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COMPLETED Phase 3

Safety and Efficacy of Lebrikizumab (LY3650150) in Combination With Topical Corticosteroid in Moderate-to-Severe Atopic Dermatitis.

NCT04250337 · View on ClinicalTrials.gov ↗

Study Summary

This is a randomized, double-blind, placebo-controlled, parallel-group study which is 16 weeks in duration. The study is designed to evaluate the safety and efficacy of lebrikizumab when used in combination with topical corticosteroid (TCS) treatment compared with placebo in combination with TCS treatment for moderate-to-severe atopic dermatitis.

Conditions Studied

Interventions

  • OTHER Placebo
  • BIOLOGICAL Lebrikizumab
  • OTHER Topical Corticosteroid

Study Locations (20)

California

  • Orange County Research Institute — Anaheim
  • Bakersfield Dermatology and Skin Cancer Medical Group — Bakersfield
  • Wallace Medical Group, Inc. — Beverly Hills
  • First OC Dermatology — Fountain Valley
  • Center For Dermatology Clinical Research, Inc. — Fremont
  • California Allergy and Asthma Medical Group + Research Center — Los Angeles
  • Keck School of Medicine University of Southern California — Los Angeles
  • Dermatology Research Associates — Los Angeles
  • LA Universal Research Center, INC — Los Angeles
  • ACRC Studies — San Diego
  • University Clinical Trials, Inc. — San Diego
  • Southern California Dermatology, Inc. — Santa Ana

Florida

  • St. Francis Medical Institute — Clearwater
  • University of Florida - Gainesville — Gainesville
  • Direct Helpers Medical Center — Hialeah
  • The Community Research of South Florida — Hialeah
  • GSI Clinical Research, LLC — Margate
  • Vitae Research Center, LLC — Miami

Arizona

  • Investigate MD — Scottsdale

District of Columbia

  • Foxhall Dermatology — Washington D.C.

Trial Details

FieldValue
Enrollment Target 228 participants
Start Date 2020-02-03
Est. Completion 2021-09-16
Phase Phase 3

Sponsor

Eli Lilly and Company

704 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04250337

The ClinicalTrials.gov registry entry for NCT04250337 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 228 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Eli Lilly and Company, which has 704 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Atopic Dermatitis appearing as the primary indexed condition, and to 3 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04250337 reports 20 study locations spanning 4 distinct geographic areas — top geographies include California, Florida, Arizona. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT04250337 about?

NCT04250337 is a clinical study titled "Safety and Efficacy of Lebrikizumab (LY3650150) in Combination With Topical Corticosteroid in Moderate-to-Severe Atopic Dermatitis.". This is a randomized, double-blind, placebo-controlled, parallel-group study which is 16 weeks in duration. The study is designed to evaluate the safety and efficacy of lebrikizumab when used in combination with topical corticosteroid (TCS) treatment compared with placebo in combination with TCS tre...

What is the current status of trial NCT04250337?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 228 participants. The study started on 2020-02-03. Estimated completion is 2021-09-16.

What conditions does trial NCT04250337 study?

This clinical trial studies the following conditions: Atopic Dermatitis. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04250337?

The interventions under investigation include: Placebo (OTHER), Lebrikizumab (BIOLOGICAL), Topical Corticosteroid (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04250337?

This trial is sponsored by Eli Lilly and Company, which has 704 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT04250337 being conducted?

This trial has 20 study locations across Arizona, California, District of Columbia, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial