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NCT04250350 · ClinicalTrials.gov registry record · Phase 3
Study to Assess the Safety and Efficacy of Lebrikizumab (LY3650150) in Adolescent Participants With Moderate-to-Severe Atopic Dermatitis
A Phase 3 study of Atopic Dermatitis, sponsored by Eli Lilly and Company.
- Completed
- Registry status
- Phase 3
- Development phase
- 206
- Enrollment target
- 20
- Study locations
NCT04250350: Completed Phase 3 study of Atopic Dermatitis, sponsored by Eli Lilly and Company.
NCT04250350 is a Phase 3 study of Atopic Dermatitis that has completed, run by Eli Lilly and Company. The registered enrollment target is 206 participants, below the 608-participant average among 150 other Atopic Dermatitis trials with a reported enrollment target (66% lower). The trial reports 20 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04250350, a Phase 3 study of Atopic Dermatitis, has completed, sponsored by Eli Lilly and Company.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 206 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is an open-label, single arm study of 52 weeks duration. The study will assess the safety and efficacy of lebrikizumab in adolescent participants (≥12 to \<18 years weighing ≥40 kilograms) with moderate-to-severe atopic dermatitis (AD) who are candidates for systemic therapy.
Primary Outcome
The percentage of participants who discontinued from study treatment due to 1 or more AEs assessed is summarized cumulatively. A summary of all SAE's, regardless of causality, is located in the Reported Adverse Events section.
Conditions Studied
Interventions
- BIOLOGICAL Lebrikizumab
Study Locations (20)
Florida
- C&R Research Services USA - Coral Gables
- Florida Academic Centers Research and Education, LLC - Coral Gables
- Pediatric Skin Research, LLC - Coral Gables
- Encore Medical Research - Hollywood
- Solutions Through Advanced Research, Inc. - Jacksonville
- Well Pharma Medical Research Corp. - Miami
- Sanchez Clinical Research Inc - Miami
- Miami Dermatology and Laser Research - Miami
- Park Avenue Dermatology - Orange Park
- ForCare Clinical Research - Tampa
California
- Hope Clinical Research - Canoga Park
- First OC Dermatology - Fountain Valley
- MD Studies - Fountain Valley
- Integrative Skin Science and Research - Sacramento
- University of California, San Diego/Rady Children's Hospital, San Diego - Pediatric & Adolescent Dermatology - San Diego
- Southern California Dermatology, Inc. - Santa Ana
Alabama
- Pinnacle Research Group - Anniston
Arkansas
- Arkansas Research Trials, LLC - North Little Rock
Colorado
- IMMUNOe International Research Centers - Centennial
Georgia
- Georgia Pollens Clinical Research Centers, Inc - Albany
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 206 participants |
| Start Date | 2020-02-11 |
| Est. Completion | 2022-06-22 |
| Phase | Phase 3 |
What the finished NCT04250350 record still lists
NCT04250350 is an interventional study that assigns participants to a tested intervention. The registered 206 participants enrollment target is mid-sized for trials with a published cap, below the 608-participant average among 150 other Atopic Dermatitis trials with a reported enrollment target (66% lower).
The record links to 1 condition, with Atopic Dermatitis appearing as the primary indexed condition, and to 1 intervention - of which Lebrikizumab is the first listed.
NCT04250350 names 20 study sites across 6 states, led by Florida, California, Alabama.
Frequently Asked Questions
What is clinical trial NCT04250350 about?
NCT04250350 is a clinical study titled "Study to Assess the Safety and Efficacy of Lebrikizumab (LY3650150) in Adolescent Participants With Moderate-to-Severe Atopic Dermatitis". This is an open-label, single arm study of 52 weeks duration. The study will assess the safety and efficacy of lebrikizumab in adolescent participants (≥12 to \<18 years weighing ≥40 kilograms) with moderate-to-severe atopic dermatitis (AD) who are candidates for systemic therapy.
What is the current status of trial NCT04250350?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 206 participants. The study started on 2020-02-11. Estimated completion is 2022-06-22.
What conditions does trial NCT04250350 study?
This clinical trial studies the following conditions: Atopic Dermatitis.
What interventions are being tested in trial NCT04250350?
The interventions under investigation include: Lebrikizumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT04250350?
This trial is sponsored by Eli Lilly and Company, which has 1,341 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04250350 being conducted?
This trial has 20 study locations across Alabama, Arkansas, California, Colorado, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Atopic Dermatitis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04250350's enrollment target sits among peer trials
206 55th of 150 higher than 96 of 150 other Atopic Dermatitis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Atopic Dermatitis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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