Atopic DermatitisPhase 2NCT03443024
A Study of Lebrikizumab (LY3650150) in Participants With Moderate-to-Severe Atopic Dermatitis
A Phase 2 study testing Lebrikizumab in people with Atopic Dermatitis, run by Eli Lilly and Company at 58 sites in United States.
Trial summary
The purpose of this study is to evaluate the safety and efficacy of lebrikizumab compared with placebo in participants with moderate-to-severe atopic dermatitis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- Lebrikizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 280 participants
- Where
- 58 sitesUnited States
- Study dates
- 30 Jan 2018to 23 May 2019
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 10Show fewer
- 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.
Trial locations and contacts
58 sites in 1 country.
58 sites in 1 country
United States58 sites
Academic Dermatology Associates
Albuquerque, New Mexico, 87106
Arlington Research Center, Inc.
Arlington, Texas, 76011
Westlake Dermatology Clinical Research Center
Austin, Texas, 78746
Meridian Clinical Research, LLC
Baton Rouge, Louisiana, 70808
Bellaire Dermatology Associates
Bellaire, Texas, 77401
ActivMed Practices & Research, Inc.
Beverly, Massachusetts, 01915
Tufts Medical Center
Boston, Massachusetts, 02111
Total Vein and Skin
Boynton Beach, Florida, 33437
Dermatology Trial Associates
Bryant, Arkansas, 72022
Clinical Research Center of the Carolinas
Charleston, South Carolina, 29407
Piedmont Plastic Surgery and Dermatology
Charlotte, North Carolina, 28277
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
Florida Academic Centers Research and Education, LLC
Coral Gables, Florida, 33134
Menter Dermatology Research
Dallas, Texas, 75246
Center for Dermatology Clinical Research, Inc.
Fremont, California, 94538
Rivergate Dermatology Clinical Research Center
Goodlettsville, Tennessee, 37072
The University of Texas Health
Houston, Texas, 77030
Dawes Fretzin Clinical Research Group, LLC
Indianapolis, Indiana, 46256
Clinical Partners, LLC
Johnston, Rhode Island, 02919
Olympian Clinical Research
Largo, Florida, 33770
JDR Dermatology Research
Las Vegas, Nevada, 89148
University of Southern California
Los Angeles, California, 90033
Dermatology Research Associates
Los Angeles, California, 90045
Skin Sciences, PLLC
Louisville, Kentucky, 40217
Marietta Dermatology Clinical Research, Inc.
Marietta, Georgia, 30060
International Clinical Research - Tennessee LLC
Murfreesboro, Tennessee, 37130
Tennessee Clinical Research Center
Nashville, Tennessee, 37215
Schweiger Dermatology, PLLC
New York, New York, 10022
Icahn School of Medicine
New York, New York, 10029
Sadick Research Group, LLC.
New York, New York, 10075
Virginia Clinical Research, Inc.
Norfolk, Virginia, 23502
Tory Sullivan, MD PA
North Miami Beach, Florida, 33162
Lynn Health Science Institute
Oklahoma City, Oklahoma, 73112
Kansas City Dermatology, PA
Overland Park, Kansas, 66215
The Indiana Clinical Trials Center
Plainfield, Indiana, 46168
Oregon Medical Research Center
Portland, Oregon, 97223
ActivMed Practices & Research, Inc.
Portsmouth, New Hampshire, 03801
Wake Research Associates, LLC
Raleigh, North Carolina, 27612
Stanford Medicine Outpatient Center-Medical Dermatology Clinic
Redwood City, California, 94063
Dermatology and Skin Cancer Specialists, LLC
Rockville, Maryland, 20850
Northwest Arkansas Clinical Trials Center
Rogers, Arkansas, 72758
Center for Dermatology and Laser Surgery
Sacramento, California, 95819
Progressive Clinical Research, PA
San Antonio, Texas, 78213
UCSD Dermatology
San Diego, California, 92122
TCR Medical Corporation
San Diego, California, 92123
Advanced Medical Research, PC
Sandy Springs, Georgia, 30328
International Clinical Research - US, LLC
Sanford, Florida, 32771
Clinical Science Institute
Santa Monica, California, 90404
Clear Dermatology & Aesthetics Center
Scottsdale, Arizona, 85255
Dermatology Associates of Seattle
Seattle, Washington, 98101
Premier Clinical Research
Spokane, Washington, 99202
DermResearchCenter of New York, Inc.
Stony Brook, New York, 11790
Somerset Skin Centre
Troy, Michigan, 48084
George Washington Medical Faculty Associates
Washington D.C., District of Columbia, 20037
Center for Clinical Studies, LTD. LLP
Webster, Texas, 77598
Dundee Dermatology
West Dundee, Illinois, 60118
Integrated Clinical Research, LLC
West Palm Beach, Florida, 33406
Wilmington Dermatology Center
Wilmington, North Carolina, 28405
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Trial to Evaluate the Efficacy and Safety of Lebrikizumab in Patients With Moderate-to-Severe Atopic Dermatitis
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.
- Conditions
- Atopic Dermatitis
- Being tested
- Lebrikizumab, Placebo
- Keywords
- Eczema
- Medical subject headings
- Dermatitis, Atopic, Eczema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LebrikizumabBiological
Also called LY3650150, DRM06
Sterile liquid solution administered subcutaneously.
PlaceboDrug
Solution administered subcutaneously.
| Study group | Role | What they receive |
|---|---|---|
| 125 milligrams (mg) Lebrikizumab - Every 4 Weeks (Q4W) | Experimental | 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. Receives: Biological: Lebrikizumab; Drug: Placebo |
| 250 mg Lebrikizumab - Q4W | Experimental | 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. Receives: Biological: Lebrikizumab; Drug: Placebo |
| 250 mg Lebrikizumab - Every 2 Weeks (Q2W) | Experimental | 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). Receives: Biological: Lebrikizumab; Drug: Placebo |
| Group 4 - Placebo | Placebo comparator | 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change From Baseline in Eczema Area and Severity Index (EASI)
The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 to 72 (severe).
Least Square (LS) Means were calculated using analysis of covariance (ANCOVA) with the factor of treatment and the baseline EASI as covariate.
Note: Missing values were imputed using Markov Chain Monte Carlo (MCMC) multiple imputation.
Measured: Baseline, Week 16
Secondary outcomes (11)
Percentage of Participants With a 75% Improvement From Baseline in EASI (EASI75) at Week 16
The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 to 72 (severe).
The EASI responder is defined as a participant who achieves a ≥ 75% improvement from baseline in the EASI score.
Measured: 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)
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.
Measured: Week 16
Percentage of Participants With EASI <7 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).
Measured: Week 16
Percentage of Participants Achieving EASI50 at Week 16
The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 to 72 (severe).
The EASI responder is defined as a participant who achieves a ≥ 50% improvement from baseline in the EASI score.
Measured: Week 16
Percentage of Participants Achieving EASI90 at Week 16
The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 to 72 (severe).
The EASI responder is defined as a participant who achieves a ≥ 90% improvement from baseline in the EASI score
Measured: Week 16
Percent Change From Baseline in the Sleep Loss Scale Score
The Sleep Loss Scale is used by the participants to report the impact of itching on their sleep every night. Participants responded to the question to what extent did your itching interfere with your sleep last night. The scale ranged from 0 to 4, with 0 (not at all) to 4 (unable to sleep at all). Higher scores indicated a greater impact and worse outcome. Assessments were recorded daily by the participant using an electronic diary.
Least Squares (LS) Means were calculated using ANCOVA with the factor of treatment and the baseline sleep-loss scale as covariates.
Measured: Baseline, Week 16
Percent Change From Baseline in Pruritus Numeric Rating Score (NRS)
The Pruritus NRS is an 11-point scale used by participants to assess their worst itch severity over the past 24 hours, with 0 indicating no itch and 10 indicating worst itch imaginable. Pruritus assessments were recorded daily by the participant using an electronic diary.
LS Means were calculated using ANCOVA with the factor of treatments and the baseline pruritus NRS as covariates.
Measured: Baseline, Week 16
Percentage of Participants With Pruritus NRS Change of ≥3 at Week 16
The Pruritus NRS is an 11-point scale used by participants to assess their worst itch severity over the past 24 hours, with 0 indicating no itch and 10 indicating worst itch imaginable. Assessments were recorded daily by the participant using an electronic diary.
The percentage of participants who are dichotomized to success (pruritus NRS greater than or equal to 3-point improvement) at Week 16 will be analyzed using a Cochran-Mantel-Haenszel (CMH) test.
Measured: Week 16
Percentage of Participants With Pruritus NRS Change of ≥4 From Baseline to Week 16
The Pruritus NRS is an 11-point scale used by participants to assess their worst itch severity over the past 24 hours, with 0 indicating no itch and 10 indicating worst itch imaginable. Assessments were recorded daily by the participant using an electronic diary.
