Clinical trial NCT07006792: A Study to See How Well Lebrikizumab Works in Adults and Adolescents With Moderate Atopic Dermatitis (Eczema) and High Itch Burden
Official title: A Phase 4, Multicenter, Open-label, Single-arm Study to Investigate the Efficacy of Lebrikizumab in Adult and Adolescent Participants With Moderate Atopic Dermatitis and High Itch Burden
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Atopic Dermatitis
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2025-06-05
Enrollment: 200
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Have chronic atopic dermatitis (AD) (according to American Academy of Dermatology Consensus Criteria) that has been present for ≥1 year before screening visit.
* Have 10% to 25% body surface area (BSA) of AD involvement at screening and baseline.
* Have pruritus numeric rating scale (NRS) ≥6 at baseline.
* Have an Eczema Area and Severity Index (EASI) score ≥16 at screening and baseline.
* Have an Investigator's Global Assessment (IGA) score ≥3 (on a scale of 0 to 4) at screening and baseline.
* Based on investigator judgement, have a history of inadequate response to treatment with topical medications, or determination that topical treatments are otherwise medically inadvisable.
* For participants aged 12 to less than 18, have a body weight ≥40 kilograms (kg) at baseline.

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:

  * Serious (requiring hospitalization, and/or intravenous or equivalent oral antibiotic treatment).
  * Opportunistic - Note: Herpes zoster is considered active and ongoing until all vesicles are dry and crusted over.
  * Chronic (duration of symptoms, signs, and/or treatment of 6 weeks or longer).
  * Recurring (including, but not limited to, recurring cellulitis and chronic osteomyelitis).
* 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:

  * systemic immunosuppressive or immunomodulating drugs (for example, systemic corticosteroids, cyclosporine, mycophenolate mofetil, interferon-gamma,
  * azathioprine, methotrexate, and other immunosuppressants)
  * small molecules (for example, Janus kinase inhibitors \[topical or systemic\]), or
  * phototherapy and photochemotherapy for AD.
* Treatment with B-cell-depleting biologics, including rituximab, within 6 months prior to baseline.

