Los Angeles, California 90025

  • Atopic Dermatitis

Purpose:

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.


Criteria:

Inclusion Criteria: 1. Male or female adult and adolescents (≥12 years to <18 years, and weighing ≥40 kg). 2. Chronic AD (according to American Academy of Dermatology Consensus Criteria) that has been present for ≥1 year before the screening visit. 3. Eczema Area and Severity Index (EASI) score ≥16 at the baseline visit. 4. Investigator Global Assessment (IGA) score ≥3 (scale of 0 to 4) at the baseline visit 5. ≥10% body surface area (BSA) of AD involvement at the baseline visit. 6. History of inadequate response to treatment with topical medications. Exclusion Criteria: 1. Participation in a prior lebrikizumab clinical study. 2. 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. 3. Treatment with a live (attenuated) vaccine within 12 weeks of the baseline visit or planned during the study. 4. Uncontrolled chronic disease that might require bursts of oral corticosteroids. 5. Evidence of active acute or chronic hepatitis 6. History of human immunodeficiency virus (HIV) infection or positive HIV serology at screening. 7. 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. 8. Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed during the study.


Study is Available At:


Original ID:

17803


NCT ID:

NCT04250337


Secondary ID:

2019-004300-34


Study Acronym:

ADhere


Brief Title:

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


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


Overall Status:

Completed


Study Phase:

Phase 3


Genders:

N/A


Minimum Age:

12 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Eli Lilly and Company


Oversight Authority:

There was an error processing this request


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

228


Enrollment Type:

Actual


Overall Contact Information

Official Name: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)
Study Director
Eli Lilly and Company

Study Dates

Start Date:February 3, 2020
Completion Date:September 16, 2021
Completion Type:Actual
Primary Completion Date:August 11, 2021
Primary Completion Type:Actual
Verification Date:May 2022
Last Changed Date:May 5, 2022
First Received Date:January 30, 2020
First Results Date:March 14, 2022

Study Outcomes

Outcome Type:Primary Outcome
Measure: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.
Time Frame:Baseline to Week 16
Safety Issues:False
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 eryth
Outcome Type:Primary Outcome
Measure:Percentage of Participants Achieving Eczema Area and Severity Index (EASI-75) (≥75% Reduction From Baseline in EASI Score) at Week 16
Time Frame:Baseline to Week 16
Safety Issues:False
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) eryt
Outcome Type:Secondary Outcome
Measure:Percentage of Participants Achieving EASI-90 (≥90% Reduction From Baseline in EASI Score) at Week 16
Time Frame:Baseline to Week 16
Safety Issues:False
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) eryt
Outcome Type:Secondary Outcome
Measure:Percent Change in Pruritus Numerical Rating Scale (NRS) Score From Baseline to Week 16
Time Frame:Baseline, Week 16
Safety Issues:False
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." Least Squares (LS) Mean was calculated using analysis covariance (ANCOVA
Outcome Type:Secondary Outcome
Measure:Percentage of Participants With a Pruritus NRS of ≥4-Points at Baseline Who Achieve a ≥4-Point Reduction From Baseline to Week 16
Time Frame:Baseline to Week 16
Safety Issues:False
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."
Outcome Type:Secondary Outcome
Measure:Percentage of Participants With a Pruritus NRS of ≥5-points at Baseline Who Achieve a ≥4-point Reduction From Baseline to Week 16
Time Frame:Baseline to Week 16
Safety Issues:False
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."
Outcome Type:Secondary Outcome
Measure:Percent Change in EASI Score From Baseline at Week 16
Time Frame:Baseline, Week 16
Safety Issues:False
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) eryt
Outcome Type:Secondary Outcome
Measure:Change From Baseline to Week 16 in Percent Body Surface Area (BSA)
Time Frame:Baseline, Week 16
Safety Issues:False
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% t
Outcome Type:Secondary Outcome
Measure:Percentage of Participants Achieving EASI-90 at Week 4
Time Frame:Baseline to Week 4
Safety Issues:False
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) eryt
Outcome Type:Secondary Outcome
Measure:Percent Change in Sleep-loss Score From Baseline to Week 16
Time Frame:Baseline, Week 16
Safety Issues:False
Description: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
Outcome Type:Secondary Outcome
Measure:Change From Baseline in Sleep-loss Score at Week 16
Time Frame:Baseline, Week 16
Safety Issues:False
Description: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
Outcome Type:Secondary Outcome
Measure:Percentage of Participants With a Pruritus NRS of ≥4-points at Baseline Who Achieve a ≥4-point Reduction From Baseline to Week 4
Time Frame:Baseline to Week 4
Safety Issues:False
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.
Outcome Type:Secondary Outcome
Measure:Percentage of Participants With a Pruritus NRS of ≥4-points at Baseline Who Achieve a ≥4-point Reduction From Baseline to Week 2
Time Frame:Baseline to Week 2
Safety Issues:False
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.
Outcome Type:Secondary Outcome
Measure:Percentage of Participants With a Pruritus NRS of ≥4-points at Baseline Who Achieve a ≥4-point Reduction From Baseline to Week 1
Time Frame:Baseline to Week 1
Safety Issues:False
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.
Outcome Type:Secondary Outcome
Measure:Percentage of Participants With a Pruritus NRS of ≥5-points at Baseline Who Achieve a ≥4-point Reduction From Baseline to Week 4
Time Frame:Baseline to Week 4
Safety Issues:False
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.
Outcome Type:Secondary Outcome
Measure:Percentage of Participants With a Pruritus NRS of ≥5-points at Baseline Who Achieve a ≥4-point Reduction From Baseline to Week 2
Time Frame:Baseline to Week 2
Safety Issues:False
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.
Outcome Type:Secondary Outcome
Measure:Percentage of Participants With a Pruritus NRS of ≥5-points at Baseline Who Achieve a ≥4-point Reduction From Baseline to Week 1
Time Frame:Baseline to Week 1
Safety Issues:False
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.
Outcome Type:Secondary Outcome
Measure:Percentage of Topical Corticosteroid (TCS)/Topical Calcineurin Inhibitors (TCI) Free Days From Baseline to Week 16
Time Frame:Baseline to Week 16
Safety Issues:False
Description: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.
Outcome Type:Secondary Outcome
Measure:Median Time (Days) to TCS/TCI-free Use From Baseline to Week 16
Time Frame:Baseline to Week 16
Safety Issues:False
Description: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).
Outcome Type:Secondary Outcome
Measure:Percent Change in SCORing Atopic Dermatitis (SCORAD) From Baseline to Week 16
Time Frame:Baseline, Week 16
Safety Issues:False
Description:The SCORAD index uses the rule of nines to assess disease extent and evaluates 6 clinical characteristics to determine disease severity: (1) erythema, (2) edema/papulation, (3) oozing/crusts, (4) excoriation, (5) lichenification, and (6) dryness on a scal
Outcome Type:Secondary Outcome
Measure:Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 16
Time Frame:Baseline, Week 16
Safety Issues:False
Description: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 leisur
Outcome Type:Secondary Outcome
Measure:Percentage of Participants With a DLQI Score ≥4 Points at Baseline Who Achieve a ≥4 Points
Time Frame:Baseline to Week 16
Safety Issues:False
Description: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 leisur
Outcome Type:Secondary Outcome
Measure:Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) at Week 16 Health State Index
Time Frame:Baseline, Week 16
Safety Issues:False
Description: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
Outcome Type:Secondary Outcome
Measure:Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) at Week 16 Visual Analog Score (VAS)
Time Frame:Baseline, Week 16
Safety Issues:False
Description: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
Outcome Type:Secondary Outcome
Measure:Change From Baseline in Patient Oriented Eczema Measure (POEM) at Week 16
Time Frame:Baseline, Week 16
Safety Issues:False
Description: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 answe
Outcome Type:Secondary Outcome
Measure:Change From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety at Week 16 - Adults
Time Frame:Baseline, Week 16
Safety Issues:False
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 anxiety has 8 questions on Emotion Dis
Outcome Type:Secondary Outcome
Measure:Change From Baseline in PROMIS Depression at Week 16 - Adults
Time Frame:Baseline, Week 16
Safety Issues:False
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
Outcome Type:Secondary Outcome
Measure:Change From Baseline in PROMIS Anxiety at Week 16 - Pediatrics
Time Frame:Baseline, Week 16
Safety Issues:False
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 E
Outcome Type:Secondary Outcome
Measure:Change From Baseline in PROMIS Depression at Week 16 - Pediatrics
Time Frame:Baseline, Week 16
Safety Issues:False
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 o
Outcome Type:Secondary Outcome
Measure:Change From Baseline in Asthma Control Questionnaire (ACQ-5) Score at Week 16 in Participants Who Have Self-reported Comorbid Asthma
Time Frame:Baseline, Week 16
Safety Issues:False
Description: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 Lik
Outcome Type:Secondary Outcome
Measure:Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) at Week 16
Time Frame:Baseline, Week 16
Safety Issues:False
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 e

Study Interventions

Intervention Type:Other
Name:Topical Corticosteroid
Description:Topical Corticosteroid
Arm Name:Lebrikizumab + Topical Corticosteroid
Intervention Type:Other
Name:Placebo
Description:Subcutaneous injection
Arm Name:Placebo + Topical Corticosteroid
Intervention Type:Biological
Name:Lebrikizumab
Description:Subcutaneous injection
Arm Name:Lebrikizumab + Topical Corticosteroid
Other Name:LY3650150

Study Arms

Study Arm Type:Experimental
Arm Name:Lebrikizumab + Topical Corticosteroid
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.
Study Arm Type:Placebo Comparator
Arm Name:Placebo + Topical Corticosteroid
Description: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

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Eli Lilly and Company
Agency Class:Industry
Agency Type:Collaborator
Agency Name:Dermira, Inc.

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: February 01, 2023

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