The percentage of participants who are dichotomized to success (pruritus NRS greater than or equal to 4-point improvement) at Week 16 will be analyzed using a Cochran-Mantel-Haenszel (CMH) test.
Measured: Week 16
Change From Baseline in Body Surface Area (BSA) Involved With Atopic Dermatitis (AD)
The body surface area (BSA) affected by AD will be assessed for 4 separate body regions: head and neck, trunk (including genital region), upper extremities, and lower extremities (including the buttocks). Each body region will be assessed for disease extent ranging from 0% to 100% involvement. BSA was calculated using the participant's palm using the 1% rule, 1 palm was equivalent to 1% with estimates of the number of palms it takes to cover the affected AD area. Maximum number of palms were 10 palms for head and neck (10%), 20 palms for upper extremities (20%), 30 palms for trunk, including axilla and groin (30%), 40 palms for lower extremities, including buttocks (40%). Percent of BSA for a body region was calculated as = total number of palms in a body region * % surface area equivalent to 1 palm. Overall percent BSA of all 4 body regions ranges from 0% to 100 % with higher values representing greater severity of AD.
Measured: Baseline, Week 16
Change From Baseline in Atopic Dermatitis Impact Questionnaire (ADIQ) Score
The ADIQ is a 17-item questionnaire used to assess the participant's AD-specific health-related quality of life. Each item is rated on a 5-point scale from 0 to 4, with higher numbers indicating greater burden. The questionnaire assesses AD's impact on emotions, energy, activities of daily living, and social activities. The ADIQ has a recall specification of 7 days. Assessments were recorded by the participant using an electronic diary and transferred to the clinical database.The ADIQ score is calculated by summing the score of each of the 14 questions resulting in a maximum of 56 and a minimum of 0, with higher scores indicating greater burden.
Measured: Baseline, Week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2018
- Study start30 Jan 2018
- Primary completion7 Feb 2019
- Study completion23 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 280 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Dermira, Inc.
- Responsible party
- Sponsor
- Investigators
- 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03443024
- Sponsor's protocol ID
- 17826
- Other IDs
- J2T-DM-KGAF, DRM06-AD01
- Status last verified
- Jul 2020
- First submitted
- 16 Feb 2018
- Last updated
- 4 May 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
Rams A, Baldasaro J, Bunod L, Delbecque L, Strzok S, Meunier J, ElMaraghy H, Sun L, Pierce E. Sleep-loss related to itch in atopic dermatitis: assessing content validity and psychometric properties of a patient-reported sleep-loss rating scale. J Patient Rep Outcomes. 2024 Jul 22;8(1):77. doi: 10.1186/s41687-024-00764-2.
PubMed 39039395Rams A, Baldasaro J, Bunod L, Delbecque L, Strzok S, Meunier J, ElMaraghy H, Sun L, Pierce E. Assessing Itch Severity: Content Validity and Psychometric Properties of a Patient-Reported Pruritus Numeric Rating Scale in Atopic Dermatitis. Adv Ther. 2024 Apr;41(4):1512-1525. doi: 10.1007/s12325-024-02802-3. Epub 2024 Feb 16.
PubMed 38363461Guttman-Yassky E, Blauvelt A, Eichenfield LF, Paller AS, Armstrong AW, Drew J, Gopalan R, Simpson EL. Efficacy and Safety of Lebrikizumab, a High-Affinity Interleukin 13 Inhibitor, in Adults With Moderate to Severe Atopic Dermatitis: A Phase 2b Randomized Clinical Trial. JAMA Dermatol. 2020 Apr 1;156(4):411-420. doi: 10.1001/jamadermatol.2020.0079.
PubMed 32101256
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Trial to Evaluate the Efficacy and Safety of Lebrikizumab in Patients With Moderate-to-Severe Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT03443024
- Acronym / sponsor ID
- 17826
- Conditions
- Atopic Dermatitis
- Keywords
- Eczema
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 280 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Collaborators
- Dermira, Inc.
