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

April 9, 2021 updated by: Eli Lilly and Company

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
280

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85255
        • Clear Dermatology & Aesthetics Center
    • Arkansas
      • Bryant, Arkansas, United States, 72022
        • Dermatology Trial Associates
      • Rogers, Arkansas, United States, 72758
        • Northwest Arkansas Clinical Trials Center
    • California
      • Fremont, California, United States, 94538
        • Center for Dermatology Clinical Research, Inc.
      • Los Angeles, California, United States, 90033
        • University of Southern California
      • Los Angeles, California, United States, 90045
        • Dermatology Research Associates
      • Redwood City, California, United States, 94063
        • Stanford Medicine Outpatient Center-Medical Dermatology Clinic
      • Sacramento, California, United States, 95819
        • Center for Dermatology and Laser Surgery
      • San Diego, California, United States, 92122
        • UCSD Dermatology
      • San Diego, California, United States, 92123
        • TCR Medical Corporation
      • Santa Monica, California, United States, 90404
        • Clinical Science Institute
    • District of Columbia
      • Washington, District of Columbia, United States, 20037
        • George Washington Medical Faculty Associates
    • Florida
      • Boynton Beach, Florida, United States, 33437
        • Total Vein and Skin
      • Coral Gables, Florida, United States, 33134
        • Florida Academic Centers Research and Education, LLC
      • Largo, Florida, United States, 33770
        • Olympian Clinical Research
      • North Miami Beach, Florida, United States, 33162
        • Tory Sullivan, MD PA
      • Sanford, Florida, United States, 32771
        • International Clinical Research - US, LLC
      • West Palm Beach, Florida, United States, 33406
        • Integrated Clinical Research, LLC
    • Georgia
      • Marietta, Georgia, United States, 30060
        • Marietta Dermatology Clinical Research, Inc.
      • Sandy Springs, Georgia, United States, 30328
        • Advanced Medical Research, PC
    • Illinois
      • West Dundee, Illinois, United States, 60118
        • Dundee Dermatology
    • Indiana
      • Indianapolis, Indiana, United States, 46256
        • Dawes Fretzin Clinical Research Group, LLC
      • Plainfield, Indiana, United States, 46168
        • The Indiana Clinical Trials Center
    • Kansas
      • Overland Park, Kansas, United States, 66215
        • Kansas City Dermatology, PA
    • Kentucky
      • Louisville, Kentucky, United States, 40217
        • Skin Sciences, PLLC
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70808
        • Meridian Clinical Research, LLC
    • Maryland
      • Rockville, Maryland, United States, 20850
        • Dermatology and Skin Cancer Specialists, LLC
    • Massachusetts
      • Beverly, Massachusetts, United States, 01915
        • ActivMed Practices & Research, Inc.
      • Boston, Massachusetts, United States, 02111
        • Tufts Medical Center
    • Michigan
      • Troy, Michigan, United States, 48084
        • Somerset Skin Centre
    • Nevada
      • Las Vegas, Nevada, United States, 89148
        • JDR Dermatology Research
    • New Hampshire
      • Portsmouth, New Hampshire, United States, 03801
        • ActivMed Practices & Research, Inc.
    • New Mexico
      • Albuquerque, New Mexico, United States, 87106
        • Academic Dermatology Associates
    • New York
      • New York, New York, United States, 10029
        • Icahn School of Medicine
      • New York, New York, United States, 10022
        • Schweiger Dermatology, PLLC
      • New York, New York, United States, 10075
        • Sadick Research Group, LLC.
      • Stony Brook, New York, United States, 11790
        • DermResearchCenter of New York, Inc.
    • North Carolina
      • Charlotte, North Carolina, United States, 28277
        • Piedmont Plastic Surgery and Dermatology
      • Raleigh, North Carolina, United States, 27612
        • Wake Research Associates, LLC
      • Wilmington, North Carolina, United States, 28405
        • Wilmington Dermatology Center
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • University Hospitals Cleveland Medical Center
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73112
        • Lynn Health Science Institute
    • Oregon
      • Portland, Oregon, United States, 97223
        • Oregon Medical Research Center
    • Rhode Island
      • Johnston, Rhode Island, United States, 02919
        • Clinical Partners, LLC
    • South Carolina
      • Charleston, South Carolina, United States, 29407
        • Clinical Research Center of the Carolinas
    • Tennessee
      • Goodlettsville, Tennessee, United States, 37072
        • Rivergate Dermatology Clinical Research Center
      • Murfreesboro, Tennessee, United States, 37130
        • International Clinical Research - Tennessee LLC
      • Nashville, Tennessee, United States, 37215
        • Tennessee Clinical Research Center
    • Texas
      • Arlington, Texas, United States, 76011
        • Arlington Research Center, Inc.
      • Austin, Texas, United States, 78746
        • Westlake Dermatology Clinical Research Center
      • Bellaire, Texas, United States, 77401
        • Bellaire Dermatology Associates
      • Dallas, Texas, United States, 75246
        • Menter Dermatology Research
      • Houston, Texas, United States, 77030
        • The University of Texas Health
      • San Antonio, Texas, United States, 78213
        • Progressive Clinical Research, PA
      • Webster, Texas, United States, 77598
        • Center for Clinical Studies, LTD. LLP
    • Virginia
      • Norfolk, Virginia, United States, 23502
        • Virginia Clinical Research, Inc.
    • Washington
      • Seattle, Washington, United States, 98101
        • Dermatology Associates of Seattle
      • Spokane, Washington, United States, 99202
        • Premier Clinical Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 125 milligrams (mg) Lebrikizumab - Every 4 Weeks (Q4W)

