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| ID | Type | Description | Link |
|---|---|---|---|
| J2T-MC-KGCE | Other Identifier | Eli Lilly and Company |
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The purpose of this study is to measure how well taking lebrikizumab alone works for participants with fewer places on the body with eczema (atopic dermatitis), but these places may be very itchy.
Participation in this study will last up to approximately 38 weeks (9 and a half months) including 24 weeks (6 months) of treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lebrikizumab | Experimental | Lebrikizumab administered subcutaneously (SC). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lebrikizumab | Drug | Administered SC |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving Eczema Area and Severity Index-75 (EASI-75) (≥75% Reduction from Baseline in EASI), or a ≥4-point Reduction in Pruritus Numerical Rating Scale (NRS) from Baseline | The primary endpoint will be a composite endpoint as defined by achieving either EASI-75 or Pruritus NRS≥4-point Reduction from Baseline. | Week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving EASI-75 | Baseline to Week 24 | |
| Percentage of Participants Achieving a ≥4-point Reduction from Baseline in Pruritus NRS | Baseline to Week 24 | |
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Inclusion Criteria:
Exclusion Criteria:
Have an uncontrolled chronic disease that might require multiple intermittent uses of oral corticosteroids at screening (as defined by the investigator).
Have known liver cirrhosis and/or chronic hepatitis of any etiology.
History of malignancy, including mycosis fungoides or cutaneous T-cell lymphoma, within 5 years before the screening, except completely treated in situ carcinoma of the cervix of completely treated and resolved nonmetastatic squamous or basal cell carcinoma of the skin with no evidence of recurrence in the past 12 weeks.
Are diagnosed with active endoparasitic infections or at high risk of these infections.
Have a known or suspected history of immunosuppression, including history of invasive opportunistic infections despite infection resolution; or unusually frequent, recurrent, or prolonged infections, per the investigator's judgment.
Have presence of skin comorbidities that may interfere with study assessments.
Have a severe concomitant illness(es) that in the investigator's judgment would adversely affect the participant's participation in the study.
Have had any of the following types of infection within 3 months of screening or develop any of these infections during screening:
Have an active or acute infection requiring treatment with systemic antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 2 weeks before the baseline visit or superficial skin infections within 1 week before the baseline visit.
Have had any prior treatment with a biologic therapy for AD.
Have had treatment with any of the following agents within 4 weeks prior to the baseline visit:
Treatment with B-cell-depleting biologics, including rituximab, within 6 months prior to baseline.
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| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Total Skin & Beauty Dermatology Center, PC DBA Total Dermatology | Birmingham | Alabama | 35203 | United States | ||
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.
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.
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
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| Percentage of Participants with an Investigator's Global Assessment (IGA) of 0 or 1 and a Reduction ≥2 points from Baseline |
| Baseline to Week 24 |
| Percentage of Participants Achieving EASI-90 | Baseline to Week 24 |
| Change from Baseline in Body Surface Area (BSA) Involvement | Baseline, Week 24 |
| Percentage of Change from Baseline in Pruritus NRS Score | Baseline, Week 24 |
| Percentage of Participants with a Sleep-loss Scale Score of ≥2 points at Baseline Who Achieve a ≥ 2-point Reduction | Baseline to Week 24 |
| Percentage Change from Baseline in Sleep-loss Scale | Baseline, Week 24 |
| Percentage of Participants with a Skin Pain NRS of ≥4 Points at Baseline Who Achieve a ≥4-point Reduction | Baseline to Week 24 |
| Change from Baseline in Dermatology Quality of Life (DLQI) | Baseline, Week 24 |
| Change from Baseline in Children's Dermatology Quality of Life (CDLQI) | Baseline, Week 24 |
| Research Solutions of Arizona |
| Litchfield Park |
| Arizona |
| 85340 |
| United States |
| Alliance Dermatology and Mohs Center | Phoenix | Arizona | 85032 | United States |
| California Dermatology & Clinical Research Institute | Encinitas | California | 92024 | United States |
| Dermatology Research Associates | Los Angeles | California | 90045 | United States |
| NorCal Clinical Research | Rocklin | California | 95765 | United States |
| Suncoast Research Associates | Doral | Florida | 33172 | United States |
| Encore Medical Research | Hollywood | Florida | 33024 | United States |
| Solutions Through Advanced Research | Jacksonville | Florida | 32256 | United States |
| Life Arc Research Centers - Miami | Miami | Florida | 33126 | United States |
| MCR Research | Miami | Florida | 33126 | United States |
| Health Clinical Research | Miami | Florida | 33176 | United States |
| Deluxe Health Center | Miami Lakes | Florida | 33014 | United States |
| Renstar Medical Research | Ocala | Florida | 34470 | United States |
| Leading Edge Dermatology | Plantation | Florida | 33317 | United States |
| Dermatology Affiliates Research Institute | Atlanta | Georgia | 30305 | United States |
| DeNova Research | Chicago | Illinois | 60602 | United States |
| Southern Indiana Clinical Research Center | Columbus | Indiana | 47201 | United States |
| Dawes Fretzin Clinical Research Group, LLC | Indianapolis | Indiana | 46250 | United States |
| Southern Indiana Clinical Trials | New Albany | Indiana | 47150 | United States |
| Equity Medical - Bowling Green | Bowling Green | Kentucky | 42104 | United States |
| Allergy & Asthma Specialists, P.S.C. | Owensboro | Kentucky | 42301 | United States |
| Foxhall Research Center | Chevy Chase | Maryland | 20815 | United States |
| Great Lakes Research Group, Inc. | Bay City | Michigan | 48706 | United States |
| Revival Research Institute, LLC | Troy | Michigan | 48084 | United States |
| Albuquerque Clinical Trials, Inc. | Albuquerque | New Mexico | 87102 | United States |
| Equity Medical | New York | New York | 10023 | United States |
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | United States |
| Hickory Dermatology Research Center | Hickory | North Carolina | 28602 | United States |
| ObjectiveHealth - Goodlettsville Dermatology Research | Goodlettsville | Tennessee | 37072 | United States |
| Reveal Research Institute - Frisco | Frisco | Texas | 75033 | United States |
| Biopharma Informatic, LLC | Houston | Texas | 77084 | United States |
| Prime Clinical Research - Mansfield | Mansfield | Texas | 76063 | United States |
| Texas Dermatology and Laser Specialists - San Antonio - South New Braunfels Avenue | San Antonio | Texas | 78235 | United States |
| Jordan Valley Dermatology & Research Center | South Jordan | Utah | 84095 | United States |
| CONEXA Investigacion Clinica S.A. | Buenos Aires | 1012 | Argentina |
| CIPREC | Buenos Aires | 1061 | Argentina |
| Centro de Investigaciones Metabólicas (CINME) | Buenos Aires | C1056ABI | Argentina |
| DOM Centro de Reumatología | Buenos Aires | C1111 | Argentina |
| Instituto de Neumonologia Y Dermatologia | Buenos Aires | C1425BEA | Argentina |
| Psoriahue | Buenos Aires | C1425DKG | Argentina |
| Fundación Respirar | Buenos Aires | C1426ABP | Argentina |
| Parra Dermatología | Mendoza | 5500 | Argentina |
| INECO Neurociencias Oroño | Rosario | 2000 | Argentina |
| Instituto de Investigaciones Clinicas Rosario | Rosario | S2000CVD | Argentina |
| Centro de Investigaciones San Miguel | San Miguel | 1663 | Argentina |
| AlergoAlpha - Barueri | Barueri | 06454-010 | Brazil |
| PUC Trials- Nucleo de Pesquisa clinica da Escola de Medicina da PUCPR | Curitiba | 80230-130 | Brazil |
| Irmandade da Santa Casa de Misericórdia de Porto Alegre | Porto Alegre | 90050-170 | Brazil |
| Hospital São Lucas da PUCRS | Porto Alegre | 90610-000 | Brazil |
| IBPClin - Instituto Brasil de Pesquisa Clínica | Rio de Janeiro | 20241-180 | Brazil |
| Centro de Pesquisas da Clínica IBIS | Salvador | 41820-020 | Brazil |
| Faculdade de Medicina do ABC | Santo André | 09060-870 | Brazil |
| ISPEM - Instituto São José dos Campos em Pesquisas Médicas | São José dos Campos | 12243-280 | Brazil |
| CEPIC - Centro Paulista de Investigação Clínica | São Paulo | 04266-010 | Brazil |
| Brunswick Dermatology Center | Fredericton | E3B 1G9 | Canada |
| Maritime Dermatology | Halifax | B3K 5R3 | Canada |
| Lovegrove Dermatology | London | N6A 5R9 | Canada |
| Skin Care West | Nanaimo | V9V 1A3 | Canada |
| Kanata Allergy Clinic | Ottawa | K2T 0N7 | Canada |
| SKiN Centre for Dermatology | Peterborough | K9J 5K2 | Canada |
| Centre de Recherche Saint-Louis | Sherbrooke | J1G 1X9 | Canada |
| Eternal Springtime Dermatology | Thunder Bay | P7C 4Y7 | Canada |
| North York Research Inc | Toronto | M2N 3A6 | Canada |
| Dr. Samuel Sanchez PSC | Caguas | 00725 | Puerto Rico |
| CMRC Headlands, LLC | San Juan | 00918 | Puerto Rico |
| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C561806 | lebrikizumab |
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