

72758

Country

United States

Facility Name

Center for Dermatology Clinical Research, Inc.

City

Fremont

State/Province

California

ZIP/Postal Code

94538

Country

United States

Facility Name

University of Southern California

City

Los Angeles

State/Province

California

ZIP/Postal Code

90033

Country

United States

Facility Name

Dermatology Research Associates

City

Los Angeles

State/Province

California

ZIP/Postal Code

90045

Country

United States

Facility Name

Stanford Medicine Outpatient Center-Medical Dermatology Clinic

City

Redwood City

State/Province

California

ZIP/Postal Code

94063

Country

United States

Facility Name

Center for Dermatology and Laser Surgery

City

Sacramento

State/Province

California

ZIP/Postal Code

95819

Country

United States

Facility Name

UCSD Dermatology

City

San Diego

State/Province

California

ZIP/Postal Code

92122

Country

United States

Facility Name

TCR Medical Corporation

City

San Diego

State/Province

California

ZIP/Postal Code

92123

Country

United States

Facility Name

Clinical Science Institute

City

Santa Monica

State/Province

California

ZIP/Postal Code

90404

Country

United States

Facility Name

George Washington Medical Faculty Associates

City

Washington

State/Province

District of Columbia

ZIP/Postal Code

20037

Country

United States

Facility Name

Total Vein and Skin

City

Boynton Beach

State/Province

Florida

ZIP/Postal Code

33437

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

Olympian Clinical Research

City

Largo

State/Province

Florida

ZIP/Postal Code

33770

Country

United States

Facility Name

Tory Sullivan, MD PA

City

North Miami Beach

State/Province

Florida

ZIP/Postal Code

33162

Country

United States

Facility Name

International Clinical Research - US, LLC

City

Sanford

State/Province

Florida

ZIP/Postal Code

32771

Country

United States

Facility Name

Integrated Clinical Research, LLC

City

West Palm Beach

State/Province

Florida

ZIP/Postal Code

33406

Country

United States

Facility Name

Marietta Dermatology Clinical Research, Inc.

City

Marietta

State/Province

Georgia

ZIP/Postal Code

30060

Country

United States

Facility Name

Advanced Medical Research, PC

City

Sandy Springs

State/Province

Georgia

ZIP/Postal Code

30328

Country

United States

Facility Name

Dundee Dermatology

City

West Dundee

State/Province

Illinois

ZIP/Postal Code

60118

Country

United States

Facility Name

Dawes Fretzin Clinical Research Group, LLC

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46256

Country

United States

Facility Name

The Indiana Clinical Trials Center

City

Plainfield

State/Province

Indiana

ZIP/Postal Code

46168

Country

United States

Facility Name

Kansas City Dermatology, PA

City

Overland Park

State/Province

Kansas

ZIP/Postal Code

66215

Country

United States

Facility Name

Skin Sciences, PLLC

City

Louisville

State/Province

Kentucky

ZIP/Postal Code

40217

Country

United States

Facility Name

Meridian Clinical Research, LLC

City

Baton Rouge

State/Province

Louisiana

ZIP/Postal Code

70808

Country

United States

Facility Name

Dermatology and Skin Cancer Specialists, LLC

City

Rockville

State/Province

Maryland

ZIP/Postal Code

20850

Country

United States

Facility Name

ActivMed Practices & Research, Inc.

City

Beverly

State/Province

Massachusetts

ZIP/Postal Code

01915

Country

United States

Facility Name

Tufts Medical Center

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02111

Country

United States

Facility Name

Somerset Skin Centre

City

Troy

State/Province

Michigan

ZIP/Postal Code

48084

Country

United States

Facility Name

JDR Dermatology Research

City

Las Vegas

State/Province

Nevada

ZIP/Postal Code

89148

Country

United States

Facility Name

ActivMed Practices & Research, Inc.