Primary outcomes:
measure: 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
timeFrame: Week 16
Secondary outcomes:
measure: Percentage of Participants Achieving EASI-75
timeFrame: Baseline to Week 24
measure: Percentage of Participants Achieving a ≥4-point Reduction from Baseline in Pruritus NRS
timeFrame: Baseline to Week 24
measure: Percentage of Participants with an Investigator's Global Assessment (IGA) of 0 or 1 and a Reduction ≥2 points from Baseline
timeFrame: Baseline to Week 24
measure: Percentage of Participants Achieving EASI-90
timeFrame: Baseline to Week 24
measure: Change from Baseline in Body Surface Area (BSA) Involvement
timeFrame: Baseline, Week 24
measure: Percentage of Change from Baseline in Pruritus NRS Score
timeFrame: Baseline, Week 24
measure: Percentage of Participants with a Sleep-loss Scale Score of ≥2 points at Baseline Who Achieve a ≥ 2-point Reduction
timeFrame: Baseline to Week 24
measure: Percentage Change from Baseline in Sleep-loss Scale
timeFrame: Baseline, Week 24
measure: Percentage of Participants with a Skin Pain NRS of ≥4 Points at Baseline Who Achieve a ≥4-point Reduction
timeFrame: Baseline to Week 24
measure: Change from Baseline in Dermatology Quality of Life (DLQI)
timeFrame: Baseline, Week 24
measure: Change from Baseline in Children's Dermatology Quality of Life (CDLQI)
timeFrame: Baseline, Week 24
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Total Skin & Beauty Dermatology Center, PC DBA Total Dermatology
state: Alabama
city: Los Angeles
country: United States
facility: Dermatology Research Associates
state: California
city: Plantation
country: United States
facility: Leading Edge Dermatology
state: Florida
city: Atlanta
country: United States
facility: ObjectiveHealth - Dermatology Affiliates Research Institute
state: Georgia
city: Chicago
country: United States
facility: DeNova Research
state: Illinois
city: Columbus
country: United States
facility: Southern Indiana Clinical Research Center
state: Indiana
city: Indianapolis
country: United States
facility: Dawes Fretzin Clinical Research Group, LLC
state: Indiana
city: New Albany
country: United States
facility: Southern Indiana Clinical Trials
state: Indiana
city: Bay City
country: United States
facility: Great Lakes Research Group, Inc.
state: Michigan
city: New York
country: United States
facility: Equity Medical
state: New York
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
city: Goodlettsville
country: United States
facility: ObjectiveHealth - Goodlettsville Dermatology Research
state: Tennessee
city: San Antonio
country: United States
facility: Texas Dermatology and Laser Specialists
state: Texas
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: Instituto de Neumonologia Y Dermatologia
state: Buenos Aires
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: Psoriahue
state: Buenos Aires
city: Ciudad Autónoma de Buenos Aires
country: Argentina
facility: Fundación Respirar
state: Buenos Aires
city: San Miguel
country: Argentina
facility: Centro de Investigaciones San Miguel
state: Buenos Aires
city: Rosario
country: Argentina
facility: INECO Neurociencias Oroño
state: Santa Fe
city: Rosario
country: Argentina
facility: Instituto de Investigaciones Clinicas Rosario
state: Santa Fe
city: Buenos Aires
country: Argentina
facility: CONEXA Investigacion Clinica S.A.
city: Buenos Aires
country: Argentina
facility: CIPREC
city: Ciudad Autónoma de Buenos Aires
country: Argentina
facility: Centro de Investigaciones Metabólicas (CINME)
city: Ciudad Autónoma de Buenos Aires
country: Argentina
facility: DOM Centro de Reumatología
city: Mendoza
country: Argentina
facility: Parra Dermatología
city: Salvador
country: Brazil
facility: Centro de Pesquisas da Clínica IBIS
state: Bahia
city: Curitiba
country: Brazil
facility: PUC Trials- Nucleo de Pesquisa clinica da Escola de Medicina da PUCPR
state: Paraná
city: Porto Alegre
country: Brazil
facility: Irmandade da Santa Casa de Misericórdia de Porto Alegre
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: Hospital São Lucas da PUCRS
state: Rio Grande Do Sul
city: Santo Andre
country: Brazil
facility: Faculdade de Medicina do ABC
state: São Paulo
city: Sorocaba
country: Brazil
facility: Clinica de Alergia Martti Antila
state: São Paulo
city: São José dos Campos
country: Brazil
facility: ISPEM - Instituto São José dos Campos em Pesquisas Médicas
state: São Paulo
city: Rio de Janeiro
country: Brazil
facility: IBPClin - Instituto Brasil de Pesquisa Clínica
city: São Paulo
country: Brazil
facility: CEPIC - Centro Paulista de Investigação Clínica
city: Calgary
country: Canada
facility: Dermatology Research Institute
state: Alberta
city: Nanaimo
country: Canada
facility: Skin Care West
state: British Columbia
city: Fredericton
country: Canada
facility: Brunswick Dermatology Center
state: New Brunswick
city: Halifax
country: Canada
facility: Maritime Dermatology
state: Nova Scotia
city: London
country: Canada
facility: Lovegrove Dermatology
state: Ontario
city: Ottawa
country: Canada
facility: Kanata Allergy Clinic
state: Ontario
city: Peterborough
country: Canada
facility: SKiN Centre for Dermatology
state: Ontario
city: Richmond Hill
country: Canada
facility: Oak Ridges Aesthetics Centre
state: Ontario
city: Thunder Bay
country: Canada
facility: Eternal Springtime Dermatology
state: Ontario
city: Toronto
country: Canada
facility: North York Research Inc
state: Ontario
city: Sherbrooke
country: Canada
facility: Centre de Recherche Saint-Louis
state: Quebec
Study officials:
affiliation: Eli Lilly and Company
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)
role: STUDY_DIRECTOR
References: