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Safety and Efficacy of Lebrikizumab (LY3650150) in Combination With Topical Corticosteroid in Moderate-to-Severe Atopic Dermatitis. (ADhere)

Primary Purpose

Atopic Dermatitis

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Lebrikizumab

Placebo

Topical Corticosteroid

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 adult and adolescents (≥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.

Exclusion Criteria:

Participation in a prior lebrikizumab clinical study.
Treatment with the following prior to the baseline visit:
1. An investigational drug within 8 weeks or within 5 half-lives (if known), whichever is longer.
2. Dupilumab within 8 weeks.
3. B-cell-depleting biologics, including to rituximab, within 6 months.
4. 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

Investigate MD
Orange County Research Institute
Bakersfield Dermatology and Skin Cancer Medical Group
Wallace Medical Group, Inc.
First OC Dermatology
Center For Dermatology Clinical Research, Inc.
California Allergy and Asthma Medical Group + Research Center
Keck School of Medicine University of Southern California
Dermatology Research Associates
LA Universal Research Center, INC
ACRC Studies
University Clinical Trials, Inc.
Southern California Dermatology, Inc.
Foxhall Dermatology
St. Francis Medical Institute
University of Florida - Gainesville
Direct Helpers Medical Center
The Community Research of South Florida
GSI Clinical Research, LLC
Vitae Research Center, LLC
Well Pharma Medical Research Corp.
ForCare Clinical Research
Advanced Medical Research
The Indiana Clinical Trials Center
Dermatology and Skin Cancer Specialists
ActivMed Practices and Research
Beacon Clinical Research LLC
Fivenson Dermatology
Clarkston Skin Research
MediSearch Clinical Trials
ALLCUTIS Research
Psoriasis Treatment Center of Central New Jersey
Sadick Research Group
OnSite Clinical Solutions
Wilmington Dermatology Center
Clinical Research Institute
Oregon Dermatology and Research Center
Oregon Medical Research Center
OHSU Center for Health and Healing
Clinical Partners, LLC
Clinical Research Center of the Carolinas
Arlington Research Center, Inc
Dermatology Treatment and Research Center
CARe Clinic
Dr. Chih-ho Hong Medical Inc.
Enverus Medical Research
Wiseman Dermatology Research Inc.
SKiN Centre for Dermatology
International Dermatology Research
Klinikum der Johann Wolfgang Goethe-Universität Frankfurt
Elbe Klinikum Buxtehude
Technische Universitaet Dresden - Universitaetsklinikum Carl Gustav Carus - Klinik und Poliklinik fuer
Praxis für Ganzheitliche Dermatologie im Ärztehaus
TFS Trial Form Support GmbH
DermMEDICA Sp. z o.o.
Alergo-Med Specjalistyczna Przychodnia Lekarska Sp Z O.O.
Kliniczny Szpital Wojewodzki nr. 1 Klinika Dermatologii
COPERNICUS Podmiot Leczniczy sp. z o.o.
Labderm s.c.
Gabinet Dermatlogiczny. Beata Krecisz
Clinica Vitae Sp. z o.o.
Clinical Research Group Sp. z o.o.
Centralny Szpital Kliniczny MSWiA

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Lebrikizumab + Topical Corticosteroid

Placebo + Topical Corticosteroid

Arm Description

500 mg Lebrikizumab (2 x 250 mg) subcutaneous (SC) injections of lebrikizumab as a loading dose at Baseline and Week 2 followed by a single injection of 250 mg Lebrikizumab every 2 weeks (Q2W) from Week 4 until Week 14. Topical corticosteroid (TCS) will be initiated at Baseline in all participants and may be tapered or stopped, or restarted as needed, based on treatment response.

Two placebo subcutaneous (SC) injections as a loading dose at Baseline and Week 2 followed by a single injection of placebo every Q2W from Week 4 until Week 14. TCS will be initiated at Baseline in all participants and may be tapered or stopped, or restarted as needed, based on treatment response

Outcomes

Primary Outcome Measures

Percentage of Participants With an Investigator's 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 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 From Baseline in EASI Score) 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.