City

Portsmouth

State/Province

New Hampshire

ZIP/Postal Code

03801

Country

United States

Facility Name

Academic Dermatology Associates

City

Albuquerque

State/Province

New Mexico

ZIP/Postal Code

87106

Country

United States

Facility Name

Schweiger Dermatology, PLLC

City

New York

State/Province

New York

ZIP/Postal Code

10022

Country

United States

Facility Name

Icahn School of Medicine

City

New York

State/Province

New York

ZIP/Postal Code

10029

Country

United States

Facility Name

Sadick Research Group, LLC.

City

New York

State/Province

New York

ZIP/Postal Code

10075

Country

United States

Facility Name

DermResearchCenter of New York, Inc.

City

Stony Brook

State/Province

New York

ZIP/Postal Code

11790

Country

United States

Facility Name

Piedmont Plastic Surgery and Dermatology

City

Charlotte

State/Province

North Carolina

ZIP/Postal Code

28277

Country

United States

Facility Name

Wake Research Associates, LLC

City

Raleigh

State/Province

North Carolina

ZIP/Postal Code

27612

Country

United States

Facility Name

Wilmington Dermatology Center

City

Wilmington

State/Province

North Carolina

ZIP/Postal Code

28405

Country

United States

Facility Name

University Hospitals Cleveland Medical Center

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44106

Country

United States

Facility Name

Lynn Health Science Institute

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73112

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

Clinical Research Center of the Carolinas

City

Charleston

State/Province

South Carolina

ZIP/Postal Code

29407

Country

United States

Facility Name

Rivergate Dermatology Clinical Research Center

City

Goodlettsville

State/Province

Tennessee

ZIP/Postal Code

37072

Country

United States

Facility Name

International Clinical Research - Tennessee LLC

City

Murfreesboro

State/Province

Tennessee

ZIP/Postal Code

37130

Country

United States

Facility Name

Tennessee Clinical Research Center

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37215

Country

United States

Facility Name

Arlington Research Center, Inc.

City

Arlington

State/Province

Texas

ZIP/Postal Code

76011

Country

United States

Facility Name

Westlake Dermatology Clinical Research Center

City

Austin

State/Province

Texas

ZIP/Postal Code

78746

Country

United States

Facility Name

Bellaire Dermatology Associates

City

Bellaire

State/Province

Texas

ZIP/Postal Code

77401

Country

United States

Facility Name

Menter Dermatology Research

City

Dallas

State/Province

Texas

ZIP/Postal Code

75246

Country

United States

Facility Name

The University of Texas Health

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Facility Name

Progressive Clinical Research, PA

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78213

Country

United States

Facility Name

Center for Clinical Studies, LTD. LLP

City

Webster

State/Province

Texas

ZIP/Postal Code

77598

Country

United States

Facility Name

Virginia Clinical Research, Inc.

City

Norfolk

State/Province

Virginia

ZIP/Postal Code

23502

Country

United States

Facility Name

Dermatology Associates of Seattle

City

Seattle

State/Province

Washington

ZIP/Postal Code

98101

Country

United States

Facility Name

Premier Clinical Research

City

Spokane

State/Province

Washington

ZIP/Postal Code

99202

Country

United States

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/

Citations:

PubMed Identifier

32101256

Citation

Guttman-Yassky E, Blauvelt A, Eichenfield LF, Paller AS, Armstrong AW, Drew J, Gopalan R, Simpson EL. Efficacy and Safety of Lebrikizumab, a High-Affinity Interleukin 13 Inhibitor, in Adults With Moderate to Severe Atopic Dermatitis: A Phase 2b Randomized Clinical Trial. JAMA Dermatol. 2020 Apr 1;156(4):411-420. doi: 10.1001/jamadermatol.2020.0079.

Results Reference

derived

Learn more about this trial

A Study of Lebrikizumab (LY3650150) in Participants With Moderate-to-Severe Atopic Dermatitis

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