A Study to See How Well Lebrikizumab Works in Adults and Adolescents With Moderate Atopic Dermatitis (Eczema) and High Itch Burden

Phase 4

Not yet recruiting

• Conditions: Atopic Dermatitis
• Interventions: Drug: Lebrikizumab

• Registration Number: NCT07006792
• Lead Sponsor: Eli Lilly and Company

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-05
• Study First Submitted: 2025-05-28
• Study First Submitted QC: 2025-05-28
• Last Update Submitted: 2025-05-28
• Study Start: 2025-06
• Study First Posted: 2025-06-05
• Last Update Posted: 2025-06-05
• Primary Completion: 2026-04
• Study Completion: 2026-09

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 200

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Lebrikizumab	Lebrikizumab	Lebrikizumab administered subcutaneously (SC).

Primary Outcome Measures

Name	Time	Method
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	Week 16	The primary endpoint will be a composite endpoint as defined by achieving either EASI-75 or Pruritus NRS≥4-point Reduction from Baseline.

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants Achieving EASI-75	Baseline to 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
Percentage of Participants Achieving a ≥4-point Reduction from Baseline in Pruritus NRS	Baseline to Week 24
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
Change from Baseline in Dermatology Quality of Life (DLQI)	Baseline, 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
Change from Baseline in Children's Dermatology Quality of Life (CDLQI)	Baseline, Week 24

Trial Locations

Locations (44)

Total Skin & Beauty Dermatology Center, PC DBA Total Dermatology; 🇺🇸 Birmingham, Alabama, United States

Dermatology Research Associates; 🇺🇸 Los Angeles, California, United States

Leading Edge Dermatology; 🇺🇸 Plantation, Florida, United States

ObjectiveHealth - Dermatology Affiliates Research Institute; 🇺🇸 Atlanta, Georgia, United States

DeNova Research; 🇺🇸 Chicago, Illinois, United States

Southern Indiana Clinical Research Center; 🇺🇸 Columbus, Indiana, United States

Dawes Fretzin Clinical Research Group, LLC; 🇺🇸 Indianapolis, Indiana, United States

Southern Indiana Clinical Trials; 🇺🇸 New Albany, Indiana, United States

Great Lakes Research Group, Inc.; 🇺🇸 Bay City, Michigan, United States

Equity Medical; 🇺🇸 New York, New York, United States

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