Secondary Outcome Measures

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

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 covariance (ANCOVA) model includes treatment, baseline value, and stratification factors of geographic region, age group, baseline IGA score as fixed factors.

Percentage of Participants With a Pruritus NRS of ≥4-Points at Baseline Who Achieve a ≥4-Point Reduction 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 of ≥5-points at Baseline Who Achieve a ≥4-point Reduction 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 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). LS Mean was calculated using ANCOVA model with treatment, baseline value, and stratification factors of geographic region, age group, baseline IGA score (IGA 3 versus 4) as fixed factors.

Change From Baseline to Week 16 in Percent 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.

Percentage of Participants Achieving EASI-90 at Week 4

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

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.

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

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.

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

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.

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

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.

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

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.

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

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.

Percentage of Topical Corticosteroid (TCS)/Topical Calcineurin Inhibitors (TCI) Free Days From Baseline to Week 16

Number of the total TCS/TCI free days divided by total number of days during the treatment period. The mixed model repeated measures (MMRM) includes treatment, visit, the interaction of treatment by-visit, geographic region, age group, baseline IGA score.

Median Time (Days) to TCS/TCI-free Use From Baseline to Week 16

Days from first study drug injection to the day participant stopped using all TCS/TCI (if a participant started and stopped using low or midpotency TCS/TCI multiple times, use the last stop date as the stop date for this participant).

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, baseline value, and stratification factors of geographic region, age group, baseline IGA (3 versus 4) score as fixed factors.

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 With a DLQI Score ≥4 Points at Baseline Who Achieve a ≥4 Points

Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) 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, baseline value, and stratification factors of geographic region, age group, baseline IGA (3 versus 4) score as fixed factors.

Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) at Week 16 Visual Analog Score (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, baseline value, and stratification factors of geographic region, age group, baseline IGA (3 versus 4) score as fixed factors.

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 - 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. Each question has 5 response options with values from 1 to 5. Total raw scores were converted to T-scores with higher scores indicating greater severity of symptoms. 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.

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. Each question has 5 response options with values from 1 to 5. Total raw scores were converted to T-scores with higher scores indicating greater severity of symptoms. 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.

Change From Baseline in PROMIS Anxiety at Week 16 - Pediatrics

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 with higher scores indicating greater severity of symptoms. 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.

Change From Baseline in PROMIS Depression at Week 16 - Pediatrics

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 with higher scores indicating greater severity of symptoms. 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.

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

The ACQ-5 has been shown to reliably measure asthma control and distinguish participants with well-controlled asthma (score ≤0.75 points) from those with uncontrolled asthma (score ≥1.5 points). It consists of 5 questions that are scored on a 7- point Likert scale with a recall period of 1 week. The total ACQ-5 score is the mean score of all questions; a lower score represents better asthma control. LS Mean was calculated using ANCOVA with treatment, baseline value, geographic region, age group, baseline IGA (3 versus 4) score as fixed factors.

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

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

Full Information

NCT ID

NCT04250337

First Posted

January 30, 2020

Last Updated

May 5, 2022

Sponsor

Eli Lilly and Company

Collaborators

Dermira, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT04250337

Brief Title

Safety and Efficacy of Lebrikizumab (LY3650150) in Combination With Topical Corticosteroid in Moderate-to-Severe Atopic Dermatitis.