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.
Biological: Lebrikizumab
Sterile liquid solution administered subcutaneously.
Other Names:
  • LY3650150
  • DRM06
Drug: Placebo
Solution administered subcutaneously.
Experimental: 250 mg Lebrikizumab - Q4W

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.
Biological: Lebrikizumab
Sterile liquid solution administered subcutaneously.
Other Names:
  • LY3650150
  • DRM06
Drug: Placebo
Solution administered subcutaneously.
Experimental: 250 mg Lebrikizumab - Every 2 Weeks (Q2W)

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).
Biological: Lebrikizumab
Sterile liquid solution administered subcutaneously.
Other Names:
  • LY3650150
  • DRM06
Drug: Placebo
Solution administered subcutaneously.
Placebo Comparator: Group 4 - Placebo

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.
Drug: Placebo
Solution administered subcutaneously.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percent Change From Baseline in Eczema Area and Severity Index (EASI)
Time Frame: Baseline, 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).

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.
Baseline, Week 16

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Percentage of Participants With a 75% Improvement From Baseline in EASI (EASI75) at Week 16
Time Frame: 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.
Week 16
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)
Time Frame: 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.
Week 16
Percentage of Participants With EASI <7 at Week 16
Time Frame: 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).
Week 16
Percentage of Participants Achieving EASI50 at Week 16
Time Frame: 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.
Week 16
Percentage of Participants Achieving EASI90 at Week 16
Time Frame: 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
Week 16
Percent Change From Baseline in the Sleep Loss Scale Score
Time Frame: Baseline, Week 16

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.
Baseline, Week 16
Percent Change From Baseline in Pruritus Numeric Rating Score (NRS)
Time Frame: Baseline, 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. 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.
Baseline, Week 16
Percentage of Participants With Pruritus NRS Change of ≥3 at Week 16
Time Frame: 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.
Week 16
Percentage of Participants With Pruritus NRS Change of ≥4 From Baseline to Week 16
Time Frame: 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.
Week 16
Change From Baseline in Body Surface Area (BSA) Involved With Atopic Dermatitis (AD)
Time Frame: Baseline, Week 16
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.
Baseline, Week 16
Change From Baseline in Atopic Dermatitis Impact Questionnaire (ADIQ) Score
Time Frame: Baseline, Week 16
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.
Baseline, Week 16

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Eli Lilly and Company

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Dermira, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 30, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 7, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 23, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 16, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 16, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 22, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 4, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 9, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 17826
  • J2T-DM-KGAF (Other Identifier: Eli Lilly and Company)
  • DRM06-AD01 (Other Identifier: Dermira, Inc)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD 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 Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Clinical Study Report (CSR)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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