A Study of Lebrikizumab Treatment in Adults and Adolescents With Moderate-to-Severe Atopic Dermatitis
NCT06526182 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 520
Last updated 2026-04-21
Summary
The main purpose of this study is to evaluate the effectiveness of 24 weeks of lebrikizumab in improving disease severity, signs, and symptoms in adults and adolescents with moderate-to-severe AD in Part 1 and to describe how similar is the current maintenance dosing regimen of lebrikizumab 250 mg every 4 weeks (Q4W) to the new proposed; lebrikizumab 500 mg every 12 weeks (Q12W), in terms of efficacy, safety, PK, ADA and blood biomarkers.
Conditions
- Dermatitis, Atopic
- Eczema
Interventions
- BIOLOGICAL
-
Lebrikizumab
Lebrikizumab solution for injection administered subcutaneously.
- OTHER
-
Placebo
Lebrikizumab Matching placebo solution for injection administered subcutaneously.
Sponsors & Collaborators
-
Almirall, S.A.
lead INDUSTRY
Principal Investigators
-
Study Director · Almirall, S.A.
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 12 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-07-03
- Primary Completion
- 2027-04-25
- Completion
- 2027-04-25
Countries
- Spain
Study Locations
More Related Trials
-
A Study to See How Well Lebrikizumab Works in Adults and Adolescents With Moderate Atopic Dermatitis (Eczema) and High Itch Burden
NCT07006792 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE4
-
A Study of Lebrikizumab (LY3650150) in Participants 6 Months to <18 Years of Age With Moderate-to-Severe Atopic Dermatitis
NCT05559359 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE3
-
A Study to Assess the Impact of Lebrikizumab on Health-Related Well-Being and Control of Skin Manifestations in Participants With Moderate-to-Severe Atopic Dermatitis
NCT06815380 ·Status: RECRUITING
-
A Study to Evaluate the Safety of Lebrikizumab Compared to Topical Corticosteroids in Adult Patients With Atopic Dermatitis
NCT02465606 ·Status: COMPLETED ·Phase: PHASE2
-
Evaluation of the Efficacy and Safety of Lebrikizumab (LY3650150) in Moderate to Severe Atopic Dermatitis (ADvocate1)
NCT04146363 ·Status: COMPLETED ·Phase: PHASE3
-
A Study of Lebrikizumab (LY3650150) With/Without Topical Corticosteroid Treatment in Participants With Moderate-to-Severe Atopic Dermatitis
NCT06280716 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE3
-
Lebrikizumab in Moderate-to-severe Atopic Dermatitis
NCT06906497 ·Status: RECRUITING ·Phase: PHASE4
-
A Study to Assess the Long-Term Safety and Efficacy of Lebrikizumab (LY3650150) in Participants 6 Months to <18 Years of Age With Moderate-to-Severe Atopic Dermatitis
NCT05735483 ·Status: ENROLLING_BY_INVITATION ·Phase: PHASE3
-
A Study of Lebrikizumab in Participants With Persistent Moderate to Severe Atopic Dermatitis
NCT02340234 ·Status: COMPLETED ·Phase: PHASE2
-
Study to Assess the Safety and Efficacy of Lebrikizumab (LY3650150) in Adolescent Participants With Moderate-to-Severe Atopic Dermatitis
NCT04250350 ·Status: COMPLETED ·Phase: PHASE3
-
Long-term Safety and Efficacy Study of Lebrikizumab (LY3650150) in Participants With Moderate-to-Severe Atopic Dermatitis (ADjoin)
NCT04392154 ·Status: COMPLETED ·Phase: PHASE3
-
Safety and Efficacy of Lebrikizumab (LY3650150) in Combination With Topical Corticosteroid in Moderate-to-Severe Atopic Dermatitis.
NCT04250337 ·Status: COMPLETED ·Phase: PHASE3
-
A Study of Lebrikizumab (LY3650150) in Combination With Topical Corticosteroids in Japanese Participants With Moderate-to-Severe Atopic Dermatitis
NCT04760314 ·Status: COMPLETED ·Phase: PHASE3
-
A Study of Lebrikizumab (LY3650150) in Participants With Moderate-to-Severe Atopic Dermatitis
NCT03443024 ·Status: COMPLETED ·Phase: PHASE2
-
A Study to Evaluate the Efficacy and Safety of Subcutaneous Amlitelimab on Background Topical Corticosteroids Therapy in Participants Aged 12 Years and Older With Moderate-to-severe AD Who Have Had an Inadequate Response to Prior Biologic Therapy or an Oral JAK Inhibitor
NCT06241118 ·Status: RECRUITING ·Phase: PHASE3
-
A Study to Investigate the Efficacy and Safety of Lebrikizumab in Participants With Moderate-to-Severe Atopic Hand and Foot Dermatitis
NCT06921759 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE3
-
A Study to Assess the Efficacy and Safety of Ruxolitinib Cream in Children and Adolescents (6 to <18 Years Old) With Moderate Atopic Dermatitis
NCT06832618 ·Status: RECRUITING ·Phase: PHASE3
-
A Study of Lebrikizumab (LY3650150) on Vaccine Response in Adults With Atopic Dermatitis (ADopt-VA)
NCT04626297 ·Status: COMPLETED ·Phase: PHASE3
-
Proof of Concept Study of Rilzabrutinib in Adult Patients With Moderate-to-severe Atopic Dermatitis
NCT05018806 ·Status: COMPLETED ·Phase: PHASE2
-
A Study to Evaluate the Efficacy and Safety of Subcutaneous Amlitelimab Monotherapy Compared With Placebo in Participants Aged 12 Years and Older With Moderate-to-severe Atopic Dermatitis
NCT06130566 ·Status: COMPLETED ·Phase: PHASE3
-
A Study of LY3375880 in Adults With Moderate-to-Severe Atopic Dermatitis
NCT03831191 ·Status: TERMINATED ·Phase: PHASE2
-
A Study to Evaluate the Efficacy, and Safety Study of Ruxolitinib Cream in Adults With Moderate Atopic Dermatitis
NCT06238817 ·Status: COMPLETED ·Phase: PHASE3
-
A Study to Evaluate the Effectiveness and Safety of Treatments, Either Alone or in Combination, for the Treatment of Moderate to Severe Atopic Dermatitis
NCT06718101 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
A Study of LY3454738 in the Treatment of Adult Participants With Moderate-to-Severe Atopic Dermatitis
NCT05911841 ·Status: TERMINATED ·Phase: PHASE2
-
Results in Real Clinical Practice of Treatment of Moderate-severe Atopic Dermatitis
NCT05078294 ·Status: UNKNOWN