Acronym

ADhere

Official Title

A Randomized, Double-Blind, Placebo-Controlled Trial To Evaluate The Efficacy and Safety of Lebrikizumab When Used In Combination With Topical Corticosteroid Treatment In Patients With Moderate-To-Severe Atopic Dermatitis

Study Type

Interventional

2. Study Status

Record Verification Date

May 2022

Overall Recruitment Status

Completed

Study Start Date

February 3, 2020 (Actual)

Primary Completion Date

August 11, 2021 (Actual)

Study Completion Date

September 16, 2021 (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 16 weeks in duration. The study is designed to evaluate the safety and efficacy of lebrikizumab when used in combination with topical corticosteroid (TCS) treatment compared with placebo in combination with TCS treatment for 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, 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

Allocation

Randomized

Enrollment

228 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Lebrikizumab + Topical Corticosteroid

Arm Type

Experimental

Arm Description

Arm Title

Placebo + Topical Corticosteroid

Arm Type

Placebo Comparator

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

Intervention Type

Other

Intervention Name(s)

Topical Corticosteroid

Intervention Description

Topical Corticosteroid

Primary Outcome Measure Information:

Title

Percentage of Participants With an Investigator's 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 From Baseline in EASI Score) at Week 16

Description

Time Frame

Baseline to Week 16

Secondary Outcome Measure Information:

Title

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

Description

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 of ≥4-Points at Baseline Who Achieve a ≥4-Point Reduction 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 of ≥5-points at Baseline Who Achieve a ≥4-point Reduction 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 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). LS Mean was calculated using ANCOVA model with treatment, baseline value, and stratification factors of geographic region, age group, baseline IGA score (IGA 3 versus 4) as fixed factors.

Time Frame

Baseline, Week 16

Title

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

Description

Time Frame

Baseline, Week 16

Title

Percentage of Participants Achieving EASI-90 at Week 4

Description

Time Frame

Baseline to Week 4

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

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.

Time Frame

Baseline to Week 4

Title

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

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.

Time Frame

Baseline to Week 2

Title

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

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.

Time Frame

Baseline to Week 1

Title

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

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.

Time Frame

Baseline to Week 4

Title

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

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.

Time Frame

Baseline to Week 2

Title

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

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.

Time Frame

Baseline to Week 1

Title

Percentage of Topical Corticosteroid (TCS)/Topical Calcineurin Inhibitors (TCI) Free Days From Baseline to Week 16

Description

Time Frame

Baseline to Week 16

Title

Median Time (Days) to TCS/TCI-free Use From Baseline to Week 16

Description

Time Frame

Baseline to Week 16

Title

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

Description

Time Frame

Baseline, Week 16

Title

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

Description

Time Frame

Baseline, Week 16

Title

Percentage of Participants With a DLQI Score ≥4 Points at Baseline Who Achieve a ≥4 Points

Description

Time Frame

Baseline to Week 16

Title

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

Description

Time Frame

Baseline, Week 16

Title

Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) at Week 16 Visual Analog Score (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 - 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. Each question has 5 response options with values from 1 to 5. Total raw scores were converted to T-scores with higher scores indicating greater severity of symptoms. 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.

Time Frame

Baseline, Week 16

Title

Change From Baseline in PROMIS Anxiety at Week 16 - Pediatrics

Description

Time Frame

Baseline, Week 16

Title

Change From Baseline in PROMIS Depression at Week 16 - Pediatrics

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 with higher scores indicating greater severity of symptoms. 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.

Time Frame

Baseline, Week 16

Title

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

Description

Time Frame

Baseline, Week 16

Title

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

Description

Time Frame

Baseline, Week 16

10. Eligibility

Sex

All

Minimum Age & Unit of Time

12 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male or female adult and adolescents (≥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. 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

Investigate MD

City

Scottsdale

State/Province

Arizona

ZIP/Postal Code

85255

Country

United States

Facility Name

Orange County Research Institute

City

Anaheim

State/Province

California

ZIP/Postal Code

92801

Country

United States

Facility Name

Bakersfield Dermatology and Skin Cancer Medical Group

City

Bakersfield

State/Province

California

ZIP/Postal Code

93309

Country

United States

Facility Name

Wallace Medical Group, Inc.