- Study start
- 30 Jan 2018 (actual)
- Primary completion
- 7 Feb 2019 (actual)
- Study completion
- 23 May 2019 (actual)
- First posted
- 22 Feb 2018 (actual)
- Results
- Posted 4 May 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 125 milligrams (mg) Lebrikizumab - Every 4 Weeks (Q4W) | Experimental | Biological: Lebrikizumab, Drug: Placebo125 mg Lebrikizumab administered subcutaneously (SC) once Q4W. Baseline: Loading dose 250 mg Lebrikizumab SC (two injections SC 1-milliliter (mL) of 125 mg/mL Lebrikizumab and 1-mL placebo). Week 2: Four 1-mL SC injections placebo. Weeks 4, 8, 12: 125 mg SC Lebrikizumab and 1-mL SC placebo. Weeks 6, 10, 14: Two 1-mL SC placebo. |
| 250 mg Lebrikizumab - Q4W | Experimental | Biological: Lebrikizumab, Drug: Placebo250 mg Lebrikizumab administered SC once Q4W. Baseline: Loading dose of 500 mg (four 1-mL SC injections of 125 mg/mL Lebrikizumab). Week 2: Four 1-mL SC injections of placebo. Weeks 4, 8, 12: 250 mg (two 1-mL injections of 125 mg/mL Lebrikizumab). Weeks 6, 10, 14: Two 1-mL injections of placebo. |
| 250 mg Lebrikizumab - Every 2 Weeks (Q2W) | Experimental | Biological: Lebrikizumab, Drug: Placebo250 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). |
| Group 4 - Placebo | Placebo comparator | Drug: PlaceboPlacebo 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (10 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LebrikizumabAlso: LY3650150, DRM06Sterile liquid solution administered subcutaneously. | Biological | 125 milligrams (mg) Lebrikizumab - Every 4 Weeks (Q4W), 250 mg Lebrikizumab - Every 2 Weeks (Q2W), 250 mg Lebrikizumab - Q4W |
| PlaceboSolution administered subcutaneously. | Drug | 125 milligrams (mg) Lebrikizumab - Every 4 Weeks (Q4W), 250 mg Lebrikizumab - Every 2 Weeks (Q2W), 250 mg Lebrikizumab - Q4W, Group 4 - Placebo |
Primary outcome
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.
11 secondary outcomes
Percentage of Participants With a 75% Improvement From Baseline in EASI (EASI75) at Week 16
Time frame: 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
Percentage of Participants With EASI <7 at Week 16
Time frame: Week 16
Percentage of Participants Achieving EASI50 at Week 16
Time frame: Week 16
Percentage of Participants Achieving EASI90 at Week 16
Time frame: Week 16
Percent Change From Baseline in the Sleep Loss Scale Score
Time frame: Baseline, Week 16
Percent Change From Baseline in Pruritus Numeric Rating Score (NRS)
Time frame: Baseline, Week 16
Percentage of Participants With Pruritus NRS Change of ≥3 at Week 16
Time frame: Week 16
Percentage of Participants With Pruritus NRS Change of ≥4 From Baseline to Week 16
Time frame: Week 16
Change From Baseline in Body Surface Area (BSA) Involved With Atopic Dermatitis (AD)
Time frame: Baseline, Week 16
Change From Baseline in Atopic Dermatitis Impact Questionnaire (ADIQ) Score
Time frame: Baseline, Week 16
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39039395Rams A, Baldasaro J, Bunod L, Delbecque L, Strzok S, Meunier J, ElMaraghy H, Sun L, Pierce E. Sleep-loss related to itch in atopic dermatitis: assessing content validity and psychometric properties of a patient-reported sleep-loss rating scale. J Patient Rep Outcomes. 2024 Jul 22;8(1):77. doi: 10.1186/s41687-024-00764-2.
- Derived from this study: PubMed 38363461Rams A, Baldasaro J, Bunod L, Delbecque L, Strzok S, Meunier J, ElMaraghy H, Sun L, Pierce E. Assessing Itch Severity: Content Validity and Psychometric Properties of a Patient-Reported Pruritus Numeric Rating Scale in Atopic Dermatitis. Adv Ther. 2024 Apr;41(4):1512-1525. doi: 10.1007/s12325-024-02802-3. Epub 2024 Feb 16.
- Derived from this study: PubMed 32101256Guttman-Yassky E, Blauvelt A, Eichenfield LF, Paller AS, Armstrong AW, Drew J, Gopalan R, Simpson EL. Efficacy and Safety of Lebrikizumab, a High-Affinity Interleukin 13 Inhibitor, in Adults With Moderate to Severe Atopic Dermatitis: A Phase 2b Randomized Clinical Trial. JAMA Dermatol. 2020 Apr 1;156(4):411-420. doi: 10.1001/jamadermatol.2020.0079.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
58 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lebrikizumab in people with Atopic Dermatitis, run by Eli Lilly and Company at 58 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 58 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 May 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent Change From Baseline in Eczema Area and Severity Index (EASI) (time frame: Baseline, Week 16). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03443024, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2021.