City

Beverly Hills

State/Province

California

ZIP/Postal Code

90211

Country

United States

Facility Name

First OC Dermatology

City

Fountain Valley

State/Province

California

ZIP/Postal Code

92708

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

California Allergy and Asthma Medical Group + Research Center

City

Los Angeles

State/Province

California

ZIP/Postal Code

90025

Country

United States

Facility Name

Keck School of Medicine 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

LA Universal Research Center, INC

City

Los Angeles

State/Province

California

ZIP/Postal Code

90057

Country

United States

Facility Name

ACRC Studies

City

San Diego

State/Province

California

ZIP/Postal Code

92119

Country

United States

Facility Name

University Clinical Trials, Inc.

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

Foxhall Dermatology

City

Washington

State/Province

District of Columbia

ZIP/Postal Code

20016

Country

United States

Facility Name

St. Francis Medical Institute

City

Clearwater

State/Province

Florida

ZIP/Postal Code

33765

Country

United States

Facility Name

University of Florida - Gainesville

City

Gainesville

State/Province

Florida

ZIP/Postal Code

32606

Country

United States

Facility Name

Direct Helpers Medical Center

City

Hialeah

State/Province

Florida

ZIP/Postal Code

33012

Country

United States

Facility Name

The Community Research of South Florida

City

Hialeah

State/Province

Florida

ZIP/Postal Code

33016

Country

United States

Facility Name

GSI Clinical Research, LLC

City

Margate

State/Province

Florida

ZIP/Postal Code

33063

Country

United States

Facility Name

Vitae Research Center, LLC

City

Miami

State/Province

Florida

ZIP/Postal Code

33135

Country

United States

Facility Name

Well Pharma Medical Research Corp.

City

Miami

State/Province

Florida

ZIP/Postal Code

33143

Country

United States

Facility Name

ForCare Clinical Research

City

Tampa

State/Province

Florida

ZIP/Postal Code

33613-1244

Country

United States

Facility Name

Advanced Medical Research

City

Sandy Springs

State/Province

Georgia

ZIP/Postal Code

30328

Country

United States

Facility Name

The Indiana Clinical Trials Center

City

Plainfield

State/Province

Indiana

ZIP/Postal Code

46168

Country

United States

Facility Name

Dermatology and Skin Cancer Specialists

City

Rockville

State/Province

Maryland

ZIP/Postal Code

20850

Country

United States

Facility Name

ActivMed Practices and Research

City

Beverly

State/Province

Massachusetts

ZIP/Postal Code

01915

Country

United States

Facility Name

Beacon Clinical Research LLC

City

Quincy

State/Province

Massachusetts

ZIP/Postal Code

02169

Country

United States

Facility Name

Fivenson Dermatology

City

Ann Arbor

State/Province

Michigan

ZIP/Postal Code

48103

Country

United States

Facility Name

Clarkston Skin Research

City

Clarkston

State/Province

Michigan

ZIP/Postal Code

48346

Country

United States

Facility Name

MediSearch Clinical Trials

City

Saint Joseph

State/Province

Missouri

ZIP/Postal Code

64506

Country

United States

Facility Name

ALLCUTIS Research

City

Portsmouth

State/Province

New Hampshire

ZIP/Postal Code

03801

Country

United States

Facility Name

Psoriasis Treatment Center of Central New Jersey

City

East Windsor

State/Province

New Jersey

ZIP/Postal Code

08520

Country

United States

Facility Name

Sadick Research Group

City

New York

State/Province

New York

ZIP/Postal Code

10075

Country

United States

Facility Name

OnSite Clinical Solutions

City

Charlotte

State/Province

North Carolina

ZIP/Postal Code

28277

Country

United States

Facility Name

Wilmington Dermatology Center

City

Wilmington

State/Province

North Carolina

ZIP/Postal Code

28405

Country

United States

Facility Name

Clinical Research Institute

City

Medford

State/Province

Oregon

ZIP/Postal Code

97504

Country

United States

Facility Name

Oregon Dermatology and Research Center

City

Portland

State/Province

Oregon

ZIP/Postal Code

97210

Country

United States

Facility Name

Oregon Medical Research Center

City

Portland

State/Province

Oregon

ZIP/Postal Code

97223

Country

United States

Facility Name

OHSU Center for Health and Healing

City

Portland

State/Province

Oregon

ZIP/Postal Code

97239

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

Arlington Research Center, Inc

City

Arlington

State/Province

Texas

ZIP/Postal Code

76011

Country

United States

Facility Name

Dermatology Treatment and Research Center

City

Dallas

State/Province

Texas

ZIP/Postal Code

75230

Country

United States

Facility Name

CARe Clinic

City

Red Deer

State/Province

Alberta

ZIP/Postal Code

T4N 6V7

Country

Canada

Facility Name

Dr. Chih-ho Hong Medical Inc.

City

Surrey

State/Province

British Columbia

ZIP/Postal Code

V3R 6A7

Country

Canada

Facility Name

Enverus Medical Research

City

Surrey

State/Province

British Columbia

ZIP/Postal Code

V3V 0C6

Country

Canada

Facility Name

Wiseman Dermatology Research Inc.

City

Winnipeg

State/Province

Manitoba

ZIP/Postal Code

R3M 3Z4

Country

Canada

Facility Name

SKiN Centre for Dermatology

City

Peterborough

State/Province

Ontario

ZIP/Postal Code

K9J 5K2

Country

Canada

Facility Name

International Dermatology Research

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H3H1V4

Country

Canada

Facility Name

Klinikum der Johann Wolfgang Goethe-Universität Frankfurt

City

Frankfurt am Main

State/Province

Hessen

ZIP/Postal Code

60590

Country

Germany

Facility Name

Elbe Klinikum Buxtehude

City

Buxtehude

State/Province

Lower Saxony

ZIP/Postal Code

21614

Country

Germany

Facility Name

Technische Universitaet Dresden - Universitaetsklinikum Carl Gustav Carus - Klinik und Poliklinik fuer

City

Dresden

State/Province

Saxony

ZIP/Postal Code

01307

Country

Germany

Facility Name

Praxis für Ganzheitliche Dermatologie im Ärztehaus

City

Berlin

ZIP/Postal Code

13055

Country

Germany

Facility Name

TFS Trial Form Support GmbH

City

Hamburg

ZIP/Postal Code

20537

Country

Germany

Facility Name

DermMEDICA Sp. z o.o.

City

Wroclaw

State/Province

Dolnoslaskie

ZIP/Postal Code

51-318

Country

Poland

Facility Name

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

City

Tarnow

State/Province

Malopolska

ZIP/Postal Code

33100

Country

Poland

Facility Name

Kliniczny Szpital Wojewodzki nr. 1 Klinika Dermatologii

City

Rzeszow

State/Province

Podkarpackie

ZIP/Postal Code

35-055

Country

Poland

Facility Name

COPERNICUS Podmiot Leczniczy sp. z o.o.

City

Gdansk

State/Province

Pomorskie

ZIP/Postal Code

80-219

Country

Poland

Facility Name

Labderm s.c.

City

Ossy

State/Province

Slaskie

ZIP/Postal Code

42-624

Country

Poland

Facility Name

Gabinet Dermatlogiczny. Beata Krecisz

City

Kielce

State/Province

Swietokrzyskie

ZIP/Postal Code

25-155

Country

Poland

Facility Name

Clinica Vitae Sp. z o.o.

City

Gdansk

State/Province

Woj. Pomorskie

ZIP/Postal Code

80-405

Country

Poland

Facility Name

Clinical Research Group Sp. z o.o.

City

Warszawa

ZIP/Postal Code

01-142

Country

Poland

Facility Name

Centralny Szpital Kliniczny MSWiA

City

Warszawa

ZIP/Postal Code

02-507

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/4gJ6pg3ypXbcm8LEXb9M3b

Description

Safety and Efficacy of Lebrikizumab (LY3650150) in Combination With Topical Corticosteroid in Moderate-to-Severe Atopic Dermatitis. (ADhere)

Learn more about this trial

Safety and Efficacy of Lebrikizumab (LY3650150) in Combination With Topical Corticosteroid in Moderate-to-Severe Atopic Dermatitis.

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